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中文新聞來源：七星天 Metis IP
英文新聞來源：IPRdaily.com、Bloomberg
據(jù)Law360于美國時間12月15日發(fā)布的消息，美國特拉華州聯(lián)邦地區(qū)法院的陪審團(tuán)（Federal Jury）裁定美國制藥巨頭吉利德科學(xué)公司（Gilead Sciences, Inc.，以下簡稱“吉利德”）侵犯了另一家制藥公司Idenix Pharmaceuticals LLC（以下簡稱“Idenix”）的兩項名為“丙型肝炎病毒的治療方法及混合物（Methods And Compositions For Treating Hepatitis C Virus）”的專利：US Patent No. 6,914,054（’054專利）和US Patent No. 7,608,597（‘597專利）,并在經(jīng)過了9天的法庭辯論后，認(rèn)定被告為故意侵權(quán)，需將涉案產(chǎn)品所獲利潤的10%賠付給原告，賠償金額高達(dá)驚人的25.4億美元[1]。
這也創(chuàng)下了聯(lián)邦地區(qū)法院專利侵權(quán)判罰賠償?shù)男掠涗洝?/strong>此前的記錄為2009年的強(qiáng)生訴雅培案，其時德克薩斯州的一個陪審團(tuán)判罰雅培賠償強(qiáng)生16.7億美元。
一、原告與被告
原告Idenix現(xiàn)隸屬于百年制藥巨頭Merck & Co.（默沙東）公司。據(jù)悉，默沙東距今已經(jīng)有125年的歷史了。該企業(yè)關(guān)注的領(lǐng)域有糖尿病、傳染病、腫瘤、疫苗、動物健康及相關(guān)保健產(chǎn)品、家畜以及寵物的疾病預(yù)防、醫(yī)療及控制等多個領(lǐng)域[2]。
被告吉利德公司是一家位于美國加利福尼亞州的生物制藥研發(fā)型企業(yè)，成立于1987年, 并已在納斯達(dá)克上市。據(jù)悉，美國國防部部長拉姆菲爾德還曾在1997年至2001年期間擔(dān)任其董事會主席。該公司致力于治療各種病毒傳染（如艾滋病病毒）、肝臟疾病、癌癥、炎癥和呼吸系統(tǒng)疾病、心血管疾病的藥物研發(fā)和生產(chǎn)，以及相關(guān)治療方案的制定[3]。
二、案件簡述
Idenix與吉利德的專利糾紛始于2013年12月1日。當(dāng)時，Idenix以專利侵權(quán)為由將吉利德告上了馬薩諸塞州聯(lián)邦地區(qū)法院。次日，法院就向被告發(fā)出了傳票，案件號為1:13-cv-13052。
2014年7月1日，此案正式轉(zhuǎn)移至特拉華州聯(lián)邦地區(qū)法院進(jìn)行審理，案件號為1:14-cv-00846。
作為Idenix的東家，默沙東的發(fā)言人曾于本周三表示：“專利局之所以將專利授權(quán)給我們，就是因為我們的技術(shù)是具有獲得專利的資格的。而被告吉利德至今仍在沒有獲得我們許可的情況下生產(chǎn)著侵犯我方專利權(quán)益的產(chǎn)品。對于這種故意侵權(quán)行為，相信法官將會作出三陪賠償?shù)呐袥Q。”
默沙東的發(fā)言人此次特別強(qiáng)調(diào)其專利的有效性絕不是空穴來風(fēng)，早在去年，吉利德就向聯(lián)邦地區(qū)法院申請對上述兩項專利的有效性進(jìn)行復(fù)審。然而，法庭在12月15日表示，吉利德沒有為陪審團(tuán)提供足夠的證據(jù)證明上述兩項專利是無效的，并在當(dāng)日做出了25億的巨額賠償判罰。
此次對于特拉華州聯(lián)邦地區(qū)法院的判罰，被告吉利德很可能將上訴至巡回法院。
我們將持續(xù)為您關(guān)注此案的后續(xù)發(fā)展。
[1] “Idenix Wins $2.5B Verdict In Gilead Hep C Drug Patent Fight”，Law360：http://www.law360.com/ip/articles/873098/breaking-idenix-wins-2-5b-verdict-in-gilead-hep-c-drug-patent-fight?nl_pk=7602ee70-a639-490f-81f5-3b6bcbbd4968&utm_source=newsletter&utm_medium=email&utm_campaign=ip
[2] “About Us”, Merck Co.& Inc.: http://www.merck.com/about/home.html& “關(guān)于默沙東”，默沙東：http://www.msdchina.com.cn/Pages/home.aspx
[3]“About Gilead”, Gilead: http://www.gilead.com/about
附：美國默克公司勝訴吉利得公司專利案，判賠25億美金（英文新聞）
Merck Wins Record $2.5 Billion Patent Verdict Against Gilead
作者：Christopher Yasiejko and Susan Decker
Gilead Sciences Inc. was told by a federal jury to pay $2.54 billion to Merck & Co. for using a patented invention as the basis for its blockbuster drugs for the potentially deadly liver disease hepatitis C -- the biggest patent-infringement verdict in U.S. history.
The jury in Wilmington, Delaware, deliberated for less than two hours and rejected Gilead’s arguments that Merck’s patent is invalid. The judge in the case had already decided that Merck’s patent was infringed by Gilead’s Sovaldi and Harvoni, which account for more than half the drugmaker’s revenue.
