《戒毒癮學名藥》原廠 Indivior 再度小贏! Dr. Reddy's請求暫停禁制令 被聯邦法院駁回 !

喧騰一時的SUBOXONE®(buprenorphine and naloxone)戒毒癮舌下片學名藥臨時禁制令一案,Indivior發布新聞稿表示,學名藥廠Dr. Reddy’s除了提出抗告之外,也提出緊急動議(emergency motions),希望法院能將臨時禁制令暫停實施,不過本周二美國聯邦上訴巡迴法院(CAFC) 駁回Dr.Reddy’s的緊急動議申請,換句話說,Dr. Reddy’s暫時還是不能賣藥,雙方公司還是依原訂時程,今年10月第一周進行口頭辯論。

此事緣於6月14日Dr. Reddy’s取得此學名藥的FDA藥證,但15日原廠Indivior隨即向法院申請臨時禁制令(PI),要求法院在No. 9,931,305新的專利訴訟沒有結果之前,禁止Dr. Reddy’s銷售。後來法院裁定臨時禁止令生效,Dr.Reddy’s自然是不服,隨即提出抗告,並提出暫停實施(指禁制令)的緊急動議。

不過顯然Dr. Reddy’s的如意算盤沒能實現,PI暫停實施的緊急動議未獲准,不過之前法院已經給Dr. Reddy’s加速審理的資格,所以整個臨時禁制令的抗告將在10月第一周進行口頭辯論。

Indivior在新聞稿裡指出,公司將持續積極的捍衛SUBOXONE®的專利權,包括反對印度Dr. Reddy’s禁制令的抗告外,要將持續進行目前在德拉瓦州有關專利514(No. 8,603,514)的上訴(一審由dr.reddt's勝訴,原廠indivior提起上訴)以及最近在紐澤西所提起針對'305、 '454以及221專利的訴訟主張。 

以下為新聞稿原文:
– Indivior PLC (LON: INDV) (Indivior or the Company) today announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) has denied Dr. Reddy’s Laboratories’ (DRL’s) motion for a stay of the July 13, 2018 preliminary injunction (PI) previously granted by the District of New Jersey. The PI prohibits DRL from using, importing, selling, or offering to sell its generic buprenorphine/naloxone sublingual film product. DRL appealed this ruling, and filed emergency motions seeking to expedite the appeal of the PI, and to stay the PI pending a ruling on appeal. Today’s ruling means that DRL continues to be prohibited from using, importing, selling, or offering to sell its generic buprenorphine/naloxone sublingual film product pending a favorable outcome for DRL on its appeal of the PI, or the District of New Jersey litigation related to U.S. Patent No. 9,931,305 (the ‘305 Patent); 9,687,454 (the ’454 Patent); and 9,855,221 (the ’221 Patent). The CAFC previously granted DRL’s motion to expedite the appeal, and oral argument will be held the first week of October 2018.

Indivior will continue to vigorously defend its patent rights to SUBOXONE®Film, including opposing DRL’s PI appeal, and continuing to pursue the appeal of the District of Delaware’s noninfringement ruling related to U.S. Patent No. 8,603,514 (the ’514 Patent), and the recently filed litigation asserting the ’305, ’454, and ’221 Patents in the District of New Jersey.

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