Indian Bayh-Dole Bill Update

India's Parliamentary Standing Committee has held meetings to discuss India's "Protection and Utilisation of Public Funded Intellectual Property Bill," (also known as the "Indian Bayh-Dole Bill") first introduced in 2008.  In collaboration with other organizations including MSF-India, Third World Network and Lawyers Collective HIV/AIDS Unit, we identified our concerns with the Indian Bayh-Dole Bill.  UAEM previously submitted comments to both India's Parliament and the Ministry of Science and Technology expressing our views regarding the Bill's original draft language as well as the proposed amendments to the Bill.   

In UAEM's white paper, we highlighted some of the failings of the U.S. Bayh-Dole model and urged the Indian government to take these comments into consideration.  We expressed concerns that the Bayh-Dole model focuses too narrowly on patenting and licensing and also was overly-broad in scope.  We further noted that the patent regimes often do not provide appropriate public health safeguards.  We also called into question whether patents are the best method for publicly funded research because much of university research concerns "upstream" research; patents on these types of inventions creates patent thickets and can hinder future innovation.  We questioned whether the Bill too greatly focused on licensing revenue, noting that in the United States, most technology transfer offices lose money.  Finally, we encouraged the Indian government to provide ample time and opportunity for civil society and the public to voice concerns over the Indian Bayh-Dole Bill to ensure that any legislation accounted for the public health.

Additionally, the white paper contained suggestions to address the problems of the Bayh-Dole model.  We encouraged the Indian government to include a statutory research exemption and strong language for march-in rights in the Bill.  We suggested that the government consider mandating or encouraging open source licensing and open access publishing.  Also, the paper noted that the Indian government should look not place such a heavy emphasis on patenting and licensing and consider alternative mechanisms instead. 

The SpicyIPIndia Blog recently analyzed the Standing Committee's report on the Indian Bayh-Dole Bill, noting that "In all, the report is a welcome one and if implemented in the right spirit, will result in a much more evolved version of the Bill than the previous one."  Hopefully the Indian government will accept the report and frame a new bill to address the potentially pitfalls of the Indian-Bayh-Dole bill as it currently stands.    

It appears that the Standing Committee has accepted at least some of our concerns regarding the Indian Bayh-Dole Bill.  

• The Committee agreed that mandatory patenting may not be the best method result for inventions created through publicly funded research.  "[T]he provision of mandatory patenting in all cases as provided in the Bill has its other fall-outs too.  Blind patenting of all IP created, may prove to be counter productive because all of them, may not be potent enough to be converted into a product or technology."
• Additionally, the Report found that "one of the objectives of this Bill is likely to commercialize knowledge which goes against the tenets of our tradition of imparting knowledge and wisdom to the world.  The Bill is, therefore, likely to promote crass competitiveness away from creativity in universities and research institutes."
• The Committee also agreed that the Bill was overly-broad, covering essentially all forms of intellectual property that goes "far beyond inventions."
• The report (which the Committee highlighted in bold text) also found that the idea that universities can become self-reliant based the Bill's focus on licensing revenue misses the point: "such a forceful yet unfounded assertion on making universities financially self-reliant creates a wrong impression.  At the same time, Govt. cannot absolve itself of the responsibility to provide adequate fund that it owes towards universities and research institutions.  The Committee, therefore, recommends that the relevant paragraph should be suitably amended."  UAEM previously drew attention to the fact that most technology transfer offices lose money.
• The Committee acknowledged the concerns of civil society that "essential drugs will go out of the reach of the common man who cannot afford to pay market prices" and also noted the risk that inventors "will aim at technologies in areas that will fetch market place profits rather than the social sector good, the driving force being the profit and profit alone.  Promoting such a profit oriented motif would give fillip to the tendency to focus on applied research or to develop technologies rather than to concentrate on basic science/academic or other fundamental research to develop models of understanding."
• Additionally, the Secretary of the Department of Science and Technology accepted the concerns regarding research for societal good and "stated that a separate Bill will be brought out to cater to the requirement of Research & Development so that research on diseases such as Malaria, Cholera, Diabetes, Tuberculosis, etc. could be encouraged and promoted."  
• In drafting any legislation regulating inventions from publicly funded research, the Government "must strive to strike a fine balance between social sector and market driven model so as to serve public interest in the best possible way."  The Committee further noted that non-exclusive licensing benefits the public; while exclusive licensing can increase revenue, the private good ends up being higher than the public good.  It stated its opinion that "the overall welfare of the society should take precedence over mere commercial interests to decide whether exclusive or non-exclusive license needs to be granted.  Therefore, grant of exclusive or non-exclusive license should be decided on case-to-case basis depending upon its merit and keeping in view the interests of the poor people so as to ensure that the benefits of the public-funded research percolate down to the lowest strata of the society.  To avoid misuse of the exclusivity of the license, a provision for reviewing the operation of license at regular intervals should be provided for in the Bill."
• The Committee recommended that the Bill include march-in rights and even suggested that a reasonable pricing requirement be a measure by which the Government might revoke an exclusive license to ensure accessibility to the public.  Where there has been non-compliance and the patented invention has been assigned an exclusive license to a private entity and "is not available to the public at a reasonable and affordable price, Government should revoke the license and acquire the patent to ensure overall societal benefit."
• Finally, the Committee Report concluded with a call for transparency, noting the views of experts who suggested that the recipient or creator of the invention be required to publish the details of the publicly-funded intellectual property acquired, assigned or licensed.  UAEM's comments pushed heavily for increased transparency and appreciates the Standing Committee's focus on providing such transparency.

