INTRODUCTION

Background 1. The Patent Act, 1970 came into force on 20.4.1972 replacing Indian Patents and Designs Act, 1911. When India became independent, the Govt. of India appointed the Patent Enquiry Committee under the Chairmanship of Dr. Bakshi Tek Chand, a retired Judge of Lahore High Court in 1949 with a view to ensure that the Patent system was more conducive to national interest. The committee submitted its final report in April 1950. A bill based on the recommendations of this Committee was introduced in the Parliament in 1953, but it lapsed due to dissolution of the Lok Sabha. In 1957, Govt. of India further appointed Justice N. Rajgopalan Ayyanger to examine and review the Patent law in India who submitted his report in September 1959 recommending the retention of Patent System despite its shortcomings. The Patent Bill, 1965 based mainly on his recommendations and incorporating a few changes, in particular relating to Patents for food, drug, medicines, was introduced in the lower house of Parliament on 21st September, 1965. The bill was referred to a joint committee of Parliament on 25th November 1965. A bill was formerly moved in lower house of Parliament on 5th December 1966, which eventually lapsed with the dissolution of Lok Sabha on 3rd March 1967. Finally the bill was cleared by the Parliament and became law known as the Patents Act, 1970 after more than two decades. The present law was suited to changed political situation and economic needs for providing impetus to technological development by promoting inventive activities in the country. The present Act contains XXIII chapters, which are relating to Patenting procedure, International arrangement and other misc. matters. This Act is regulated by the Patents Rules, 1972 which inter alia include Five Schedules concerning with fees, forms etc. Under the existing Act the Government of India is authorized to make rules for carrying out the purposes of the Act and regulating the Patent Administration and accordingly Govt. brought into force Patents Rules, 1972 w.e.f. 20.4.1972. These Rules were amended on 2.6.99, under the present Act and rules in addition to grant of Patents. Provisions of grant of EMR have also been provided. There are five Schedules to Patents Rules, 1972; the First Schedule prescribes the fees to be paid in respect of any matter arising out under the Act. Where any form specified in the Second Schedule to the Patents

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Rules, 1972, it shall be accompanied by specified fees or where payment is made within a prescribed period of time after the forms have been filed, the specified fee shall be paid within that period. The texts of various forms required in connection with activities under the Patents Act, 1970 are set out in this schedule. These forms must be used wherever required and they are not to be modified without the consent of the Controller. The Third Schedule prescribes form of Patent that to be granted. The Fourth Schedule prescribes various types of costs to be awarded in various proceedings under the Act. As stated above, the fifth schedule specifies certain amendments to the Indian Patents & Designs Rule, 1933. 6. The Patents Act, 1970 in comparison with Indian Patents and Designs Act, 1911 has far more reaching effect in some areas such as food, Drug and Medicines where all the patents granted under this category and deemed to be endorsed with the words Licence of Right. Further the term of Patents related to Food, Drug & Medicines is seven years from the date of Patent or 5 years from its grant whichever is less. More elaborate definition of invention has been provided. Product Patents for Drugs & Medicines including certain class of chemicals, which are produced by chemical reactions, have been abolished. However, inventions relating to methods or processes of their manufacture are patentable. The area of search for novelty has been extended to any documents published anywhere in the world. The provisions for appeals to the High Court from the decision of Controller have also been provided. The provision for grant of compulsory license, license of right and revocation of Patent on the ground of nonworking has also been incorporated. Many of these provisions are kept in line with the development of Patent law in developed countries, particularly Great Britain. The major departure is in the reduction of the term of patent for the invention relating to the drug, Medicine & food and abolition of Product patent per se for Drug, Medicines, Food and Chemicals. The chapter XXII provides international arrangements with the countries outside India, which afford to the applicants for Patents in India or citizens of India, similar privileges as are granted to its own citizens in respect of grant of Patent and the protection of their patent rights. Accordingly the Central Govt. may by notification in the Official Gazette declare such country/countries to be a conventional country/countries for the purpose of the Act. India has become a member of the Paris Convention and PCT w.e.f. 7.12.1998 and by virtue of this, the Head Office of Patent Office & its Branch offices have become receiving offices for the purpose of international applications filed under PCT. In view of these developments, the Patents Rules, 1972 have been amended by incorporating a new chapter IIA dealing with international application which can be filed at

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Head office of the Patent office at Calcutta or Branch Offices at Delhi, Chennai & Mumbai w.e.f. 17.11.99 as applicable. 9. The present Act under Chapter IVA provides specific provisions for the grant of EMR (Exclusive Marketing Rights) with a view to fulfill its international obligation under the provisions of article 70.8 & 70.9 of TRIPs agreement which are in force w.e.f. 1.1.1995.

ii. GUIDELINES FOR OBTAINING PATENTS IN INDIA 1. The commercial value of any industrial product depends upon a large number of factors, such as, its utility, cost of production, attractiveness of appearance and the reputation established for it in trade. Advantages in respect of utility and cost of production may be gained by the adoption of inventions leading to a new manner of manufacture; advantage in respect of attractiveness of appearance may be secured by the adoption of new or original designs for the shape, configuration or ornamentation of the vendible product; and advantage as regards reputation in the course of trade may be gained by adopting and popularizing a suitable trade mark for marketing the product.

2. TYPES OF PATENT APPLICATIONS a. Patent applications under Patents Act 1970. b. International applications under PCT. 3. GENERAL PRECAUTION FOR APPLICANT 3.1 It is a common experience that through ignorance of patent law, inventors act indiscreetly and jeopardize the chance of obtaining patents for their inventions. The most common of these indiscretions is to publish their inventions in newspapers or scientific and technical journals, before applying for patents. Publication of an invention, even by the inventor himself, would (except under certain rare circumstances) constitute a bar for the subsequent patenting of it. Similarly, the use of the invention in Public, or the commercial use of the invention in public or even in secrecy, prior to the date of the patent would be a fatal objection to the grant of a patent for such invention thereafter. Hence inventors should not tell the world about their inventions before they apply for patents nor should they use their inventions for commercial purposes. There, is however, no objection to the secret working of the invention by way of reasonable trial or experiment, or to the disclosure of the invention to other confidentially.

3.2 Another mistake, which is frequently made by inventors, is to wait until their inventions are fully developed for commercial working, before applying for patents. Delay in making application for a patent involves risks, namely, (i) that other inventors might forestall the first inventor in applying for the patent, and (ii) that there might be either an inadvertent publication of the invention by the inventor himself, or the publication thereof by others independently of him. It is, therefore, advisable to apply for a patent as soon as the inventors idea of the nature of the invention has taken a definite shape. 3.3 In this connection inventors should note that it is permissible to file an application for a patent accompanied by a Provisional Specification describing merely the nature of the invention. The application may therefore, be made even before the full details of working the invention are developed. The filling of an application for a patent disclosing merely the nature of the invention would secure provisional protection*, and thereby enable the inventor to work out the practical details of the invention under protection . 3.4 Another matter, which should not be neglected by inventors, is the clarification of their rights with reference to those of their employers, coworkers, contractors and assistants, if any, with whom they are brought into contact in the course of the development of their inventions. Neglect in this direction may lead to costly litigation. 4. DOCUMENTS REQUIRED FOR FILING AN APPLICTION FOR PATENT a) Application form in triplicate in the prescribed form no. 1. b) Provisional or complete specification in triplicate. If the provisional specification is filed it must be followed by a complete specification within 12 months (15 months with extension) to be drawn on prescribed form no. 2. c) Drawing in triplicate (if necessary). d) Abstract of the invention in triplicate. e) Information and undertaking listing the number, filing date and current status of each foreign patent application in duplicate on the prescribed form no. 3. f) Priority document(s) (if priority date is claimed) in case of convention application. g) Declaration of inventorship where provisional specification is followed by complete specification complete specification or in case of convention application on prescribed form no. 5. h) Power of attorney (if filed through Patent Agent). i) Fee (Patent in cash/by cheque/by demand draft).

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PROVISIONAL SPECIFICATION Application for patent may be accompanied by the provisional specification. It should contain the description of the invention with drawing if required. It is not necessary to include claim. However the complete specification including claims fairly based on the matter disclosed in the provisional specification should be filed within 12 months (extendable by 3 months) from the date of filing of provisional specification. The date of patent will be the date of filing of complete specification.

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COMPLETE SPECIFICATION Complete specification should fully describe the invention with drawing if required disclosing the best method known to the applicant and end with claim/claims defining the scope of protection sought. Normally it should contain the following matter. 1) Title of invention 2) Field of invention 3) Background of invention with regard to the drawback associated with prior art 4) Object of invention 5) A summary of invention 6) A brief description of the accompanying drawing if any 7) Detailed description of the invention with reference to examples and drawing 8) Claim(s)

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ABSTRACT The abstract is the concise summary of the invention preferably within 150 words. It should be prepared in such a way that one can understand the technical problem and solution with its usefulness. If necessary most relevant drawing should also be included in the abstract particularly in mechanical type inventions. However, it cannot be used for the purpose of interpreting the scope of protection in legal proceeding.

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DRWAING Drawing should be filed on standard A4 size sheet in triplicate one of which should be on tracing cloth or transparent paper or semi transparent sheet or plastic/ fiberglass film or thick & durable paper. Drawing should be drawn in black Indian indelible ink on the sheet with margin of 2.5 cm on each side. Figure should be shown clearly on sufficient scale in upright position with respect to top & bottom position of the sheet. At left-hand top corner of the sheet the name of the applicant should be mentioned. No. of sheets & sheet no. Should be mentioned at

the right hand top corner. At the right-hand bottom signature of the applicant/agent should be made mentioning the name there under. A reference letter/numerals as used in the description should also be used in denoting the corresponding component/part in the figure (s). No descriptive matter should appear on drawing except under certain cases such as flow sheet, chemical & other reaction etc. The sheets may be of a size, either 13 X8 or 30.00 centimeters X 20.50 centimeters or 13 X 16, or 33.00 centimeters X 41.00 centimeters, the 13 or 33.00 centimeters side being the top to bottom side when the drawing is placed in the erect position. There should be a clear blank margin of OR 1.50centimeters in width all round. Photographs are not acceptable. Sketches or drawings should not be inserted in the letter press or the specifications. The same type of reference letters and figures, i.e., italic or Roman should be used on the drawing and in the letter-press. The following types are suitable: A B C D a b c d 1 2 3 4. The same letters or numerals should be used in different views of the same parts. If the scale is given, it should be drawn, and not denoted by words. In complicated drawings or when there is no room to write the reference letters in their proper places, the letters should be shown outside the figures and connected by fine lines with the parts to which they refer. 9. Application Under Patent Cooperation Treaty (PCT) The Patent Cooperation Treaty is an agreement for international cooperation in the field of patents. It is the most significant advancement in international cooperation in this field since the adoption of the Paris Convention itself. It is, however, largely a treaty for rationalization and cooperation with regard to the filing, searching and examination of patent applications and the dissemination of the technical information contained therein. The PCT does not provide for the grant of international patents. The task and responsibility for granting patents remain exclusively in the hands of the patent Offices of, or acting for, the countries where protection is sought (the regional Offices). PCT is a special agreement under the Paris Convention open only to states, which are also party to the Paris Convention. The PCT does not compete with but, in fact, complements the Paris convention.

