India dusts out Mashelkar report seeking to extend patents to incremental inventions

The revised report stresses the need for including incremental pharmaceutical inventions too under patentability criteria

The Mashelkar Committee Report, that seeks to extend the scope of India’s patentability criteria for new drugs in India to include incremental pharmaceutical inventions, has been re-submitted under governments repeated request, it is learnt.

The Mashelkar Committee report on pharmaceutical and micro-organism patents in India, which drew a lot of flak form both the industry and politicians a couple of years ago, has resurfaced in a revised form.

India is yet to unambiguously define certain fundamental aspects of Indian Patent Law such as patentability and data exclusivity, even though the country had assured in a product patent regime on 1st of  January 2005, following TRIPS obligations.

Dr Mashelkar along with a team of technical members was assigned with the task of figuring out terms and definitions for the new patentability criteria and the scope of patenting micro-organisms in accordance with the TRIPS agreement.

Though revised, the contents of the new report are essentially the same as the original, re-iterates the committee which has submitted the new report to the Union Ministry for Commerce and Trade recently.

The new Mashelkar report notes, as earlier, that any attempt to exclude an entire class of inventions i.e. incremental pharmaceutical inventions would violate the mandate under Article 27 of TRIPS to grant patents to all inventions in all fields of technology.

The government appointed committee to define patentability criteria for new chemical entities headed by the veteran technocrat Dr Mashelkar submitted heir recommendations towards the end of the year 2006.

The Mashelkar Committee Report was submitted by the TEG (technical expert group) to the government on 29 December 2006. However, Dr Mashelkar soon sought permission form the government to withdraw the report as some ‘technical inaccuracies’ were pointed out in the report. The chairman (Dr Mashelkar) wrote a letter dated 19th February 2007 to seek government’s approval to ‘`withdraw the Report, re-examine it and resubmit a report, which meets with the requirements of the highest standards.

The revised Mashelkar committee report explains the reasons behind the withdrawing of the earlier report and its current resubmission: “Due to certain developments, the chairman of the Committee expressed his desire to resign from the chairmanship of the TEG vide letter dated 15th of March 2007. The Government, however, did not accept this request of resignation vide D.O. letter No.12/14/2—5-IPR II dated 1st May 2007 and requested the TEG to submit the report incorporating the changes.’’ notes the report.

And recently, the committee was requested to expedite and submit the report at the earliest. “Vide letter dated 9th March 2009, the chairman, while respecting the decision by the government, agreed to accept his responsibility as the Chairman again and to submit the report. Accordingly, the report, incorporating the changes, has been resubmitted,’’ notes the report.

However, the highly controversial key conclusions, continue to be unchanged in the revised report too.

“The Technical Expert Group (TEG) concludes that it would not be TRIPS compliant (Article 27 of TRIPS) to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a “statutory exclusion of a field of technology”.

At the same time the Mashelkar committee repeatedly endorses the view that every possible efforts should be taken ensure availability of drugs at affordable prices to the people of India — a key aspect, which some sections of the Indian pharma industry feels would be thwarted by granting patents to all new drugs.

The new Mashelkar report also stresses the need to prevent the grant of frivolous patents and ‘ever-greening’. `Detailed Guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated,” says the report.

Some of the other highlights of the new Mashelkar report include: are Apart from the above, the main highlights of the technical expert group (TEG) are outlined right at the start of the report in a couple of paragraphs as below:

Doha Declaration and Article 7/8 of TRIPS

The committee notes that neither the Doha Declaration on Public Health nor Articles 7 and 8 can detract from the conclusion that an outright exclusion of incremental inventions from patentability would violate TRIPS.

“4.2. The TEG carefully examined the flexibilities allowed under the TRIPS Agreement to the member states (especially Articles 7 & 8 ) and also as a consequence of the Doha Declaration. The detailed analysis and reassessing provided in the report has led TEG to conclude that it is debatable as to whether national interest or the flexibility allowed under the agreement to member states would be accommodated by such ‘statutory exclusion’ of an entire class of inventions.”

Encouraging incremental innovation

The TEG also stresses on the importance of using the patent system to incentivise more incremental innovation.

“4.4 The process of innovation is continuous and progressive leading to an ever extending chain of knowledge. Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation.

Entirely new chemical structures with new mechanisms of action are a rarity rather than a rule. Therefore, “incremental innovations” involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged. What is important, however, is for the patent office to be vigilant about setting high standards of judging such innovations so that efforts on “evergreening” are scrupulously prevented,’’ according to the report.

The current version of the Indian patents act, through section 3.d and other provisions provides a robust enough mechanism to help prevent evergreening.

Some of the recent rejections following oppositions are listed below

1. Pfizer’s Applications Claiming Caduet (rejected pursuant to a PreGrant Opposition filed by Torrent Pharma)

2. Novartis’ application claiming the alpha crystalline form of imatinib mesylate (opposition filed by Sun Pharma and Okasa)

3. Glaxo’s Application for Rosiglitazone Salt

4. Gilead’s application for the Tamiflu drug (Oseltamavir): Pursuant to pre-grant opposition filed by Cipla.

Section 3(d)

Regarding the highly contentious Section 3 (d) of the Indian Patent Law 2005, the committee has made clear in its revised report that its report has nothing to do with section 3(d):

“4.5 The TEG was not mandated to examine the TRIPS compatibility of Section 3(d) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself with these issues.”

Patenting of Micro-organisms in India

In its earlier report, the committee concluded that excluding micro-organisms from patentability would contravene TRIPS. It reiterates the same conclusion in the revised report.