News & Analysis as of

Pharmaceutical Industry Supreme Court of the United States En Banc Review

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

Rothwell, Figg, Ernst & Manbeck, P.C.

A Potential Pivot in Patent Procedure – Will the Supreme Court Hear Amgen’s Challenge to the Standard of Review for Enablement?

As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha®...more

King & Spalding

Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs

King & Spalding on

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more

Akin Gump Strauss Hauer & Feld LLP

IP Newsflash - August 2015 #4

SUPREME COURT CASES - The Supreme Court Upholds Prohibition on Charging Royalties After Patent Expiration - In Kimble v. Marvel Entertainment LLC, 576 U.S. ---- (2015), the Supreme Court declined to overrule its 1964...more

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