SpicyIP Tidbit: 'Outlook' carries a story on the proposed Indian Bayh Dole Bill

The Outlook a leading weekly news magazine has recently carried a story on SpicyIP’s pet subject – the Public Funded R&D Projects (Protection of Intellectual Property) Bill also known as the Bayh Dole Act of India. As our readers must already be aware several media outlets had already picked up this story from SpicyIP and several of these reports have agreed with SpicyIP’s contention that the Bill is being introduced without enough consultation and debate.

The Bill essentially allows universities and other entities to patent research generated from public funds thereby allowing them to commercialize the inventions. As per the bill the scientists who worked on the project are entitled to 30% of the royalties that may be generated from the commercialization of the invention. The Bayh Dole Act worked quite well in the USA both in terms of the quantity and quality of research as also the fact that Universities managed to become financially independent. But then again just because this legislation worked in the USA does not mean its going to work in India. The bill therefore has to be tailored for Indian conditions. Apart from this there are also concerns as to whether the Indian version has learnt from America’s experience with the Bayh Dole Act i.e. has the Bayh Dole Act affected research in basic sciences which have no scope for commercialization but are nonetheless important. In this regards it is important to understand to what extent the American industry has affected the course of research in American Universities? In short the Ministry has not conducted an adequate empirical study before introducing this Bill or if they have conducted the study they have not released the findings of this study. For our previous posts on the Bayh Dole Act please click here. Below is the entire article from Outlook:

Whose Test Tube Babies? A bill to let government scientists patent their work raises questions of propriety

byDebarshi Dasgupta

There is nothing ignoble about the intention, especially if you frame it as a means to encourage research and nurture talent. But questions are being raised about a bill that allows scientists working in public institutions to patent their work in their own name and keep a share of the sale profits.

Should the product of research conducted in public institutions, using government funds, be allowed to generate wealth for an individual? What about collaborative efforts that are increasingly the norm in domains like nanotechnology and biotechnology? These are some of the problems that, experts say, the Public Funded R&D Projects (Protection of Intellectual Property) Bill leaves unaddressed. The idea for such a law, inspired by the American Bayh Dole Act of 1980, was apparently put forth by Raghunath Mashlekar, former director-general of the Council for Scientific & Industrial Research (CSIR). It was endorsed then by the National Knowledge Commission. The Union law ministry is now finalising a bill that will be presented to the cabinet for approval. Once enacted into law, the bill's key provision will allow government scientists to patent their inventions and keep at least 30 per cent of the net earnings such work brings to the institution or university in which they are employed. The bill also covers any research conducted elsewhere with government funds. A senior official from the department of biotechnology, which is spearheading the initiative on behalf of government scientists, says such a law is necessary to boost intellectual wealth generation in the country and ensure better transfer of technology for the public good. Somenath Ghosh, CMD of the National Research Development Corporation (NRDC), mandated to carry out technology transfer, shares the optimism: "It will increase the level of awareness about patenting, which is as of now extremely low in government institutes." But the bill is also drawing a lot of criticism. "It is a highly contentious assumption that protection of intellectual property is the only way to induce R&D," says K.M. Gopakumar of the New Delhi-based Centre for Trade & Development. "If that were the case, we wouldn't have been still using a detection kit for tuberculosis that was designed way back in the 19th century." Moreover, say critics, the bill promotes a model of proprietary and secretive research. Collaborative effort—which is de rigueur in biotechnology, drug development, and other specialised areas, even in private firms like GlaxoSmithKline—gets the go-by. The bill, in its present form, also curbs the right of scientists to leave their work freely in the public domain. For, it will fall upon the intellectual property management cell of the institute employing them to decide if a work should be patented or remain available for use to anyone. "Since the cell's performance is measured solely in terms of patents, they are unlikely to leave university research in the public domain, which enables knowledge spillovers," says Shamnad Basheer, a research associate at the IP Research Centre at Oxford University.

Groups like Doctors Without Borders are concerned about such a bill, as it will make drugs made from public-funded research more expensive. This has happened in the past: anti-retroviral drugs like didanosine and cancer drug imatinib, developed in American universities, were commercialised. Imatinib, sold as Glivec by Novartis, was the subject of a heated dispute in India last year when the Madras High Court allowed generic manufacture of the drug to continue.

Brian Drucker, professor of medicine at the Oregon Health & Science University Cancer Institute and widely credited as the scientist who created imatinib, wrote in an Indian newspaper during the dispute that the abuse of exclusive rights by Novartis by charging excessive prices was not justified, given the vital government funding that went into developing the drug. Without access, he added, medical research was no better than a "luxury good—a cause for considerable discomfort for me."

Leena Menghaney, a campaigner for Doctors Without Borders, says that in the US, under the Bayh Dole Act, government labs at least have the rights to enforce fair use in case research is misused by a private party.

"But the Indian version has insufficient safeguards to prevent misuse. It absolves them (the institutes) completely by saying disputes will be settled under the Indian Patents Act and places no additional checks to ensure public research actually benefits the public. We want an alternative model for research that delinks the cost of R&D from the price of the pharmaceutical product," she said. Dinesh Abrol, a science policy researcher at the National Institute of Science, Technology & Development Studies, feels that such measures may render Indian universities subordinate to market forces. "Bayh Dole in the US has generated much conflict of interest. There have been instances of scientists in universities tailoring their results to industry preferences. This, when universities are expected to act for the civil society, independent of the government or private bodies," he says.

Such problems are likelier in Indian universities, says P.M. Bhargava, former vice-chairman of the National Knowledge Commission. This is because, he says, Indian universities haven't yet developed an independent character.

"Even vice-chancellors in India are appointed on a political basis and there are few intellectuals in Indian universities who oppose government moves like the one to introduce astrology as a science subject," he says. "This lack of integrity will surely be exploited by the industry with such a bill. When universities are not exercising academic autonomy, do you expect them to exercise this kind of autonomy?"

The alternative, says Basheer, would be to come up with a more evolved version of the Bayh Dole Act: "It should leave space for options like open source research and non-exclusive licensing in areas where the invention is of critical public importance." But a contentious trial run seems imminent before law effectively mediates between intellectual property rights and public good.