Imperfect Compromise Seen In India Data Exclusivity Report18/06/2007 by Tatum Anderson for Intellectual Property Watch Leave a CommentShare this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)IP-Watch is a non-profit independent news service, and depends on subscriptions. To access all of our content, please subscribe now. You may also offer additional support with your subscription, or donate.By Tatum Anderson for Intellectual Property Watch When the Indian government published its report recently on yet another pharmaceutical patent-related issue predicted to split the industry, the Indian newspapers were divided as to whether brand name producers, generics producers or public health advocates had won.The reason for the confusion is that the report is an exercise in appeasement, said Shamnad Basheer, a law professor at George Washington University Law School, and expert on this latest controversial subject, called data exclusivity, which is the rights drugs producers have over the data used to obtain marketing approval in a country.“It seems like an effort to try and please everyone – the generics, the public health groups. There also is a clear attempt to appease the originator companies,” he said.Industry observers say the notorious Mashelkar affair has overshadowed the report. (A senior government official, Dr. R.A. Mashelkar, director of India’s industrial research and development institutions, was accused of plagiarising elements of a crucial intellectual property report and was forced to resign earlier this year).As a result, the Indian government is unwilling to court more controversy over intellectual property, they say.“This report has taken a very cautious approach to show they are concerned about both public health and the economy” said Tahir Amin, a lawyer for Initiatives for Medicines, Access and Knowledge (I-MAK), which published a report analysing data exclusivity and protection issues in India that was considered in the government consultation.The report was carried out over two-and-a-half years by an inter-ministerial committee and was led by Satwant Reddy, secretary of the Department of Chemicals & Petrochemicals. It looked at the way in which India treats data generated by pharmaceutical companies when they test new drugs on animals and humans in pre-clinical and clinical trials, and whether this is compliant with the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The intent was to determine if a policy change is necessary.So how has the report tried to appease everyone?First, it has agreed that the minimum requirements of TRIPS do not require data exclusivity and that the status quo ? no data exclusivity – will continue for the time being. That pleases public health activists and generics producers that want to copy drugs. (The report did also propose data exclusivity for agro-chemicals and traditional medicine, however).But the report has agreed to tighten India’s data protection by detailing explicit rules to prevent data being leaked by the regulator.Secondly, and crucially for originator pharmaceutical companies, the government said a five-year data exclusivity term will be imposed in the future after a “transition period.” It acknowledges that data exclusivity goes beyond the minimum requirements of TRIPS but believes it will provide incentives for the pharmaceutical industry to create new drugs, thereby encouraging more foreign direct investment in India.India’s larger generic companies, as well as originators, and are thought to be in favour of data exclusivity because they are increasingly moving into creating, rather than copying, drugs.The report has also proposed a series of safeguards to ensure that data exclusivity does not lead to medicines becoming too expensive, or being delayed from reaching the market. For instance, when introduced in India, the data exclusivity period would begin from the time that a drug first receives marketing approval anywhere in the world.Often companies register their drugs in the richer countries first, and delay applying for market approval in poorer countries, so that consumers there must wait longer periods before they can access drugs says Professor Brook K. Baker of Health GAP and the Northeastern University School of Law (US), who welcomes this safeguard.However, by attempting to appease everyone in the government, no one is totally happy.Many safeguards prevent adequate data exclusivity says Krishna Sarma, managing partner at Corporate Law Group, a law firm that represents originator companies in India. “They give with one hand and take with the other,” she said.Sarma is particularly concerned that generics can be granted marketing approval by the India regulator using data submitted to regulators in other countries. In addition, she said she is disappointed that the government failed to specify a date when exclusivity might be introduced and that data exclusivity rules will not apply to exports.Conversely, opponents suggest there is little proof that data exclusivity increases foreign direct investment, citing a recent report by Oxfam on the experiences of Jordan’s new intellectual property rules.Others say many safeguards are unclear. Crucially, the government has failed to define exactly what sort of chemical entities would qualify for data exclusivity. This has huge consequences said I-MAK’s Amin. If it uses a definition that is less strict than that used within India’s patent law, many drugs that are unpatentable could still be prevented from reaching the Indian market using data exclusivity. Depending on the definition used, there is a risk that companies might use data exclusivity to evergreen their products (extend patents based on minor changes to the product), say observers.Many agree, however, that not enough analysis has been carried out so far: “The report paraphrases our view and the other side’s view but puts it together without resolving it,” said CL Group’s Sarma. “They haven’t tried to find middle ground.”Tatum Anderson may be reached at email@example.com.Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Related"Imperfect Compromise Seen In India Data Exclusivity Report" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.