News & Analysis as of

Obviousness BPCIA Pharmaceutical Industry

McDonnell Boehnen Hulbert & Berghoff LLP

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

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

Goodwin

Federal Circuit Affirms Injunction Against Samsung and Formycon in Aflibercept BPCIA Litigation

Goodwin on

On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

Goodwin on

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

Goodwin

Kashiv Files IPRs on Amgen Process Patents

Goodwin on

On March 7, 2019, Kashiv Biosciences filed two IPR petitions (IPR2019-00791 and IPR2019-00797) against Amgen process patents – U.S. Patent Nos. 8,940,878 and 9,643,997. The ‘878 and ‘997 patents are directed to methods to...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for December 2018?

This month we highlight two Federal Circuit obviousness-type double patenting decisions. CASES - Federal Circuit - Section 156 Patent Term Extension and Obviousness-Type Double Patenting - Novartis AG v. Ezra...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for August 2018?

This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for July 2018?

This month, we highlight significant developments from July 2018, including the FDA’s Biosimilar Action Plan for “reducing gaming of FDA requirements or other attempts to unfairly delay competition” and the much anticipated...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in May 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA intended to curb REMS “abuses,” and case law developments at the Federal...more

McDermott Will & Emery

ANDA Update - Volume 2, Number 2

McDermott Will & Emery on

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

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