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Principal Objectives Of The PCT

The principal objective of the PCT is to simplify and to render more effective and more economicalin the interests of the users of the patent system and the offices which have responsibility for administering itthe previously established means of applying in several countries for patent protection for inventions. Before the introduction of the PCT system, virtually the only means by which protection of an invention could be obtained in several countries was to file a separate application in each country; these applications, each being dealt with in isolation, involved repetition of the work of the filing and examination in each country. To achieve its objective, the PCT: establishes an international system which enables the filing, with a single patent Office (the Receiving Office), of a single application (the International Application) in one language having effect in each of the countries which are party to the PCT which the applicant names (designates) in his application; provides for the formal examination of the International Application by a single patent Office, the Receiving Office; subjects each International Application to an international search which results in a report citing the relevant prior art (mainly published patent documents relating to previous inventions) which may have to be taken into account in deciding whether the invention is patentable; that report is made available first to the applicant and is later published; provides for centralized international publication of International Applications with the related international search reports, as well as their communication to the designated Offices; and provides the option of an international preliminary examination of the International Application which gives to the Offices that have to decide whether or not to grant a patent, and to the applicant, a report containing an opinion as to whether the claimed invention meets certain international criteria for patentability.

The procedure described in the preceding paragraph, comparing it with the traditional procedure, is illustrated by two timelines such as chapter I and chapter II of PCT. It is commonly called the International Phase to describe the first part of the patenting procedure, whereas one speaks of the National Phase to describe the last part of the patent granting procedure which, as explained in paragraph above, which is the task of the designated Offices, that is, the national Offices of, or Regional offices acting for the countries

which have been designated in the International Application. (In PCT terminology, a reference to national Office, national phase and national fees, includes the reference to the procedure before a regional patent Office.) Under the PCT system, by the time the International Application reaches the national Office, it has already been examined as to form by the Receiving Office, searched by the International Searching Authority and possibly examined by an International Preliminary Examining Authority, thus providing the national patent Offices with the important benefit of reducing their work loads since they have the benefit of these international phase centralized procedures and thus need not duplicate those efforts. Further main objectives of the PCT are to facilitate and accelerate access by industries and other interested sectors to technical information related to inventions and to assist developing countries on gaining access to technology. 9.2 Functions Of The Receiving Office 1. Receiving Office receives the International Application from the applicant. 2. Receiving Office checks the International Application to determine whether it meets the prescribed requirements as to form and content of International Applications. This check is of a formal nature only and does not go into the substance of the invention. It therefore extends only to a certain number of rather elementary requirements specified in the Treaty as forming part of that check. 3. Receiving Office accords an international filing date (Article 11). 4. Receiving Office checks certain formal and physical requirements (Article 14). That check by the Receiving Office may show that the International Application does not meet certain requirements as to form and content and that the fees are not, or not fully, paid. In that case, the Receiving Office communicates with the applicant in order to give him an opportunity to correct any defect. 5. If, possibly after correction, the check by the Receiving Office shows that the International Application meets the requirements of Article 11(1) for giving the application an international filing date, the Receiving Office accords the international filing date. 6. If the language of filing of the International Application is accepted by the Receiving Office but is not accepted by the International Searching Authority that is to carry out the international search, the applicant is required to furnish, within one month from the filing of the application, a translation into a language which is all of the following: (i) a language accepted by the International Searching Authority that is to carry out the international search; (ii) a language of publication; and (iii) a language accepted by the Receiving

Office (unless the International Application is filed in a language of publication). In cases where the applicant fails to furnish, within the applicable time limit, a translation for the purposes of international search, the Receiving Office invites the applicant to furnish the missing translation, in certain cases subject to the payment of a late furnishing fee. A separate invitation procedure is provided for the case where the request does not comply with language requirements. Where the applicant does not furnish the missing translation within the time limit fixed in the invitation, the International Application will, subject to certain safeguards for the applicant, be considered withdrawn and the Receiving Office will so declare. 7. Not all the requirements of the International Application are required to be examined by the Receiving Office. For instance, the Receiving Office does not deal with substantive questions such as whether the disclosure of the invention in the application is sufficient and whether the requirement of unity of invention is complied with. It also does not check all the many detailed physical requirements of the International Application. Those requirements are only checked to the extent that compliance with such requirements are necessary for the purpose of reasonably uniform international publication. 8. Typical examples of defects which may be corrected without affecting the international filing date are: non-payment or partial payment of fees; lack of signature of the request; lack of a title of the invention; lack of an abstract; physical defects. 9. As stated, in all such cases lack of correction leads to the application being considered withdrawn, except where a physical defect would not prevent reasonably uniform international publication and except for the payment of fees. With regard to the later, Rule 16b provides that the Receiving Office must invite the applicant to pay the missing fees together with a late payment fee. If the applicant still does not pay the fees within the time limit fixed in the invitation, the Receiving Office will declare that the International Application is being considered withdrawn. This solution protects the applicant against any loss of his application due to an erroneously delayed or incomplete payment of fees. 10. The third step in the procedure before the Receiving Office is that it must transmit the record copy of the International Application to the International Bureau and the search copy to the International Searching Authority. The Receiving Office keeps a third copy, the home copy. The transmittals do not take place if and as long as national prescriptions concerning national security apply. The Receiving Office will then declare that national security provisions prevent the International Application from being treated as such. 11. The Receiving Office must mail the record copy promptly to the International Bureau and in any case not later than five days prior to the

expiration of the 13th month from the priority date. In many cases, the International Application claims the priority of an earlier national application and is filed at the end of the 12-month priority period; the Receiving Office has only a few weeks for its processing tasks 12. The search copy must be transmitted by the Receiving Office to the International Searching Authority at the time of the transmittal of the record copy to the International Bureau except where the search fees has not been paid on time, in which case the transmittal of the search copy takes place after that fee has been paid. 13. If an applicant who is a resident or national of a PCT Contracting State; erroneously files his International Application with a national office which acts as a Receiving Office under the Treaty but which is not competent under Rule 19.1 or 19.2, having regard to the applicants residence and nationality, to receive that International Application, or if an applicant files his International Application with the competent Receiving Office in a language which is not accepted by that Office under Rule 12.1(a) but is in a language accepted under that Rule by the International Bureau as Receiving Office, the International Application will be considered to have been received by the national Office on behalf of the International Bureau as Receiving Office on the date on which it was received by the national Office, and will be promptly transmitted to the International bureau as Receiving Office (unless such transmittal is prevented by national security prescriptions). The transmittal may be subjected by the national Office to the payment of a fee equal to the transmittal fee. All other fees already paid to that Office will be refunded by that Office to the applicant and the applicable fees will have to be paid to the International bureau as Receiving Office 9.3 The following conditions should be fulfilled for according an international filing date: (i) the applicant should be a resident or national of the Contracting State for which the Receiving Office acts, and has consequently the right to file with that Receiving Office (note, however, that the International Application is to be transmitted to the International Bureau as Receiving Office under Rule 19.4(a)(i) if that condition is not fulfilled); (ii) the International Application should be in the language, or one of the languages, accepted by the Receiving Office for the purpose of filing International Applications (note, however, that the International Application is to be transmitted to the International Bureau as Receiving Office under Rule 19.4(a)(ii) if that condition is not fulfilled); (iii) the International Application should contain at least the following elements: (a) an indication that it is intended to be an International Application, (b) the specific designation of at least one Contracting State under Rule 4.9(a),

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the name of the applicant in a form allowing the applicants identity to be established, a part which on the face of it appears to be a claim or claims.

(iv) If one of these requirements is only complied with after correction, the international filing date will be the date on which the correction was received. In other words, in these cases a defect which is corrected later affects the international filing date. If all such defects are not properly corrected, the application will not be treated as an International Application. (v) For all the other cases, non-compliance with the formal requirements does not affect the international filing date. In other words, if the applicant corrects a defect in such cases, the international filing date remains unchanged. If the applicant does not correct, the defect properly, the International Application will, however, be considered withdrawn by the Receiving Office. Extension of the time limit fixed by the Receiving Office for the correction of defects under Article 14 may be requested. 9.4 Monitoring of time limits Easy supervision and monitoring of only a few time limits and events is required by applicants, namely: (i) monitoring the receipt of the confirmation of receipt of the International Application by the Receiving Office; (ii) monitoring the time limits for payment of fees; (iii) checking the notification from the International Bureau confirming the receipt of the International Bureau confirming the receipt of the record copy (Form PCT/IB/301) for correctness of the designations indicated on the Form and if needed, confirm precautionary designations within 15 months from the priority date; (iv) deciding, after receipt of the international search report, whether or not to file a demand for international preliminary examination (which must be filed prior to the expiration of 19 months from the priority date in order to delay entry into the national phase until at least 30 months from the priority date); (v) deciding, after receipt of the international search report, whether or not to file amended claims under Article 19, within the applicable time limit; this will usually be considered only if demand for international preliminary examination is not filed; (vi) monitoring the receipt, during the 19th month from the priority date, of the notice from the International Bureau (Form PCT/IB/308) that the publication of the International Application and its communication to the designated Offices (Article 20) has been effected;

(vii) entering the national phase before the expiration of 20 months from the priority date, or 30 months if Chapter II applies (in some designated or elected Offices, even later), by paying the national fees and furnishing (if required) a translation of the International Application. 9.5 Filing of the International Application: a) Request form : 1. International Application must be filed with any of the receiveing offices i.e. Patent office ,Calcutta,New Delhi,Mumbai, and Channai or IB of WIPO. The International Application must contain a request, a description, one or more claims, one or more drawings (where required) and an abstract; it must comply with the prescribed physical requirements; it must be in one of the prescribed languages; finally, the required fees must be paid. These requirements will be dealt with one by one. The request may be made on a printed form, copies of which can be obtained free of charge from the Receiving Office or from the International Bureau of WIPO. The request may also be presented as a computer printout as prescribed by Section 102(h) of the Administrative Instructions or, alternatively, as a computer printout prepared using the PCT-EASY software, in which case it must be accompanied by a computer diskette containing a copy in electronic form of the data contained in the request and of the abstract. The request must first of all contain a petition, that is, a request that the International Application be processed according to the PCT. It must further contain the title of the invention, the necessary data concerning the applicant, the inventor and the agent representing the applicant, the designation of the Contracting States for which protection is desired, that is, a list of the Designated States. It must be signed by the applicant or his agent. Where there are two or more applicants, each applicant must sign at his choice either the request or, if the request is signed by an agent, a separate power of attorney. The request may contain some optional indications, in particular a priority claim according to the Paris Convention for the Protection of Industrial Property. Further, when a Designated State offers several kinds of protection for inventions, such as patents for invention and utility models, the applicant can indicate his choice in the request.

