This bill will, in all likelihood, be submitted to a Parliamentary standing committee, tasked with a careful scrutiny of the bill. This committee will prepare a report, based on views of stakeholdea and members of the public. It is likely that the Committee will take about 4-6 months to hear parties, receive submissions etc and submit their report to the Parliament. One can expect considerable politicking around this bill and the standing Committee will have to be prepared for a great number of submissions that span several ideological spectra.
Ben Butkus of Biotech Transfer Week has a very well researched and interesting article on this bill, parts of which I reproduce below:
As India Mulls Bill Modeled on Bayh-Dole, Critics Claim It May Stifle Innovation
By Ben Butkus
A controversial intellectual property-ownership bill modeled on the US Bayh-Dole Act has been approved by India’s Union Cabinet, the nation’s highest executive authority, and is currently being considered in Indian Parliament, multiple news sources reported last week.
The bill would alter existing IP rules by allowing academic institutions, not the federal government, to patent publicly funded research, and would reward institutions and inventors with a share of royalties or licensing fees from resulting commercial products.
However, it was approved by the Union cabinet without an official draft having been released or publicly debated, according to reports, which spurred heavy criticism by scholars both in India and in the US.
For instance, the US student-run watchdog group Universities Allied for Essential Medicines last week warned that the legislation fails to provide safeguards to guide the direction of publicly funded research, and that its emphasis on commercialization may ultimately stifle innovation and impede access to medicines in India and other developing nations.
Further details of the bill, entitled the “Protection and Utilisation of Public Funded Intellectual Property Bill 2008,” or the “Indian IP Bill,” are unavailable as the Indian government has not publicly released an official version of it.
Shamnad Basheer, an associate at New Delhi’s Oxford Intellectual Property Research Center who has been following the bill’s progression on his blog SpicyIP, told BTW in an e-mail this week that the bill was likely first prepared in 2005 by the Indian Department of Science and Technology with the assistance of an IP law firm.
Currently in India, the federal government controls the rights to IP developed at academic or research institutions with the support of public funds. The bill would require the inventing institution to be assigned these rights, much like the Bayh-Dole Act does in the US.
In addition, the bill would require that any royalties generated from licensing the IP or selling products based on the invention be split equally among the inventing scientist or scientists; the academic institution that employs them; and Indian funding agencies, according to the reports.
Late last month, the Hindu Business Times reported that the bill was approved at a meeting of the Union Cabinet chaired by Indian Prime Minister Manmohan Singh, and is expected to be introduced into Indian Parliament soon.
Basheer told BTW that the bill will need to clear both houses of India’s Parliament, known as Rajya Sabha and Lok Sabha, before it becomes law. He did not provide an estimated time frame for the bill’s consideration by Parliament, but said that he believes it will pass — though not in its current form. He did not elaborate.
Representatives from the Indian Union Cabinet or Parliament could not be reached for comment.
An editorial published earlier this month by LiveMint.com, an online version of the Indian business newspaper The Mint, also confirmed that the bill will be reviewed by Parliament without an official draft having been released and publicly debated.
If the bill is significantly altered or shelved, it would be at the behest of several academic groups and media outlets in India and the US that have seen portions of the bill and claim that, as written, it could stifle innovation and impede access to healthcare innovations in developing nations.
In an editorial published on Nov. 1, The Mint intoned the latter argument by writing that “the sad significance” of the bill moving as far as it has without public review stems from two factors: “First, it is all about patenting output of research financed by public money. Second, it is strictly geared to exclusive licensing for commercial use of what could be crucial innovations for public health.”
According to Basheer, “the key advantage [of the bill] is that it provides more clarity on title and ownership to IP when government money is used. The key disadvantage is that it doesn’t protect public interest as much as it ought to have … and doesn’t vest enough discretion in the hands of the inventor.”
Basheer did not elaborate, but on SpicyIP and in an article published on SciDev.net, he noted that a laudable aspect of bill is that, unlike the Bayh-Dole Act, which leaves royalty-sharing policies to the academic institutions, the Indian IP Act would ensure that inventors receive at least 30 percent of any royalties stemming from licensing.
“But despite this guarantee of a share in the profits, individuals are left with little option of determining how their invention can be used,” Basheer wrote in the SciDev.net article. “For example, even if researchers wish to place their invention in the public domain or license it non-exclusively, they cannot do so — rather, the bill puts this discretionary power in the university’s [tech-transfer office].”
The Mint editorial agreed, writing that “the scientist will have no say here. So, [the Indian government] would not have the power to repeat past decisions such as not patenting an antimalarial compound that could make a low-priced drug available. As we’ve argued before, this bill needs to encourage open source and non-exclusive licensing, too.”
Scary stuff. Even the bastion of English conservatism, the Economist, agreed that Bayh-Dole’s very raison d’être was flawed, and that there were too many unintended consequences.
