Title: Ms. Arpita Sawhney
1Patent Law In IndiaQuestions Outstanding
2- This presentation comprises of the following
- Background
- Critical appraisal of Section 3 (d) of the
Patents Act, 1970 vis-Ã -vis TRIPS-Defaults at
legislative level - Analysis of Section 3(d)
- Novartis case- An insight and
- Burning topic Patent Linkage
3 4WTO/TRIPS AND INDIAS OBLIGATIONS
- India became a member of WTO/TRIPS Agreement
effective, January 01, 1995 - India, being a developing country was given ten
years transition period to fully comply with
TRIPS - This was done in three stages effective
- January 01, 1995
- Filing of Black-Box applications
- Provision for Exclusive Marketing Rights
- May 20, 2003
- Uniform patent term of 20 years
- January 01, 2005
- Grant of product patents in all fields of
technology including drugs, food and chemical
substances
5PRODUCT PATENTS ALLOWABLE interalia FOR
- Drug Molecules
- Pharmaceutical preparations
- Synergistic Combinations
- Agrochemicals
- Chemical products i.e., resulting from chemical,
bio-technological, microbiological or
biochemical processes - Microorganisms
6- Critical appraisal of Section 3 (d)
- vis-Ã -vis TRIPS
7ITS ALL ABOUT TRIPS
- Indias obligation to TRIPS is recorded in the
final amending Act passed by the Indian
Parliament effective January 1, 2005 - While considering the third set of amendments
to the Act, efforts have been made not only to
fulfill our final obligation under the TRIPS
Agreement but also to simplify and rationalize
the procedure..
8Pre- amendment- How Section 3(d) read?
- The mere discovery of any new property or mere
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
9India defaults at the legislative level- YEAR 2005
- Post-amendment of Section 3(d) Road Block
- 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 - Explanation For the purposes of this clause,
salts, esters, ethers, polymorphs, metabolites,
pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other
derivatives of known substance shall be
considered to be the same substance, unless they
differ significantly in properties with regard to
efficacy. -
- This clause is of a great significance (The
Pharma Industry)
10- Therefore, Article 27 of TRIPS lays down
following criteria for - patentability
- Patents shall be available for any inventions,
whether products or processes, in all fields of
technology, provided - They are new
- Involve an inventive step and
- Are capable of industrial application.
- The Indian Patents Act almost follows this
definition.
11ARTICLE 27-EXHUSTIVE-EXCEPTIONS PROVIDED THEREIN
- Exception to patentability on the basis of
- 1. ordre public or morality, including to protect
human, animal or plant life or health or to avoid
serious prejudice to the environment, provided
that such exclusion is not made merely because
the exploitation is prohibited by their law. - 2. diagnostic, therapeutic and surgical methods
for the treatment of humans or animals - 3. plants and animals other than micro-organisms
-
12- Unfortunately- in giving legislative effect to
TRIPS, for certain inventions such as chemicals,
India has laid down an additional condition of
proving enhanced efficacy over and above three
known standards of patentability- Novelty,
inventive step and industrial applicability and
has thereby contravened the provisions of TRIPS.
13WORTH NOTING
-
- Article 28 (1) (a) of the TRIPs Agreement and
Section 48 (a) of the Act, dealing with the
exclusive rights being conferred on grant of a
patent, are identical - also
- while defining the term invention, Article 27
of the TRIPS and Section 2(1) (j) of the Act are
identical - but
- Indian legislation did not stop at that.
- It made the definition of invention under
Section 2(1) (j) restrictive by amending Section
3(d). -
14 15- Mere Discovery Enhanced Efficacy Invention
- Invention- Enhanced Efficacy Mere Discovery
- As per section 3(d)
- Discovery of a new form of a known substance
would not come within the purview of an
invention, if it does not result in enhancement
of a known efficacy of that substance. In other
words, mere discovery qualified by enhancement of
known efficacy of the substance, is an invention
or to put it otherwise, invention devoid of
enhanced efficacy boils down to a mere
discovery. - Another limb of the argument
- If a new product satisfies the conditions laid
down in section 2(1)(j) of the Act, (new,
involvement of an inventive step and capable of
an industrial application), it is an invention
and in that event, term enhanced efficacy
appearing in Section 3(d) of the Act still is
another hurdle for an applicant to cross and
overrides Section 2(1) (j) of the Act.
16Explanation of Section 3(d)
KNOWN SUBSTANCE
- Salts
- Esters
- Ethers
- Polymorphs
- Metabolites
- Pure form particle size isomers
- Mixtures of isomers
- Combinations
- Complexes
- Other derivatives
SAME SUBSTANCE Unless they differ significantly
in properties with regard to efficacy
17 ENHANCED EFFICACY?????
- Not defined
- Touchstone elements
- Increased Stability
- Increased bioavailability
- Faster response time
- Reduction in treatment period
- Wider spectrum of activity
- Lesser side effects
- Evidence necessary
- Clinical data/Experimental trials
- Technical affidavit
18Section 3(d)- A closer look
- Section 3 (d) allows patenting of a new form of a
known substance only if it results in the
significant enhancement of known efficacy of that
substance. - CONTRADICTION- Mere discovery of a new form is
a contradiction in terms in that new form
requires human intervention. By the same token
every derivative is the product of human
intervention. - c) ILLOGICAL- Concept of a mere discovery
graduating into a patentable invention on the
basis of enhanced efficacy defies logic.
