2023 年 2 月 21 日，仿製藥製造商 Hikma Pharmaceuticals USA, Inc. (“Hikma”) 對 Amarin Pharma, Inc. (“Amarin”) 提起反壟斷訴訟，指控該製藥公司採取反競爭行為阻礙與其心臟藥物（和唯一產品）VASCEPA® 競爭仿製藥的上市。

VASCEPA® 是源自魚油的一種二十碳五烯酸乙酯，經美國食品和藥物管理局 (“FDA”) 批准用於治療甘油三酯水平極高的患者並以及他汀類（statin）治療降低心血管事件（例如心肌梗 塞、中風或冠狀動脈血運重建術）的風險。

在 Hikma 和 Dr. Reddy 尋求 FDA 批准銷售 VASCEPA ®仿製藥後，Amarin 最初試圖通過對兩家公司提起專利侵權訴訟來阻止仿製藥競爭，但在下級法院以顯而易見性為由宣布相關專利無效後敗訴。為了扭轉這一不利裁決，Amarin向美國最高法院提出上訴，但再次敗訴。

Hikma 最終於 2020 年 11 月推出了 VASCEPA ®的第一個仿製藥，但聲稱 Amarin 從事反競爭行為以維持其壟斷地位，即使在輸掉專利侵權訴訟後。

據稱，這家製藥公司通過與供應商簽訂排他性供應協議，“故意和謹慎地鎖定了”二十碳五烯乙酯的供應，二十碳五烯乙酯是製造 VASCEPA®仿製藥所需的關鍵活性藥物成分。向美國新澤西州地區法院提起的這一新的反壟斷訴訟將有助於揭示這一系列的行爲，並決定該等行爲是否違反了美國相關的反壟斷法規。

參考資料：https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf | Learn About Amarin | VASCEPA® (icosapent ethyl) | HIKMA PHARMACEUTICALS USA, INC. v. AMARIN PHARMA, INC. et al 3:2023cv01016 | US District Court for the District of New Jersey | Justia | Hikma accuses Amarin of suppressing generic versions of heart pill | Reuters

Hikma Pharmaceuticals launches anti-trust lawsuit against Amarin Pharma

In a On February 21, 2023, generic drug manufacturer Hikma Pharmaceuticals USA, Inc. (“Hikma”) filed an anti-trust lawsuit against Amarin Pharma, Inc. (“Amarin”), accusing the pharmaceutical company of resorting to anticompetitive practices to impede generic competition for its heart drug (and sole product) VASCEPA®.

VASCEPA® is an ethyl ester of eicosapentaenoic acid, derived from fish oil, approved by the U.S. Food and Drug Administration (“FDA”) for use in the treatment of patients with very high triglyceride levels and to reduce the risk of cardiovascular events (like myocardial infarction, stroke, or coronary revascularization) in addition to statin therapy.

Amarin initially tried to block generic competition by filing a patent infringement lawsuit against Hikma and Dr. Reddy’s after they sought FDA approval to market generic versions of VASCEPA®, but lost after the lower court invalidated the related patents on obviousness grounds. Hoping to reverse this unfavorable ruling, the pharmaceutical company lodged an appeal before the U.S. Supreme Court, but lost yet again. 

Hikma eventually launched the first generic version of VASCEPA® in November 2020, but claims that Amarin engaged in anticompetitive practices to maintain its monopolistic position, even after losing the patent infringement lawsuit.

Allegedly, the pharmaceutical company “deliberately and meticulously locked up the supply” of icosapent ethyl, the key active pharmaceutical ingredient needed to manufacture the generic equivalent for VASCEPA®, by entering into exclusive agreements with suppliers. This new antitrust lawsuit, filed before the US District Court for the District of New Jersey, will help shed some much-needed light on these practices, and decide whether they violate the relevant U.S. antitrust statutes.

Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf | Learn About Amarin | VASCEPA® (icosapent ethyl) | HIKMA PHARMACEUTICALS USA, INC. v. AMARIN PHARMA, INC. et al 3:2023cv01016 | US District Court for the District of New Jersey | Justia | Hikma accuses Amarin of suppressing generic versions of heart pill | Reuters

by 黃愷蜜 顧問