E.mail — : idma@vsal.com idma@idmaindia.com ww. idma-acsn.org, 91 Fax :91 Wel PARTNERS IN GLOBAL HEALTHCARE April 24, 2008 Office of the Controller General of Patents, Designs and Trade Marks, SM Road, Antop Hills, Mumbai — 400037 E Mail: mumbai-patent@niv.in “ia ailing eae conticlion Ge, oo ease, ort at Su ations on the Patents’ Manual ‘omments/ Ob: x Dear Sir, Our conimenie/ observations on some Paras of the manual are giv they may please be considered. Point 1. A General Observation on Chapter III. Patentable Subject Matter general rule, foreign caze law should be used cautiously in India because our Patentabi rig adopted in industrially developed countries AS ctiteria differ substantially from the cr particularly USA. We should accept only thace Pulings which are not against the letter and spirit of the Indian Patents’ Act 1970 as amended up (o date. This particularly important on es relating to 1, Pateniability, 2. Pre-grant Oppacition, 3. Compulsory Licences; and 4, Inian Traditional Knowledge. Point 2 Determination of Novelty Para 3.2 Novelty of Invention Sub para 3.2.1: In the last line, the words “snd haz unrelated features” be added afier the word “domain”. Para 3.3.7: In fifth line after the word “essential”, the words “and unrelated” may be added. AFFORDABLE MEDICINES FOR ALL Jo, Pom.111/1961 GEB SD Mo, FAIS (Pom) Di, 11-8467Point 3 Para 3.3.4 (Text) 3.3.4 In order io demonstrate lack of noveliy, she aniicipatory slisclasure must be entirely contained within a single decumeni If more than one documeni is clied, each must stam on its own, The cumulative efjeci of ihe disclosures cannai be iaken inio consideration nor eam the lack of navelly be established by forming i masaic af elements iaken from several documents. This may be done only when arguing obviousness (Ammonia's Application, 49 RPC 402). However, if.a cited documeni refers ta a disclosure in another document in such a way os to indicaie thai, ihr disclosure is imended to be included in that of the cited documen, then the iwo ave read iogerher as iho h they were a single document. Comments — This judgment appears to bar tal:ing recome to more than one document indicating ‘anticipatory disclosure’ i.e. if there are (wo or more ceparate sourees dealing in parts of the same one iscue, they cannot be uced (o delermine ‘novelty’. Bul the eave is different in India’s Traditional nowledge, where sch r yy be described partly in one bool: and partly in another ancient book. We must see things in tolalily. Therefore, this case lavy should nat be used. This Para should be deleted. Point 4, Para 3.3.6 Text 3.3.6 Special care is taken when relying on dimensions derived frara drawings. Although features shown solely in a drawing form part af ihe sivie af the avi when a ckilled person could derive a technical eaching froin them withoui further description, ii is generally not possible to derive a technical ieaching by measuring dimensions in a stiagrammotic represemaiion and the dimensions uniler these circumstances slo not, therefore, form part of the staie of ihe art. [T204/83 (QJEPO 10/85)] ns and drawings’, It applies als more since this is Para to Comments — Ruling in T 204/83 (OJEPO) 10/85 relates to ‘dimenst to scientific inventions, But in ow Traditional Knowledge where w frequently than in Western countries, this decision does noi hold ge decision applies mainly to seientific documents, a nove can he given in the end af t the point relating (o Indian ancient test books. str Point 5 Para 3.3.12 Text - 3.3.12 The invention is tal:en as Iscking in novelty if information shout anything falling within 5 scope has already been disclosed. Thus, for example, if a claim specifies alternatives or defines the invention by reference to a range of values (e.g. of composition, temperature, ete), then ihe invention is not new if one of these allemalives, or if single example falling within this range, is already known, Thus, a specific example is sufficient to novelty of a elsimto the same thing defined genetically. For e:ample, disclosure of a metal coil spring anticipates a claim to resilient means. Cin the other hand, a generic disclosure does noi impugn the novelty of amore specific claim, so that an eailier reference (o a metal coil spring eamvol be used to attack the novelty of a claim specifying such spring made of copper. In come eases, however, the disclosure of a comparatively small and reciricted field of poscible altematives mi held to be a disclosure of each and every member; for example, * uid? may be both liquid and gas, if the conte::l warrants it, and a reference to an electric motor may be regarded ac dicelosing the use of both ceries and tunt-wound types. Comment -The sentence on Page 24“ On the other hand .....cpring made of copp suggested io be deleted because ‘novelty’ az we consider under the Indian law, would be affected by a ‘generic dicclosur ven in thic illustration, » againct a claim such Point 6 Prior Public Use Para 3.6.9 Text 3.6.9 If'an article or a mauerial is unconditionally supplies io a member of the public, possibly as the result of just «1 single sale (T4889 QJEPO 11/9), it is regarded as making available information io ihe public if that information could be obtained by dismantling or analysing the article or material or even destruction of ihe article (G1/9? OJEPO 5/93) ld be construed ac dicelosure »y Sec 32 ~ “Anticipation by h the Patent Applicant ean put iefore, this Para in the Manual Comments - In this illustration the Puling is thai a single ‘cale” or “making available information (© Public”. Under our Patents? L public working”... there is a grace period of one year during whi the produet to teat by “working” i.e, supplying it 6 public. Ther needs re-drafting, Point 7 Mosaicing Multiple Docnments Para 3.11.m Page 37. Text 3.11, m. Where an inveniion can be thought of as