Basics of Patent Law in India

http://have-an-opinion.blogspot.com

For IPR Syllabus of Vth Term LL.B (2017)

University of Delhi
Dr. Sunanda Bharti
Faculty of Law, DU
 Functional Meaning of Patent
 Legal grant of monopoly right
 For a fixed term (20 years now from the date of filing of
patent)
 For a new and useful invention
 2(1)(j): “invention” means a new product or process involving an
inventive step and capable of industrial application
 In return of his disclosing the invention
In the nature of a deal (bargain theory)
To encourage scientific research, new technology and
industrial progress (ref. s83 for aims and objects of grant of
patent)
 The patent is a creature of law by which the state bars public
exploitation of that invention for a fixed period. The economic
reward from the invention is earned during this time after
which it goes to the public domain.
 Monopoly Right
 Exclusive privilege to own, use or sell the invention (statutory
right/no common law right available)
1. Right to exploit the patent (ss 48 and 50)/make
commercial use during the term of patent
2. Right to license/assign (s 70)/ if patentee not willing to
exploit the patent himself, he may authorise
3. Right to surrender the patent (s 63) at any time by giving
a notice to the Controller of Patents/invention comes in public
domain
 Not absolute rights, but subject to limitations

 Patent right is territorial in nature and a patent obtained in

one country is not enforceable in other country. The inventors
are required to file separate patent applications in different
countries for obtaining the patent in those countries: NO
GLOBAL/INTERNATIONAL PATENT
Duties of Patentee


Maintenance of the patent: Pay renewal fees every year
till the end of the term
– Which can be paid every year or in lump sum
– Failure results in cessation
– Restoration of patent can be filed within eighteen months from the date of
cessation of patent along with the prescribed fee. After the receipt of the
request, the matter is notified in the official journal for further processing of the
request

Working of the patent: Inventions are to be worked in
India on commercial scale. Failing which compulsory
license may be issued
•
If the grant of the patent is for a product, then the patentee has a right to
prevent others from making, using, offering for sale, selling or importing the
Infringement of Patent
patented product in India.

•
If the patent is for a process, then the patentee has the right to prevent others
from using the process, using the product directly obtained by the process,
offering for sale, selling or importing the product in India directly obtained by the
process.
Infringement cont’d...
• Patent infringement proceedings can only be initiated after grant of
patent in India but may include a claim retrospectively from the date of
publication of the application for grant of the patent.

• Infringement of a patent consists of the unauthorized making,

importing, using, offering for sale or selling any patented invention
within India.

• Under the (Indian) Patents Act, 1970 only a civil action can be initiated
in a Court of Law. Further, a suit for infringement can be defended on
various grounds including the grounds on which a patent cannot be
granted in India and based on such defence, revocation of Patent can
also be claimed.
 Limitations on rights of Patentee
Use of patent by govt.(ss 99-103)
This may be with or without consent of patentee, for public
purpose (eg; distributing an invention relating to medicine
to hospitals and dispensaries or allowing its use by any
person for educational purposes)
Acquisition of invention by govt.
For public purpose
Compulsory license regime serves as important
limitation
(Under certain circumstances like when reasonable requirements
are not satisfied, a very high royalty is quoted, when the patentee
does not work the patent, the Controller can grant a license to an
interested person.)
For a New and Useful Invention
 Novelty...
Testing for novelty is
synonymous to a “spot the
difference” exercise.
The following image illustrates
the novelty aspect of a patent.
The image on the left is that of a  While the body of the patented
glass vessel with a resealable lid glass vessel is present in the
prior art, the absence of the
from patent application US resealable lid in the prior art
20130075356; the one on the makes the invention novel.
right is a normal glass vessel,
which forms the prior art.
 Novelty and Inventive Step/
Non Obviousness
 So in order to assess whether your invention is novel, you
should compare it with prior art for that invention-is there
any patent application that was made before in relation to
the same or similar invention? Is it already out in the
public, being already worked by the public? On comparing,
you may find that none of the prior art has all the features
of your invention-your invention is novel.
 For establishing obviousness, mosaicing is allowed-that is
you are allowed to cite a mosaic of prior arts (2 or more
prior art references may be combined)...if the invention is
predictable on the basis of available prior art-as assessed by
a person skilled in the art, inventive step is lacking and
invention is obvious
Our very own/old Safety Pin

Back in 1849 Mr. Hunt

protected his idea of a pin
for clipping of different
fabric pieces together.