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b) Priority 1. Only one certified copy is required of each priority application, within 6 months from the priority date; no copies for each designated Office are needed. The copies for the designated Offices are preparedat no additional cost to the applicantby the International Bureau. 2. Transmittal of the priority document need not be monitored if a request for transmittal by the Receiving Office to the International Bureau of an application filed with that Receiving Office was made in the Request Form and the applicable fee for a priority document was paid to the Receiving Office. c) Description

1. The description of the invention in the International Application must disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. 2. The description first repeats the title of the invention. It then specifies the technical field to which the invention relates. It indicates the so-called background art, that is, the technical and, in particular, patent literature, pertaining to that technical field, constituting the prior art or state of the art or known technology for the newly filed application. It discloses the intention in a way which allows the technical problem and its solution to be understood. It states the advantageous effects of the invention as compared with the known technology. It briefly describes the figures in the drawings. It sets forth the best mode contemplated by the applicant for carrying out the invention and any other mode he wants to include. Finally, it indicates the way in which the invention is capable of exploitation in industry. d) Sequence Listing : 1. Section 806 of PCT allows a designated Office to require that a copy of a sequence listing part filed only on an electronic medium under new Section 801 be furnished , for the purposes of the national phase, on paper. 2. For applicants who do not wish to file the sequence listing part of their international applications under new Section 801, the current provisions will continue to apply, including the filing in written form only (under Rule 5.2) and the concurrent or subsequent furnishing, as provided under PCT Rule 13ter and Section 208, of the sequence listing parts in computer readable from but only for the purposes of international search and/or international preliminary examination. In such cases the current system for calculating the basic fee, on the basis of the total number of sheets of the international application including the sequence listing part, will continue to apply (see item 1(b) of the Schedule of Fees).

3. It is important to note that international application filed under new section 801 may only be filed with receiving Offices, which are prepared to accept them, and on such electronic media as specified by the receiving Offices (for further details pl. see PCT Applicants Guide). e) Claims : 1. The claims must define the subject matter of the invention for which protection is sought. They must be clear and concise and fully supported by the description. 2. With respect to the structure and drafting of claims, the PCT requirements are largely similar to what is accepted in most patent Offices. f) Drawings: 1. The drawings are only required where they are necessary for the understanding of the invention. This will be the case for a mechanical invention. It will not be the case when an invention cannot be drawn, as is the case for a chemical product. Here again, the requirements are similar to those of most patent Offices. g) Abstract : 1. The abstract is intended to serve the purpose of technical information. The Treaty says clearly that it cannot be taken into account for any other purpose. This means in particular that it cannot be used for the purpose of interpreting the scope of the protection sought. 2. The abstract consists of a concise summary of the disclosure of the invention as contained in the description, claims and drawings in preferably not more than 50 to 150 words. It must be drafted in a way which allows the clear understanding of the technical problem, the gist of the solution of that problem through the invention, and the principal use of the invention..

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International Search. A high quality international search report is established by the International Searching Authority. For the purpose of Indian applicant following are Competent International Searching Authorities( ISAs) Austrian Patent Office(AT) Australian Patent Office (AU) European Patent Office(EP) China Intellectual Property Office(CN) United States Patent & Trademark Office (US) Swedish Patent Office(SE)

2. If the International Application did not claim any priority, the international search report is available within nine months from the international filing date, which is before the payment of designation fees becomes due. If priority is claimed, that report is available usually during the 16th month from the priority date. Even where priority is claimed, the international search report is normally available in time before publication of the International Application. This allows time for the applicant to withdraw the application before publication, if desired. 9.7 Language : 1. The International Application must be filed in the language, or one of the languages which the Receiving Office accepts for that purpose (Rule 12.1(a)). Neither the Treaty nor the Regulations enumerate the languages in which International Applications may be filed. Whether a given language can be used depends on the readiness of the Receiving Office to accept International Applications in that language. Each Receiving Office must, however, accept at least one language for the filing of International Applications which is both a language accepted by the International Searching Authority or, if applicable, by at least one International Searching Authority, competent for the international searching of International Applications filed with that Receiving Office and one of the languages of publication (that is, Chinese, English, French, German, Japanese, Spanish or Russian), so that applicants always have the option of filing the international search or international publication purposes; in other words, either words, either the International Application in its original language or the translation will be sufficient for the processing by the Receiving Office, for international search and for international publication. 2.If the language of filing of the International Application is accepted by the Receiving Office but is not accepted by the International Searching Authority, the applicant is required to furnish, within one month from the date of receipt of the application, a translation into a language which is all of the following: (i) a language accepted by the International Searching Authority that is to carry out the international search; (ii) a language of publication; and (iii) a language accepted by the Receiving Office (unless the International Application is filed in a language of publication) (Rule 12.3). 3.If the language of filing of the International Application is accepted by the Receiving Office and the International Searching Authority but is not a language of publication (at present, this is the case only where the International Application is filed in Dutch and certain Nordic languages), the International Application will be published in English, the translation into that language being prepared under the responsibility of the International Searching Authority which undertakes the search (see Rule 48.3). 4.The request must always be filed in a language which is accepted by the Receiving Office and which is also one of the seven languages of publication.

9.8 Fees: 1.International Application filing fees can be paid in the national currency and to one Office, the Receiving Office. They may all be paid within one month after filing (for the designation fee, however, see next paragraph). 2.Designation fees must be paid before the end of the priority year or within one month after filing, whichever time limit expires later. If no priority is claimed and designation to all Contracting States has been made in the International Application, the option is kept openat no costfor one year to select designations and pay designation fees only for those countries where the applicant wants the International Application to remain in effect. 3.Only one designation fee must be paid under the PCT for a regional patent independent of the number of States party to the regional patent treaty which are designated for a regional patent. It is therefore advisable to designate in the International Application all States party to the regional patent treaty concerned and make the selection of individual States at the start of the regional phase (for example, in respect of a European patent, at 21 months from the priority date, or 31 if Chapter II applies, when payment of the European designation fee for each individual State is required). The same observation applies to the designation of states for the purpose of an ARIPO patent. 4.A maximum designation fee under the PCT (which corresponds to 6 designation fees) permits the designation of all Contracting States. Each designation in excess of 6 is free of charge. This makes it possible to designate all Contracting States at reasonable cost at the time of filing and to thereby keep the option for a foreign patent open in any Contracting State until at least 21 months from the priority date, or at least 31 months if Chapter II applies. 5. Failure to pay fees or underpayment of fees can be corrected under Rule 16b is. An invitation to pay missing amounts will be issued by the Receiving Office. Payment can be made later, together with a late payment fee. 6. Mode of Payment: To facilitate the payment in US Dollar, as required by International Bureau of World Intellectual Property Organisation and International Searching Authority selected by the applicant, an account has been opened by RO/IN in the name of the controller General of Patents, Designs & Trade Marks, with the State Bank of India, New York Branch, 460, Park Avenue, New York-NY-10022 assigning account No. 2111-250821-001.

THE PCT FEES, AN INDIAN APPLICANT REQUIRED TO PAY: a. To Receiving Office (The Patent Office, Calcutta and its branch offices at New Delhi, Mumbai, Chennai) i. Transmittal fee : INR 1,500 [for individual(s)] INR 5,000 [for legal entity] ii. Basic fee : USD 382* iii. Designation fee : USD 82* per designation (maximum 6, any designation over 6 being free of charge) iv. Supplement per sheet : USD 9* in excess of 30 v. Search fee : ISA/AT USD 170 ISA/EP USD 846** ISA/AU USD 510 ISA/CN USD 100 ISA/US USD 700 ISA/SE USD 990 vi. Fee for preparing : INR 1,000 [for individual(s)] certified copy of priority INR 3,000 [for legal entity other than document and transmission of the same IB. To the International Preliminary Examination Authority (IPEA) (Optional). i. Handling fee* IPEA/AT ATS 2022.76 IPEA/AU AUD 238 IPEA/EP DEM 287.57 OR EUR 147 IPEA/CN CNY EQUIVALENT TO CHF 233 IPEA/US USD 153 IPEA/SE SEK 1,270 ii. Preliminary Examination Fee (Optional) IPEA/AT ATS 2,200 IPEA/AU AUD 450 IPEA/EP DEM 2,998.29** (OR EUR 1,533) IPEA/CN CNY 800 IPEA/US USD 750*** IPEA/SE SEK 4,200

b.

In view of above, an Indian applicant, filing an International Application for Patent under Patent Cooperation Treaty, is required to remit the consolidated

amount in US Dollar by Demand Draft, payable to the Controller of Patents at State Bank of India, New York Branch, for payment towards basic fee, designation fee and search fee.