Allow me to reproduce a short bit:
A law of unintended consequences
“Yet the yelps from critics have grown louder over the years. Many scientists, economists and lawyers believe the act distorts the mission of universities, diverting them from the pursuit of basic knowledge, which is freely disseminated, to a focused search for results that have practical and industrial purposes. Whether that is a bad thing is a matter of debate. What is not in dispute is that it makes American academic institutions behave more like businesses than neutral arbiters of truth. For example, a study published in 2003 by Jerry and Marie Thursby, of Emory University and the Georgia Institute of Technology respectively, showed that more than a quarter of the licences issued by universities and research institutes include clauses allowing the business partner in the arrangement to delete information from research papers. Almost half allow them to insist on publication being delayed.
“Moreover, there is ample evidence that scientific research is being delayed, deterred or abandoned due to the presence of patents and proprietary technologies. Researchers (and particularly their minders in university patent-licensing offices) are increasingly reluctant to share materials and knowledge with others unless such sharing is accompanied by legal agreements about “reach-through” royalties on potential findings and the right to restrict publication of results. A study released in October by the American Association for the Advancement of Science noted that 35% of academic biotechnology researchers experience difficulties getting hold of patented technologies that they need for their work, even though non-commercial research is supposed to be exempt from the normal restrictions of patents. The question is just how “non-commercial” such research really is. Lawsuits between universities and researchers over patents and royalties are now common. Indeed, though he was eventually exonerated, a student from the University of South Florida ended up doing a stint on a prison chain gang for “stealing” the intellectual property he created.
“Even industry is starting to complain about a gold-digger mentality among academic administrators. The most notorious example is Columbia University, which tested the boundaries of the law by seeking to re-patent a technique whose patent had already expired. (It was for a technology called co-transformation that is used to place external DNA into cells, and is important in making certain drugs.) Columbia eventually backed down, but only in the face of both public criticism and a series of writs from biotechnology companies. Another case ensnared the University of Utah, which licensed its patent on a gene underlying hereditary breast cancer exclusively to one company, Myriad Genetics. That gave Myriad a monopoly on diagnostic testing for the disease, which was controversial enough. But then the firm started suing universities that were using its technology in follow-up research, bringing the non-commercial research exemption still further into question.”
This, in essence, negates the conclusion that the Economist reached in 2002.
Hope you keep up the excellent coverage.
Dear AC,
Thanks for the excellent reference to the Economist article. I was particularly struck by the reference to Mary Thursby’s work, as she is generally very pro-Bayh Dole–which means that one must take her views on the deletion of info from acad papers etc more seriously than one would have –had it come out of the regular Bayh Dole skeptics.
Thanks again for your extremely thoughtful interventions.
Dear Shamnad,
Thanks for the extensive coverage of this issue. I agree that the Bill still doesn’t deal with vital areas of concern.
However, I am very sceptical at your insistence that individual scientists ought to decide how the invention is licensed.
Why do you think that the scientist will make a more objective decision that favours public interest? Why do you not expect the institution to do the same?
Is it not far more democratic to leave the decision to an institution rather than an individual?
On the one hand, you seem to argue that the the Bill ought to protect public interest since it uses tax-payers money. On the other hand, you seem to be accept that the decision on what to do with tax payers money ought to vest with an individual scientist.
I see a contradiction there.
I think an individual is far more susceptible to the kind of economic manipulation that you are apprehensive about.
I am sure that you will agree that every scientist is NOT a bespectacled, benevolent, septuagenerian who is driven solely by the love for Science and his dislike for commercial interests.
At least with an institution/ Government, a decision can be subject to challenge in a court of law, through writ proceedings. This avenue of challenge lends greater accountability.
You will NOT have that option if a scientist exercises his discretion in a perverse manner.
You cannot question his/her discretion in a court of law. This lack of an opportunity to challenge is damaging to the basis of any democratic set up.
To that extent, I believe that the insistence on allowing the scientist to decide the utilisation of the invention not only frustrates the purpose of the Bill, it will lead to results that run contrary to the public interest that you wish to secure.
Anon
Dear Anon,
I couldn’t agree with you more. I ought to have clarified the point further: i.e. that the discretion ought not to be left to the scientist alone. Rather, the scientist ought to compulsorily form part of any panel etc that takes a call on this. My apprehension was that merely having the TTO take a call on this would invariably swing the decision one way–in favour of more exclusive rights. Lessons from the US teach us that TTO’s merely wish to drum up quick money–as that is how their performance is measured. Which is why I argued in one of my earliest posts on this blog that the government should also use this occasion to help evolve performance yardsticks for TTO’s that deals with “knowledge transfer” broadly and not just with licensing revenues. Conceptualised this way, we’d also have a focus on publications and other modes of knowledge transfer, that the present Bayh Dole does not seem to capture.
So yes, leaving it to the scientist alone also may not be optimal. A panel that consists of TTO members, the scientist and other leading scholars from the University concerned might address these concerns better.