Idenix声称Gilead丙肝新药|sofosbuvir侵犯其专利

开始神话

2013年12月4日讯 --随着Gilead公司研制的治疗丙肝新药sofosbuvir接近获得FDA最终许可，这家制药巨头也开始面对来自各方竞争者知识产权方面的挑战。而就在最近，Idenix生物医药公司声称，Gilead公司的这项丙肝突破性药物侵犯了Idenix的三项专利。在最近披露的两项诉讼案中，Idenix公司认为sofosbuvir侵犯了其关于核苷酸高活性化合物的专利，并要求法院宣布其在110亿美元收购Pharmasset过程中获得的相关专利无效。不过Idenix公司同时表示，公司仍然希望能寻找到和平解决这一侵权行为的手段。

不过如果Idenix公司希望凭借这一方法分润sofosbuvir，恐怕其只能排队等待了，因为早在今年8月份，默沙东公司和罗氏公司都先后声称其对sofosbuvir具有一定权利。而Gilead也对此作出回应。不过Gilead目前尚未对Idenix公司作出回应。

详细英文报道：

As Gilead ($GILD) nears a virtually guaranteed FDA approval for the hepatitis C-fighting sofosbuvir, the biotech is facing intellectual property challenges from a bevy of competitors, most recently Idenix Pharmaceuticals ($IDIX), which claims the blockbuster hopeful infringes its patents.

In two lawsuits disclosed this week, Idenix alleges that Gilead violated three of its patents tied to nucleotide prodrugs, or "nucs," and the company is asking the court to invalidate a separate Gilead patent stemming from its $11 billion Pharmasset buyout. The latest squabble follows an ongoing suit-countersuit fight between the pair over two other sofosbuvir-related patents. Idenix remains confident in its position, general counsel Maria Stahl said.

"While we have attempted to resolve this matter with Gilead without resorting to infringement litigation, we intend to diligently and vigorously protect our patent rights for the benefit of our company and our shareholders and prevent infringing use by others," Stahl said in a statement.

If the Massachusetts biotech wants a piece of sofosbuvir, it'll have to get in line. In August, Gilead hit Merck ($MRK) with a preemptive lawsuit after the pharma giant laid claim to 10% of sofosbuvir's future sales, saying the drug cribbed from two of its patents. Meanwhile, Roche ($RHHBY) has stepped up with a claim of its own, arguing that a Pharmasset partnership from 2004 gives it an exclusive license on sofosbuvir. Gilead has swept that notion aside, pointing out Roche's deal ended long before its 2011 buyout.

Gilead didn't respond to a request for comment on the latest lawsuits, but the company has said it believes any claims on sofosbuvir to be without merit. Analysts have expressed little alarm over any of the suits filed so far. With peak sofosbuvir sales pegged at around $5 billion a year, the company will likely spare no expense in defending its exclusive right to sell the drug.

Meanwhile, Gilead's hep C hopeful is scheduled for a Dec. 8 final decision from the FDA. After picking up a unanimous co-sign from a panel of agency advisors in October, the drug is widely expected to win approval.

开始神话

Meanwhile, Gilead's hep C hopeful is scheduled for a Dec. 8 final decision from the FDA. After picking up a unanimous co-sign from a panel of agency advisors in October, the drug is widely expected to win approval.