As you see in the picture,

several configurations of
the pin were provided,
whereas several of them
being used even today.
It might seem there is
nothing else to invent
here…
However, almost 150 years later –
• In Year 1994 – an american
inventor Michail A. Mussell
made an improvement on
Hunt’s pin.(US 5303456)

• For more than a hundred

years such improvement
was not obvious to the
manufacturers of pins-
requirement of inventive
step was fulfilled
 Non Patentable Inventions(S 3 & 4)
As said earlier, EVERY INVENTION IS NOT
PATENTABLE
Following are not, as per section 3:
Frivolous invention or one that claims anything obviously
contrary to natural laws @ machine to destroy matter
Invention use of which could be contrary public order or
morality or which causes serious prejudice to human,
animal or plant life or health or to the environment @
device for house breaking
A mere discovery of anything occurring naturally in nature
@ while you could not patent the leaves of different plants,
you could patent a pharmaceutical drug made out of those
leaves (as well as the process of making it).
A method of agriculture or horticulture @ Step farming
Contd.
 Non Patentable Inventions (S 3 contd.)
 Mental Processes and Mathematical Algorithms or formulas-A process claim
reciting an algorithm or abstract idea is patentable only if (1) it is tied to a
particular machine or apparatus, or (2) it transforms a particular article into a
different state or thing.

 An invention, which in effect is traditional knowledge or just a compilation of

known properties of a traditionally known component
 A U.S. patent on turmeric was awarded to University of Mississippi Medical Center in
1995, specifically for the "use of turmeric in wound healing."
 This patent also granted them the exclusive right to sell and distribute turmeric.
 Two years later, a complaint was filed by India's Council of Scientific and Industrial
Research, which challenged the novelty of the University's "discovery,"
 U.S. patent office investigated the validity of this patent and in 1997, the patent was
revoked.
 The invention was non-novel and had in fact been traditionally practiced in India for
thousands of years
 As was eventually proven by ancient Sanskrit writings that documented turmeric’s
extensive and varied use throughout India’s history.
 Inventions relating to atomic energy, not patentable for security reasons
(s 4).
 Patentable Subject Matter

=
Products and Processes
Excluding the products and
processes mentioned under
section 3 and 4
 Evergreening Issue & abuse of 3(d)
 Section 3(d) of the Patent Act, 1970
"The mere discovery of a new form of a known substance
 which does not result in the enhancement of the known efficacy of
that substance
or 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.
Is NOT patentable

 Companies sometimes resort to evergreening to extend the

duration of their hold of a patent. Evergreening is the art of
extending the life of the patent under the guise of incremental
innovations.
 Prevents generic versions to enter the market--adversely
affects access to medicines and adds to consumer cost
Evergreening contd.
A company manufactures a product ‘A’ for which it
secures a patent. Shortly before the expiration of that
patent ‘A’, the company will file a new patent
application ‘A+’ which is closely similar to the
original. When the original patent ‘A’ expires, a new
patent ‘A+’ is in effect, which prevents the
manufacture of generic versions of the product.
Hoffman versus Cipla Preface
Hoffman Roche (Swiss) applied for patent for ‘erlotinib’
(sold under tarceva brand name) in 2007 in India costing
Rs4,800 per tablet meant for treating cancer
Later that year, Cipla announced that it was going to sell
the drug under the label 'Erlocip' at Rs1,600 per tablet
(generic version)
Roche then sued Cipla for allegedly infringing on its
patent
CIPLA counterclaimed that the invention is invalid for
want of novelty and unaffordable price: as the drug
was a tweaked version of an older drug and that its prices
were out of reach for most Indian patients
AND THE WINNER IS YET TO BE ANNOUNCED…
 SC )
 Novartis claimed a patent for Gleevec, a cancer drug which was
refused under section 3(d). It came under immediate attack from
oppositions initiated by generic companies that were already
selling Gleevec in India. Patent was refused. Matter came to the
Supreme Court eventually.
  Section 3(d) is a test of patentability. Since it says that in the
absence of evidence of enhancement of known efficacy, the
mere discovery of a new form of a known substance is not an
invention deserving the grant of patent, patent should be refused
to Gleevec.
  Imatinib Mesylate was the known substance and Novartis
claimed a patent for its (the substance) beta-crystalline form.
  The Supreme Court asked: “Now, when all the pharmacological
properties of beta crystalline form of Imatinib Mesylate are
equally possessed by Imatinib in free base form or its salt,
where is the question of the subject product having any
Proper reading of section 3(d)
 If an invention fails the 3(d) test, it means there was no
inventive step. There was no intellectual property in the
alleged invention, and nothing that could be stolen!
 The Supreme Court said that it was not ruling that all
incremental innovations were non-patentable and that every
case would be examined. Our law says that new forms of
known substances which do not have enhanced efficacy are
in effect advances without real innovation. Therefore,
Section 3(d) is actually a catalyst for genuine inventions.
 SECTION 3(d) DOES NOT ENTIRELY prohibit the grant
of patents which seek to claim to be a new form of a known
substance. Patents have been granted in India for new
forms of even known substances when efficacy is proved.
Tackling the American allegation
“The TRIPS agreement does not prevent patent
applicants from having to demonstrate enhanced
efficacy for their allegedly new and useful inventions
The sovereignty of a country includes its power to
make laws. Any person who pursues commercial
interests in another country must submit
himself/herself to the laws of the country. No one can
attack our regime as being discriminatory only because
his/her invention did not stand up to the test of our
legislation
 Authorities under the Act
 The Patent Office, under the Department of Industrial Policy
& Promotion, Ministry of Commerce & Industry, performs the
statutory duties in connection with the grant of patents etc.
Patent Offices are located at Kolkata , Mumbai, Chennai and
Delhi to deal with the applications for patents originating within
their respective territorial jurisdictions
Head Office of the Patent Office (seat of Controller General of
Patents, Designs and Trade Mark’s) is at Kolkata
The Patent Office comes under the Ministry of Commerce &
Industry.

