The issue of linking grant of marketing approval to the patent status of a drug is being raised by the multinational drug companies once again in the country. MSD India, the subsidiary of the US multinational Merck, last week sought an injunction in the Delhi High Court against the sale of generic drug, Januvia, launched by Glenmark pharmaceuticals claiming that the Indian company infringed upon its intellectual property. MSD India wanted to block the sale of generic on the ground that it has a valid patent for its diabetic drug, sitagliptin, in India and therefore the marketing approval granted to Glenmark should be disallowed. By moving court against Glenmark, MSD is seeking to establish that patents granted for drugs are not defeated by the marketing approval under the Drugs & Cosmetics Act during the term of the patent. In other words, the MNC wants to link the regulatory approval of a drug product to its patent status through a court intervention. The stand of the MNC would thus mean that the Drugs Controller General of India has to deal with patent issues while processing applications for drug approval.
A similar dispute came up in 2008 in the case of Sorefenib tosylate, a cancer drug, between Bayer and Cipla. Bayer had filed a writ petition before the Delhi High Court against Union of India, the DCGI and Cipla Ltd seeking an order that the DCGI should consider the patent status of Sorefenib tosylate before granting a marketing approval to generic versions and refuse marketing approval to all generic versions. The Delhi High Court had dismissed Bayer’s petition ruling that 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 case is now pending before the Supreme Court. Under these circumstances, it will be wrong to even consider a legislative review of the Drugs & Cosmetics Act and that too when submissions have been made by the DCGI that it cannot be asked to enforce the private rights of a patentee and especially when DCGI lack the necessary expertise to deal with patent issues. Introducing such a provision is also an issue that requires a policy direction by the Central government. Patent linkage is considered to be against the public interests as it can delay entry of generics into the market and thus keep cheaper generics out of reach to those who need them. Most drug regulatory authorities including the US FDA do not have the 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 effect in India in 2005, a large number of patents have been issued to pharmaceutical companies and many of them are bogus and frivolous.