Jeevani, the globally renowned herbal drug, does not enjoy a global patent protection even after a decade after its development, but only has an Indian process patent which is not valid in international markets, it is learnt.

The scientists who masterminded the Jeevani product development, patenting and technology transfer since 1992, besides benefit sharing to the tribal custodians of the drug for the first time in the history of ethnomedicine, admitted to Pharmabiz that so far they have not even initiated the global patenting process.

The revelation is sure to question the integrity of the celebrity scientists who had conveyed not only to the public, but also to the Coimbatore Arya Vaidya Pharmacy (AVP) management during the technology transfer in 1995 that the drug was being globally patented. Industry observers felt this leads to assumption that the various crucial stakeholders involved, either ignored the most important aspect of drug research and delivery or consciously kept concealed that Jeevani was open to any global company for more than a decade.

In an interaction with Pharmabiz from Lucknow, former Tropical Botanical Garden and Research Institute (TBGRI) director and the main inventor of Jeevani, Dr P Pushpangadan said then the institute could not have afforded to bear the prohibitive expenses related to the filing of international patents on Jeevani in developed countries. "The drug was developed at a modest cost of Rs.5 lakh. The institute has carried only the preliminary clinical studies needed to prove the efficacy of the product. Much more studies would have been needed if the institute wanted to apply for a product patent in lucrative markets like the US. The institution simply didn't have the resources needed for such an exercise," he said.

Asked about the unfortunate developments that led to the loss of trade mark rights on Jeevani to Nutriscience Innovations LLC in the US, Dr Pushpangadan felt that the trade mark was probably registered with the knowledge of Coimbatore Arya Vaidya Pharmacy (AVP), the company that had bagged the license for manufacturing and marketing the product for seven years. Dr Pushpangadan declined to comment more on the issue as he is presently not associated with TBGRI and is heading National Botanical Research Institute, Lucknow.

Reacting to this from Bangalore, Dr GG Gangadharan, former general manager (Product Development) of AVP and a senior biotech scientist mainly instrumental in the technology transfer, told Pharmabiz, the top TBGRI scientists had conveyed to AVP that the drug was being globally patented during the technology transfer period.

"We had enquired whether they were trying for a global patent, and the scientists including Dr Pushpagandan had told us they were in the process of globally patenting Jeevani. They did not do that and therefore AVP could not directly sell Jeevani in lucrative markets like USA. We were able to ascertain Jeevani's lack of global patent protection only one or two years ago when we had found Nutri Science, which had taken a few bulk supplies from AVP, registered Jeevani as a trademark product in US. However, we did not stress to expose and pursue the issue as already the license period was nearing completion and AVP was already a big loser in the bargain," admitted Dr Gangadharan.

He also preferred to keep away from controversy and declined to comment on Dr Pushpagandan's observation that Nutriscience registered the trademark rights probably with the connivance of AVP.

When contacted, Dr GM Nair, TBGRI director said " In fact I had been following only the legacy of my predecessor (Dr Pushpagandan), and admit I did not seriously pursue the probable complications to Jeevani until Pharmabiz broke the trademark infringement story, last month. During the 1995-96 period, all were excited by the prospects of a blockbuster drug and everything was done in a hurry. Please do not draw me into this controversy. I do not want to criticize or comment on what all had happened earlier. What I can tell you now is we are in the process of revalidating the drug and is planning for a global tender, including applying for a global patent," said Dr Nair.

He also revealed that TBGRI is now planning to pursue the case through CSIR on this trademark registered by US firms with Pharmabiz reports as supportive evidence, and was planning to seek expert opinion from people like Dr RA Mashelkar, CSIR director.