Tag Archives: biotechnology law

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The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated.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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Supreme Court Rewrites the Law of Enhanced Damages

This is a guest post by Janice M. Mueller of Chisum Patent Academy. Today the Supreme Court rewrote the law of enhanced damages for willful patent infringement by issuing a unanimous decision in No. 14-1513, Halo Elecs., Inc. v. Pulse … Continue reading

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