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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
For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more
In This Issue - Assignor Estoppel: When Are Inventors Allowed to Attack Their Own Inventions? In Minerva v. Hologic, the Supreme Court recently upheld the patent-law doctrine of assignor estoppel—which bars the...more
The Background: In the Supreme Court's landmark 2013 decision in FTC v. Actavis, the Court determined that large payments by branded drugmakers to potential generic entrants to settle patent disputes could be anticompetitive....more
On January 25, 2021, just weeks after Congress directed the Federal Trade Commission (FTC) to scrutinize the healthcare industry for anti-competitive activity, the FTC filed a meticulously detailed complaint against Endo...more
In the latest decision addressing antitrust liability for FRAND commitments, Judge Barbara M. G. Lynn of the Northern District of Texas dismissed a complaint from Continental Automotive Systems, Inc. (“Continental”) alleging,...more
Qualcomm has for years dominated the market for cellphone chips. Its patented technologies have been included in many cellphone standards on the condition, common among standards setting organizations (SSOs), that Qualcomm...more
On 11 August 2020, a panel of the U.S. Court of Appeals for the Ninth Circuit (“Ninth Circuit”), in a unanimous opinion by Judge Callahan, reversed the U.S. Federal Trade Commission’s (“FTC’s”) win in the district court...more
In a much anticipated opinion, the U.S. Court of Appeals for the Ninth Circuit reversed a California district court decision holding that Qualcomm violated U.S. antitrust laws in its licensing of standard-essential patents in...more
...Think your company and its employees are beyond the reach of U.S. authorities? Maybe you don’t have U.S. operations there, or your company isn’t publicly traded on a U.S. stock exchange. Perhaps you don’t directly sell or...more
The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...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
As the Obama Administration drew to a close, its antitrust enforcers took two actions of note for those involved in intellectual property (IP) licensing. The first, the joint release by the U.S. Department of Justice (DOJ)...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
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Antitrust challenges to so-called “pay-for-delay” settlements in drug patent suits are allowed under the U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc....more
On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation....more
Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more
The U.S. Supreme Court issued its much-anticipated opinion today in FTC v. Actavis, Inc., ruling that so-called “reverse payment” patent settlements between innovator and generic pharmaceutical manufacturers that are...more
Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more