FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II
FCPA Compliance and Ethics Report-Episode 82, continued fallout from GSK in China
FCPA Compliance and Ethics Report-Episode 15-GSK in China: a Game Changer in Compliance
Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc....more
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO...more
Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more
On May 15, 2023, the Supreme Court denied certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC et al., a case some argued had enormous implications for so-called “skinny labeling” practices amongst generic drug...more
M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more
The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays....more
In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more
Background - On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more
Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more
The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more
On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more
I continue with the multi-part blog post series based upon the New York Times (NYT) article by Alexandra Stevenson and Sui-Lee Wee, entitled “Selling CT Scanners with Bricks of Bills in China”, which details allegations of...more
After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more
On September 26, 2018, the EU General Court (the Court) upheld the European Commission’s refusal to reinvestigate GlaxoSmithKline SA’s (GSK) Spanish “dual-pricing” distribution arrangements, 20 years after the alleged conduct...more
Yesterday, Merck Sharp & Dohme Corp. filed four IPR petitions (IPR2018-01229, IPR2018-01236, IPR2018-01234, and IPR2018-01237) against GlaxoSmithKline process patents – US Patent Nos. 8,753,645 and 9,265,839. The ‘645 and...more
This past year has seen renewed challenges to reverse payment settlement agreements in the pharmaceutical industry. Since the Supreme Court’s Actavis decision in mid-2013, potentially anti-competitive agreements are...more
Case Name: GlaxoSmithKline LLC v. Teva Pharma. USA, Inc., No. 14-878, 2018 U.S. Dist. LEXIS 51169 (D. Del. Mar. 28, 2018) (Stark, J.). Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S. Patent No. RE40,000 (“the...more
The Third Circuit recently denied a petition for rehearing en banc a panel’s earlier decision in the In re Flonase Antitrust Litigation. In that case, the panel decision addressed the degree to which class settlements can...more
The Third Circuit Court of Appeals affirmed a Pennsylvania district court decision holding the Eleventh Amendment to the United States Constitution prevented a private party from enjoining the state of Louisiana from bringing...more
The Peltz/P&G drama continues, with the company suggesting that Trian has lost its bid for a Board seat and the fund arguing that it disagrees with the company’s counting of the ballots....more