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Inter Partes Review (IPR) Proceeding Biosimilars Appeals

Venable LLP

Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™

Venable LLP on

On April 15, 2025, Biocon announced it reached a settlement agreement with Regeneron, dismissing CAFC Appeal No. 24-2002 and Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more

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

Does the Term “Human Antibody” Include Humanized Antibodies?

In the context of Immunex’s patent on IL-4 antibodies, the Federal Circuit says yes. On October 13, 2020, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (the “Board”) final written decision in...more

Goodwin

Federal Circuit Issues Two Rulings in Biosimilar-Related IPR Appeals

Goodwin on

This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings....more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

McDermott Will & Emery

Mootness on Appeal from PTAB

The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more

Goodwin

Biosimilar IPR Appeal Updates

Goodwin on

Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a...more

Knobbe Martens

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company

Knobbe Martens on

Federal Circuit Summaries - Before Newman, Dyk, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: An injury-in-fact is required to establish Article III standing for judicial review of agency action,...more

Troutman Pepper Locke

Sometimes the Patent Office Has the Last and Only Word

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The Federal Circuit just issued a decision that confirms its stance on Article III standing for appeals from inter partes reviews (IPRs), making it tougher for unsuccessful IPR petitioners to obtain judicial review of U.S....more

Goodwin

Federal Circuit Dismisses Momenta’s Appeal of Adverse Final Written Decision in Abatacept IPR

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This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR...more

Goodwin

Momenta Contends ORENCIA IPR Appeal Is Not Moot

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On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to...more

Troutman Pepper Locke

Attorney General’s Office May Weigh In on Constitutionality of IPRs involving Pre-AIA Patents

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The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more

Goodwin

BMS and Momenta File Additional Letters Regarding Standing in Orencia IPR Appeal

Goodwin on

As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product. Momenta has not yet filed an...more

Goodwin

Biosimilar Litigation Updates

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Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

Core Wireless v. LG affirms the denial of summary judgment as to unpatentable subject matter, ruling that the asserted claims are directed to an improved user interface for computing devices, not to the abstract idea of an...more

WilmerHale

Federal Circuit Patent Updates - July 2016 #2

WilmerHale on

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

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The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

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