Reddy Thikkavarapu Prashant
A-408, LGF, Defence Colony, New Delhi - 110024, India.
Pharm Pat Anal. 2016 Jul;5(4):211-6. doi: 10.4155/ppa-2016-0012. Epub 2016 Jun 27.
For several years after the reinstitution of a pharmaceutical patent regime in India, most innovator pharmaceutical companies have faced a string of high-profile defeats during litigation in India. In the last 2 years, however, the fortunes of pharmaceutical patentees have changed dramatically. Not only have Indian courts enforced pharmaceutical patents and issued injunctions restraining Indian generic companies from infringing valid patents, but they have also refused to invoke 'public interest' arguments to delay the enforcement of patents. This string of victories for pharmaceutical patents indicates a new era for the innovator industry in India. These victories for the innovator industry demonstrate the objectivity of the Indian judiciary. Even on the issue of compulsory licensing, the Patent Office, which functions as a part of the central government, has been restrained - granting only one compulsory license for a drug owned by Bayer but declining two other similar requests. Similarly, even the Indian judiciary while enforcing patents has also remained sensitive to the flexibilities in the Patents Act, such as the 'Bolar-type' provisions and compulsory licensing provisions.
在印度重新建立药品专利制度后的几年里,大多数创新型制药公司在印度的诉讼中都遭遇了一系列备受瞩目的败诉。然而,在过去两年中,药品专利权人的命运发生了巨大变化。印度法院不仅执行药品专利并发布禁令,限制印度仿制药公司侵犯有效专利,还拒绝援引“公共利益”论点来拖延专利的执行。药品专利的这一连串胜利标志着印度创新产业进入了一个新时代。创新产业的这些胜利彰显了印度司法机构的客观性。即使在强制许可问题上,作为中央政府一部分的专利局也有所克制——仅为拜耳公司拥有的一种药物授予了一项强制许可,但拒绝了其他两项类似请求。同样,即使印度司法机构在执行专利时,也对《专利法》中的灵活性条款保持敏感,比如“博拉型”条款和强制许可条款。