On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...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
7/6/2023
/ Anti-Competitive ,
Antitrust Litigation ,
Antitrust Violations ,
Generic Drugs ,
HIV ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reverse Payments
The Seventh Circuit recently confirmed that Actavis is the appropriate framework to assess biosimilar patent settlements, despite the differences in the regulatory structure—the first appellate court ruling on this issue. In...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an interview with Foresight Diagnostics co-founder and CEO Jake Chabon conducted by Matthew Meyer, the firm’s Chief...more
On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit issued an opinion in Impax Laboratories, Inc v. Federal Trade Commission, affirming the Federal Trade Commission's (FTC) unanimous decision that Endo...more
Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
On May 28, 2015, the FTC announced that it settled its longstanding antitrust suit against Cephalon, Inc., which is now owned by Teva Pharmaceutical Industries, Ltd. The FTC's suit alleged that Cephalon unlawfully protected...more
The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more
Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more
The United States Department of Justice Antitrust Division (DOJ) recently served two U.S.-based generic pharmaceutical manufacturers with criminal grand jury subpoenas. It is reported that the subpoenas request all...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
The transfer of certain patent rights in the pharmaceutical industry will remain subject to the premerger notification rules under the Hart-Scott-Rodino Act (HSR Act) after a federal judge rejected a challenge brought by the...more
A federal judge’s recent order to unwind the acquisition of Saltzer Medical Group, an independent physicians group, by St. Luke’s Health System, Ltd., a hospital system with its own staff of physicians, presents challenges...more
Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...more
The Federal Trade Commission (FTC) recently announced that it has finalized amendments to the premerger notification rules (HSR Rules) that provide a framework for determining when a transaction involving the transfer of...more
On June 17, 2013, after years of litigation in the lower courts, the United States Supreme Court issued its long-awaited decision in FTC v. Actavis. The 5-3 decision, however, did not have a clear winner, and the case was...more