Domestic, MNC pharma clash over data protection

Gireesh Chandra Prasad G I, Mumbai

As pharmaceutical industry associations in the country and experts clash over the desirability of the Trade Related Aspects of Intellectual Property Rights (Trips) obligation to protect innovator's proprietary clinical trials data against unfair commercial practices, interpretations remain diametrically opposite in the high octane debate on its connection with patentability and the protection term's preferred beginning.

While experts leaning towards the multinational view feel 'data exclusivity' term, during which the regulator may not rely on the innovator's data for generic approval or disclose it without safeguards against unfair commercial use, should begin from the date of marketing approval, others feel the date of first submission in any convention country should be applicable.

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the International Federation of Pharmaceutical Manufacturers (IFPMA) maintain data exclusivity is independent of other forms of intellectual property rights such as patents, an argument that instantly absolves them of patent evergreening charges besides giving some lee way to claim an exclusivity term beyond the patent life and even in cases without an underlying patent.

According to city-based patent expert Gopakumar Nair, the country shall provide some protection to the proprietary data submitted by the innovator and it would be better not to antagonise these associations entirely as 70 per cent of the Indian companies' market are in the US and Europe.

He said the term of protection the country might agree on should ideally begin on the date of first patent filing or at least the date of first submission for marketing approval in any convention country as the MNC demand for the marketing approval date's applicability in individual nations would further delay generic entry.

"The Big Pharma wants the term to begin as latest as possible. It is open to interpretation like calculating the age of a baby from the date of conception, childbirth or from its first birthday. If it begins from the date of actual marketing in each of the nations, they would get that much extended market exclusivity. Going by this argument, a company would get market exclusivity in India even if it introduces a product in 2005 which has been in the international market since 1995. This is highly irrational", Nair said.

Data non-reliance/ non-disclosure term should be uniformly applicable to all countries so that there would not be any delay in product launches also. Besides, compulsory licensing should be above this obligation, he added.

Professor Prabuddha Ganguli, Advisor, Vision-IPR, says since Article 39 of Trips only speaks about protection against 'unfair commercial use' and not explicitly about data exclusivity, India could review the interpretations adopted by other countries and take a view keeping in mind the spirit of Article 39.1, 39.2 and 39.3 in its entirety.

"It only says members when require submission of undisclosed or other data for approving the marketing of pharmaceutical, agricultural or chemical products which involve a new chemical entity, the origination of which involves considerable data, shall protect it against unfair commercial use. Our legislators have to define 'unfair commercial use", he said.

Protection can be for five to 10 years from the date of granting marketing approval. Besides, patent and undisclosed information are two separate issues and shall not be mixed up, he added. Patent application only requires the minimum data to justify the patent, while marketing approval requires a huge amount of precious data, which has to be protected, he added.

He said the country missed the January 1, 2000 deadline for this obligation.

Data protection is distinct from patent rights as generic players are allowed to seek marketing approval producing their own clinical trials data, something not allowed during the patent protected period.

Delinking of protection against unfair commercial use from patentability would mean the data non-reliance/ non-disclosure period could go well beyond the term of patentability and even non-patentable substances can be assured of some market exclusivity, he said.

The IFPMA justifies this in its position paper on the subject saying had generic copies of Bristol-Myers Squibb's (BMS) anti-cancer warrior Taxol (paclitaxel) been able to be approved immediately, BMS would not have been able to bring the product to the market, spending over US dollar 500 million.

PhRMA and IFPMA also insist the protection should be applicable to a complex, simple ester or salt of a previously approved substance, a demand strongly opposed by the powerful body of Indian Pharmaceutical Alliance (IPA).

IPA recently shot off a missive to the Union Chemicals and Fertilizers Ministry explaining how succumbing to these demands could harm the country's interests. IPA has no objection to strengthening laws for protection of undisclosed test data, but is opposed to grant of market exclusivity, the letter says.

IPA argues that once the concept of market exclusivity by way of data protection is accepted, pressure will mount for granting it from the date of marketing authorisation in the country. This would result in providing protection beyond the life of the patent and delay entry of generics not only in the Indian market where patent has already expired, but also in lucrative export markets.

It would also signal to the rest of the developing world to follow suit resulting in Indian generics' delayed entry in these markets until the exclusivity period is over. Besides, pre-1995 products which otherwise are not eligible for patent protection and not yet commercialised in the country would get market exclusivity, IPA argues.

The Alliance also says data exclusivity has little relevance to foreign clinical research investments in India as the data generated here is not filed here, but is used for obtaining marketing authorisation in the originator's market.