7.The required fees which must be paid to receiving office are the Transmittal Fee, the International Fee and the Search Fee. They must all be paid to the Receiving Office. 8.The Transmittal Fee is for the benefit the Receiving Office. It is intended to compensate that Office for the work which is required to be performed in connection with the International Application. The amount is left to be fixed by the Receiving Office. It is due within one month from the date of receipt of the International Application. 9.The International Fee is for the benefit of the International Bureau. It is intended to cover the cost of the work the International Bureau must perform under the PCT. The international fee consists of the basic fee and as many designation fees as there are national or regional Offices designated in the application by the applicant, with a maximum of 10 designation fees. The amounts are fixed in the Schedule of Fees which forms part of the Regulations. The basic fee is due within one month from the date of receipt of the International Application. The designation fees are due within one year from the priority date or one month from the said date of receipt, whichever is later. 10.The Search Fee is for the benefit of the International Searching Authority. It is intended to compensate that Authority for the work it must perform in connection with the establishment of the international search report. It is due within one month from the date of receipt of the International Application. The amount is fixed by the International Searching Authority. 9.9 Withdrawal: 1.An International Application can be withdrawn at any time during the international phase. Where the intent of the withdrawal is to prevent publication, the notice of withdrawal must reach the International Bureau before technical preparations for international publication have been completed (that is, not later than 15 days before the date of publication). 2.A withdrawal of an International Application can be made with the condition that the withdrawal be effective only if the international publication can still be prevented. 9.10 Amendments:

1.The claims can be adjusted to the results of the international search report by amending them once (under Article 19) with effect in all designated States. Such amendments save costs for preparation of different sets of amendments

and for local agents filing such amendments before designated Offices, and guarantee better provisional protection and patents in registration countries. Individual amendments before each designated Office are also permitted in the national phase (under Article 28 or 41) and all parts of the application can be amended (under Article 34(2)) during the international preliminary examination procedure under Chapter II.

9.11 International Preliminary Examination: 1. The following are Competent International Preliminary Examining Authorities[IPEAs] for the purpose of Indian applicant: Austrian Patent Office(AT) Australian Patent Office(AU) European Patent Office (EP)(only if ISA was AT,EP or SE) China Intellectual Property Office (CN) United States Patent & trademark office (US) Swedish patent Office (SE) 2. The use of International Preliminary Examination (i) is optional for the applicant; (ii) provides, in addition to the international search report, an international preliminary examination report containing an opinion on the usual criteria of patentability before expenses are incurred for the national phase (for translation, fees and foreign agents); (iii) helps the applicant to adapt the International Application to the results of the international search report; (iv) allows, with effect for all elected Offices, the amending of all parts of the International Application (description, claims and drawings) during international preliminary examination; (vi) defers until at least 30 months from the priority date entry into the national phase if the demand is filed within 19 months from the priority date. (vii) The international preliminary examination report gives, for minimal cost, an opinion and the probability of obtaining a patent: (viii) The application will be more or less ready for acceptance by the elected Offices after receiving international preliminary examination report. (ix) if the report is negative and it is decided to abandon the application, the applicant has saved all the expenses otherwise incurred before the elected Offices for the payment of national fees, the preparation of translations and the appointment of local agents. 9.12 The National Phase

1. The national phase follows the international phase. In the national Phase before processing and examination may start in the national phase in the

designated or elected Offices, the applicant must perform certain acts thereby effecting entry into the national phase. If the applicant does not enter the national phase, namely, if he does not perform these acts within the prescribed time limit, the International Application loses its effect in the designated or elected States concerned with the same consequences as the withdrawal of any national application in that State (Article 24). 2. For entry into the national phase before a designated or elected Office, it is necessary that the national fee be paid to it and, where the International Application has not been filed or published in the official language, or one of the official languages, of that Office, that a translation into an official language be filed. This must be done within a certain time limit, which is different depending on the circumstances: if the designated State concerned has been elected for the purpose of international preliminary examination within 19 months from the priority date, the time limit is 30 months from the priority date; in all other cases (that is, if the designated State concerned has been elected after 19 months from the priority date or if the Chapter II procedure has not been used in relation to that designated State), the time limit is 21 months from the priority date. The time limits for entry into the national phase are, in some Offices, even longer than 21 or 31 months. See Volume II of the PCT Applicants guide for further information. 3. The national fees to be paid are usually about the same as the fees required for the filing of a national or regional application. Some Offices, not in India however, levy lower national or regional filing, search or examination fees, or refund certain fees, on account of the existence of the international search report or where an international preliminary examination report has been established. This offsets, at least partly, the costs of filing an International Application. 4. Where the original drawings are of a good quality, the applicant is not required to file additional formal drawings with the Designated or Elected Offices, permitting substantial economies in some cases. It is therefore important to file drawings with the Receiving Office that fully comply with the format requirements of the Regulations under the PCT. 5. Where the priority of an earlier application is claimed and a certified copy of that application has been provided, it is not necessary to submit a certified copy of the priority document to each designated or elected Office. The International Bureau sends any required copies of the priority document to the Offices concerned. 6. Apart from the payment of the national fee and, where necessary, the filing of a translation, no designated or elected Office may require compliance with further requirements within the 21- or 31-month time limit. Certain additional requirements, such as appointment of an agent, indication of an address for service of notifications, declaration of inventor, assignment documents, and the like, are allowed, but the applicant must be given the

possibility of complying with those additional requirements after the expiration of the time limits mentioned above. 7. The PCT leaves to each Contracting State freedom to prescribe the substantive conditions of patentability applied in the national phase. This is particularly true of what constitutes prior art. However, since the requirements of prior art as defined in the PCT and its Regulations for the purposes of the international phase are generally as strict as, or stricter than, those defined in any national law, there is very little likelihood of unpleasant surprises of this kind occurring in the national phase. On the other hand, the PCT does not prevent any national law from requiring the applicant to furnish, in the national phase, evidence in respect of any substantive condition of patentability prescribed by that law. Correction Of Translation 8. Where the translation of the International Application contains an error, that error may be rectified by the applicant during the national phase before all designated Offices with the exception of the national Office of the Republic of Korea (which does not allow such correction). 9. The scope of the translation of the International Application may not, however, exceed the scope of the International Application in its original language. Where, for example, as a result of incorrect translation, the scope of the International Application in the language of the translation is narrower than in its original language, that scope may be broadened but must not exceed the original scope. Where the scope of the translation is broader than that of the International Application in its original language, the designated Office or any other competent authority of the designated Office or any other competent authority of the designated State may limit accordingly the scope of the International Application or of a patent resulting from it (Article 46). Amendments In The National Phase 10. The PCT guarantees the applicant the opportunity to amend the description, the claims and the drawings before any designated or elected Office. Thus, in addition to any amendments made in the international phase, further amendments may be filed upon entering the national phase or within a prescribed time limit thereafter. Legal Remedies; Protection Against Loss Of Rights 11. Where, as a result of a mistake which was not timely corrected, an International Application is considered withdrawn, the applicant may request review of that decision by each of the designated Offices. In addition to requesting review, the applicant has the opportunity to submit at the same time, to each designated Office, a request for excuse of failure to comply with a time limit. The legal basis of, and the conditions for, such a request are to be found in the applicable national law or regional convention, which applies

equally to International Applications. Where that law or convention provides for reinstatement, this can be requested. Where there is a possibility of requesting further processing of the application, this can also be done. Procedural safeguards are thus available in each designated State to PCT applicants in the same way as they are to applicants for national or regional applications not made via the PCT. Preparation Of Patent Applications 1. Any patent application, drafted in accordance with the requirements of the PCT, allows a maximum flexibility and benefit from the advantages of the PCT: (i) the same application documents can then be used for filing national and/or international applicants; (II) no adaptation of the original application is then required in a much as the PCT format is valid for all designated Offices (including the EPO, the Japanese Patent Office and the United States Patent and Trademark Office). 9.13 Fee savings. National fees are reduced or completely dispensed with for the procedure before some Offices which provides considerable savings, for example: European Patent Office (EPO): European search fee waved if international search report by AT, EP, ES, SE; 20% reduction of European search fee if search report by AU, CN, JP, RU, US; 50% reduction of European examination fee if international preliminary examination report by EP. German Patent Office: filing fee waived if the Office was the Receiving Office; examination fee reduced if an international search report has been established. Hungarian Patent Office: filing fee waived if the Office was the Receiving Office; report by EP. Japanese Patent Office: approximately 80% reduction of examination fee if international search report established by JPO; approximately 20% reduction of examination fee if international search report established by ISA other than JPO.

United Kingdom Patent Office: refund of part of preliminary examination and search fee. 9.14 BASIC REQUIREMENTS Under the said basic requirements to start the national phase in India, the applicant is required to file the following with the DO/IN or RO/IN within the prescribed time limit: (i) An application on a plain paper (national form is not mandatory, however the option remains with the applicant); (ii)National fee in INR : INR 1,500 for individual(s) In case of no or one priority, and multiple of INR 1,500 in case of every multiple priority, INR 5,000 for legal entity other than individual(s) In case of no or one priority, and multiple of INR 5,000 in case of every multiple priority: (iii) Where the international application has not been filed or published in one of the official languages of DO/IN or RO/IN as the case may be, a translation of the application (this replaces the requirement in (i), above) in one of the official languages, [under PCT Article 22: Description, claims (if amended, both as originally filed and amended together with any statement under PCT Article 19), any text matter of drawings, abstract. Under PCT Article 39(1), Description, claims, any text matter of drawings, abstract (if any of those parts has been amended, both as originally filed and amended by the annexes to the international preliminary examination report)] (iv)Additional Special Requirements Under the said additional special requirements (PCT Rules 51 bis), no designated Office is to require before the expiration of the applicable time limit for entering the national phase, the performance of acts other than those referred to in Article 22, namely the payment if the national fee, furnishing of a translation and, in exceptional cases, the furnishing of a copy of the international application, and indication of the name of address of the inventor. All other requirements of the national law are referred as special requirements and they may be complied with once national processing has started. As per DO/IN or RO/IN the special requirements of the Office are as follows: a) Name and address of the inventor if they have not been furnished in the Request part of the international application,

b) Instrument of assignment or transfer where the applicant in not the inventor, c) Document evidencing a change of name of the applicant if the change occurred after the international filing date and has not been reflected in a notification from the International Bureau (From PCT/IB/306), d) Declaration of inventorship by the applicant, e) Statement regarding corresponding applications in other countries, f) Power of attorney if an agent is appointed, g) Address for service in India (but no representation by an agent is required), h) Verification of translation, and i) International application or translation to be furnished in three copies.

