Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more
Oregon AG Dan Rayfield settled with AbbVie Inc. and Besins Healthcare, Inc. to resolve allegations that the pharmaceutical companies engaged in anti-competitive conduct relating to the sale of testosterone replacement gel in...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
The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed. Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more
On June 30, 2023, a jury in the Northern District of California found Gilead and Teva not liable in a trial accusing the companies of engaging in an illegal reverse payment to delay generic versions of two HIV drugs, Truvada...more
The healthcare industry faces cascading risks – one risk flows to another with compounding financial results. Three generic drug companies just experienced this cascading liability. ...more
The Court of Justice of the European Union (ECJ) has confirmed that pay-for-delay agreements with generic manufacturers ready to enter the market violate EU antitrust rules. ...more
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices...more
On October 7, 2019, California became the first state to enact legislation—Assembly Bill 824 ("AB 824")—rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive. This alert...more
On February 25, 2019, in FTC v. Shire ViroPharma, Inc., the U.S. Court of Appeals for the Third Circuit confirmed that the Federal Trade Commission (FTC) cannot plead its way into federal court via Section 13(b) of the FTC...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
On November 7, 2016, the U.S. Supreme Court declined to review an appeal from a Third Circuit decision finding that a settlement between GlaxoSmithKline (GSK) and Teva Pharmaceutical Industries Ltd. (Teva) involving the...more
It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more
The Third Circuit recently vacated class certification, granted by the Eastern District of Pennsylvania after nearly a decade of litigation, in an antitrust case alleging that a pharmaceutical company entered into agreements...more
On August 8, the District of Connecticut issued a noteworthy ruling on how to approach defining the relevant market definition in a pay-for-delay suit. In In re Aggrenox Antitrust Litigation, 3:14-md-02516 (D. Conn.), three...more
The U.S. Court of Appeals for the Second Circuit’s opinion (issued May 22, 2015 with a public, redacted version available May 28, 2015), affirming the district court’s grant of a preliminary injunction in State of New York v....more