While the Standing Committee Report has acknowledged some of the potential pitfalls of the Indian Bayh-Dole Bill, there is still much room for improvement on the Bill.  

• The Standing Committee Report does nothing to de-link intellectual property rights from innovation.  In fact, the Report seems to reinforce the idea that innovation can be tied to intellectual property.  It suggests that India needs to re-think "whether the country should continue to look at science in a traditional manner, i.e., science as a pure endeavor for pursuit of knowledge, for pleasure and for curiosity" or to patent innovations and inventions.  The Committee further notes that by patenting innovations, the country "needs to consciously think in terms of using science as an instrument of socio-economic transformation." 
• Although the Committee agreed that the Bill was overly-broad and should not include copyrights, some questions remain as to other non-patent forms of intellectual property.  The Committee Report did not provide an explicit statement regarding trademarks or plant varieties and these forms of intellectual property may find themselves subject of the Bill (though the language of the report could be read to take trademarks out of the Bill).
• Despite our extensive comments and examples regarding the failings of the U.S. Bayh-Dole model, the Report does not reference the experiences of other countries in regulating publicly-financed research.  Concerns exist that the Committee may not fully appreciate the grave and actual problems that Bayh-Dole has created in the U.S.  Through the failures of other models, India can learn from past mistakes and enact better legislation that truly takes into account the public health and societal good.
• While the Report did acknowledge that the welfare of society should take precedence over commercial interests in deciding whether to exclusively license an invention, the Committee suggests that the solution is to decide whether to grant an exclusive license on a case-by-case basis.  However, even with a provision requiring review of licenses, it may be difficult to monitor or challenge.  Review of the ways in which exclusive licenses are used could prove a costly and unwieldy endeavor.  Additionally, we believe that the public interest would be best served by mandating open licenses as a default; only extraordinary cases should warrant an exclusive license for publicly funded research. 

Although the Committee Report does not address every concern UAEM has raised about the Indian Bayh-Dole Bill, it certainly takes steps toward improvement and has accepted some of the suggestions that we--along with other civil society organizations and individuals--have proposed.  We would like the Indian Government to accept the report and rework the Bill to address the societal good and public health.  We also hope that the Indian Government will be receptive to further comments from civil society on the language of the Indian Bayh-Dole Bill.