The infringement also was found to be willful, meaning the judge could increase the damage award by as much as three times the amount set by the jury. The jury said on Thursday that Gilead owed 10 percent royalties on $25.4 billion in total sales for the two drugs.
Gilead pledged to appeal.
The patent, issued in 2009, is for a compound that Merck’s Idenix unit contends is the basis for all major treatments for hepatitis C, including ones made by Gilead. Sovaldi was approved by the U.S. Food and Drug Administration in 2013 and Harvoni got regulatory go-ahead a year later. Merck’s drug, Zepatier, was approved this year.
“We were first,” Merck lawyer Stephanie Parker said in closing arguments. “That’s the most important thing. All of the Gilead work comes after ours. Our patent was first. The Gilead story starts years later.”
Merck shares rose 0.9 percent to $62.37 in regular trading and reached as high as $63.40 in after-hours trading. Gilead shares fell 0.2 percent to $75.55 in regular trading and reached a low of $73.20 in after-hours trading.
‘No Contribution’
Gilead argued that Idenix never adequately described what it claimed to have invented, and the patent didn’t cover a new idea.
“We remain steadfast in our opinion that Idenix’s U.S. patent is invalid, and since they made no contribution and assumed none of the risk in the discovery and development of sofosbuvir and its metabolites, do not believe they are entitled to any level of damages,” the company said in a statement following the verdict.
Sovaldi is based on the compound sofosbuvir, while Harvoni combines sofosbuvir with the compound ledipasvir. Gilead, based in Foster City, California, got the compounds as part of its 2012 acquisition of Pharmasset Inc.
Gilead added that the verdict doesn’t affect its ability to sell its products.
This is the second trial between the two companies. The first, over different patents, ended in a disaster for Merck. A jury in California said that Gilead should pay $200 million in royalties, but that was thrown out because the judge said a key Merck witness lied. In that case, Merck may have to pay Gilead’s legal fees.
Hepatitis C is a virus that attacks the liver and can lead to cirrhosis or liver cancer. The disease affects 130 million to 150 million globally, according to the World Health Organization, and the Centers for Disease Control has said as many as 4 million Americans may have chronic hepatitis C infections.
Price Tag
The drugs are effective at curing the virus with fewer side effects than earlier treatments, but they have been controversial because of their costs. A complete treatment with Sovaldi costs $84,000, while Harvoni’s price tag is $94,500, though the drugs are typically discounted. A newer version that can treat more genotypes of the virus, called Epclusa, has a list price of $74,760 for a 12-week treatment.
Harvoni generated $4 billion in U.S. sales in the first nine months of the year, and Sovaldi brought in $1.78 billion. Revenue from the two drugs is falling, however, because Gilead has been forced to offer discounts to insurers due to competition from Merck and AbbVie Inc. Merck sells Zepatier for $54,600.
Gilead and Idenix have been engaged in a global fight since 2012 over who was first to invent certain compounds for treating hepatitis C. Merck had claims demanding patent royalties on sales of Sovaldi and Harvoni even before it bought Idenix in 2014, absorbing this case as part of the deal.
The case in California was Merck’s own suit against Gilead, filed in 2013 by the Whitehouse Station, New Jersey-based drugmaker.
Gilead also had been engaged in a patent fight with AbbVie over ways to treat hepatitis C. The companies resolved their disputes in August.
The previous top verdict was a $1.67 billion judgment Johnson & Johnson won against Abbott Laboratories. It was later thrown out on appeal.
The case is Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 14-846, U.S. District Court, District of Delaware (Wilmington).
The drugs are effective at curing the virus with fewer side effects than earlier treatments, but they have been controversial because of their costs. A complete treatment with Sovaldi costs $84,000, while Harvoni’s price tag is $94,500, though the drugs are typically discounted. A newer version that can treat more genotypes of the virus, called Epclusa, has a list price of $74,760 for a 12-week treatment.
Harvoni generated $4 billion in U.S. sales in the first nine months of the year, and Sovaldi brought in $1.78 billion. Revenue from the two drugs is falling, however, because Gilead has been forced to offer discounts to insurers due to competition from Merck and AbbVie Inc. Merck sells Zepatier for $54,600.
Gilead and Idenix have been engaged in a global fight since 2012 over who was first to invent certain compounds for treating hepatitis C. Merck had claims demanding patent royalties on sales of Sovaldi and Harvoni even before it bought Idenix in 2014, absorbing this case as part of the deal.
The case in California was Merck’s own suit against Gilead, filed in 2013 by the Whitehouse Station, New Jersey-based drugmaker.
Gilead also had been engaged in a patent fight with AbbVie over ways to treat hepatitis C. The companies resolved their disputes in August.
The previous top verdict was a $1.67 billion judgment Johnson & Johnson won against Abbott Laboratories. It was later thrown out on appeal.
The case is Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 14-846, U.S. District Court, District of Delaware (Wilmington).
原文鏈接：
https://www.bloomberg.com/news/articles/2016-12-15/gilead-told-to-pay-merck-2-54-billion-in-hepatitis-c-royalties
中文新聞來源：七星天 Metis IP
英文新聞來源：IPRdaily.com、Bloomberg
編輯：IPRdaily.cn 趙珍
校對：IPRdaily.cn 縱橫君
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