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Pharmaceutical Industry › Preliminary Injunctions › Biologics

Sheppard Mullin Richter & Hampton LLP

Biopharmaceutical Patent Litigation: Regeneron’s Defense Against Biosimilar Launches

Sheppard Mullin Richter & Hampton LLP on

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions of EYLEA®, a drug used to treat eye diseases, by asserting patent infringement....more

Polsinelli

Personal Jurisdiction Considerations for International Biosimilars Companies

Polsinelli on

The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

McDonnell Boehnen Hulbert & Berghoff LLP on

Note: This post addresses two Federal Circuit decisions issued on January 29, 2025.  Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more

Venable LLP

Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction

Venable LLP on

On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

American Conference Institute (ACI) on

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Herbert Smith Freehills Kramer

Biosimilars in 2020: What’s Ahead

Herbert Smith Freehills Kramer on

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Robins Kaplan LLP

When Time is Money

Robins Kaplan LLP on

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Mintz - Health Care Viewpoints on

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Issues Its First Decision Interpreting BPCIA

Patterson Belknap Webb & Tyler LLP on

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

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