Indian "Bayh Dole" and Parliamentary Committee Hearings

CH Unnikrishnan of the Mint has an excellent review of the recent Parliamentary (standing committee) hearings on the Indian Bayh Dole bill. As Unni rightly notes:

“In the first instance of its kind in Indian legislative history, a panel appointed by Parliament to suggest changes to a controversial Bill has asked the government to review the proposed law before it completes its task.”

Not too surprising, given that this law is fundamentally and conceptually flawed. More egregious than the bad drafting is the fact that this bill was kept a secret from the public and in fact, from most of its stakeholders (institutions/scientists) for over 3 years before it was introduced on the floor of the Rajya Sabha.

Now that scientists have wisened up and read the Bill, many of them are fuming over the rather harsh language in the Bill that insists that they disclose all IP to their respective institutions, which then has to disclose this to the government. One can only stare wide mouthed at the sheer transaction cost and waste of paper that this process entails! And if they dare disobey the law, they face rather harsh sanctions.

Some of us on this blog have been tracking this bill right from its nascent “secret” stage and documenting its various flaws, time and again. For all our Indian Bayh Dole related posts, see here.

The hope is that the government would now, in its wider review, consult with a wider group of stakeholders and arrive at a more evolved version. At this stage, the talk of “non exclusive” multiple licenses by the Secretary, DBT (Dept of Biotechnology), as documented by Unni in his article below is music to the ears. In this paper here, we’ve recommended that exclusive licenses be granted only after a mandatory advertisement and/or opposition phase, on much the same lines as the National Institute of Health (NIH) in the US.

Anyway, without much ado, I give you Unni’s complete write up below:

“In the first instance of its kind in Indian legislative history, a panel appointed by Parliament to suggest changes to a controversial Bill has asked the government to review the proposed law before it completes its task.

The Bill in question is the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008, which proposes to mandate scientific institutions and universities working on publicly funded research projects to patent their research output and licence it out on an exclusive basis.

“We have asked the concerned ministry to incorporate suggestions and guidance contributed by all stakeholders, including scientists, non-government agencies and scientific institutions in the Bill,” Subbarami Reddy, chairman of the panel appointed by Parliament, told Mint on Tuesday.

The panel will continue discussion on the legislation, known as the Innovation Bill, after the science and technology ministry’s review, he added. The date of the panel’s next hearing has not been decided yet.

The panel on Monday heard representatives from key scientific institutions, non-profit organizations and activists in New Delhi.

M.K. Bhan, secretary of the department of biotechnology in the ministry of science and technology, and one of the key proponents of the Bill, confirmed that the committee wants the ministry to review the Bill. He also said some of the changes the panel has been seeking have already been incorporated.

“We had interesting discussions with all parties concerned, and the changes will be mainly (relating to) the convergence of the views shared by scientific community,” he said.

According to him, the language of the Bill should be able to clearly communicate the interests of all stakeholders and promote innovation. “It should allow multiple licensing of such inventions, especially in case of agriculture technologies, as the government always intend to do,” he said.

The key changes anticipated in the Bill, introduced in the Rajya Sabha in January 2009, are removal of the clause for mandatory patenting of publicly funded inventions and exclusive licensing.

The local scientific community, non-profit organizations working in the area of healthcare and agriculture, economists and experts in intellectual property law have in several forums raised doubts on the relevance of the Bill, modelled on Bayh-Dole Act of the US of 1980.

The Bayh-Dole Act vests institutes with the right to acquire patents over inventions that result from publicly funded research and development. It also mandates that individual inventors be paid a minimum of 30% of any royalties that result from the licensing of patents by publicly funded institutes.

The Bill, introduced without any public debate, created a controversy and was put under scrutiny by the Reddy-led parliamentary panel.

After the review, it will be placed before the two houses of Parliament for final approval.

While the Bill presents an opportunity to regulate publicly funded research and patenting associated with such research for the first time, its critics say that there is a disconnect between its objectives and the efficacy of a Bayh-Dole structure in achieving them.

“The case for a full-fledged law in this regard is very weak,” said Shamnad Basheer, a professor of IP Law at the National University of Juridical Sciences in Kolkata.

According to him, if the government is keen on offering incentives for the registration of publicly funded research patents, it may be more sensible to attempt this through flexible policy measures evolved by the Scientific Advisory Council instead of attempting to do so through legislation. “It would be far easier to make changes to a policy by the science council and evolve as we go along but it is incredibly difficult to amend a law,” he said.

Leena Menghaney, India coordinator of Medecins Sans Frontieres, an independent humanitarian medical aid agency, said the country needed to identify priority areas of research by publicly funded institutions, such as drugs for malaria and other tropical diseases. “Exclusive licensing of technologies by these institutions will lead to abuse of such inventions,” she said.

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