iho resuli of a selection from a mumber af alternatives, to demonsivate thar ihe invenifon is noi obvious, it is usually only necessary to show that it solves «1 technical problem in a surprising or unexpected way. Plea narrowing th: import of the Paragraph. U prior to a distineily obvious or frivolous invention for grant of a patent. delete word “only” in... it ie uenally only necescary” beeance thi of term » “Surpri wvention, should be treate as digqualifying thePoint 8 Inventins not patentable Section 3(d) Para 4.5.3 Page 58 Text 4.5.3 The examiner makes comparison wiih regard to properties or enhancement of efficacy between ihe known substance and the new form of known substance. In ease the new fori is further converied into amather new form, the comparison is made benween the already existing form andl another new form bui noi berween the base compound and another new form. Comments and suggestion ~ This is an imporiant para, bul gives rise to many questions. It should be clearly indicated as lo what the scope of comparison will be, Whether the base ‘compound or the new form or both will be compared with another new form, Point 9 Isomers Text - 4.5.7 Some of ihe examples of new forms ave given below withoui limiting the scope of the application of the provisions of the Act. (i Isomers: Isomers swe differeni compounds thai have ihe same molecular formula which may be broully divided into nwo kinds, namely, = struciural isomers or pasitional isomers and, - stereo isomers. Sivuctural isomers or positicnal isomers may be sivucivrally similar ov dissimilar compounds, The simplest examples awe butane and isobutane end ethanol cmd dimethyl ether. In the former case the compounds are having structural and functional similarity. 59 However, In the secon! sei of cemnpounds, alihough ihey have the same molecular formula but are structurally and functionally differem: Such isomers even having close similarity mav be be novel ever: the prior wri Isomers having the same al formuls bot having siruchwal differences may be cons uvally different. red novel and may not emp: ormually of Example: yelohexylstyrene is nov considered prima facie obvious aver priorart isohexyl styrene. Para 4.5.7 (j) Isomers ~‘isomers’ are non-patentable unlece they “differ significantly with regard toefficacy”. If Isomers which are cimucuually different are really therapeutically different then they can be concidered for patenting. Thic para , therefére, needs come more clarifications,Point 10 Contents of complete specification Para 5.6.1 Text - 5.6.1 Complete Specificanion is required ia have the following components 104 (Title (b) Preamble of the invention (0) Name, adress and nationality of the applicant (d) Field of Invention (6) Use of Invention : A brief statement of ihe advaniages of the invention Prior Art (a) Problem to be solved (i) Object of Inventicn(iay be more than one) (9 General siaiement of invention Gj) Detailed Description of Invemtion{ with reference. to drenwings , ifany) (2) Best method Axample of working af the invention ( Siaiement of claims (na) Signature with date (n) Drawings (0) Abstract Aci the applicant must Comment 1 - As per Section 10.4. Proviso (ji) (D) of ihe Pater ierial. Therefore this point should disclose the somes and geographical origin of ihe biological m be added to the list clating lo the “Access and Benefit sharing Comment 2~ They should also mention the de 1 Diversity Act - 2002”. Agreement” if any, with the Competeni Auihority under the “Bi Point 11 Para 5.9: Sufficiency of disclosure Sub para $.9.2 deals with patent application where there is mention of bielogical material. This para needs to be expanded to provide for the requirement of agreement with the biological matevial cupplier and agreement reached with him about benefit sharing. Point 12 CHAPTER. VIL: OPPOSITION PROCEEDINGS TO GRATIT PATENT Page 178, para 7.1.2: Proceedings under pre-grant opposition.ing representation against granting of patent or allowing, e logical conclusion of allowing appeal Sub para (viii) provides for re grant of patent. The decision of the Controller should h: to either party againal the decision of the Controller Point 13 Para $.3 Prohibition (o apply Patent for invention ontside India. Page 215 sup para 9.3.3, i relevant for defence purpose and atomic energy, the invention 20 be incorporated f In addition to the inventi relating io biodiversity material of India should a Point 14 Page 226, para 10,12 Term of Patent Para 10.12.1 Preference (o patent term which had nol expired on 20" May, 2003 under Patents (Amendment) Act 2002, should be clarified ac “provess paient” instead of “patent” which may not be misiaken as ‘product patent’, Point 15 CHAPTER XIV: SURRENDEP. AND REVOCATION OF PATENTS Page 252, para 14.2.5 Revocation of patent for non-working There have been instances in the pact when supplies of critical matztial/eomponent were blocked at the instance of the concerned foreign government for important concerns. The instances of blocking of critical materials ae after the atomic ezperiments at Pokhan, Under these circumsiances, it would be appropriate for the governmment/Controller to revoke the relevant patent, It would be a challenge for the dom arch and produce that particular material blocked by the foreign patent Ih nent. This imporiant aspect could also be added in this para,Point 16 Page 295 para 18.2.1 wumental cau The circumstances for extreme urgency could loo be due to pollution of air, pollution of water or pollution of soil. Tt would be desirable to incorporate these important circumstances for notification by the Government ihe circumstances of extreme urgency and grant of compulsory licences immediately under Seetion 92 (3), Thanking you, Yours faithfully, For Indian Dug Manufacturers’ Association, Gove Gajanan Wakankar IFS (Reta) Executive Director