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Pharmaceutical Industry › Article III › Biosimilars

DLA Piper

Distribution of Biosimilar Pharmaceuticals Through Third Parties is Not Enough to Avoid Personal Jurisdiction

DLA Piper on

In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit recently held that biosimilar pharmaceutical companies that filed abbreviated Biologics License Applications (aBLAs) and planned to make a single sale to a...more

McDermott Will & Schulte

Mootness on Appeal from PTAB

McDermott Will & Schulte on

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

Foley & Lardner LLP

Court Dismisses Biosimilar Petitioner's IPR Appeal For Lack of Standing

Foley & Lardner LLP on

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta’s appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar...more

WilmerHale

Federal Circuit Holds Petitioner Lacks Standing to Appeal Inter Partes Review Decision

WilmerHale on

On February 7, 2019, in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed an appeal brought by a petitioner in an inter partes review (IPR) for lack of standing and mootness because...more

Troutman Pepper Locke

Sometimes the Patent Office Has the Last and Only Word

Troutman Pepper Locke on

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

Year in Review: Top Five Biosimilar Legal Developments of 2018

Goodwin on

Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more

Goodwin

Federal Circuit Orders Momenta to Show Cause in ORENCIA IPR Appeal

Goodwin on

As we have previously reported, Momenta appealed a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product. On October 1, 2018, Momenta informed the Court...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

Patterson Belknap Webb & Tyler LLP

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar...

Patterson Belknap Webb & Tyler LLP on

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more

Proskauer - New England IP Blog

Biosimilars Update

Proskauer - New England IP Blog on

Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more

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