展旺上櫃路遇亂流！遭美原廠提專利訴訟 鉅亨網記者張旭宏 台北2015-08-2512:07 原料藥廠展旺(4166-TW)將於9月8正式掛牌上櫃，掛牌價暫訂25元，將發行23000張。但展旺上櫃前向美國FDA提出產品Ertapenem的學名藥申請後，原廠Merck Sharp&Dohme提出專利訴訟，公司表示，此專利訴訟為法規程序，因產品尚未上市，故無侵權賠償問題，公司營運一切正常。展旺為全球培南藥物的主導藥廠，培南為靜脈點滴注射的抗生素，在醫院中屬於最後線抗感染用藥，公司產品包括美洛培南，佔營收8成、亞胺培南則佔2成及新開發的厄他培南，旗下兩個製造廠區，分別坐落於竹南的新竹科學園區與台南科學園區，其製造廠垂直整合原料藥與針劑產品，供應全球各大藥廠原料藥無菌製劑半成品與無菌針劑產品，已通過美國、歐盟與日本政府的查廠，為全球前三大培南藥供應商，其各國家銷售註冊案已超過200個，出貨全球30多國。展旺日前向美國FDA提出產品Ertapenem的學名藥申請，並對橘皮書中的專利提出Paragraph IV認證，原廠Merck Sharp&Dohme，因此對公司提出專利訴訟。展旺強調，此專利訴訟為法規程序，因產品尚未上市，因此沒有侵權賠償問題，對財務影響僅限進行訴訟程序所產生訴訟費用，日常營運資金應足以支付，對財務尚無重大不利影響。
Patent 5,478,820 protects INVANZ and is included in one NDA. There has been one Paragraph IV challenge on Invanz. Protection for INVANZ has been extended six months for pediatric studies, as indicated by the *PED designation. This patent has fifty-one patent family members in thirty-three countries.
The present invention relates to carbapenems and provides a compound of the formula (I): ##STR1## or a pharmaceutically acceptable salt or in vivo hydrolysable ester thereof wherein: R.sup.1 is 1-hydroxyethyl, 1-fluoroethyl or hydroxymethyl; R.sup.2 is hydrogen or C.sub.1-4 alkyl; R.sup.3 is hydrogen or C.sub.1-4 alkyl; R.sup.4 and R.sup.5 are the same or different and are selected from hydrogen, halo, cyano, C.sub.1-4 alkyl, nitro, hydroxy, carboxy, C.sub.1-4 alkoxy, C.sub.1-4 alkoxycarbonyl, aminosulphonyl, C.sub.1-4 alkylaminosulphonyl, di-C.sub.1-4 alkylaminosulphonyl, carbamoyl, C.sub.1-4 alkylcarbamoyl, di-C.sub.1-4 alkylcarbamoyl, trifluoromethyl, sulphonic acid, amino, C.sub.1-4 alkylamino, di-C.sub.1-4 alkylamino, C.sub.1-4 alkanoylamino, C.sub.1-4 alkanoyl(N-C.sub.1-4 alkyl)amino, C.sub.1-4 alkanesulphonamido and C.sub.1-4 alkylS(O).sub.n -- wherein n is zero, one or two: with the proviso that there is no hydroxy or carboxy substituent in a position ortho to the --NR.sup.2 --. Processes for their preparation, intermediates in their preparation, their use as therapeutic agents and pharmaceutical compositions containing them.
發佈日期: 1995年12月26日/申請日期: 1993年2月2日/優先權日期: 1992年2月4日
Merck sues Taiwan company over generic antibiotic product Aug 25, 2015, 4:31pm EDT Merck Sharp & Dohme Corp. has filed suit against a Taiwan-based firm, alleging the firm has violated Merck's patent on an antibiotic product marketed under the name Invanz. Merck Sharp & Dohme Corp. has filed suit against a Taiwan-based firm, alleging Merck Sharp & Dohme Corp. has filed suit against a Taiwan-based firm, alleging the firm has violated Merck's patent on an antibiotic product marketed under the name Invanz. Merck Sharp & Dohme Corp. is a subsidiary of pharmaceutical giant Merck & Co. According to an Aug. 21 complaint filed in federal court in Raleigh, Merck alleges Savior Lifetec Corp. attempted to gain approval from the U.S. Food and Drug Administration to manufacture a generic version of Invanz. Invanz is an injectable antibiotic used to treat severe abdominal and pelvic infections, as well as those brought on by colorectal surgery. Merck has owned a patent on Invanz since 1999. But according to the complaint, Savior allegedly sent a letter to Merck on July 9 that said Savior had filed an Abbreviated New Drug Application with the FDA, which would allow Savior to manufacture, use and sell a generic version of Invanz. The letter allegedly stated that Merck's patent was invalid. Merck claims Savior is attempting to violate the alleged patent protections on Invanz, which would "substantially and irreparably harm" the company if Savior is not barred from moving forward with its product. Merck is seeking a court order stating that Savior has violated its patent. Merck is also seeking an injunction barring Savior from continuing the alleged infringement. Merck is represented by Timothy Barber of King & Spalding's Charlotte office. A spokeswoman for Merck declined to comment on the case. No attorneys have entered an appearance on behalf of Savior. Efforts to contact a spokesman for the company were not successful.
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