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Patent Trial and Appeal Board Pharmaceutical Industry AbbVie

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Goodwin

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Haug Partners LLP

FDA Acting Commissioner of Food and Drugs Seeks Collaboration Between FDA and USPTO to Address Pharmaceutical Patent-Related...

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On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

Biosimilar Legal Decisions to Keep an Eye out for in 2019

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Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more

Goodwin

Biosimilar-Related Appeals Pending before the Federal Circuit

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There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Goodwin

Recent IPR Updates

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The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

Goodwin

PTAB Issues Additional Final Written Decisions Finding AbbVie’s Humira Patent Unpatentable

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On July 6, 2017, the PTAB issued two additional Final Written Decisions finding AbbVie’s U.S. Patent 8,889,135 (“the ‘135 patent”) unpatentable as obvious over the prior art. The Final Written Decisions were issued in...more

Goodwin

PTAB Finds Two Abbvie Adalimumab Method of Use Patents Unpatentable in Final Written Decisions

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The PTAB has issued Final Written Decisions in IPRs filed by Coherus against two of Abbvie’s patents, IPR2016-00188 (U.S. Patent No. 9,017,680) and IPR2016-00189 (U.S. Patent No. 9.073,987), finding the challenged claims...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - June 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Idenix Pharmaceuticals LLC et al. v. Gilead Pharmasset LLC 1:15-cv-00416; filed May 21, 2015 in the District Court of...more

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