“Bolar Amendment” Provides Broad Protection For Drug Research, Supreme Court Says
This article was originally published in The Pink Sheet Daily
The Waxman/Hatch safe harbor from patent infringement claims encompasses preclinical research on compounds that are not ultimately the subject of an FDA submission, the Supreme Court unanimously rules in the Merck v. Integra case.
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During oral arguments in the Merck KGaA v. Integra case, several justices suggest that preclinical efficacy data are a key consideration during the IND process and may warrant “safe harbor” protection from patent infringement claims under the “Bolar Amendment.”
Pharma companies and BIO ask the high court not to create a “bright line” test for determining what types of research are protected. The appeals court decision in Merck KGaA v. Integra found that the Waxman/Hatch “safe harbor” protection from patent infringement claims did not extend to preclinical research.
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