Tag Archives: biotechnology law

Federal Circuit Denies En Banc Review of Athena v. Mayo

On July 3rd, the Fed. Cir. denied Athena’s petition for rehearing en banc. The three-page order is a 7/5 denial accompanied by more than 80 pages of concurrences and dissents. Concurring in various combinations are Judges Lourie, Hughes, Dyk, Reyna, … Continue reading

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FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this … Continue reading

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USPTO will “Fast Track” Cancer Immunotherapy Applications

On June 29, 2016, Director Lee promulgated rules to implement a one-year pilot program to effectively grant “Fast Track” status to applications with at least one claim to treating cancer using immunotherapy. (A copy of this document can be found … Continue reading

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“Unclean Hands” Doctrine Erases Merck’s Damage Award

In my last post on the district court’s ruling in Gilead v. Merck, I implied that Gilead had convinced the Judge that Merck had employed inequitable conduct (“IC”) in conducting its negotiations with Pharmasset, the company Gilead later purchased to … Continue reading

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