Ms. Arpita Sawhney

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Patent Law In IndiaQuestions Outstanding
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• 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

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• Background

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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

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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

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• Critical appraisal of Section 3 (d)
• vis-à-vis TRIPS

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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..

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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

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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)

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• 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.

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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

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• 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.

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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).

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• Analysis of Section 3(d)

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• 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.

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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
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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

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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.

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• 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.

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Novartis case- An insight
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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?

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• 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.

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• 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.
•  

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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.

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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.

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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

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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.

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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.

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• 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?

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• 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.

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• 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.

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CONCLUSION

• LAWYERS TO HAVE A FIELD DAY

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• THANK YOU