 Controller of Patents
Processes application/s and grants patents (ss 12)
Grants Compulsory licences (s 93)

Appellate Board (IPAB)


 Compulsory License (ss 84)
 Is granted by Controller of Patents upon receipt of application
by any interested party (s 84)
 May be granted, subject to conditions, to anyone who is
interested in working the patent
 Can be granted after expiry of 3 years from the grant of patent
on grounds like (even in CL the patent holder has clear 3 years
to commercially exploit ):
Reasonable requirement of public have not been met
 @ refusal to grant license=>stifling of an industry
 @ demand not being met due to inadequate supply either in India or an
export market etc.
Invention not available at reasonable price
Invention not being worked in the territory of India, so people
being forced to import
 Act seeks to maintain a balance between individual monopoly
rights-national interest-interest of the public
 Factors to be taken into account
• The nature of invention;
• The time elapsed, since the sealing of the  patent;
• The measures already taken by the patent holder or the licensee to
make full use of the invention;
• The ability of the applicant to work the invention to the public
advantage;
• Whether applicant has made efforts to obtain a license from the
patent holder on reasonable terms and conditions;
• National emergency or other circumstances of extreme urgency;
It cannot be claimed as a matter of right, as the same is subject to the
fulfilment of above conditions and discretion of the Controller of
Patents. Further judicial recourse is available against any arbitrary or
illegal order of the Controller of Patents for grant of compulsory license.
 Terms of CL

