The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more
ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...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
The US District Court for the Northern District of California certified classes of direct purchasers and end-payers in a pay-for-delay multidistrict litigation involving Lidoderm. In re Lidoderm Antitrust Litigation, Case No....more
Addressing questions of federal jurisdiction, the US Court of Appeals for the Third Circuit ruled that it, and not the US Court of Appeals for the Federal Circuit, had jurisdiction over two consolidated appeals arising from...more
Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more
On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more
On 16 February 2016, the European Commission (EC) took the next step in its antitrust investigation into the use of price increase letters by 15 container liner shipping companies (carriers). The concern identified by the...more
In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...more
Recently, the FTC announced that it reached a settlement in its pay-for-delay lawsuit, FTC v. Cephalon Inc. in the U.S. District Court for the Eastern District of Pennsylvania, with Teva Pharmaceuticals Industries, Ltd.,...more
The Federal Trade Commission staff recently issued a report detailing the number of “potential pay-for-delay settlements” that took place in fiscal year 2013. The FTC is a staunch opponent of so-called “pay-for-delay”—also...more
In one of the first tests of the Supreme Court’s 2013 ruling in Federal Trade Commission v. Actavis, Inc. addressing the antitrust treatment of pharmaceutical patent settlements, a recent jury on Dec. 5, 2014, returned a...more
After six weeks of trial and two days of deliberation, the jury has returned its verdict in favor of the defendants in In re: Nexium. This trial began as a challenge to the allegedly anticompetitive effects of the settlements...more
Last week, the Nexium district court ruled on defendants’ motions seeking judgment as a matter of law. As we previously reported in several earlier posts, In re: Nexium is the first pay-for-delay case to go to trial since...more
India's competition authority, the Competition Commission of India (CCI), has begun scrutinizing and investigating pharmaceutical patent settlement agreements between brand and generic firms for potential anticompetitive...more
In This Issue: *News from the Bench - Unanimous Supreme Court Ruling on Gene Patentability: Natural DNA “No”/ cDNA “Yes” - CAFC Reverses Denial of Permanent Injunction Based on Perceived Future...more
In June 2013, two important decisions regarding 'pay-for-delay' arrangements in the pharmaceuticals industry were made in the EU and US. Generally speaking, 'pay-for-delay' or 'reverse-payment settlements' involve a type of...more