IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
Last September, the Federal Trade Commission (FTC) promulgated a “policy statement” entitled “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” regarding the FTC’s allegations...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In H. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, and 2022-1246 (December 7, 2023), the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid...more
Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
Case Name: Sanofi-Aventis U.S. LLC v. Sandoz, Inc., No. 20-804-RGA, 2023 WL 4175334 (D. Del. June 26, 2023) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patent No. 10,716,777 (“the ’777...more
Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more
Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
On December 3, 2020, the Federal Trade Commission (FTC) published its annual report on pharmaceutical patent settlements filed with the FTC under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003...more
The Federal Trade Commission carried out an (in)famous crusade against reverse payment (more provocatively, "pay for delay") settlements in ANDA litigation for almost a decade before eventually having the Supreme Court see...more
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more
On March 13, 2020, the U.S. Court of Appeals for the D.C. Circuit affirmed the D.C. District Court’s 2018 summary judgment ruling in favor of Eagle Pharmaceuticals and against the FDA, finding that (1) the Orphan Drug Act...more
THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more
The Federal Circuit exhibited the current status of its obviousness jurisprudence in affirming the District Court's determination that the asserted claims of U.S. Patent No. 8,410,131 were obvious in a decision handed down...more
Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued...more
Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc. (In re Copaxone Consol. Cases), 906 F.3d 1013, Fed. Cir. No. 2017-1575, 2018 U.S. App. LEXIS 28751 (Fed. Cir. Oct. 12, 2018) (Circuit Judges Reyna, Bryson, and Stoll; Opinion...more
Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more
On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more