• Royalty to be given to the patentee

• Invention to be worked to the fullest possible extent
by the grantee
• Non-assignable right
• For the balance term of the patent or shorter if decided
by Controller
 Bayer v NATCO
Bayer, international pharma company based in Germany
obtained a patent in India on Sofraenib (brand name
Nexavar) a medicine for treatment of kidney cancer/sold
@ Rs 280000/month.
Natco asks for a licence and is refused by Bayer/ to be
sold at 8800/month
Natco applies for CL to the Controller citing unreasonable
pricing and that reasonable requirements of public in
India not met -Bayer contests that it is being supplied by
CIPLA @ 28880/month so no shortage of supply in India
Controller grants first CL in India-stressing (life saving
drug and not a luxury item/supply only in major metros
and that too inadequate/patentee by its own supply has to
meet the demands-cant piggyback CIPLA for this
Contd…
• Bayer given patent in India in 2008 for Nexavar after
assessing that it would fulfill the reasonable
rewuirements of the public (Bayer argues that 23000
bottles per month was small as per global demand)
• 2008-2010, Bayer did not manufacture the drug in
India and focused on fulfilling the demand through
imports (Bayer argues that working does not mean
manufacturing in India)
• Life Saving drug/not a luxury item and was in short
supply besides being exorbitantly priced (bayer argues
to this in justification)
• Notable is that Bayers sale increased to 934 million $
for rest of the world-neglectful conduct of patentee
 Verdict of Bayer…
• CL valid till the expiry of patent that is 2021
• Cannot assign or sub-lisence to any party
• For a pack of 120 tablets, NATCo cannot exceed
beyond 8880 rs
• Supply the drug free of cost to at least 600 needy
patients every year (in Consonance with section 90)
• 6% royalty on sales to Bayer
• No liability on Bayer for the drug manufactured by
Natco
• Natco cannot represent to the public that it is Bayers
Nexavar.
 Who can file -- section 6
• True and first inventor
• LR of deceased inventor
• Assignee of Inventor
• LR of the deceased assignee
• It may be a natural person or any other legal person on
whom personality has been conferred by Law
(companies, universities)
• Start-ups included recently since the May 2016
amendment to the Patent Rules 2003 (less than year
old and <25 crore annual turnover)
 How can it be filed
• E filing
• Physical filing (additional 10% fee)
• In English and even Hindi
 Procedure for obtaining Patent (I)
Filing of application (ss 6-11)-a techno-legal document-
expert may be required
Unlike copyright that is vested in the author the moment a
work is created, patent in an invention does not get vested
automatically
Patent Application can be filed at any of the four patent
offices in India. Patent Offices are located at Kolkata, New
Delhi, Chennai and Mumbai.
For every invention, a separate application must be filed (s
7(1))
Application to be accompanied by provisional or
complete specifications. A provisional patent application
and a regular patent application are not two different
ways of filing patents; rather they are two different
 Provisional Specification
Specification is a technical document describing the
invention
The purpose is to make the details available to public
when the patent falls in public domain
Provisional sp. gives initial description
Generally filed at a stage where some experimentation is
required to perfect the invention
Filing of a provisional specification allows the applicant to
get an early application date (Date of Priority)
 Complete Specification
Complete specification gives full description, so that a
person skilled in the art can perform the invention when he
reads it
Must be filed within 12 months of filing the provisional (s 9)
Otherwise application deemed as abandoned
Inventor has 12 months to work out the practical details of
invention
More may be required by Controller
• The Controller may ask for samples, models,
prototypes or simply drawings which shall, if the
Controller so requires, be supplied for the purposes of
any specification, whether complete or provisional
[Section 10(1 & 3)]
• Any drawings etc so supplied may or may not, as per
the direction of the Controller, form a part of the
specification
 What does filing involve?
 An ordinary patent application shall be filed using
Form-1 along with Provisional / Complete
Specification, with the prescribed fee as given in
First Schedule at an appropriate office (patent office
of jurisdiction)

