News & Analysis as of

En Banc Review Pharmaceutical Patents Pharmaceutical Industry

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

Federal Circuit Stays Teva v. Amneal Ruling

In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange...more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

Fenwick & West LLP on

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

McDonnell Boehnen Hulbert & Berghoff LLP

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

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

A Potential Pivot in Patent Procedure – Will the Supreme Court Hear Amgen’s Challenge to the Standard of Review for Enablement?

As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha®...more

Harris Beach Murtha PLLC

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

Morrison & Foerster LLP - Federal Circuitry

Know Your En Banc Petition Process—How An En Banc Petition In GlaxoSmithKline v. Teva Led To A New Panel Argument Without Apparent...

Although argument week isn’t until next week, the Federal Circuit heard oral argument today in two cases. One was rescheduled from earlier this month for medical reasons. But the other, GlaxoSmithKline LLC v. Teva...more

Patterson Belknap Webb & Tyler LLP

USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more

Goodwin

Bristol Myers Squibb, Bavarian Nordic, and Enzo Biochem file amicus brief supporting Amgen’s petition for en banc consideration of...

Goodwin on

As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more

Sheppard Mullin Richter & Hampton LLP

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

K&L Gates LLP

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

K&L Gates LLP on

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

Akin Gump Strauss Hauer & Feld LLP

IP Newsflash - August 2015 #4

SUPREME COURT CASES - The Supreme Court Upholds Prohibition on Charging Royalties After Patent Expiration - In Kimble v. Marvel Entertainment LLC, 576 U.S. ---- (2015), the Supreme Court declined to overrule its 1964...more

Robins Kaplan LLP

Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc

Robins Kaplan LLP on

Case Name: Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 769 F.3d 1339 (Fed. Cir. Oct. 20, 2014) (Chief Judge Prost, Circuit Judges Newman, Plager, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)

Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more

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