The Federal Commerce Fee (“FTC”) has filed an amicus temporary in Teva Branded Prescribed drugs Merchandise R&D, Inc. v. Amneal Prescribed drugs of New York, LLC to additional the company’s efforts to advertise and defend generic drug and biosimilar competitors. Within the case, Teva asserts that Amneal’s Abbreviated New Drug Utility (“ANDA”) for an bronchial asthma inhaler infringes upon 5 patents it has listed within the FDA’s Orange Ebook–a problem that beneath FDA laws triggers a 30-month keep of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler machine and dose counter, relatively than the drug itself, have been improperly listed and has requested the court docket for judgment on the pleadings and an order to delist the patents at situation.
The FTC has lengthy expressed considerations in regards to the affect of the Orange Ebook patent itemizing course of on generic competitors. The FTC has characterised improperly listed patents as an abuse of the regulatory system that creates a man-made barrier to entry and prevents decrease price drug alternate options from getting into the market, hindering aggressive drug pricing and harming the patron and healthcare system as an entire. The FTC has cited such improper Orange Ebook listings as actionable conduct in difficult monopolization beneath Part 2 of the Sherman Act, asserting that the specter of infringement fits by model drug producers could chill funding specifically therapies.
The FDA’s Orange Ebook lists all accepted drug merchandise, and consists of, amongst different issues, info regarding a product’s patent and exclusivity protections. Underneath the Hatch-Waxman Amendments to the federal Meals, Drug, and Beauty Act (FDCA), all New Drug Utility (NDA) candidates should submit sure info regarding patents that declare both the drug itself—i.e., a drug substance (energetic ingredient) patent or drug product (formulation or composition) patent— or a way of utilizing the drug. Upon approval, FDA consists of such patent info within the Orange Ebook itemizing for the drug. The Orange Ebook places generic firms on discover of patent protections for model medicine. Generic firms in search of to file an ANDA should embrace inside their software certifications regarding the patent protections of the model drug. If a model firm well timed sues a generic competitor for infringement of an Orange Ebook listed patent, this triggers an automated statutory bar on the FDA’s approval the generic drug for as much as 30 months.
In September 2023, the FTC issued a Coverage Assertion (supported and endorsed by the FDA) on Model Pharmaceutical Producers’ Improper Itemizing of Patents in Orange Ebook[1] warning pharmaceutical firms that they may face authorized motion in the event that they improperly record patents within the Orange Ebook and outlined numerous potential enforcement strategies for combatting these perceived harms. In November 2023, the FTC issued discover letters to numerous model drug producers difficult greater than 100 patents held by producers of brand-name medicine and drug merchandise as improperly or inaccurately listed within the Orange Ebook.[2] Amongst these warning letters have been notices to Teva masking, amongst others, the inhaler device-related patents at situation within the case towards Amneal.
The FTC’s amicus temporary argues for a slender interpretation of the forms of patents that could be listed within the Orange Ebook—excluding any patent that’s not on its face particular to any FDA-approved drug. The FTC argues that machine patents, such because the Teva patents at situation, that don’t point out any drug of their claims don’t meet the statutory standards for Orange Ebook itemizing. On this case, the FTC notes that the identical patents at situation are additionally listed within the Orange Ebook entries for 21 different medicine, solely a few of which comprise the identical energetic ingredient because the bronchial asthma inhaler that’s the topic of Amneal’s ANDA. The FTC cites favorably the First and Second Circuit opinions in In re Lantus Direct Purchaser Litigation, 950 F.3d 1 (2020) and United Meals & Com. Employees Loc. 1776 & Taking part Emps. Well being & Welfare Fund v. Takeda Pharm. Co., 11 F.4th 118 (2021), in assist of its place.
Each model title and generic pharmaceutical and medical machine producers ought to concentrate on these developments. We’ll proceed to watch the FTC’s high-priority marketing campaign to make the most of the FDA’s public remark processes, in addition to its authority to implement the federal antitrust legal guidelines to affect competitors by generic drug growth.
FOOTNOTES
[1] Fed. Commerce Comm’n, Coverage Assertion, “Federal Commerce Fee Assertion Regarding Model Drug Producers’ Improper Itemizing of Patents within the Orange Ebook” (Sept. 14, 2023), accessible right here.
[2] See Fed. Commerce Comm’n, Press Launch, “FTC Challenges Extra Than 100 Patents as Improperly Listed within the FDA’s Orange Ebook” (Nov. 7, 2023), accessible right here.
