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
In the much-anticipated Lundbeck case (i.a. C-591/16 P), the European Court of Justice (“ECJ”) on 25th March 2021 confirmed the decision of the European Commission (“Commission”) to impose fines on Lundbeck and several...more
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...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
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 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
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 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
As Congress focuses on how to drive down drug prices, there is bipartisan support for prohibiting reverse payment agreements, also known as “pay-for-delay” arrangements. These arrangements involve a brand-name pharmaceutical...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
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
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 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
A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...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