Justia Patents Opinion SummariesArticles Posted in US Court of Appeals for the First Circuit
In re Lantus Direct Purchaser Antitrust Litigation
The First Circuit held that Sanofi-Aventis U.S., LLC improperly submitted a patent for listing in "the Orange Book" and that Sanofi was potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly.At the center of this appeal was a publication maintained by the FDA called Approved Drug Products with Therapeutic Equivalence Evaluations, known as "the Orange Book," which lists patents said by their owners to claim FDA-approved drugs. When a patent is listed in the Orange Book the patent-owning drug manufacturer has the ability to trigger an automatic, thirty-month suspension of the FDA's approval of a competing product. Plaintiffs alleged that Sanofi artificially restricted competition in the market for insulin glargine by improperly listing a certain patent in the Orange Book, thereby delaying competition in the insulin glargine market and resulting in inflated prices. The district court dismissed Plaintiffs' Sherman Act claims. The First Circuit vacated the dismissal as to Sanofi's alleged improper Orange Book listing of the patent, holding that Sanofi improperly submitted the patent for listing in the Orange Book and that Sanofi potentially liable under the antitrust laws to drug purchasers who were allegedly harmed by the effective extension of Sanofi's monopoly. View "In re Lantus Direct Purchaser Antitrust Litigation" on Justia Law
United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund v. Novartis Pharmaceuticals Corp.
In these consolidated appeals from orders dismissing two putative antitrust class actions, the First Circuit affirmed the judgment of the district court holding that purchasers of a brand-name prescription drug had not plausibly alleged that either exception to Noerr-Pennington immunity applied to the alleged conduct of the drug maker and, on that basis, dismissing the putative class actions for failure to state a claim.Plaintiffs filed these antitrust actions alleging that Defendant unlawfully delayed the entry of generic versions of the drug at issue into the United States market by a fraud on the United States Patent and Trademark Office. Defendant moved to dismiss the actions, arguing that there was no fraud and claiming that it was immune from antitrust liability based on the Noerr-Pennington doctrine. See United Mine Workers of America v. Pennington, 381 U.S. 657 (1965). The district court dismissed the putative class actions under Fed. R. Civ. P. 12(b)(6), concluding that Noerr-Pennington immunity applied to Defendant’s alleged conduct and that the two exceptions to the immunity did not apply here. The First Circuit affirmed, holding that there was no reason to disturb the district court’s ruling dismissing Plaintiffs’ antitrust suits for failure to state a claim. View "United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund v. Novartis Pharmaceuticals Corp." on Justia Law
In re Application of George W. Schlich
The First Circuit affirmed the decision of the district court denying Petitioner’s request for discovery from Respondents in relation to opposition proceedings before the European Patent Office (EPO) under 28 U.S.C. 1782(a) for lack of relevance to the foreign proceeding.In the opposition proceedings, Petitioner, a patent agent, challenged the validity of several of Respondents’ European patents involving CRISPR-Cas9 technology used in the programmable genome editing of mammalian cells. Petitioner filed an application for discovery under section 1782 seeking documents and testimony from Respondents. The district court denied Petitioner’s petition, ruling that Petitioner had not demonstrated that the discovery sought was “relevant” to the opposition proceedings and failed to show that the EPO would be receptive to the district court’s assistance in providing the requested discovery. The First Circuit affirmed, holding that the district court did not misapply the law in denying the requested discovery under section 1782. View "In re Application of George W. Schlich" on Justia Law