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
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
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
In March 2021, our experienced intellectual property, antitrust, and health care litigation lawyers shared some predictions on antitrust policy and enforcement in the health care sector. In “Health Care Antitrust under...more
On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more
On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator...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
In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...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
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 12 December 2018, the General Court (“Court”) partially annulled the European Commission’s decision of 9 July 2014 in the Servier case and consequently reduced Servier’s fine by more than 30%, from €330.99 million to...more
On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic...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 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing fines on Lundbeck, an originator company, and Merck (the parent company of...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
Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more
Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...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
Portions of a reverse payment suit against Endo Pharmaceuticals and others were recently dismissed by Judge William H. Orrick of the Northern District of California. The case was brought by plaintiffs who allege that a...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
Nearly two years ago the Supreme Court issued its opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013), holding that a reverse payment made by a brand manufacturer to a generic manufacturer to resolve pending patent litigation...more
As we reported earlier, the jury in In re: Nexium found that AstraZeneca had violated the antitrust laws by acting to keep generics off the market but that no generic would have been introduced earlier in the market even...more
As reported previously, the first post-Actavis jury verdict in a “reverse payment” antitrust case handed a win to the defendants. Now, plaintiffs in In re: Nexium (Esomeprazole) Antitrust Litigation have moved for a new...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
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