Hot Topics In Life Science Patents Current IP Strategies and Issues

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Hot Topics In Life Science PatentsCurrent IP
Strategies and Issues
Brian Kingwell
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Research Tools

• 1) What Kinds of Claims are Available?
• 2) How Can the Scope be Maximized?
• 3) When Will the Claims be Infringed?
• 4) When is there Freedom to Operate?
• 5) How can they be Licensed?

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Reach Through Claims

• Extending Your Grasp Claims made to products, or
  to uses for products, based upon the disclosure
  of screening methods or tools for the
  identification of such products.

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U.S. Patent No. 6,048,850

• University of Rochester Press Release, April
  2000
• Hot off the presses...
• University of Rochester Awarded Patent forNew
  Class of Drugs Known as Cox-2 Inhibitors Files
  Infringement Suit Against Searle, Pfizer
• Historic drug patent is likely to bethe most
  lucrative in U.S. history

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U.S. Patent No. 6,048,850

• University of Rochester Press Release, March 5,
  2003
• University to Appeal Ruling in Patent Case
  Against Pfizer and Pharmacia
• Federal Circuit Court to Decide Landmark
  CaseInvolving the Arthritis Drug Celebrex
• The University of Rochester intends to
  appeal a federal courts decision, issued today,
  that ruled invalid its patent covering the class
  of drugs known as cox-2 inhibitors.

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U.S. Patent No. 6,048,850

• Pfizer News Release, February 16, 2004
• Pfizer Says Dismissal of University of Rochester
  COX-2 Use Patent Lawsuit Affirmed by U.S Court of
  Appeals
• We are very pleased that our position with
  respect to this patent has been confirmed on
  appeal

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U.S. Patent No. 6,048,850

• University of Rochester Press Release, Friday,
  July 02, 2004
• Statement from the University of Rochester on
  Ruling in Cox-2 Infringement Case
• "This is obviously disappointing, although the
  fact that there are five separate opinions
  written confirms the view that this is a major
  issue of patent law," said University President
  Thomas H. Jackson. "We will be reading the
  opinions and considering our next steps over the
  coming days.

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Obtaining Broad Claims

• In the absence of reach through claims, are
  meaningful claims available?
• How can the scope of claims be expanded?

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U.S. Patent No. 6,048,850 v. U.S. Patent No.
6,469,012

• Pfizer still enforcing its broad VIAGRA patent
• Claims use of a class of compounds based on
  single working example
• Found invalid for obviousness in UK and AU
• revoked in CN
• In the US, re-examination of claim 24 proceeds
• Litigation is pending in Australia, Brazil,
  Canada, Mexico, New Zealand and South Africa.

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Experimental Evidence is Needed to Prove
Enablement

• Rasmusson v. SmithKline Beecham, Fed. Cir. 27
  June 2005
• A person of skill in the art would not have
  believed on the date of the priority application
  that the claimed invention would be effective in
  treating prostate cancer.
• 'when there is a complete absence of data
  supporting the statements which set forth the
  desired results of the claimed invention.'

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Experimental Evidence is NOT Needed to Anticipate

• Rasmusson v. SmithKline Beecham, Fed. Cir. 27
  June 2005
• A European patent application anticipated the
  SmithKline patent. Even though a prior art
  reference must be enabling, enablement for
  purposes of anticipation does not require proof
  of efficacy. A disclosure that fails to prove
  efficacy may be entirely adequate to anticipate a
  claim and, at the same time, entirely inadequate
  to support the allowance of such a claim.
• The scorched earth is a reality.

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Detailed Disclosure is Required for Nascent
Technologies

• Chiron Corp. v. Genentech, Fed. Cir. Mar. 30,
  2004
• If you file CIPs with additional data to support
  your claims, you can lose your priority date.
• "The law does not expect an applicant to disclose
  knowledge invented or developed after the filing
  date. Such disclosure would be impossible.
  Nascent technology, however, must be enabled with
  a 'specific and useful teaching."

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Utility of Genomic Research Tools

• Europe invention must be susceptible of
  industrial application
• The industrial application of a sequence or a
  partial sequence of a gene must be disclosed in
  the patent application.
• US Utility must be specific, substantial and
  credible (Utility Guidelines)
• If a credible utility is not apparent or
  disclosed, it may be established by evidence
  submitted after filing.

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US Utility Guidelines

• Usefulness must be based upon specific
  combination of claimed elements (e.g. transgene
  animalsphenotype)
• General use such as snake food neither
  sufficiently specific or substantial, unless
  invention is directed to enhanced animal feed
• Credibility depends on explicit or implicitly
  disclosed utility, assessed from perspective of
  skill and knowledge in the art

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Utility of Research Tools

• In Re Fisher , (CAFC 7 September 2005)
• Endorsed Utility Guidelines
• An assessment that focuses on whether an
  invention is useful only in a research setting
  does not address whether the invention is in fact
  useful in a patent sense. The PTO must
  distinguish between inventions that have a
  specifically identified substantial utility and
  inventions whose asserted utility requires
  further research to identify or reasonably
  confirm.

