Data Exclusivity

The Curious Case of the "Data Exclusivity" Volte Face

In an earlier post, we referred to a rather curious article by Financial Express (FE) which claimed that some of our biggest generic names, namely Dr Reddys and Glenmark executed a stunning volte face and were now cosying up to the idea of data exclusivity. Certainly had my alarm bells ringing, as I’m sure it did for many of you tracking this space.

I spoke immediately with that tireless crusader and one man army that goes by the name of DG Shah (Chairman of the Indian Pharmaceutical Alliance, an association of India’s leading generic companies) and it now turns out that none of these companies had ever expressed this sentiment. Shah informs us that all the relevant head honchos (Glen Saldanha et al) have again reaffirmed their commitment to the IPA position paper, which we have now uploaded on the SpicyIP website. This paper opposes “data exclusivity” of any form.

I then spoke with the FE reporter in question, BV Mahalakshmi, who claims that her primary source for this story was a very senior OPPI official. And that her original story which contained more details and more sources had been chopped up by an editor. Prashant’s earlier blog post covering the FE article had rightly noted this lack of citation of any source for the story.

OPPI (Orgn of Pharma Producers of India) represents the interests of drug originators and is dominated by Western multinational pharmaceutical firms. If what Mahalakshmi states is indeed true, was OPPI attempting to create mischief by leaking this falsehood in the midst of a highly contentious India EU FTA negotiation? Or was this a case of genuine belief that our generic biggies were interested in risking sanction under section 309 of the Indian Penal Code, a provision that criminalises an attempt to commit suicide?

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

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