2月7日，美国联邦巡回上诉法院裁决辉瑞旗下普瑞巴林的一项专利有效，从而将该镇痛药物仿制药的竞争阻止到2018年10月30日。这项裁决支持之前地方法院的一项决定，法院在裁决中认定，包括阿特维斯、Lupin及梯瓦制药在内的仿制药厂商如果其普瑞巴林仿制药上市将侵犯辉瑞的专利权。
这一案例集中在普瑞巴林物质专利的组成上，涉及的其它仿制药厂商包括Mylan制药、Sun制药和Wockhardt制药。仿制厂商认为这项专利并未描述一种新的发明，争辩说该产品显然是现有化合物的一种变化形式。然而，上诉法院认为地方法院对这项专利所涵盖专利要求的解释正确无误。
这起诉讼由辉瑞与西北大学于2009年提出，西北大学拥有这款药物的活性成分专利。辉瑞指出，仿制药厂商可以通过上诉法院请求复审或通过最高法院请求审查。辉瑞还补充说，在特拉华州针对其它仿制药厂商的相同专利诉讼还未做出裁决。
普瑞巴林于2012年获FDA批准用于治疗与脊髓损伤有关的神经性疼痛，这款药物去年实现46亿美元的全球销售额，其中美国市场大约占20亿美元。该药物也获批用于治疗与多种疾病有关的神经性疼痛，包括糖尿病和纤维肌痛。
US appeals court upholds Pfizer's Lyrica patent, preventing generic competition until 2018
The US Court of Appeals for the Federal Circuit in Washington ruled Thursday that a patent for Pfizer's Lyrica (pregabalin) is valid, preventing generic competition for the pain therapy until December 30, 2018. In its ruling, which upheld a previous district court decision, the court determined that generic drugmakers including Actavis, Lupin and Teva would infringe upon Pfizer's patent if their generic versions of the product were launched.
The case, which also included Mylan, Sun Pharma and Wockhardt, centred on the composition of matter patent covering Lyrica. The generic drugmakers contended that the patent did not describe a new invention, arguing that the product was an obvious variation of existing compounds. However, the appeals court said that it identified "no error in the district court's construction" of what the patent claim covers.
Pfizer noted that in the same decision, the appeals court ruled that arguments relating to a second patent covering the use of Lyrica for the treatment of pain are "moot," given the determination on the first patent. The lawsuit was brought in 2009 by the company and Northwestern University, which owns the patent covering the drug's active ingredient. Pfizer indicated that the generic drugmakers may request a rehearing by the appeals court or a review by the Supreme Court. The company added that litigation on the same patents is pending in federal court in Delaware against other generic companies.
Lyrica, which gained clearance from the FDA in 2012 for the treatment of neuropathic pain associated with spinal cord injury, generated $4.6 billion in global revenue last year, including US sales of about $2 billion. The drug is also approved to treat nerve pain associated with a number of diseases, including diabetes and fibromyalgia, as well as for the treatment of partial onset seizures in adults with epilepsy who take one or more drugs for seizures.
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