The proposal to incorporate the status of patent(s) of a drug, in its marketing proposal, has been shelved. The proposal made by the Drugs Controller General of India, (DCGI), was abandoned, pursuant to an intense debate, with perspectives from industry factions and public health advocates.

The concept of patent-linkage implied that a generic drug regulatory application submitted to the drug controller general of India (DCGI) would not be approved, so long as a patent covered that drug. The Cipla-Roche controversy, witnessed Cipla being permitted to continue carrying out the sale of a cheaper version of Roche’s lung cancer drug, vouching “public interest” as the rationale for its allowance. However, the decision of the Court, under the speculative eye of the drug manufacturers was criticized on the count that had the Drug Controller not allowed Cipla’s drug, the Court might have rendered its decision differently. This clamor, led to the DCGI’s initial announcement of his decision to begin formulating guidelines, so as to bring about the “drug-patent” linkage into force in India. However, eventually, the DCGI backtracked upon his decision to formulate such a policy.

Developing countries including the European Union, have refrained from advocating patent linkages in their respective jurisdictions. The reason for this might lie in the fact, that such a practice delays the entry of generics, since the approval process cannot be initiated until the patent expires, while the time taken for the approval process may span over a couple of years. Further, the entry of generics is justified by the “Bolar Exception clause” (enshrined in Section 107A (a) of the Patents Act, 1970), the purpose of which finds defeat, if the practice of patent-linkage be given a go-ahead. Further, the drug regulator, an authority, having no specific expertise in the arena of patents, will have to indulge himself in the complexities that patents present.