Nearly four years since embarking on a product patent regime, and even after granting thousands of product patents, India’s intellectual property laws continue to remain in an elusive zone.

In January 2005, India made it loud and clear to the world that it started recognizing IP rights of innovative products as well – a reversal from its long-held stand of honoring only novel processes for making a drug-obligated by TRIPS among WTO members. And the Indian Patent Office issued a record number of over 15,200 patents in various categories during the 2007-08 period. Despite this, the country is still struggling to strike a balance between different sections of the industry on certain vital aspects of the new patent legislation.

The very criteria of patentability itself – what qualifies a product to obtain patent in India – is at the crux of the issues being disputed. The new version of the patent law has it that salts, complexes and other derivatives of known substances shall be considered to be the same substance and hence they will not be eligible for fresh patent ‘unless differ significantly with regard to efficacy.’ This contentious section – Section 3 (d) – of the Patent Act moved to center-stage when Novartis fought in Indian courts to eliminate it with respect to Glivec case.

Incremental or Innovative

Innovators reason that modifications or improvements on the existing drugs – the so-called incremental innovations – top the list of new therapies at any given point of time. Very often research does not lead to novel drugs but an improvement on the existing drug class. Most of the innovations that have contributed to improved healthcare are incremental.

They also argue that it is not patents that come in the way to access to medicines, but compliance. “Innovations that improve patient compliance – like reduced dosage and easier administration – are more important in India than in developed countries,” stated Ranga Iyer, president of the Organization of Pharmaceutical Producers India (OPPI), the umbrella body representing innovator firms.

Those on the other side of the fence counter the MNC’s lobbying for exclusivity for incremental innovation, pointing out that it is competition, not exclusivity, that drives technological development. There is no one model that fits all. So, each country has to have its own patent laws taking account of the stages of development.

“Have we reached a level where we can do away with the flexibility offered under TRIPS? And if we do away with that, what will be its consequences?” asked Dilip G. Shah, secretary-general, Indian Pharmaceutical Alliance (IPA), the conglomerate of Indian generic majors. According to Mr. Shah, India should evolve an IPR system which ensures balance between the interests of the innovator and the consumer, “a system that encourages real innovation while ensuring access to medicines.”

The government, caught between powerful lobbies and other drug groups, has started referring the issue to expert committees for recommending a solution.

Hold On! Give it Time

Some people say that incremental innovation in India would be the ideal thing. There are others who feel that it would lead to “evergreening” (simply adding patents to a single product), said a senior bureaucrat from the Ministry of Commerce and industry, recently. “Three or three-and-a-half years in the life of an Act or law is not too long a period. There has to be some degree of patience, understanding that these things take time to evolve,” the official added.

The way in which 3 (d) exclusions are operated in practice will determine whether India is truly compliant with TRIPS, observers feel.

Data protection and pre-grant opposition of patents include other major areas of concern that defy a broader consensus.

The authorities are yet to act on the recommendation for granting a definitive period of safe-guard for the know-how submitted for marketing approval. In this case, the discord is not only among different sections of pharma industry but among various ministries involved as well.

Formal grounds for opposing a patent before granting have always been listed. However, the new procedures for pre-grant opposition often put a patent applicant to disadvantage since they sets no time limits with respect to a specific starting date and an end date.

Patent experts see the system is not yet fully “fit for the purpose,” although they welcome the passage of 2005 Act as a major step forward.

The government, nevertheless, looks rather optimistic. “As you know in this country of one billion plus, there are almost one billion voices. But we hope some consensus will emerge and we will be able to ensure that we give a clear message to the world,” gleamed our ministry official.

S. Harachand is a pharmaceutical journalist based in Mumbai.