Chapter I Preliminary

Contents 1.1.0 1.2.0 1.3.0 Short title, extent and commencement Definitions and interpretation Patentable inventions

1.1.0

Short title, extent and commencement:

1.1.1 Section 1 sub-section (1) of the Act relates to the title of the Act, which is to be called as the patents Act, 1970. Sub section (2) provides that this act is applicable to whole of India. It does not exclude any part of India. Sub section (3) provides that the Central Govt. may appoint any date from which the Act comes into force. It also provides that different provisions of the Act may come into force on different dates. This sub section further provides that any reference in any provisions to the commencement of the Act shall be construed as a reference to the coming into force of that provision. All the provision of this act except sections 12 (2), 13(2), 24(A) to 24(F), 157A, 28, 68 and 125 to 132 have come into force on 20th April, 1972 vide Gazette notification No. S.O. 300 (E) dated 20.4.1972 in Gazette of India Extra Part II Section 3(ii), pages 735. The provisions of sections 12(2), 13(2), 28, 68 & 125 to 132 have come into force on 1.4.1978 vide notification no. S.O. 799 dated 10.3.78 in Gazette of India 1978 part II Section 3(ii) page 764. 1.1.2 Provisions of Section 24 A to 24 F which relate to Exclusive Marketing Right and provisions of Section 157A which relates to protection of Security of India have come into force from 1.1.1995 by Act 17 of 1999 notified in Gazette of India Extra part II, Section 3, dated the 26th March, 1999.However vide same notification the provision of section 39 which related to prior permission for person resident in India to apply for Patent outside India have been abolished. 1.2.0 Definitions and interpretations

1.2.1 Sec. 2(1)(a): Assignee includes an assignee of assignee & the legal representative of a deceased assignee & references to assignee of any person includes reference to assignee of legal representative or assignee of that person. Therefore, assignee may be: (i) An assignee of the assignee (ii) Legal representative of deceased assignee (iii) Reference to assignee of any person includes references to the assignee of legal representative or assignee of that person 1.2.2 Sec. 2(1) b: Controller means the Controller General of Patents Designs & Trade Marks referred to in Sec. (73) of the Act. (i) Controller General of Patents, Designs & Trade Marks appointed under Sec. 4(I) of Trade and Merchandise and Merchandise Marks Act, 1958 should be the Controller of Patents for the purpose of this Act. Controller includes Assistant Controller, Deputy Controller, Joint Controller, & Senior Joint Controller.

(ii)

(iii)

(iv)

(v)

The functions and duties performed by Assistant Controller, Deputy Controller, Joint Controller, & Senior Joint Controller shall be deemed to have been performed by Controller. In the absence of the respective Controller to whom the case relates shall be transferred to the other Controller in writing by the Senior most controller present on the particular day. The powers enjoyed by the Controller of Patents under the Act or otherwise under administrative system shall be enjoyed in the same manner by Assistant Controller, Deputy Controller, Joint Controller, & Senior Joint Controller. Any reference to the Controller shall be construed as including a reference to any Officer discharging the function of the Controller in pursuance of Sec. 73 of the Act.

1.2.3

Sec. 2(1)(c): Convention Application means an application for patent by virtue of Sec. 135. (i) (ii) Convention application should be filed in India within 12 months from the date of filing of basic application in the convention country. The convention application can be filed by any person whether natural or legal entity or legal representative or assignee of that person. Application filed under PCT claiming priority date of member country of the Paris Convention. The application filed by a person who is the national of any of the member countries notified by Central Govt. by notification in the Official Gazette declaring such member country to be a convention country within prescribed time shall also be considered as convention application.

(iii) (iv)

1.2.4 Sec. 2(1)(d): Convention Country means a country notified as such under sub section (1) of Sec. 133. The Central Govt. has power to notify a country or group of countries or union of countries as convention country.Convention countries include those countries which have been notified as convention countries by Central Govt. vide notification dated Jan. 3,1995, September, 28, 1998 in Gazette of India Part II Sec. 3 1.2.5 Sec. 2(1)(e): District court has the meaning assigned to that expression by the Code of Civil Procedure, 1908 (V of 1908). (1)District court is defined Under Sec. 2(4) of Civil Procedure Code as follows. District means the local limit of the jurisdiction of a principal Civil Court of original jurisdiction called as a District Court.

(2)The term District Court includes all the district courts of all states falling within the jurisdiction of appropriate office. 1.2.6 Sec. 2(1)(f): Exclusive Licence means a licence from a patentee which confers on the licencee and persons authorized by him, to the exclusion all other persons (including the patentee), any right in respect of the patented invention, and exclusive licencee shall be construed accordingly. (i) (ii) (iii) Licence may be explicit, implied and statutory. Exclusive licencee excludes all other persons including patentee from the right to use the invention. Exclusive licencee is a person to whom the rights in respect of patented invention have been assigned to the exclusion of all other persons including the patentee.

1.2.7 Sec. 2(1)(g): Food means any article of nourishment and includes any substance intended for the use of babies, invalids or convalescents as an article of food or drink. (i) (ii) Any article of nourishment having some calorific value is a food. Any substance, which can be used for the use of babies, invalids or convalescents as an article of food or drink, shall also be considered as food. Any substance used for nourishment of plants or animals shall not be considered as food for the purpose of this Act. e.g. fertilizer, plants growth promoters or plant growth hormones.

(iii)

1.2.8 Sec. 2(1)(h): Government undertaking means any industrial undertaking carried on(i) (ii) (iii) By a department of the Government, or By a corporation established by a Central Provincial or State Act, which is owned or controlled by the Government, or By a Government company as defined in section 617 of the Companies Act, 1956 (1 of 1956)

and includes the Council of Scientific and Industrial Research and any other institution which is financed wholly or for the major part by the said council. Government undertaking means any Industrial undertaking carried on by a department of Government or by a corporation established by a Central provincial or state act, which is owned or controlled by the Government or by a govt. company as defined in Section 617 of the company Act, 1956.

(i)

It also includes the council of Scientific & Industrial Research or any other institution, which is financed wholly or for the major part, by the said council.

1.2.9 Sec 2(1)(i) High Court means(i) (ii) In relation to the Union territory of Delhi, the High Court of Delhi; In relation to the State of Arunachal Pradesh and the State of Mizoram, the Gauhati High Court ( the High court of Assam, Nagaland, Meghalaya, Manipur, Tripura, Mizoram and Arunachal Pradesh); In relation to the Union territory of the Andaman and Nicobar Island, the High Court at Calcutta; In relation to the Union territory of the Lakshadweep, the High Court of Kerala; In relation to the Union territory of Goa, Daman and Diu and the Union territory of Dadra and Nagar Haveli, the High Court at Bombay; In relation to the Union territory of Pondicherry, the High Court at Madras; In relation to the Union territory of Chandigarh, the High Court of Punjab and Hayana; and In relation to any other State, the High Court for that State;

(iii) (iv) (v)

(vi) (vii) (viii)

1.2.10 Sec. 2(1)(j):Invention means any new and useful(i) (ii) (iii) Art, process, method or manner of manufacture Machine, apparatus or other article; Substance produced by manufacture,

and includes any new and useful improvement of any of them, and an alleged invention. The detailed interpretation of the word invention is given under the title patentable subject matter. 1.2.11 Sec. 2(1)(k): Legal representative means a person who in law represents the estate of a deceased person. (i) (ii) A person to become legal representative should be capable of representing the deceased person by any means under the law. It recognizes that right to apply is a right, which on the death of the owner right devolves to his legal representative.

1.2.12 Sec. 2(1)(l):medicine or drug means:(i) (ii) All medicines for internal or external use of human beings or animals, All substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseased in human being or animals. All substances intended to be used for or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals. Insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants, All chemical substances, which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines, or substances above referred to. 1. All substance capable of being used for internal or external use of human beings or animals are medicine or drug. It does not include all the above-referred substance for internal or external use of plants. If a Substances falls within the scope of section 3(b) of the Drugs & Cosmetics Act of 1940 it is also to be considered as Drug or medicine [Reference ICI Ltd Patent 1976, IPLR 185 at Page-188] The term drug under Drugs & Cosmeticd Act, 1940 defined as(I) All medicines for internal or external use of human being or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals and (II) Such substances other than foods intended to effect the structure or any function of the human body or intended to be used for the destruction of the vermins or insects which cause diseases in human beings or animals, as may be specified from time to time by the Central Govt. by notification in the official Gazette.

(iii)

(iv)

(v)

2.

The Central Govt., have, by notification [Ministry of Health Notification No. 1-20/60-D, dated 3-6-1961] specified by following substances as drug (1) Contraceptives (2) Disinfectant, (i) Disinfective fluids made from coaltar oils, coal tar acid or similar acids derived from petroleum with or without hydrocarbons

(ii) Disinfectant fluids made from synthetic or naturally occurring substances other than those mentioned in (I) above by virtue of their Composition possessing disinfectant properties or with claim to possess disinfectant properties. 3. All the substances falling in this section as drug or medicine if used for the purposes other than the use for human beings or animals shall not be considered as used for drug and medicine. 4.An undertaking to that effect those substances are not used for human beings or for animals, shall be given in the specification. 5.The substances capable of being used as drug or medicine when used in detergents and paint preparations, they are not considered as drug for the reason that they are only preventive and not curative. Moreover, they are not being used for the treatment of human being and animals. 1.2.13 Sec. 2(1)(m): Patent means a patent granted under this Act and includes for the purposes of section 44, 49, 50, 51, 52, 54, 55, 56, 57, 58, 63,65, 66, 68, 70. 78. 134. 140. 153, 154 and 156 and Chapters XVI, XVII and XVIII, a patent granted under the Indian Patents and Designs Act, 1911 (2 of 1911) (i) It includes patent of addition, patent granted on divisional application and all other types of patents permissible under the Act.

1.2.14 Sec. 2(1)(n); Patent agent means a person for the time being Registered under this act as a patent agent. (i) A person acting or intending to act as patent agent should be registered in the register of patent agent. (ii) While signing the document he should give a registration number. and year in which he is registered. (iii) The applicant on the prescribed form with the prescribed court/stamp fee should duly authorize him. (iv) The person acting as a patent agent should give declaration that he is acting in good faith, honestly deligently and with proper authorization along with the statement that he is well conversant with the matter he is dealing with. 1.2.15 Sec. 2(1)(o): patented article and patented process means respectively an article or process in respect of which a patent is in force. (i) In case where patent is granted in respect of an article or a process, but not being in force by virtue of non payment of renewal

(ii)

fee or otherwise shall not be construed as patented article or patented process. Patented article includes any article made by a patented process but may not include an article made by a patented machine if the machine alone could be said to be a patented article. [Cooperative Union Ltds application 1934) 50 RPC 161].

