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【技术产业】辉瑞立普妥专利案最新进展(06.1
Pfizer Court Ruling on Lipitor's U.S. Patent Stands (Update1)
By Susan Decker
Oct. 23 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, won an appeals court ruling that keeps generic copies of its best-selling drug Lipitor off the market until 2010.
The U.S. Court of Appeals for the Federal Circuit today refused, without comment, to reconsider an Aug. 2 decision that upheld one patent on the drug and invalidated a second that was to expire in 2011. The appeals court, based in Washington, often provides the final ruling in patent cases.
Ranbaxy Laboratories Ltd., India's biggest drugmaker, had asked the court to reconsider its decision on the 2010 patent and to make it clear that the defect in the 2011 patent is one that can't be corrected. New York-based Pfizer urged the appeals court to deny Ranbaxy's request.
Lipitor, used to reduce cholesterol, was the world's best- selling medicine last year with sales of $12.2 billion, and New York-based Pfizer projects sales will reach $13 billion this year. Analysts estimate that Lipitor accounts for about 40 percent of Pfizer's profit.
Pfizer has said the decision that threw out the 2011 patent was based on a ``technical defect'' and that it can ask the U.S. Patent and Trademark Office to reissue the patent with the necessary change. Pfizer would then have to file a new suit against Ranbaxy over that reissued patent.
Pfizer spokesman Bryant Haskins and Charles M. Caprariello, spokesman for Gurgaon, India-based Ranbaxy, had no immediate comment on today's decision, which was posted on the court's Web site.
Pfizer shares rose 1 cent to $27.69 at 11:39 a.m. in New York Stock Exchange composite trading, valuing the company at $201 billion. Shares are up 19 percent so far this year.
Ranbaxy shares fell 4.55 rupees to 410.6 rupees ($9.05) on the Bombay Stock Exchange and are up 13 percent this year
The case is Pfizer Inc. v. Ranbaxy Laboratories Ltd., 06- 1179, U.S. Court of Appeals for the Federal Circuit. The lower court case is Pfizer Inc. v. Ranbaxy Laboratories Ltd., 03cv209, U.S. District Court, District of Delaware (Wilmington).
To contact the reporter on this story: Susan Decker in Washington at sdecker1@bloomberg.net ;
Last Updated: October 23, 2006 11:55 EDT 本人已认领该文编译,48小时后若未提交译文,请其他战友自由认领。
译者按:
之所以要编译该文主要是与我的一段经历有关,七年前我刚刚研究生毕业走上工作岗位的时候做过一段时间药物的学术培训工作,因为当时学的东西对于我来说基本都是新的,所以印象比较深刻,当时我负责培训的恰恰是普伐他汀(来适可)之后的辛伐他汀,当时默克的舒降之正在颠峰,国产的辛伐他汀尽管已在吆喝性价比高,同样安全有效,也很难分到一杯羹,何况当时北大维信的血脂康也卖的不错,所以当时我常有黔驴技穷之感。当时看到中国新药杂志上已经报道辉瑞公司开发成功阿托伐他汀,商品名在欧美为lipitor,当时还未进入中国市场。记得当时国内好像已有一家红叶制药(记不准了)也开发了(应该是在仿制)相似产品,商品名定为:阿乐,不知道最终上市没有。现在回首往事,不胜感慨。有两点虽然大家都比较熟了,我还是再聒噪一遍吧:
1.前一段时间RNAi研究获得诺贝尔生理与医学奖后,大家又在争议中国何时有本土科学家能加入这个大师的行列当中。这个就目前来看,我个人认为不乐观。原因是我们缺乏原创性的思维和工作,目前的机制似乎也不太有利于这种工作的产生。我们现在有了很好的人才,也有了很好的设施,但似乎还缺乏相应的土壤,就像当年鲁迅先生所说的那样。举例来说:就想下文提到的印度与辉瑞的知识产权的争议,起码是通过合法的途径进行的,而我们呢,不管什么规模的制药企业,最大的投入不是R&D,而是广告,这太可怕了,一味模仿自以为走了捷径,其实可能南辕北辙,其它领域的研究亦然,科学本身是老老实实的东西,没有也不应该有捷径可走。
2.再一个问题可能是由以上问题派生出来的,目前国内博士毕业大都要求发表SCI,所以SCI的数量上去了,当时真正有质量的工作还是不多,比如在Cell、Nature、Science上所发表的工作结果与我们国家的研究投入与规模差距巨大。这一方面是由于我们的工作做的不够好,另外一方面我认为是因为我们的学术诚信经常会受到质疑,原因是我们缺乏完善的知识产权保护,我们经常不按游戏规则出牌,比如药物99%以上都是仿制,似乎没有什么人为此付过钱,也没有通过任何法律途径,这样一来人家恨乌及屋,自然会对我们的学术诚信打个问号。当然,很多在国外的和已回国的达人已经通过他们的努力正在扭转这种所谓的偏见,但还需要更多更好的工作来证明。
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作者:admin@医学,生命科学 2010-10-27 17:11
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