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FTC Continues to ‘Dispute’ Orange Book Device Patent Listings, But Still No Antitrust Enforcement

Over the last eight months, the US Federal Trade Commission (FTC) has focused on what it characterizes as “improper” Orange Book listings and the impacts of such listings on generic entry....more

Cooley’s 2022 Life Sciences M&A Year in Review

Although 2022 saw a general decline in M&A activity in the life sciences industry compared to 2021’s frenetic pace (when deal volume was up 52% from 2020), life sciences deal flow in 2022 on balance remained strong despite...more

Cooley’s 2021 Life Sciences M&A Year in Review

General trends in life sciences M&A Although the COVID-19 pandemic that defined 2020 continued to shape much of the life sciences industry in 2021, the way that it did was markedly different. While 2020’s M&A landscape was...more

Alert: Agreements Involving Biosimilars Must Be Reported to FTC and DOJ Under New Law

Biologic drug makers will soon have to alert the Federal Trade Commission and Department of Justice of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement...more

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

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

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

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