1.2.16 Sec. 2(1)(p): Patentee means the person for the time being entered on the register as the grantee or proprietor of the patent. (i) (ii) Patentee includes exclusive licencee or assignee or legal representative or assignee of assignee. Such a person has the power to assign;/grant licence under or otherwise deal with the patent and to give effectual receipts for any consideration for any such assignment, licence or dealing subject to the provision of this act.

1.2.17 Sec. 2(1)(q): Patent of addition means a patent granted in accordance with section 54. (i) (ii) (iii) (iv) (v) (vi) (vii) Grant of patent of addition cannot be objected on the ground of novelty. The patent of addition is granted for a term equal to a patent granted for a main invention. The term of patent of main patent and Patent of Addition therefore run concurrently. No renewal fee is payable for patent of addition. Application for patent of addition shall be filed in the office where the application for main application filed. A separate application shall be filed for each patent of addition distinct only to main application. Application for patent of addition cannot be filed for series of inventions for which separate patent are in existence (HSJs Application, 31 RPC 47). Patent Office means the patent office referred to in

1.2.18 Sec. 2(1)( r): section 74. (i)

(ii)

Patent office under the Act means the Head Office of the Patent office, existing branch offices and any more branch office which may be opened in future as the Central Government has power to do so under section 74 of the Act. The patent office is the office established for the purpose of The Act to administer various provisions relating to the grant of Patent and maintenance of the register of patent. The officers appointed by the Central Govt. will discharge the function of the Controller, which

the Controller may authorize them to discharge. While discharging the function of the Controller under the power delegated to them, the Officers have to work within the provision of the Act. If any person uses on his place of business, or any document issued by him or otherwise the words PATENT OFFICE or any other words suggesting that his place of business is, or is officially connected with, the patent office, he shall be punishable with imprisonment for a term which may extend to six months, or with fine, or with both. Hours of Business : The office is open to the public from 9.30 A.M. to 6.P.M. on all working days from Monday to Friday. On Saturdays, Sundays and Government Holidays the office remains closed to the public. 1.2.19 Sec. 2(1) (s): (i) (ii) (iii) (iv) Person includes the Govt.

For the purpose of the Act, a person may be natural or legal entity or registered society. The Govt. is also a person under the Patents Act 1970 whether it is Central Govt. or State Govt.. Corporations, Govt. undertakings and other autonomous institution will also be a person under the Act. Partnership firm or body, which is un-incorporated, is not a person and is not considered as a person under the Act because the partners operate the firm and it has no independent existence. The actual karta of partnership firm are its partners. The application may be filed in names of all personally responsible partners.

1.2.20 Sec. 2(1)(t): Person interested includes a person engaged in, or in promoting, research in the same field as that to which the invention relates. (i) The person to be interested person under the Act should have in his possession a patent or patents relating to the same field or he should have manufacturing interest or trading interest. A person who has assigned his interest in a patent application has no locus standi subsequently to oppose the application or to apply for revocation of patent granted on the basis of the application. A financial interest of a holding company, whose subsidiary is a person interested suffices to enable the holding company to oppose the grant of the patent (KAISER Aluminum & Chemicals Corporation Vs. Reynold Metals Co. (1972 RPC 648). In addition to the above a person who can establish any bonafide interest can also be a person interested under the Act.

(ii)

(iii)

(iv)

1.2.21 Sec. 2(1)(u): prescribed means in relation to proceedings before High Court, presented by the rules made by the High Court and in other cases prescribed by the rules under this Act. 1.2.22 Sec. 2(1)(v): Prescribed manner includes the payments of the prescribed fee. For the purpose of this Act, the form as prescribed under 2nd schedule of the patent rules should be used. (ii) This should be filed within prescribed time. (iii) The forms or any letter should be filed if necessary along with prescribed fee. (iv) Prescribed fee shall mean the fee prescribed under first schedule of the rules of the Patents Rules, 1972 as amended by the Patents (Amendment) Rules,1999. (i) 1.2.23 Sec. 2(1)(w); Secton 11. 1.2.24 Sec. 2(1)(x): sec. 67. (i) Priority date has the meaning assigned to it by

Register means the register of patents referred to in

Register of patents maintained at the branch offices are also Register of patents under this Act.

1.2.25 Sec. 2(1) (y): True & first inventor does not include either the first importer of invention to India or a person to whom an invention is first communicated from outside India. (i) (ii) The first importer of invention into India is not a true & first inventor. First communicatee is also not a true & first inventor.

1.3.0 Patentable Inventions 1.3.1 Patentable inventions: The fundamental principle of Patent law is that, any subject matter to be patentable must be an invention. Sec. 2(1)(j) of this Patent Act, 1970 defines the term invention as follows. Invention means any new & useful(i) Art, process method, or manner of manufacture, (ii) Machine, apparatus or another article,

(iii)

Substances produced by manufacture, and include any new & useful improvement of any of them, and an alleged invention.

1.3.2

According to this definition of invention there are three ingredients (i) (ii) (iii) the subject matter should be a manner of manufacture it should be new, and it should be useful (utility)

1.3.3 Manner of Manufacture Any subject matter to be Patentable should relate to a manner of manufacture, which includes not only a process of manufacture but also a manufactured product. The word manufacture has not been defined under the Patents Act, 1970. Therefore in the absence of any definition of the term in this Act, it is established law that natural meaning of the word manufacture, in the standard dictionaries, should be accepted. i.) The dictionary meaning of the word manufacture in most of the standard dictionaries is, making of any article, substance or product, by hand or construction. ii) The reason why any art, process method or a manner of manufacture should result into a substance or an article is that, the provision of sec. 48(2) of patents Act, 1970 Confers on the patentee, the exclusive right only for an article or substance or a method or process of manufacture of an article or substance. An article includes any machine or apparatus. iii) A manner of adopting natural material by the hands of man or by man made devices or machinery is a manner of manufacture (48 RPC 185). iv) The term art refers to applied art or technology of manufacture and not to fine art for which protection should be sought under copyright law. v) An alleged invention means something, which is alleged as a manner of new manufacture, even though, in fact, it may not be a new manufacture. But an alleged invention must satisfy the requirement of the other definition. vi) In GEC Application Justice Morten held that a method or process is a manner of manufacture if it (a) results in the production of some vendible product, or (b) improves or restores to its former condition, of a vendible product or (c) has the effect of preserving from deterioration some vendible products to which it is applied. However this is not a hard and fast rule to cover each and every case. 1.3.4 Invention relating to improvement or combination 1. An improvement on something known before or combination in different manner already known, in order to be patentable should be more than

mere workshop improvement and should independently satisfy the test of invention. 2. The improvement or combination should produce a new result or a new article or a better article. 3. The combination of old known integers should be such that it should result in a improved process or article by their inter-related working. 4. Mere colocation of more than one integers or things, not involving the exercise of any inventive faculty does not qualify as invention. 5. The subject matter for patent may satisfy the requirement of manner of manufacture but may lack in novelty. In such case the subject matter cannot be considered as invention. 1.3.5 Novelty 1. In order to be novel the subject matter should satisfy the criteria of novelty as laid down under section 13 of Patents Act with exceptions provided under the heading ANTICIPATION in chapter VI of the Act. 1.3.6 Utility:1. An invention to be Patentable must be useful or has some utility.If the subject matter is devoid of utility it does not satisfy the requirement of invention. 2. For the purpose of utility ,the element of commercial or pecuniary success has no relation to the question of utility in patent law. However, where the improvement by reason of cheaper production, such a consideration is of the very essence of the patent itself and the question is of thing claimed can not be considered an invention unless that condition is fulfilled [4RPC 449 p. 462 (HL) per Lord Chancellor] If the invention gives the result as promised in the specification, objection on the ground of usefulness should fail. The usefulness of an alleged invention depends not on whether by following the directions in the complete specification all the results not necessary for commercial success can be obtained, but on whether by such directions the effects that the application/patentee professed to produce could be obtained. The meaning of usefulness is therefore useful for the purpose indicated by the applicant or patentee whether a non-commercial utility is involved.

3.

4.

5.

6.

The usefulness of the invention is to be judged, by the reference to the state of things at the date of filing of the patent application, if the invention was then useful, the fact that subsequent improvement have replaced the patented invention render it obsolete and commercially of no value, does not invalidate the patent.

1.3.7 Patentability of Biotechnological Inventions. In view of the Office instructions of the Controller General of Patents, Designs & Trademarks dated 15th July, 1991, view point regarding patentability of biotechnological inventions in India is: (1) Inventions relating to organisms or biological material per se viz (a) living entities of natural or artificial origin such as animals, plants and microorganisms, biological material such as plasmids, viruses, gene, recombinant DNA, bacteria, fungi, algae and other materials having self replicating properties and parts thereof, (b) naturally occurring substances from living entities, biological materials and also process for their production, are not Patentable under the Act. Hence no claim is allowable for such inventions. Inventions relating to process or methods of production of tangible and nonliving substances like enzymes, antibiotics, insulin, hormones, interferon, alcohols, vaccines etc. by bioconversion or using such microorganisms or by utilizing the above referred biologically active substances as well as chemical substances produced by using genetically engineered organisms or such existing substances made more economically by use of biotechnology and/or microbiology are patentable under the Patent Act, 1970. While claiming the inventions in respect of above subject where strain/bacteria have been used and deposited in depositing authorities and allotted their accession number, such depositions or accession number should be followed by the characteristics of such strain or bacteria.

