Tuesday, March 09, 2010

Fixing Hatch-Waxman

Note the article in the 26 Feb 2010 issue of Science, Fixing the Legal Framework for Pharmaceutical Research, by Sherry M. Knowles, Chief Patent Counsel, Glaxo. In the sub-headline, the Hatch-Waxman Act is referred to as outdated.

KSR v. Teleflex appears as "holding an invention unpatentable if there are finite number of predictable alternatives that would be obvious to try." Knowles also stated that KSR applied retroactively.

Knowles recommended amending Hatch-Waxman to increase the period of R&D data exclusivity from 5 to 14 years. Related to the "retroactive" comment, Knowles concludes: "Congress should pass a law that gives an appellate court discretion to mark a decision for prospective application only, if it overrules a prior interpretation of patent statutory law."


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