The Delhi High Court last week dismissed an appeal of Bayer Corporation seeking introduction of patent linkage system in India while granting marketing approvals for generic drugs. The appeal was filed by the Bayer against a judgement delivered by Justice Ravindra Bhat on 18 August 2009, rejecting its petition seeking to introduce the patent linkage through a court direction. Currently, there is no provision for patent linkage either in the Patent Act or in the Drugs & Cosmetics Act, two relevant laws in this regard. The judge has made it clear while dismissing the appeal that both the acts are distinct and separate and the attempt by Bayer to establish a linkage cannot be accepted. Introducing such a provision is an issue that requires a policy direction by the Central government. Bayer had filed a writ petition before the Delhi High Court against Union of India, the DCGI and Cipla Ltd in 2008 seeking an order that the DCGI should consider the patent status of its drug, Sorefenib tosylate, before granting a marketing approval to generic versions and refuse marketing approval to all generic versions. Sorefenib tosylate is used to treat renal cancer and is sold by Bayer at Rs 2,85,000 for 120 tablets, a month's dosage.
Patent linkage is a system in which the drug control authority in a country refuses to grant or delays marketing approval to a generic company to manufacture and sell a drug, if it is under patent. Patent linkage is known to be against public health interests as it can delay entry of generics into the market and thus keep cheap medicines out of reach to those who need them. Most drug regulatory authorities including the US FDA do not have the required expertise or resources to review patent information. Such a system can, therefore, lead to unfair enforcement of invalid patents in a country. After the new patent regime came into existence in India in 2005, a large number of patents have been issued to pharmaceutical companies. Many of them are bogus and frivolous. In such situations where the patent granted is not valid, the generic manufacturer can challenge the patent by filing for its revocation. The preamble of the TRIPS agreement recognizes that intellectual property right is a private right. Through implementation of patent linkage what MNCs seek is to make the DCGI’s office enforce patents for them. Thus, they will be spared the expenses and embarrassment of being seen to be enforcing the patent rights publicly in the courts. The key function of DCGI is to ensure safety and efficacy of medicines marketed in the country. Now, with the dismissal of the Bayer's appeal, the Delhi High Court has made that message quite loud and clear.