(2)

(3)

1.3.8 Computer Programs 1. Computer program is not patentable invention as computer program is a set of instructions for controlling a sequence of operations of a dataprocessing system. It closely resembles a mathematical method .It may be expressed in various forms eg. A series of verbal statements, a flow chart, an algorithm, or other coded form and may be presented in a format suitable for direct entry into a particular computer, or may require transcription into a different format (or computer language). It may merely be written on paper or recorded on some machine-

readable medium such as magnetic tape or disc or optically scanned record, or it may be permanently recorded in a control store forming part of a computer. Thus it is evident that a program may be presented in terms of either software or firmware. 2. Since the claims may be couched in terms which tend to obscure the fact that the invention relates to a computer program, it is always essential to analyse them, in the light of what is described and of the prior art, in order to identify the contribution to the art and hence determine whether this advance resides in, or necessarily includes, technological features, or is solely intellectual in its content. For example, if the new feature comprises a set of instructions (program), which may be formulated and presented in any one of a variety of ways, designed to control a known computer to cause it to perform desired operations, the computer being suitable for the purpose without special adoption or modification of its hardware or organization then, no matter whether claimed as a computer arranged to operate etc or as a method of operating a computer etc .Such a subject matter is not Patentable and hence excluded from patentability . The invention here relates solely to the novel program. The claim might eg stipulate that the instructions were encoded in a particular way on a particular known medium but this would not affect the issue. If however the format of the program, or the nature of the record medium (tape, disc etc.) necessitated some non-standard adaptation to the computer itself (this factor being integral to the invention and not an arbitrary unrelated addition) then the exclusion would not apply. Likewise an invention which related to a particular manner of organizing the overall operation of the Central Processing Unit and the peripheral units, regardless of whether the invention were implemented by means of a program or special hardware facilities, would not be excluded. 3. If the implementation of a new program requires internal modification to a computer of such a nature that it may reasonably be regarded as a new computer then clearly a claim to this computer is not excluded, even though at first sight the invention may seem to relate merely to a program and the purpose of modifying the computer is subsidiary to this. The modification must however be inventive itself; if a computer is modified in a manner which is the obvious way of implementing the program, then the inventive contribution will still reside solely in the program itself. 4. As a general rule a novel solution to a problem relating to the internal operations of a computer, although it may comprise a program or subroutine, will also necessarily involve technological features of the computer hardware or the manner in which it operates and thus, if appropriately claimed, may be patentable.

5. A hardware implementation performing a novel function is excluded only if that particular hardware system is known or is obvious irrespective of the function performed. 6. An invention consists of hardware along with software or computer program in order to perform the function of the hardware ,such invention may be considered Patentable

CHAPTER II Inventions Not Patentable

Contents Non Patentable inventions Non Patentable inventions relating to atomic energy Inventions where only methods or processes of manufacture Patentable

2.1.0 Section 3: Non Patentable Inventions There are certain inventions fulfilling all the criteria of patentable invention such as novelty, usefulness and manner of manufacture but they have been excluded from patentability under Sec. 3 of the Patents Act, 1970 which are as follows. 2.1.1 Section 3(a) An invention which is frivolous or which claims anything obvious contrary to well established natural laws. (i) Merely making in one piece, articles, previously made in more or two pieces is frivolous. Mere usefulness is not sufficient (Indian vaccum brake co. ltd vs. Laurd (AUR 1962 CAK 152). Perpetual motion machine alleged to be giving output without any input is not patentable as it is contrary to natural law.

(ii)

2.1.2 Section 3(b) An invention the primary or intended use of which would be contrary to law or morality or injurious to public heath. (i) The invention, the use of which is contrary to the law for the time being inforce or use of which is prohibited, is not patentable e.g. any devices, apparatus or machine for theft, gambling apparatus or method for gambling,method of adulteration of food etc. If the inventions, the use of which is found to be injurious to public health are also not Patentable eg. method of adulteration of food.

(ii)

2.1.3 Section 3(c) The mere discovery of a scientific principle or the formulation of an abstract theory. (i) Claim for discovery of scientific principle is not patentable, but such a principle when used with process of manufacture resulting into a substance, or an article, is patentable. Scientific theory is a statement about the natural world. These theories themselves are not patentable no matter how radical or revolunationary in-sight they provide, but if they lead to practical application in the process of manufacture of article or substance , they may well be patentable.

(ii)

(iii)

The claim for formulation of abstract theory is not patentable on the ground that they do not result in a manufacture of any product or process. There is a difference between discovery & invention. The discovery adds to the amount of human knowledge by disclosing something, which has not been seen before, whereas an invention also adds to the human knowledge by suggesting an act, to be done which results in a new product or a new process. The formulation of an abstract theory does not suggest any act to be done which may result in a product or a process e.g. finding that a particular known material is able to withstand much shock, is a discovery & therefore is not patentable, but a claim to a railway fastener made of the material would not fall of this exclusion and would be allowed if it passes the test of patentable invention. Although a new method of calculation is not invention but new application for performing that method resulting into a process or product, or new apparatus for carrying out that method can be considered patentable. But it must be distinguished from non calculating application by technical features for e.g. A guide rule differing from known rules only in the scales is not patentable. The fact that a known material or article is found to have a hitherto unknown property is a discovery and not an invention. But if the discovery leads to the conclusion that the material can be used for making a particular article or in a particular process, then the article or process could be patentable. For example finding out the fact that a particular known material is able to withstand mechanical shock is a discovery and therefore unpatentable, but a claim to a railway sleeper made of that material would not fall under exclusion, and would be allowable if it passed the tests for novelty and inventive step.

(iv)

(v)

(vi)

2.1.4 Section 3(d) The mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant: I. Mere discovery of new property is not patentable invention e.g. a mere discovery of a new property of the substance such as aspirin for use of treatment of some other disease cannot be considered patentable.

II. New use for a known substance is also not patentable; it means 2nd or 3rd use for a known substance cannot be allowed. III. Mere use of a known process is not patentable unless such known process results in a new product or employs at least one new reactant. IV. Mere use of Aspirin for cardio-vascular disease, which was earlier used for analgesic purpose, is not patentable. However, a new and alternative method for preparing Aspirin is patentable.

V. Metric time showing Device (101/Bom/72) was held not patentable. The device comprises a normal clock or watch having usual hands for indicating hours, minutes and seconds, wherein dial or like visual numerical indicators are divided into 10 large divisions for hours, hours divisions are divided into 100 divisions indicating minutes and each minute divided into 100 parts representing seconds. It was held to be a mere use of known device hence not patentable. 2.1.5 Section 3(e) A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance: (i) A claim for a substance obtained by mere admixture of ingredients resulting only in the aggregation of the properties of such components or ingredients is not patentable invention e.g. a mixture of sugar and some colorants in water to produce a soft drink is a mere admixture resulting into aggregation of the properties. Similarly a mixture of different types of medicament or medicine to cure multiple diseases is also a mere admixture of substances, and is not patentable invention. However an admixture resulting into synergistic properties of a mixture instead of aggregation of properties of ingredients thereof is not considered as mere admixture e.g. soap, detergent, lubricants and polymer composition etc. Hence they are patentable. A process for producing a substance by admixing, which is resulting into the aggregation of the properties components thereof, is also not patentable invention.

(ii)

(iii)

(iv)

All the substances which are produced by mere admixing, or a process of producing such substances should satisfy the requirements of synergistic effect in order to be patentable. Anti-perspirants compositions for application to human skin (63/Bom/75) was held not patentable. The said composition comprises of : (a) non- cellulosic moisture absorbing polymer capable of absorbing moisture at least equivalent to its weight, and (b) a carrier. The composition was held admixture thereby not patentable for the reason that the composition has got the total sum of the properties of two components namely, the properties of absorbent polymer to absorb moisture or to absorb perspiration on being applied to human skin, which has not been in any way influenced by the presence of said carrier to act as carrier or diluents. A composition of two drugs, i.e. Paracetamol and Ibuprofen for curing fever and pain or process of preparation thereof is not patentable for the reasons that the composition is mere admixture of two drug components resulting into aggregation of properties thereof since Paracetamol is well known for treatment of fever and other one for treatment of pain. However, if the mixture of drugs can give some unexpected results in the treatment, then the process of preparation of such composition can be considered patentable.

(v)

(vi)

2.1.6 Section 3(f) The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way. (i) Any duplication of known device or apparatus manufactured by mere arrangement and re-arrangement in which all the devices are functioning independently in known way is not patentable. A mere juxtaposition of known devices in which each device functions independently are not patentable. It is accepted as sound law that mere placing side by side old integers so that each performs its own function independently of the others is not a patentable combination (British Celanese Ltd., Vs Courtaulds Ltd (52) RPC 171). However where the old integers where placed together have some working inter relation producing a new or improved results, then

(ii)

(iii)

(iv)

there is a patentable subject matter in the idea of the working interrelation brought about the collocation of the integers. (v) A mere juxtaposition of features already known before the priority date which have arbitrarily been chosen from among a number of a different combinations which could be chosen is not a patentable invention. Further when two or more features of an apparatus or device are known and they are justaposed without any inter dependence on their functioning of the apparatus or device should be held to have been already known (Rampratap vs Bhabha Atomic Research Center, 1976 IPLR 28 P. 35)] ,Umbrella with fan (388/Bom/73),Bucket fitted with torch,Clock and transistor in a single cabinet.They are not patentable since they are nothing but mere arrangement and rearrangement without having any working interrelationship between them and functioning independently of each other.Another example is of play-cumeducational device (1532/Cal/76). The device comprises of a chart, a set of tokens for players and one or more dice. It was held not patentable under the provisions of this section since the chart, token and dice, all are working independently of each other and there is no inter-relation between them.

2.1.7 Section 3(g) A method or a process of testing applicable during the process of manufacture for rendering the machine, apparatus or other equipment more efficient or for the improvement or restoration of the existing machine, apparatus or other equipment or for the improvement or control of manufacture. (i) A method or process of testing applicable during the process of manufacture is not patentable. Any process applicable during the process of manufacture for rendering the methods, apparatus or other equipments more efficient is also not patentable. Any process for control of manufacture is not patentable. Any method or process for restoration of existing machine is also not patentable. Process for testing of chlorine level in the water is a method of testing not patentable. Further a method of laboratory testing in water based culture media for zones of inhibition (310/Del/80) was held not patentable.

(ii)

(iii) (iv)

(v)

2.1.8 Section 3(h) A method of agriculture or horticulture. (i) (ii) Any process or method of Agriculture is not patentable. A method of producing a new form of a known plant even if it involved a modification of the conditions under which natural phenomena would pursue their inevitable course is not patentable. (N.V. Philips Gloeiammpenfabriekens Application 71 RPC 192). A method of producing improved soil from soil with nematodes by treating the soil with a preparation containing specified phosphorathioates was held not patentable (Virginia Carolina Chemical Corporation application 1958 RPC 38). A method of producing mushroom plant was held not patentable [445/Del/93]. The plant and animal varieties are also not patentable The exclusion of plant and animal varieties from patentability applies only when purely biological features characterize them. A method for cultivation of an algae (264/Cal/79) and a method for production of mushrooms (445/Del/93) are held not patentable.Both these methods were held not patentable for the reasons that the production of mushrooms and cultivation of an algae analogous to agriculture, since they belong to plant kingdom and therefore fall within the provisions of this section.

