The Delhi High Court held in a case decided in February, 2010 that there is no linkage between Patent Act and Drugs and Cosmetics Act in India. In other words, the court stated that existence of a granted patent does not have any bearing on the grant of a drug license by the Drug Controller General of India. The decision was given in a writ petition filed by Bayer asking the court to restrain the Drug Controller from granting a drug license to CIPLA to manufacture, sell and distribute its drug “sorafenib tosylate”, prescribed for the treatment of advanced renal cell carcinoma.

It was argued by Bayer that it holds a patent over the drug and that the Drug Controller General cannot grant a license to CIPLA during the validity of its patent. In response CIPLA and Drug Controller General contended that there is no link between the Patent Act and the Drugs and Cosmetics Act, which requires the Controller General to reject the drug license. After hearing the parties, the Court started its analysis by stating that enforcement of patent rights may be done under the scope of the Patents Act only.

Though section 156 makes patent rights enforceable against the government also, the Court pointed out that it does not give rise to an obligation to prevent infringement by refraining from granting a drug license. It went on to state that the objective of the Drugs and Cosmetics Act is to regulate the import, distribution, manufacture and sale of drugs and the Act does not impose any obligation under any provision on the Drug Controller General to deny marketing approval to a person based on existence of patent rights. The Court went on to state that a patent linkage for grant of marketing approval cannot be read into the Drugs and Cosmetics Act even if Form 44 requires an applicant to provide details of patents in the application because no provision provides for such an obligation and it cannot be derived from the Form.

Based on its analysis, the court concluded that Patents Act and Drugs and Cosmetics Act are two independent statutes and no linkage can be established between them in the absence of an express provision. Such provision may be brought into play only by the legislature and the court cannot bring in the patent linkage. The Court also stated that a generic version of a patented drug would not make it a spurious drug as using of the same brand would make a drug spurious and not manufacturing generic version of the drug as per the Drugs and Cosmetics Act.

Unlike in countries like USA, the Indian legislature stayed away from bringing about a patent linkage with respect to regulatory approval of drugs. As it stands today there is no linkage with respect to patent term extension, approval or any other aspect. The court in this case has rightly elucidated the law as it exists. However, whether such linkages are required is an issue worth analyzing. This post will be followed by a post on the role of patent linkages in pharma research.