News & Analysis as of

Preliminary Injunctions Appeals Notice Requirements

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2022 #4

ABC Corp. v. Tomoloo Official, Appeal Nos. 2021-2277, -2355, -2150 (Fed. Cir. Oct. 28, 2022) - ABC Corp. v. eBay, Inc., Appeal No. 2022-1071 (Fed. Cir. Oct. 28, 2022) - The following summary covers two decisions issued...more

McDermott Will & Emery

No Service, No Notice

Addressing the notice requirements of Fed. R. of Civ. Pro. 65(a)(1), the US Court of Appeals for the Fifth Circuit vacated a preliminary injunction, finding that the aggrieved party did not have sufficient notice of the...more

Knobbe Martens

Federal Circuit Review - July 2017

Knobbe Martens on

District Court Abused Discretion in Not Finding Case Exceptional - In Rothschild Connected Devices v. Guardian Protection Services, Appeal No. 2016-2521, the Federal Circuit held that a district court abused its discretion...more

McDermott Will & Emery

BPCIA 180-Day Notice of Intent to Market a Biosimilar Is Required, Enforceable by Injunction

In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)

Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Knobbe Martens

Federal Circuit Rules on Biosimilar Notice Requirement

Knobbe Martens on

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

Morgan Lewis

Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval

Morgan Lewis on

Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Decides Amgen v. Apotex, Holds that 180-Day Notice of Commercial Marketing is Always Mandatory in Biosimilar...

Yesterday, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

Patterson Belknap Webb & Tyler LLP

Both Parties Seek En Banc Intervention in Amgen v. Sandoz

Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more

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