The Delhi High Court's recent interim order in the Merck versus Glenmark case over the diabetes drug Januvia has once again revived the multinational drug companies' clamour for patent linkage in the country, for linking marketing approval of a product to its patent status.

In the recent order, the Delhi High Court had denied Merck's bid to get an injunction against Indian drug firm Glenmark for selling the copycat version of Merck's diabetes drug Januvia. Earlier, Merck's subsidiary MSD India had moved the court against the sale of generic Januvia launched by Glenmark, saying that it infringed upon intellectual property. In the court, MSD argued that the Indian company cannot market the copycat of its drug as it has a valid patent.

For quite some time, the MNCs have been fighting to ‘harmonise’ laws so that patents granted for drugs under the Patents Act are not ‘defeated’ by the approval of drugs under the Drugs and Cosmetics Act (D&C Act) during the term of the patent. In effect, what is sought by the MNCs is to link the regulatory approval of a drug product to its patent status - a practice that is referred to as ‘patent linkage’ in industry parlance. The Drugs Controller General of India (DCGI) would therefore be required to deal with patent issues while processing applications for drug approval.

Meanwhile, the DCGI in his submissions to the court has clarified that they cannot be asked to enforce the private rights of a patentee and that they lack the “institutional expertise to deal with complex patent issues”.

Apart from Merck, Bayer Corporation also sought to achieve this end by seeking a direction to this effect in a writ petition before the Delhi High Court. A single Judge of the Delhi High Court dismissed their writ petition with costs. Bayer filed an appeal which was also dismissed by a Division Bench of the Delhi High Court. Bayer then preferred a Special Leave Petition to the Supreme Court which is now pending consideration.

The demand by MNCs for linking marketing approval of a product to its patent status appears to have been revived after the interim order of Delhi High Court in Merck case, said D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA), an association of major Indian drug companies.

Legislation reflecting far-reaching IPR policy changes was implemented only in 2005 in India. It would be prudent to carefully evaluate the experience to date, the impact on public health and the national pharmaceutical industry before contemplating any changes in the legislation, Shah said and added that the existing laws are compliant with the TRIPS Agreement. Any TRIPS plus provision will raise the bar for generic entry and will delay competition. It will adversely affect access to medicines in India as well as other developing countries.

The grant of patent does not automatically create any presumptive validity to deny marketing approval for a product, Shah further said.