This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
Warning: This next entry in the series: Biotech in Countries Starting with “I” is a ‘feel-good’ update on India’s new National Intellectual Property Rights Policy, released May 12, 2016 and last discussed in early 2015 here.
First a few caveats:
Over the years I have worked closely with PhRMA and BIO members to increase awareness of the importance of effective intellectual property protection in India. While India’s biopharmaceutical sector continues to rely on global partnerships, it is safe to stay that challenges relating to acquisition or enforcement of IP rights has been a persistent irritant for US, EU and Asian partners alike.
On the other hand vesting of patent exclusivities by foreign entities continues to be a polarizing and politicized issue in India for economic and political or cultural reasons. And at least some of India’s pharma oligarchs continue to view effective patent protection as a potentially crippling threat to their business model, rather than an opportunity for value creation through innovation.
More broadly, critics of product patent protection seem to have a selective view of history – as I noted in a 2002 Essay (paywall), India paid an unconscionably high price for rescission of product patent protection through the Patents Act of 1970, losing out on potential for both social and economic value created through assimilation of innovative life sciences.
As a result, a single American innovative biotech company like Genentech, sold to Roche for $46.8B in 2009 – represents a multiple of the entire Indian pharma sector valued at approximately $13.1B in late 2015. On an empirical basis, this also translated into poor access to innovative medicines and higher prevalence of non-GMP drugs.
In this context, the new National Intellectual Property Rights Policy makes an important break from the past, with evident pride in India’s creative capacities, as stated:
India’s new IPR Policy represents an exciting, forward looking approach to encourage and nurture innovation in India. Coming almost exactly sixteen years after my first trip to India, the new IPR Policy is meaningful to me both as an advocate and as co-founder of Amrita Therapeutics, an emerging biopharmaceutical company commercializing peptide therapies from the microbiome.
Following India’s re-adoption of product patent protection, Ananda Chakrabarty and I started Amrita Therapeutics in Gujarat to demonstrate the possibility of highly innovative biopharma development in India. Working in partnership with apex Indian R&D institutions, Amrita Therapeutics has developed novel peptides, that are designed, tested and are being formulated in India. We have applied for several patents in India and internationally through the PCT.
The Modi Government’s evident enthusiasm for Indian innovation is a welcome and important step. At the 10,000 foot level, the Modi Government’s new IPR Policy demonstrates a clear understanding of the role of IP as a driver for creativity, innovation and related value generation needed to improve availability of safer and better therapies for Indian patients.
Of course anything the Modi Government says or does with regard to India’s National Intellectual Property Rights Policy will be highly controversial among India’s academics, NGOs, domestic oligarchs and assorted IP-skeptics. (I may have my own criticisms after reviewing the details.)
So for today, let’s just celebrate the ethos of India’s national IPR policy as embracing and encouraging the innate creativity and innovative capacities of Indian scientists – not to mention the authors, artists, designers, engineers and other creative classes!
About Susan Finston:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive experience relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and educational programs. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., a microbiome drug developer. Previous experience includes 5.5 years as Associate Vice President, Pharmaceutical Research and Manufacturers of America (PhRMA), where she led the international patent reform advocacy in the MENA region and South Asia (India) and 11 years in the U.S Foreign Service with tours in London, Tel Aviv, and Manila and Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.