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Patent Validity

  • Evaluation of patent validity via a fresh prior art search by a competent patent search professional.
  • For the acquisition of a small molecule therapeutics.
  • A Marpat search reveals what is covered in a Markush patent claim.
  • Other searches should be used to learn about scientific publications and presentations at conferences.
  • Additionally, cross check references cited in patent office proceedings.
  • Issues concerning the 102(b) on-sale bar are often overlooked when performing diligence on a drug candidate
  • Inequitable conduct can render a patent unenforceable and evidence of such conduct may be found in a variety of places.
  • Do the statements contradict other disclosures in publications or other patents, especially those made by the same inventors?
  • Lack of enablement or best mode can render the patent invalid under 35 U.S.C. 112.
  • Scientists should be consulted regarding whether claims are enabled.
  • It might happen if an improvement is made while the application is being prepared, and the application gets filed without disclosing the improvement.
  • If a patent validity issue or risk is suspected for one of the above reasons, then an evaluation needs to be made as to whether the potential problem can be rectified.
  • A new filing such as a continuation application, reissue or re-examination may be needed to mitigate any such risk.

Patent Validity Checklist is performed:

  • Anticipation and Obviousness
  • Sources of prior art
  • Cross-check references (e.g., from file wrappers, oppositions, etc.)
  • Target publications and presentations
  • Competitor’s patents and publications
  • Litigation
  • Scientific literature
  • Scientific conferences
  • Inequitable conduct
  • Cross-check related applications
  • Review inventor publication files
  • Review patent counsel files
  • Lack of enablement or written description
  • Consult scientist to analyze for each claim
  • Best mode
  • Confirm best mode known at time of relevant filings
  • Review inventor publications and internal memos
  • Consider need to file:
  • Amended claims
  • Continuations
  • Divisionals
  • Reissues
  • Re-examinations