Residual Issues in Patentability Criteria in India

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Residual Issues in Patentability Criteria in
India Overseas
Dr. Gopakumar G. Nair Gopakumar Nair
Associates (gopanair_at_gnaipr.net) on 11th July
2008 at Hotel Taj Krishna, Hyderabad
GNAs
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Patent Policy

• CONVERGENCE
• Indian US Patent Laws are converging
• On substantive aspects of patentability
• criteria.

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Patentability Criteria

• Novelty
• - Prior art based
• Indian Patent Offices rely on prior art
• USPTO now insists on Prior Art Disclosure as
  compulsory
• McKesson Information Solutn Inc v. Bridge
  Medical, Inc
• When related prior art material disclosures are
  not made in the patent application and are not
  continuously intimated to the patent office
  thereafter, such a conduct is considered
  inequitable and the patent application is to be
  declared invalid and unenforceable. Incase of
  prior art materials, disclosures should be made
  in the patent application and as such should be
  communicated to the patent office as and when
  available to the patent applicant

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Patentability Criteria

• Non-obviousness / inventive step
• India liberal on obviousness
• US was liberal on obviousness
• Now tightening up after
• KSR vs. Teleflex
• (SC 04-1350 decided April 30, 2007)
• Pfizer vs. Apotex
• (USCAFC 2006-1261 May 21, 2007)

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Patentability

• USA
• Anything under the sun involving manual
  intervention.
• INDIA
• INVENTIONS not PATENTABLE
• 3(a) TO 3(p)

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Non-patentability

• 3(d) New Forms without enhanced efficacy.
• (Chennai High Court on Gleevec)
• 3(p) Traditional Knowledge.

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Non-patentability

• Compulsory for microorganisms and life forms
  including plants
• ? Disclosure of Origin (Budapest Treaty)
• ? Benefit Sharing
• ? Biodiversity Act
• (The Biological Diversity Act, 2002)

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Plant Patentability

• US Plant Patents
• India Plant Varieties Protection Act
• (The Protection of Plant Varieties and Farmers
  Rights Act, 2001)
• (http//agricoop.nic.in)

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Patentability Criteria

• Anticipation
• India rigid on single Prior art-based
  anticipation
• Insists mosaic of Prior arts are not
  anticipation
• PCT/US Often cites close prior arts as
  affecting Patentability

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Unity of Invention

• India more liberal on
• group of inventions
• USPTO very restrictive
• Insists on electing one invention / Filing
  Divisionals
• Even Process / Composition / use as separate
  inventions

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Timelines

• India Rigid on extensions
• Normally extensions not granted
• US very liberal
• protracted prosecution
• Court order based fast tracking

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Publication / Public Domain Information

• India Bibliography
• US/EU Full Patent
• US Total Transparency Public Pair
• EU Legal Status
• Patent Family

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Patent Office Procedures

• India Post dating
• (allows) Complete to Provisional
• Cognates
• Addition Patents
• US Liberal procedures
• (allows) C.I.Ps
• Amendments/RCE

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US vs. INDIA

• US grants
• Patent Term extensions/adjustments
• Data Exclusivity
• Orange Book Listings
• 180 Day Exclusivity
• INDIA does not grant any of above

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Indian Patent/Regulatory

• Unlike USA/Europe, the Patent Regulatory link has
  not been formalised.
• Generic launch friendly Indian policy

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Oppositions

• USA
• Opportunity to protest Amicus Curie in
  litigation
• India (Recent Gleevec Case)
• Pre-grant Opposition
• Post-grant Opposition
• Counterclaim for Revocation
• Government use option

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Research Exemptions

• USA
• Used to be rigid
• Under Bolar exemption (Hatch - Waxman)
• Became liberal after US Supreme Court
• Judgement on Merck vs. Integra
• Contrast with Madey vs. Duke
• India
• Research Educational Exemptions
• More liberal broad
• Sec. 47A Educational
• Sec. 107A Research for ANDA

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Compulsory Licence

• USA
• 28 USC 1498
• India
• Sec. 63 to 94 92A
• Govt. use Sec. 99 to 103
• (Recent Natco Case)

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Patent Challenges

• USA
• Para IV Challenge
• Recent Developments
• Caraco vs. Forest
• MedImmune vs. Genentech
• India
• Infringement based litigation
• Roche vs. Cipla on Tarceva

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Injunctions / summary suits

• India
• Frequency increasing
• Recent Case
• Garware Wall Ropes Ltd. V. M/s. TECHFAB India (A
  "Synthetic" Judgment)
• Facts of the CaseThe present case involves two
  manufacturers of synthetic ropes, twines, yarns
  and various rope products such as gabions. The
  first of them are the appellants/patentee Garware
  Wall Ropes Ltd. and the other, the respondents
  M/S Techfab India who have been accused of
  infringing the appellants' patent on a certain
  Synthetic Rope Gabion (referred to as SRG in
  short). The judgment doesnt explain what exactly
  are the features of SRG but for a vague mention
  that it is a gabion which uses synthetic rope, as
  opposed to a metal wire, as the meshing element
  that forms the outer body of the gabion (neither
  is the specification of the patent available on
  any of the patent websites). Accordingly, the
  appellants claim that the use of synthetic rope
  imparts greater flexibility to the gabion, which
  helps overcome the disadvantages associated with
  a rigid metal frame.
• Contd

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Injunctions / summary suits(contd.)

• According to the appellants, an agent of theirs
  in Gujarat informed them of the infringement of
  their patent by the respondents early in October
  2005 and on the 17th of the same month, an
  infringement suit along with a prayer for
  ad-interim relief was filed in the District
  Court, Surat, which was granted ex-parte the next
  day. Following this, the respondents filed for an
  appeal in the Gujarat High Court against the
  injunction, exactly a week after the grant of the
  injunction. The following day, the injunction was
  vacated by a Single Judge, with the observation
  that in case the respondents feel that the
  impugned gabions are different than (from) the
  patented SRG invention of the appellant, the
  respondents were free to manufacture and sell the
  impugned gabions. The respondents were then
  directed to maintain accounts of such manufacture
  and sale.Consequent to the filing of a
  counterclaim by the respondents for revocation of
  the patent, the suit was transferred to the High
  Court (under proviso to s.104) along with an
  application by the appellants to quash the Single
  Judges order.

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THANK YOU !