24 November, 2015
There has been a lot of brouhaha in India over the issue of granting Data Exclusivity to pharmaceutical biotechnology companies. The issue of Data Exclusivity has been one of the core points of dispute between India and many developed countries during the Free Trade Agreement (FTA) negotiations. The concerns arising out of Data Exclusivity differences need to be reviewed objectively with respect to their pros and cons.
The issue on Data Exclusivity drew attention in view of provisions laid down in Article 39.3 of Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) which does not explicitly call upon member states to provide Data Exclusivity rights, nonetheless states as under:
"Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use."
The TRIPs Agreement also does not define what constitutes “unfair commercial use” and leaves it open for the member states to enact and implement its own laws regarding protection of proprietary data. Accordingly, different countries have adopted different yardsticks in interpreting the requirements of Article 39.3 of TRIPs. While, the USA provides 5 years of exclusivity for new drugs and additional 3 years for new indications of existing drugs, and 10 years for agro-chemicals; the EU provides 10 years for both pharmaceuticals and agro-chemicals and 1 additional year for new indications; China and Japan provides 6 years for both pharmaceuticals and agro-chemicals and Brazil provides data exclusivity only for agro-chemicals but not for pharmaceuticals. India presently does not provide data exclusivity for either pharmaceuticals or agro-chemicals.
While, there has been serious debate in India whether data exclusivity should be provided to both sectors, a committee (Reddy Committee Report) to study the feasibility of introducing data exclusivity in these sectors was formed, which made drastically different recommendations for the pharmaceutical and agro-chemical sectors. The Reddy Committee Report recommended that 3 years data exclusivity be provided in respect of agro-chemicals, based on which the Pesticides Management Bill, 2008 also proposed a 3 year data exclusivity for the originator’s data. It is another matter that this Bill has not seen the light of the day till date. For pharmaceuticals, it did not recommend Data Exclusivity.
The rationale given in the Reddy Committee Report for providing data exclusivity in respect of agro-chemicals, inter alia, were that unlike pharmaceuticals, efficacy tests for agro-chemicals must be repeated in every country, even in several regions in a country due to differences in crops, pests, agronomical practices, climate conditions and terrains; secondly, because of the toxic nature of the substances involved the crop protection industry must face a responsibility for environmental impact to which the pharmaceutical industry is not exposed.
However, a corollary can be drawn for grant of Data Exclusivity in respect of pharmaceuticals as well in that, when generics rely on the data of the originator’s product and show bioequivalence test for its product with the originator’s product, it would rely on the data generated by the originator in its home country, and since most of Big Pharma are based in USA or Europe, the data generated would primarily be from these countries, unless the clinical trial data submitted by the originator before the Drug Authority (CDSCO, in case of India) is based on global clinical trials which is representative of Indian patients as well.
Even in USA, the broad categories provided by USFDA in “Guidance for the Industry” on “Collection of Race and Ethnicity Data in Clinical Trials”, have recommended that data be collected in the following format for different races: (a) American Indian or Alaska Native, (b) Asian, (c) Black or African American, (d) Native Hawaiian or other Pacific Islander, (e) White. The term “Asian” would include persons having origins in the Far East to persons in India, which are diverse demographically. Even for people in India, there could be different ethnicities involved, e.g. Indo-Aryan, Dravidian, Mongoloid, Tribals, etc. and there is evidence to show that efficacy and safety of the administered drug could vary from one ethnicity to another. For example, the blood levels reached after intake of lipid lowering agent rosuvastatin are far higher in Asians, compared to Europeans and North American Caucasians, Hispanics and Blacks needing lowering of dosage. Failure to lower dose in Indians can result in severe toxicity, including life-threatening muscle injury leading to fatalities. Hence, testing of drugs in Indian ethnic groups is of paramount importance before approving any drug of foreign origin.
Therefore, there is an imperative need to generate clinical trial data for the Indian population instead of relying on data submitted before the USFDA and granting manufacturing licenses to the originator as well as the second entrant or subsequent entrants on the basis of these data. Even the Reddy Committee Report has acknowledged that such data would be in India’s interest in the long run.
However, to counterbalance the issue of ever-greening of an about-to-expire or an off-patent drug, measures can be taken to make the data exclusivity period fall within the patent expiry term, which would also resonate with the Make in India campaign by stimulating early entry/manufacturing of drugs in the Indian market.
 Mrs. Reddy et.al, Report on steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPs Agreement, GOVT. OF INDIA (2007)
 Ibid at p. 23
 Guidance for Industry: Collection of Race & Ethnicity Data in Clinical Trials, USFDA (2005) available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidelines/ucm126396.pdf
 59th report, The functioning of the Central Drug Standard Control Organisation (CDSCO), Department Related Parliamentary Standing Committee on Health, Rajya Sabha, Parliament of India (2012)
 Mrs Reddy et al. at page 44, Point 7.4.3
For further information, please contact:
Manisha Singh, Partner, LexOrbis