On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...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
The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
On August 16, 2021, the Federal Circuit handed down two rulings related to patents issued to Teva, which involve therapeutic antibodies targeting a calcitonin gene-related peptide (“CGRP”). In both cases, the Federal Circuit...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
On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic...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
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more
In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reinstated a jury's verdict that Teva infringed GSK's patented method of using its Coreg® drug product, even though Teva's product was initially...more
In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more
Teva, the global pharmaceutical giant, was indicted last week as part of DOJ’s expanding criminal conspiracy investigation focused on illegal price-fixing and customer allocations....more
Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an exclusive partnership for the commercialization of biosimilar products in...more
Unlike much of the world, the U.S. has not turned the corner on the coronavirus outbreak. But you wouldn’t know it by looking at the markets. On Tuesday, the S&P 500 topped out at its highest level ever, “capping a remarkable...more
Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S. Under the partnership agreement, Alvotech will be...more
Unable to reach a last-minute deal with investors, rental car mainstay Hertz filed for bankruptcy late Friday night, doing so “without a clear plan with creditors in place—a rare move for a company of its size.” Though, like...more
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more
2017 saw a bumper crop of Supreme Court decisions on intellectual property matters around the world including eight by the United States Supreme Court, two by the Canadian Supreme Court, and two by the United Kingdom Supreme...more
In Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al, Case No. 2:15-cv-1455-WCB (EDTX October 16, 2017 Order), a Federal District Court recently invalidated several patents covering Allergan’s dry-eye drug Restasis. The...more
Enforcement of the Foreign Corrupt Practices Act was a high priority for the Department of Justice and the Securities and Exchange Commission in 2016. There's interest in how the new administration could impact enforcement as...more
The Securities and Exchange Commission (SEC) and Department of Justice (DOJ) wrapped up 2016 on December 22 with a near record-breaking Foreign Corrupt Practices Act (FCPA) settlement involving Teva Pharmaceuticals and its...more
We begin the New Year with a three-part series on the FCPA: (1) A review of FCPA enforcement in 2016; (2) Trends from 2016 FCPA enforcement; and (3) Predictions for FCPA enforcement in 2017....more
Shearman & Sterling’s bi-annual Trends & Patterns in FCPA Enforcement report provides insightful analysis of recent enforcement trends and patterns in the US, the UK and elsewhere, as well as helpful guidance on emerging best...more
After another milestone year, here are our picks for the top-five biggest deals in the world of biosimilars in 2016: As we reported in January 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an...more