19- UNIQUE- Criterion of efficacy is not found in
Patent Legislation of any other country. - VAGUE- Efficacy has not been defined in our Act
as well. This has led to arbitrary decisions. - UNEQUAL TREATMENT- Patent protection abroad for
subject matter prohibited in India, obtainable-
resulting in an uneven playing field. - CONTRARY TO TRIPS- Article 27 of the TRIPS
Agreement provides for uniform conditions of
patentability. -
-
20Novartis case- An insight
21Novartis AG Anr. Vs Union of India Ors.
- ISSUES BEFORE THE COURT
- Whether amended Section 3(d) is in compliance
with Article 27 of TRIPS? - Whether amended Section 3(d) is arbitrary and
vague and therefore unconstitutional under
Article 14 of the Constitution of India? and - Whether a declaratory relief from the Court can
be availed to the effect that the amended
Section 3(d) is not in compliance of
Article 27 of TRIPS?
22- The Court observed
- With regard to (a) - the issue may be agitated
before the Dispute Settlement Body under
WTO/TRIPS. - With regard to (b) - Article 14 can be invoked
only when it is shown that in the exercise of a
discretionary power there is a possibility of a
real and substantial discrimination and such
exercise interferes with the fundamental rights
guaranteed by the Constitution. -
23-
- A wrong decision arrived at by the Patent
Controller based on wrong application of the
amended Section cannot be a ground to strike
down the said amended Section which was
otherwise in order. - With regard to (c) - the declaratory
relief, even if granted, would be only on
paper, as on the - basis of which, the petitioner
cannot claim any - further relief in the Indian
Courts. - Â
24WHAT COURT SAID ON EFFICACY?
- going by the meaning of the word efficacy and
therapeutic ... , what the patent applicant is
expected to show is, how effective the new
discovery made would be in healing a
disease/having a good effect on the body. In
other words, the patent applicant is definitely
aware as to what is the therapeutic effect of
the drug for which he had already got a patent
and what is the difference between the
therapeutic effect of the patented drug and the
drug in respect of which patent is asked for.
25WHAT DRAFT MANUAL HAS TO SAY ON EFFICACY?
-
- In the attempt to define the efficacy, the
Draft Manual cites Novartis case, which seeks to
define efficacy as therapeutic efficacy. This
is restrictive. The definition of enhanced
efficacy should include other parameters such as
faster response time, lesser side effects,
increased stability, increased bioavailability,
reduction in treatment period, wider spectrum of
activity, etc.
26EFFECT OF SECTION 3(d)
- Situation of ambiguity Arbitrary decisions by
the Patent Office due to non-definitive term
Enhanced Efficacy - Increased rejections of applications under
Section 3(d) - Increased pre-grant oppositions
- What a hit to Black-Box applications?
- Amended Section 3(d) requires Enhanced
efficacy data-means- - Black-Box applicants to have completed
clinical studies when Section 3(d) in its present
form was non-existent. Now requiring completed
studies for allowance of those applications would
be a retroactive denial of patentability - A state of bewilderment
27WHAT TO DO TODAY?
- AT THE DOMESTIC LEVEL
- Applicants need to be pro-active in taking up the
matter with higher forum- Precedents need to be
laid down - Reform in the system- Patent Office needs to be
trained - Laying down uniform, detailed and unambiguous
guidelines to reduce the area of conflict. - AT THE GLOBAL LEVEL
- Government(s) of developing and developed
countries to approach the Dispute Settlement Body
under TRIPS for necessary modification of
Section 3(d). - We appreciate that perfection is not easy to
achieve - BUT
- One can always strive for it.
28Patent linkage
- Another burning topic in India
-
- Patent Linkage is the practice that creates a
link between the patent status of a product and
its application for marketing authorization which
prevents approval of marketing generic/infringing
medicines. - The Drugs Cosmetics law read with the Patents
Act, 1970 provides the concept of Patent
Linkage. - In an unprecedented litigation, Bayer
Corporation Vs Union of India, our Firm had a
privilege of bringing this concept into
limelight.
29- The Court framed the following issues
- Â
- Whether the DGCI can grant marketing approval
under the DCA to generic versions of patented
drugs? - Whether the grant of such marketing approvals to
generic versions of a patented drug is in
derogation of the Patents Act? and - Whether generic drugs are spurious drugs in terms
of the DCA?
30-
- Regarding issues (1) (2), the Court observed
that the scheme of the Patents Act and the Drugs
Act had distinct and disparate objectives. The
Drugs Act was a public regulatory measure,
prescribing, amongst other things, standards of
safety and manufacturing practices which were to
be followed by the pharmaceutical industry. The
Patents Act on the other hand conferred private
monopoly rights in favour of inventors which were
certainly subject to the satisfaction of certain
conditions prescribed therein. - Accordingly, unless there are express provisions
in the DCA requiring the DCGI not to grant
marketing approval to a generic manufacturer in
respect of a patented drug, it is not possible
for this Court to read such a requirement into
the law.
31-
-
- Regarding issue (3), the Court observed that the
terms imitation and substitute occurring in
the definition of spurious drug are to be read
in conjunction with the other words in a manner
likely to deceive. This envisages a situation
where a generic manufacturer is passing off its
drug as that of the patent holder by way of
deception. It would be stretching the language of
the definition of spurious drug to an
impermissible limit to hold that all generic
versions of patented drugs, for which marketing
approval is sought from the DGCI in terms of the
DCA, should be considered spurious drugs.
32CONCLUSION
-
- LAWYERS TO HAVE A FIELD DAY
33