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Antitrust Liability Risk When Listing Patents in Orange Book

The US Court of Appeals for the First Circuit held that pharmaceutical companies that wrongly list patents in FDA’s Orange Book must prove they acted in good faith to avoid antitrust liability. In re Lantus Direct Purchaser Antitrust Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020) (Kayatta, J). In applying for FDA approval to market new drugs, drug manufacturers must list all patents that “claim” the drug or the method of using the drug in FDA’s “Orange Book.” Listing a patent in the “Orange Book” allows the drug manufacture to trigger an automatic 30-month stay of FDA approval of any application for a competing drug product. Sanofi-Aventis first obtained FDA approval to market insulin glargine under the brand name “Lantus” in 2000, and filed a patent for the drug set to expire in 2014. In 2006, Sanofi filed a “supplemental” new drug application to sell insulin glargine in a disposable injector pen device called the “Lantus SoloSTAR,” and in 2013 listed...

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Federal Circuit Leaves Controversial Noerr-Pennington Trial Court Decision Untouched

The US Court of Appeals for the Federal Circuit denied counterclaim plaintiff’s petition for panel rehearing and rehearing en banc with respect to its decision that the counterclaim plaintiff was estopped from bringing antitrust counterclaims in a patent infringement suit. Intellectual Ventures 1, LLC v. Capital One Financial Corporation, Case No. 18-1367 (Fed. Cir. Dec. 11, 2019) (per curium). In its decision, the Federal Circuit determined that the counterclaim plaintiff could not invoke Tuttle v. Arlington County School Board (4th Cir. 1999) to save its counterclaim and left unaddressed the trial court’s decision with respect to the scope of the Noerr-Pennington doctrine, which was an alternative trial court basis for dismissal of Capital One’s counterclaim. In its prior decision applying Fourth Circuit law, the Federal Circuit determined that Capital One, the counterclaim plaintiff, could not bring an antitrust counterclaim against Intellectual Ventures...

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