 Normal fee shall be applicable for applications

containing upto thirty pages in specification
and upto 10 claims. If the specification exceeds
thirty pages or claims are more than ten in number,
additional fee as given in First Schedule is payable.
 Publication of Application -- S 11A
• No application for patent shall ordinarily be open to the
public for the first 18 months from the date of filing (the
period prescribed by Rules 2003)
• However, the applicant may, in the prescribed manner, request
the Controller to publish his application at any time before the
expiry of 18 months and if this is done, the Controller has to
publish.
• IPO publishes the Application in the Official e-Journal
ordinarily within one month from the date of expiry of 18
months or within 1 month from the date of request of
publication
 Effect of Publication-
• On and from the date of publication of the
application for patent and until the date of grant of
a patent in respect of such application, the
applicant shall have privileges and rights as if
a patent for the invention had been granted on
the date of publication of the application
• The prospective patentee can claim damages from
the date of publication of his/her application.
However, he can institute a suit for infringement
only after a patent is granted
 Examination of Application
• An Application for a Patent will not be
examined unless the applicant or any other person
interested makes a request for examination. The
request is to be filed in Form 18 with the fee as
prescribed in First Schedule.
• A request for examination has to be made within
forty-eight months from the date of filing the
application. If no such request for examination is
filed within the prescribed time limit, the
application shall be treated as withdrawn by the
applicant.
 Examination of Application contd
Once a request is made, it must be completed within 18
months from the date of making it (far from true)
And the inventor can request controller to expedite (the
2016 amendment to Rules restrict this to two requests)
The patent application is referred to an Examiner by the
Controller for conducting the formal as well as substantive
examination as per the subject matter of the invention vis-à-
vis the area of specialization of the Examiner
Formal examination
 Whether application submitted in prescribed form, fee paid and
documents required furnished
Substantive examination
 Whether the matter is an ‘invention’/criteria satisfied
 Search to determine prior use, prior claims, prior publication or
prior public knowledge
 Examination contd…
• At present, the Patent Office has four examination groups
based on the broad area of specialization viz.:
– a.    Chemistry and allied subjects.
– b.   Biotechnology, Microbiology and allied
subjects.
– c.    Electrical, Electronics & related subject
– d.    Mechanical and other subjects
• The examiner conducts a search in the Indian Patent Database,
starting from 1.1.1912, and all the patent databases of other
countries such as: EPO database, WIPO database, USPTO
database, JPO DATABASE, TKDL (Traditional Knowledge
Digital Library) and other paid databases.
• The search is conducted to find out any publication which may
anticipate the claimed subject matter.
 Inviting Opposition (s 25-Pre Grant)
Pre-grant opposition-purpose of publication is to
invite this (within 6 months)
Before grant of patent
Any person may, write to Controller against the grant of any
Patent.
 Shall include evidence, if any, in support
 and a request for hearing if so desired
May be made on the following grounds (eg)
 that the invention has been published before
 that the invention so far as claimed in any claim of the complete
specification was publicly known or publicly used before etc.
Is important because prevents grant of trivial patents and
unnecessary litigation
 Inviting Opposition (Post Grant)
 Post Grant Opposition
Any interested person can file notice of opposition (along with
evidence, if any)
Anytime after the grant of Patent but before expiry of one year
from the date of publication of grant of a Patent in the Patent
Office Journal
Grounds of opposition under section 25(2) are the same as given
in case of pre grant opposition.
Post grant opposition is decided by an Opposition Board followed
by a hearing and a reasoned decision by the Controller
 If the opposition is decided in favour of the applicant (that is
opposition rejected), the patent is granted and the grant of
Patent is published in the Patent Office Journal
 Priority Date
Priority date is the date of reference used by the patent
office to determine the newness/novelty of the invention
Allows patentee to file a subsequent application in another
country, for the same invention , in peace
From the date of priority, he would have 12 months to file
subsequent applications in diff. countries
During those 12 months, even if the invention is disclosed
to public by anyone else, it will NOT affect A's patent
application
Mistake, frequently made by inventors, is to wait until
their inventions are fully developed for commercial
working.=lose the date of priority=therefore, advisable to
apply for patent as soon as the invention is conceived
 Priority Date Contd. Example
 A invents a fly/mosquito catcher and decides to apply for a patent.
 Files an Indian patent application on July 15, 2016 (Priority Right)
 Starting from July 16, 2016, A has one year to file patent applications in
other countries to be able to benefit from the date of filing of the Indian
patent application
 If A files on May 15, 2017 a patent application in United Kingdom for his
fly catcher, and if, upon filing the patent application in the United Kingdom,
A claims the right of priority, the date for examining the novelty
requirements in the United Kingdom will be July 15, 2016, not May 15,
2017.
 This means that any disclosure to the public of the invention on or after July
15, 2016 (by A or anyone else) will not prejudice A's patent application in
the United Kingdom
 If B independently invents around January 2017 the same fly catcher and
decides to directly publish in February 2017 a paper explaining how his
invention works, the publication of the paper by B will not affect the
novelty of A's patent application in the United Kingdom, even though the
publication of B's paper takes place before the actual date of filing of A's
UK patent application
 Priority Date Rationale
The priority scheme gives A one year to do whatever
is necessary to file patent applications in other
countries (translating the text of the application, filling
the application forms, sending the translated
application and forms to the foreign patent offices, pay
the filing fees, and so on) without being affected by
any intervening publication.
The actual date of filing in the United Kingdom
remains May 15, 2017, and this is the date from which
the 20-year duration of any ensuing patent is
calculated in UK.
The "basic purpose of the right of priority is to
safeguard, for a limited period, the interests of a patent
applicant in his endeavour to obtain international
protection for his invention
 International treaties for Patents
 India is a member-state of Word Intellectual Property
Organisation (WIPO), an International Organisation,
responsible for the promotion of the protection of intellectual
property throughout the world.
 India is a member of the following International Organisations
and Treaties in respect of Patents:
a) World Trade Organization (WTO) with effect from 01-01 -1995.
b) Paris Convention for the protection of Industrial Property with
effect from Dec.7, 1998.
c) Patent Co-operation Treaty (PCT) with effect from Dec.7,
1998.
d) Budapest Treaty with effect from 17th December, 2001