On November 2, the Indian Intellectual Property Appellate Board (IPAB) revoked Hoffmann-La Roche’s patent on the hepatitis C drug Pegasys. In particular, the IPAB found that Roche failed to demonstrate Pegasys is more efficacious than an earlier version of the drug. Read the ruling here. The ruling brings three critical issues to the fore.
The patent on Pegasys was granted by the Indian patent authority in 2006 and was subsequently challenged by Mumbai-based generics producer Wockhardt and the non-profit Sankalp Rehabilitation Trust on the grounds that the product was neither novel nor non-obvious.
First, the legal ruling demonstrates that Indian patent legislation is supported by a legal system that successfully resolves disputes. There will be those that argue that the decision is flawed, but all must agree that the system is working. The process of challenges and appeals is sorting out which patents are valid and which will be denied protection. This is especially noteworthy since Pegasys was the first pharmaceutical product granted protection under India’s 2005 patent law.
In addition, the ruling importantly determined that non-governmental organizations (NGOs) have the legal standing required to file a post-grant opposition to the grant of a patent. Roche raised a preliminary objection regarding the locus standi of the Sankalp Rehabilitation Trust, arguing that the NGO was not a ‘person interested’ and therefore unable to file the post-grant opposition. As stated in the ruling, “Further public interest is a persistent presence in intellectual property law and will not melt into thin air, nor dissolve. We therefore hold that the appellant who works for a community which needs the medicine is definitely a ‘person interested’. The locus standi objection is rejected.”
This ruling is clearly important for patient advocacy groups and public health advocates who both favor and oppose patent protection. This gives them a voice and acknowledges the importance of their position and their certain interest in intellectual property issues.
Finally, this ruling points to the uncertainty surrounding the strength of patent rights in India. The lengthy legal battle preceding this decision, the years required to reach this ruling and the overruling of the Indian Patent Office’s determination and the lower court’s ruling all shed doubt on the efficiency and consistency of the existing system.
Moreover, for innovative pharmaceutical companies it raises questions about the viability of the Indian market and the priority that should be placed researching future treatments. The discovery of innovative medical therapies require significant investments of time, money and talent. These are scarce resources and risky ventures. Patent protection ensures that the most promising ideas are championed and resources are devoted to them. Significant uncertainty surrounding whether such protection will exist can only diminish innovation and reduce the number of discoveries available to all of us.
These critical issues are far from being resolved. Roche is still considering its decision to appeal and upcoming rulings will further inform these issues. Nevertheless, the case does mark an important milestone in clarifying the landscape surrounding intellectual property rights in India and the future of innovation.
Dr Kristina Lybecker is Associate Professor of Economics at Colorado College in Colorado Springs. Kristina is an economist with a PhD from the University of California at Berkeley. She specialises in innovation and intellectual property rights and has been writing on these issues for 12 years. She is currently employed full-time at Colorado College. In the interests of transparency, the writer states that she has been commissioned to work for the pharmaceutical industry on issues of innovation, corruption, counterfeiting and intellectual property rights. However, she has not been compensated or otherwise rewarded for this piece which stems from her intellectual interest in the topic and closely relates to her academic research.
Pic sourced from http://www.coloradocollege.edu
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