Scope of Patentability, Exclusions, and Oppositions

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Scope of Patentability, Exclusions, and
Oppositions
Professor Amy Kapczynski University of California
at Berkeley Law School May 12, 2009
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Todays Program

• Basic requirements for patentability
• Exclusions from patentability
• Patent Oppositions and Revocation Proceedings

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Patent Requirements
20 year right to exclude others
From making, using, selling, importing the
invention

• Must first show that the invention is
• novel
• involves inventive step (non-obvious )
• is capable of industrial application (useful)

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(No Transcript)
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U.S. Patents related to Kaletra
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Worldwide Pharmaceutical Market by Region, 2005
CIPIH Report, data provided by IMS Health
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Section 3(d) of Indian Patent Act

• The following are not inventions within the
  meaning of this Act, -
• d. 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 . . .
   
• 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

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Article 27.1

• patents shall be available for any inventions,
  whether products or processes, in all fields of
  technology, provided that they are new, involve
  an inventive step and are capable of industrial
  application.
• patents shall be available and patent rights
  enjoyable without discrimination as to the place
  of invention, the field of technology and whether
  products are imported or locally produced.
• May exclude diagnostic, therapeutic, and
  surgical methods as well as plants and animals
  other than microorganisms (Art. 27.3)

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Article 27.2 and 27.3

• 2. Members may exclude from patentability
  inventions, the prevention within their territory
  of the commercial exploitation of which is
  necessary to protect 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.
•  
• 3. Members may also exclude from patentability
• (a) diagnostic, therapeutic and surgical methods
  for the treatment of humans or animals . . .

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Pre-grant Patent Oppositions

• Where an application for a patent has been
  published but a patent has not been granted, any
  person may, in writing, represent by way of
  opposition to the Controller against the grant of
  patent on the ground
• Lack of novelty
• Lack ot inventive step
• Subject matter is not patentable
• Failure to disclose certain required information
  to the patent office,
• Etc

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Article 62

• 1. Members may require, as a condition of the
  acquisition or maintenance of the intellectual
  property rights . . . compliance with reasonable
  procedures and formalities. Such procedures and
  formalities shall be consistent with the
  provisions of this Agreement.
•  
• 2. Members shall ensure that the procedures for
  grant or registration, subject to compliance with
  the substantive conditions for acquisition of the
  right, permit the granting or registration of the
  right within a reasonable period of time so as to
  avoid unwarranted curtailment of the period of
  protection.