Tag Archives: patents

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The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated.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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Rapid Litigation v. CellzDirect – A Break in the 101 Wall

On July 5, 2016, a three – judge Fed. Circuit panel of Moore, Prost and Stoll (Appeal no. 2015-1570) reversed the district court’s holding that claims to a method of isolating “hardy” twice -frozen hepatocytes (as I called them in my … Continue reading

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Bascom v. AT&T — Patent Eligibility Meet Patentability

…..Or Judge Newman proposes a blended approach when “Abstract Idea” or “Inventive Concept” is at issue. In Bascom v. AT&T, Appeal no. 2015-1763 (June 27, 2016, Fed. Cir.), panel of Judges Newman, O’Malley and Chen reversed the district court’s finding that … 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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