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Utility of ESTs

• In Re Fisher , (CAFC 7 September 2005)
• Neither the use of the ESTs to identify and
  detect polymorphisms or their use as probes or as
  a source for primers satisfied the utility
  requirement, because those were "insubstantial"
  uses without current benefit.
• The claimed invention must have a significant and
  presently available benefit to the public.

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Written Description of ESTs

• Ex parte Fisher , 72 USPQ2d 1020 (BPAI 2004)
• Written Description The Board held that the
  disclosure of SEQ ID NOs. 1-5 provided "adequate"
  written description of the nucleic acid molecules
  with those sequences, including molecules with
  "other molecules attached to either or both of
  their 5' or 3' ends.
• This suggests that applicants may be entitled to
  claims "comprising" sequences that are set forth
  in the specification, even if longer sequences
  encompassed by the open-ended language are not
  specifically described.

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CollaborationsExpand Scope

• How can organization collaborate to improve the
  prospects of obtaining broad claims?
• May Provide Data
• to substantiate utility
• to meet written description requirement
• to justify product claims

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CREATE Act

• Cooperative Research and Technology Enhancement
  Act of 2004
• Excludes (secret) prior art when
• the claimed invention was made by or on behalf of
  parties to a joint research agreement that was in
  effect on or before the date the claimed
  invention was made
• the claimed invention was made as a result of
  activities undertaken within the scope of the
  joint research agreement and
• the application for patent for the claimed
  invention discloses or is amended to disclose the
  names of the parties to the joint research
  agreement.

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CREATE Act

• May Require
• a terminal disclaimer,
• if the prior art is an issued patent, to overcome
  double patenting between applications not owned
  by the same party.
• May
• record the joint research agreement

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Infringement

• What is the territorial scope of infringing
  activities?
• How broad is the experimental use exemption?
• When does the clinical trial exemption apply?
• What is the measure of damages for research tool
  claims?
• Is the cost of enforcement prohibitive?

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Importing Data is not Infringement

• Bayer v. Housey Pharmaceuticals, CAFC 22 August
  2003
• The use of patented research tools in
  jurisdictions where no patent rights exist does
  not prevent the resulting drug product from being
  imported into or manufactured in the U.S., absent
  a patent covering the specific drug composition
  or method of manufacture. In other words,
  although a product made by a process patented in
  the U.S. can be stopped at the border, "processes
  of identification and generation of data are not
  steps in the manufacture of a final drug
  product."

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The Experimental Use Exception is Narrow

• Madey v. Duke University, Fed. Cir. 2002
• No broad research exemption or "experimental use"
  exception to patent infringement, even for
  non-profit educational institutions.
• The experimental use exception is narrow and
  applies only to activities that are "for
  amusement, to satisfy idle curiosity, or for
  strictly philosophical inquiry."

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The Experimental Use Exception is Narrow

• Madey v. Duke University, (Fed. Cir. 2002).
• Regardless of whether a particular institution or
  entity is engaged in an endeavor for commercial
  gain, so long as the act is in furtherance of the
  alleged infringer's legitimate business and is
  not solely for amusement, to satisfy idle
  curiosity, or for strictly philosophical inquiry,
  the act does not qualify for the very narrow and
  strictly limited experimental use defense.
  Moreover, the profit or non-profit status of the
  user is not determinative.

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The Clinical Research Exemption From Infringement
is Broad (the Bolar exemption under 35 USC
271(e)(1))

• Merck v. Integra Lifesciences, 13 June 2005 CAFC
• The exemption does not globally embrace all
  experimental activity that at some point,
  however attenuated, may lead to an FDA approval
  process.
• BUT, Under certain conditions, the exemption is
  sufficiently broad to cover
• (1) experimentation on drugs that are not
  ultimately the subject of an FDA submission,
  or
• (2) use of patented compounds in experiments
  that are not ultimately submitted to the FDA.

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Reach Through Royalties/Damages

• Sibia v. Cadus, Fed. Cir. 2000
• At trial, Sibia awarded a royalty of 18 million
  based on a finding that Cadus's products
  infringed Sibia's research tool patent directed
  to methods of drug discovery.
• Sibia's damages award was based on Cadus's actual
  and potential profits on its commercialized
  products.
• Sibias patent was invalidated on appeal, on
  grounds of obviousness.

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Patent Reform Act of 2005

• May reduce costs of enforcement.
• Includes
• a move to first-to-file
• changes to the duty of candor
• limitations on infringement and willfulness
  damages
• modified best mode requirement
• post grant opposition procedures

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Patent Reform Act of 2005

• Changing as it moves through Congress.
• Eliminated injunction provision, and provision
  that would limit the scope of claims in
  continuing applications.
• yet to see which measures will make it out of
  committee
• When thinking about timelines for reform
  legislation, remember that The American Inventors
  Protection Act (AIPA) was passed in 1999. The
  process to put that legislation in place started
  in 1991.

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Thank you