(iii)

(iv)

(v)

(vi)

2.1.9 Section 3 (i) Any process for the medicinal, surgical, curative, prophylactic or other treatment of human being or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products. (i) A method of treatment of malignant tumor cells and method of removal of dental plaque and carries are not patentable, since they are held to be treatment of human beings

(ii)

A method of cultivation of an algae and method of production of mushrooms as quoted above are held not patentable under the provisions of this section also for the reasons that the purpose of applicants inventions is to achieve varying degree of growth promotion, increased output, improved quality which definitely increases their economic value. A method of medicinal treatment of human beings is not patentable. Any process or methods for treatment of animals or plants to render them free of disease is also not patentable. Any process or method of treatment or animals or plants to increase their economic value or that of their product is not patentable. The art of curing illness cannot be said to be an art of manufacture (English patent practice). Surgical process and processes for the prevention and cure of disease in human beings are not patentable. In Uniliver Ltd. Application (1983) RPC 219, the patent courts in UK held that the term therapy included the prevention as well as the treatment or cure of disease, therefore any process relating to therapy is also not patentable. Prophylactic treatment such as vaccination, inoculation is to be regarded as therapy, which include treatment. The same consideration applies for animal as well as for human beings. For example prophylactic immuno therapy in animals are regarded as therapy. Any application of substance to human body purely for cosmetic purpose is not a treatment or therapy. On the other hand the application to the skin of an ointment designed to be effective to remove keratoges from the skin would be instance of medical treatment. To be treatment in relevant senses it seems that the purpose of the application to the body whether a substance or a process must be the arrest or cure of a disease or diseased condition or correcting of some malfunction or amelioration of some incapacity or disability (Joos Vs. Commissioner of Patent (1973) RPC 59).

(iii) (iv)

(v)

(vi)

(vii)

(viii)

(ix)

(x)

It was held in Lee pharmaceuticals application (1978) RPC 51 that since one of the results of sealing pits and fissures in teeth was to prevent the onset of dental decay, the purpose of the treatment was therapeutic rather than cosmetics. Patent may however be obtained for surgical therapeutic or diagnostic instrument or apparatus. In Oral Health Products Inc (Halsteads) Application, [1977] RPC 612, claims to a method of removing dental plaque and/or caries were refused, as was a claim to a method of cleaning teeth which embraced both curative and cosmetic effects. This decision has been followed under the 1977 Act in ICI Ltds Application No 7827383 (not reported), where a claim was refused to a method of cleaning teeth which removed both plaque and stains; it was argued that when applied to perfectly healthy teeth the method was purely cosmetic, but the hearing officer observed that practically all medical treatments which are preventative in nature (such as vaccination) must at times be applied to people who would have remained healthy anyway, but they remained medical treatments. Dictionary definitions of diagnosis clearly point to it being essentially concerned with identifying problems. The questions to be asked therefore, in order to determine whether a method constitutes diagnosis for the purposes of the Act, are (a) does the method, unaided by other tests, indicate whether or not a person (or animal) is suffering from a medical disorder, and (b) does the method identify the disorder where it is found to be present. If both of these questions can be answered in the affirmative, the method is diagnosis and is not patentable

(xi) (xii)

(xiii)

(xiv)

Surgery is defined as the treatment of disease or injury by operation or manipulation (SOED, Stedman, MacNalty). It is not limited to cutting the body but includes manipulation such as the setting of broken bones or relocating dislocated joints (sometimes called closed surgery), and also dental surgery. In general, any operation on the body which required the skill and knowledge of a surgeon would be regarded as surgery. In Unilever Limited (Davis) Application, [1983] RPC 219 (see also 4.08, 4.09), Falconer J observed that any method of surgical treatment, whether curative, prophylactic or cosmetic, is not patentable. This view, which was obiter, was cited by the hearing officer in Occidental Petroleum Corporations Application (not reported) in refusing to allow claims to a method of implanting an

(xv)

embryo transplant from a donor mammal into the uterus of a recipient mammal, since the method would necessarily have to be carried out by a surgeon or veterinary surgeon. (xvi) Methods of treatment of the human or animal body by surgery or therapy are excluded, as are methods of diagnosis practiced on the human or animal body. Methods of diagnosis performed on tissues or fluids, which have been permanently removed from the body, are therefore not excluded. Body should be taken to mean living body, and a method practiced on a dead body, for example in order to determine the cause of death, would not be excluded. Methods of therapy carried out on materials temporarily removed from the body for example when blood is circulated through an apparatus while remaining in living communication with the body, are not patentable (cf Calmic Engineering Co Ltds Application, [1973] RPC 684). In Ciba-Geigy AGs Application (not reported), objection was raised to certain claims for a method of controlling parasitic helminthes (worms which may develop in the animal body, for example, in the intestinal tract of animals such as sheep) by the use of a particular (novel and inventive) antihelmintic composition. The applicants contended that the composition when administered to an animal would prevent the reproduction of the helminthes and kill them should they infest the animal, but without affecting the animals body, and that its use was therefore not therapy. However, the applicants specification made it clear that an infestation of helminth worms can result in restricted growth, damage to the animals and even death if not properly treated. Moreover, the application made no mention of controlling helminthes by the use of the composition in any environment other than the animal body. The hearing officer considered that such an infestation was therefore a disease requiring medical treatment of the animal and that such treatment, whether curative or preventative, constituted therapy practiced on the animal body and consequently held that the claims in question were not allowable.

2.2.0 Section 4: Non patentable inventions relating to Atomic energy No Patent shall be granted in respect of an invention relating to Atomic energy falling within sub section (1) of section 20 of the Atomic Energy Act, 1962. (i) According to Sec. 20(1) of Atomic Energy Act, as from the commencement of this Act, no patent shall be granted for the invention when in the opinion of Central Govt. are useful for or related to the production, control, use or disposal of atomic energy or prospecting mining extraction, production, physical and chemical treatment fabrication, enrichment, canning or use of any prescribed

substance or radioactive substance or the insuring of safety in atomic energy operation. (ii) According to Sec. 2(1) of Atomic Energy Act, atomic energy means energy released from atomic nuclei as a result of any process including the fission and fusion processes. Under this Act prescribed substances means any substances including any mineral which the Central Govt. may, by notification, prescribe, being a substance which in its opinion is or may be used for the production or use of atomic energy or research into matters connected therewith and includes uranium, plutonium, thorium, beryllium, deuterium or any of these respective derivative or compounds or any other materials containing any of the aforesaid substances. Under the atomic energy Act, the term radioactive substances or radioactive material is defined as any substance or material, which spontaneously emits, radiation in excess of the levels prescribed by notification by the central govt. The Secretary, Deptt. Of Scientific Research, vide his letter no. AEC/21(28)/50/68437 Dated 12/12/1950 has directed that the Central Govt. is pleased to prescribe uranium minerals of, thorium, beryllium, vanadium, lithium and other minerals containing the said metals as necessary ingredients such as urani-ferous allamiti, Triplita, Colourmbite and Tantalite as substance which in its opinion are or may be used for the production or use of atomic energy or research under Atomic Energy Act. The central govt. vide its letter dated AEC/27(2)/50/358 dated 28.1.1951 has declared Ilmenite as substance for the production or use of atomic energy. The Central Govt. vide its letter No. AEC/DIH/1/(7)/52/2696 dated 19.5.53 by superseding the earlier notification has prescribed the substances specified in the following schedule & any of the respective compound as substances for the production or use of atomic energy under the Atomic Energy Act. THE SCHEDULE 1. 2. 3. 4. 5. Uranium Thorium Radium Zirconium Graphite

(iii)

(iv)

(v)

(vi)

(vii)

6. 7. 8. 9. 10.

Beryllium Lithium Deuterium Plutonium Neptunium

The Central Govt. has power to amend the schedule and may issue a notification at any time. 2.3.0 Section 5: Inventions where only Methods & Processes of Manufacture Patentable 2.3.1 Sec. 5(1) In the case of inventions(a) Claiming substances intended for use, or capable of being used, as food or as medicine or drug or

(b) Relating to substance prepared or produced by chemical processes (including Alloys, optical glass, semiconductor and inter-metallic compounds), no patent shall be granted in respect of claims for the substances themselves, but claims for the methods or processes of manufacture shall be patentable. (I) Only process claims are allowable in respect of substances intended for use or capable of being used as food or as medicine or drug and no product per se claims for such substances are allowable. No product per se claims are allowable in respect of substances prepared or produced by chemicals process. Only method claims are allowable.

(II)

(III)

In case of alloys, optical glass, semi conductor and intermetallic compound also, product per se claim are not allowable. The meaning of phrase substance prepared or produced by chemical process, it must be construed that the process of filtration, extraction, distillation or sublimation are within the meaning of chemical process. Calcutta High Court in Aluminum Co. of America Vs. Joint Controller of Patents & Designs affirmed this.

(IV)

(V)

The meaning of the terms food, Medicine or drug have the same meaning under this section as defined in section 2(1) (g) & 2(1) (l) including that defined under drug & cosmetics Act & also as defined by the Central Govt. by its notification from time to time.

2.3.2 Section 5(2) Notwithstanding anything contained in sub. Sec (I), a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, except the medicine or drug, specified under sub-clause (v) of clause (1) of sub section (1) of section 2, may be made and shall be dealt, without prejudice to the other provision of this Act, in the manner provided in Chapter IVA. (i) From 1.1.95 a claim for patent for invention relating to substance (product per se) intended for use or capable of being used as medicine or drug can be filed for the grant of exclusive marketing right. (ii) Claim for patent in respect of invention for all chemical substances which are ordinarily used as intermediates as defined under section 2(1) l(v) in the preparation or manufacture of any of the medicine or substances as defined in sec. 2(1)(l), is not allowable for the grant of Exclusive Marketing Right. (iii) Application for claim for patent of an invention for the above-referred substances for the grant of exclusive marketing rights should be dealt with in the manner provided in Chapter IVA. (iv) No patent can be granted on the application filed under this section unless and otherwise the provisions are made in the Act. (v) The application filed under this section shall be continued to be received and kept in the mailbox provided therefor.