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据Law360于美国时间12月15日发布的消息，美国特拉华州联邦地区法院的陪审团（Federal Jury）裁定美国制药巨头吉利德科学公司（Gilead Sciences, Inc.，以下简称“吉利德”）侵犯了另一家制药公司Idenix Pharmaceuticals LLC（以下简称“Idenix”）的两项名为“丙型肝炎病毒的治疗方法及混合物（Methods And Compositions For Treating Hepatitis C Virus）”的专利：US Patent No. 6,914,054（’054专利）和US Patent No. 7,608,597（‘597专利）,并在经过了9天的法庭辩论后，认定被告为故意侵权，需将涉案产品所获利润的10%赔付给原告，赔偿金额高达惊人的25.4亿美元[1]。
这也创下了联邦地区法院专利侵权判罚赔偿的新记录。此前的记录为2009年的强生诉雅培案，其时德克萨斯州的一个陪审团判罚雅培赔偿强生16.7亿美元。
一、原告与被告
原告Idenix现隶属于百年制药巨头Merck & Co.（默沙东）公司。据悉，默沙东距今已经有125年的历史了。该企业关注的领域有糖尿病、传染病、肿瘤、疫苗、动物健康及相关保健产品、家畜以及宠物的疾病预防、医疗及控制等多个领域[2]。
被告吉利德公司是一家位于美国加利福尼亚州的生物制药研发型企业，成立于1987年, 并已在纳斯达克上市。据悉，美国国防部部长拉姆菲尔德还曾在1997年至2001年期间担任其董事会主席。该公司致力于治疗各种病毒传染（如艾滋病病毒）、肝脏疾病、癌症、炎症和呼吸系统疾病、心血管疾病的药物研发和生产，以及相关治疗方案的制定[3]。
二、案件简述
Idenix与吉利德的专利纠纷始于2013年12月1日。当时，Idenix以专利侵权为由将吉利德告上了马萨诸塞州联邦地区法院。次日，法院就向被告发出了传票，案件号为1:13-cv-13052。
2014年7月1日，此案正式转移至特拉华州联邦地区法院进行审理，案件号为1:14-cv-00846。
作为Idenix的东家，默沙东的发言人曾于本周三表示：“专利局之所以将专利授权给我们，就是因为我们的技术是具有获得专利的资格的。而被告吉利德至今仍在没有获得我们许可的情况下生产着侵犯我方专利权益的产品。对于这种故意侵权行为，相信法官将会作出三陪赔偿的判决。”
默沙东的发言人此次特别强调其专利的有效性绝不是空穴来风，早在去年，吉利德就向联邦地区法院申请对上述两项专利的有效性进行复审。然而，法庭在12月15日表示，吉利德没有为陪审团提供足够的证据证明上述两项专利是无效的，并在当日做出了25亿的巨额赔偿判罚。
此次对于特拉华州联邦地区法院的判罚，被告吉利德很可能将上诉至巡回法院。
我们将持续为您关注此案的后续发展。
[1] “Idenix Wins $2.5B Verdict In Gilead Hep C Drug Patent Fight”，Law360：/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.: /about/home.html& “关于默沙东”，默沙东：/Pages/home.aspx
[3]“About Gilead”, Gilead: /about
附：美国默克公司胜诉吉利得公司专利案，判赔25亿美金（英文新闻）
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).
中文新闻来源：七星天 Metis IP
英文新闻来源：、Bloomberg
