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Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Biomaterials and Unclean Hands

Morrison & Foerster LLP - Left Coast Appeals on

This week, we take a look at the Ninth Circuit’s decisions construing the Biomaterials Access Assurance Act’s immunity for “biomaterials suppliers” and addressing the standard of review when a district court grants summary...more

Hogan Lovells

China adds 30 drugs to its "urgently needed" list

Hogan Lovells on

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications - On 28 March China's National Medical Products Administration (NMPA) published a list of an...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Upholds Invalidity of Athena’s Claims Directed to Methods for Diagnosing Neurological Disorders

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, a divided panel of the Federal Circuit has provided another guidepost in the search for patent-eligible subject matter in the diagnostic industry. The Court upheld a...more

Hogan Lovells

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Hogan Lovells on

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

Hogan Lovells

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Affirms PTAB Holding of No Interference in Fact in CRISPR Interference, Leaving Both Sides Free to License Their...

Akin Gump Strauss Hauer & Feld LLP on

On September 10, 2018, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) determining that there was no interference in fact between the University of California’s (“UC”) U.S. Patent...more

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