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Ms. Arpita Sawhney

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Title: Ms. Arpita Sawhney


1
Patent Law In IndiaQuestions Outstanding
2
  • This presentation comprises of the following
  • Background
  • Critical appraisal of Section 3 (d) of the
    Patents Act, 1970 vis-à-vis TRIPS-Defaults at
    legislative level
  • Analysis of Section 3(d)
  • Novartis case- An insight and
  • Burning topic Patent Linkage

3
  • Background

4
WTO/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

5
PRODUCT 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-à-vis TRIPS

7
ITS 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..

8
Pre- 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

9
India 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.

11
ARTICLE 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.

13
WORTH 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
  • Analysis of Section 3(d)

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.

16
Explanation 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

18
Section 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.

20
Novartis case- An insight
21
Novartis 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.
  •  

24
WHAT 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.

25
WHAT 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.

26
EFFECT 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

27
WHAT 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.

28
Patent 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
  •  
  • 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.

32
CONCLUSION
  • LAWYERS TO HAVE A FIELD DAY

33
  • THANK YOU
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