Pharma's Nonobvious Problem

Intellectual Property and Patents

Article Snapshot

Author(s)

Rebecca S. Eisenberg

Source

Lewis & Clark Law Review, Vol. 12, No. 2, pg. 376, May 22, 2008

Summary

This article asks whether a Supreme Court patent ruling will cause problems with pharmaceutical patents.

Policy Relevance

Flexible rules for determining the validity of patents can lengthen troublesome litigation.

Main Points

  • Inventions that would be obvious to others with ordinary skill in that field are not patentable; nonobvious inventions are patentable.

  • The Supreme Court’s 2007 decision in KSR International Co. v. Teleflex Inc. might make it easier for rivals to argue that drug companies’ patents on pharmaceutical products are invalid because the invention was “obvious.”
    • A key issue is whether only evidence of obviousness from the time that the product is invented, or evidence developed later, is considered.

  • In KSR, the Supreme Court emphasizes the need for flexibility instead of rigid rules in determining whether a patented invention is “obvious.”

  • In some cases, the Federal Circuit court, which hears patent appeals, has used rigid rules to determine obviousness of a chemical invention; in other cases involving biotechnology, the court has been more flexible.
    • Cases that avoid rigid rules and take a more flexible approach can be troubling to inventors in the industry, because flexibility can mean uncertainty and longer litigation.

  • With pharmaceuticals, courts have determined obviousness by asking whether the invention’s molecules are similar to those of earlier inventions.
    • Similarity is evidence of obviousness, but if a new invention has surprising properties, this is evidence of nonobviousness.

  • The Federal Circuit’s decisions in pharmaceutical cases are flexible, but careful, and are fairly predictable.
    • Cases decided before KSR tend to be more skeptical of patents on new versions of old drugs, but more open to patents on new drugs similar to old ones.

  • The Supreme Court’s decision in KSR might make the Federal Circuit court too flexible in ruling on pharmaceutical patents, creating uncertainty and lengthy litigation.

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