ࡱ>  tbjbj $boo Y:  ONyAyAyA8A,BlrICICICCCD@DESrUrUrUrUrUrUrTvxpUrEDDEEUrdQCCjrdQdQdQEZCCSrdQESrdQdQnlco^yAtLm rDr0rmfydQfy@codQcoqEEE%yAyA :   Patenting Publicly Funded Research: Some suggestions for India Shamnad Basheer and Shouvik Guha ABSTRACT In January 2009, the Indian government introduced the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008 in the Rajya Sabha. The bill is currently undergoing scrutiny by a Parliamentary select committee, after which it will be placed before the two houses of Parliament for approval. Since the Indian bill draws inspiration from the US Bayh-Dole (BD) Act, it will be referred to in this paper as the Indian Bayh Dole (BD) bill. Much like the US Bay Dole Act, it vest institutes with the right to acquire patents over inventions that result from publicly funded R&D. It also goes a step forward by mandating that individual inventors be paid a minimum of 30% of any royalties that result from the licensing of patents by publicly funded institutes. While the Indian bill presents a great opportunity to regulate publicly funded research and patenting activities associated with such research for the first time, there is a serious disconnect between the objectives sought to be achieved and the efficacy of a Bayh Dole structure in helping achieve them. For one, the law attempts to vest institutes with the right to patent their inventions, when under existing laws, such institutes have the right to patent anyway. The law does no more than reiterate an existing freedom. The law falls short by limiting itself to the encouragement of patenting; an activity that is but one spoke in the rather complex wheel of the innovation eco system. Not only does it seek to encourage patenting, it goes to the extent of mandating that all inventions, irrespective of their individual worth or costs relative to other modes of knowledge transfer, be patented, under threat of serious sanction. The bill does not really address bottlenecks prevalent at the stage of commercialisation, licensing and tech transfer, which are far more important steps to help achieve knowledge spill-overs and create useful products for society. The bill also seeks to make publicly funded institutes (hereafter PFIs) self sufficient, without realising that the gains from the US Bay Dole act in this regard are at best modest, with many institutes barely breaking even after paying huge sums implicit in patenting activities. This paper reflects on these objectives and the shortcomings of the bill in achieving them. Although it does propose some solutions, it does not go far enough and instead advocates that the government constitute a committee to study these issues in depth before thinking of legislating in this area. I INTRODUCTION Debates around the commercialisation of academic research have plagued mankind for at least as long as the authors have been around in this world. Proponents for the motion argue that much like all else in the capitalistic world that we know of today, academics and research also ought to be subjected to market forces. Those against the motion decry the prostitution of what was once a noble ideal (the purity of research and the pursuit of knowledge for its own sake). A small part of this debate concerns the patenting of academic research, a debate most exacerbated by the US Bay Dole of 1980, which sought to facilitate the patenting of academic research by institutions that received public funds. Here again, one faces a split verdict. While the Economist hails it as a legislation that "reverse(d) America's precipitous slide into industrial irrelevance," critics point to the rather debilitating effects that Bayh Dole has had on the nature and direction of university research. Critics of a more moderate temperament concede that it is impossible to quantify and conclusively establish the ill effects of the legislation. However, given that the positives commonly attributed to this legislation are far from being adequately quantified and established as well, they question the need for such a legislation in the first place.  Specifically they argue as below: that even prior to Bayh Dole, US Universities did patent that the rate and extent of patenting post the Bayh Dole Act had a lot to do with the advent of biotechnology in the US and the spree of biotech patenting in the aftermath of the classic Diamond vs Chakraborty. Notwithstanding this climate of policy uncertainty, India and several other developing countries chose to be inspired by the US Bay Dole model. And in that spirit of inspiration, India is now considering a legislation on similar lines. In January 2009, the Indian government introduced the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008 in the Rajya Sabha. The bill is currently undergoing scrutiny by a Parliamentary select committee, after which it will be placed before the two houses of Parliament for approval. Since the Indian bill draws inspiration from the US Bayh-Dole (BD) Act, it will be referred to in this paper as the Indian Bayh Dole (BD) bill. Much like the US Bay Dole Act, it vest institutes with the right to acquire patents over inventions that result from publicly funded R&D. It also goes a step forward by mandating that individual inventors be paid a minimum of 30% of any royalties that result from the licensing of patents by publicly funded institutes. While the Indian bill presents a great opportunity to regulate publicly funded research and patenting activities associated with such research for the first time, there is a serious disconnect between the objectives sought to be achieved and the efficacy of a Bayh Dole structure in helping achieve them. For one, the law attempts to vest institutes with the right to patent their inventions, when under existing laws, such institutes have the right to patent anyway. The law does no more than reiterate an existing freedom. The law falls short by limiting itself to the encouragement of patenting; an activity that is but one spoke in the rather complex wheel of the innovation eco system. Not only does it seek to encourage patenting, it goes to the extent of mandating that all inventions, irrespective of their individual worth or costs relative to other modes of knowledge transfer, be patented, under threat of serious sanction. The bill does not really address bottlenecks prevalent at the stage of commercialisation, licensing and tech transfer, which are far more important steps to help achieve knowledge spill-overs and create useful products for society. The bill also seeks to make publicly funded institutes (hereafter PFIs) self sufficient, without realising that the gains from the US Bay Dole act in this regard are at best modest, with many institutes barely breaking even after paying huge sums implicit in patenting activities. This paper reflects on these objectives and the shortcomings of the bill in achieving them. Although it does propose some solutions, it does not go far enough and instead advocates that the government constitute a committee to study these issues in depth before thinking of legislating in this area. The Ayyangar committee report is an excellent example in this regard where a government committee consisting of only 2 judges undertook a careful study of 1-2 years before making a slew of recommendations that went on to form the basis for the 1970 Patents Act. This committee report is cited worldwide as an excellent example of very careful and sophisticated policy analysis. This report formed the basis of the 1970 Patents Act and contributed, in no small measure, to the success of Indias pharmaceutical industry. A similar study needs to be conducted prior to adopting a legislation aimed at regulating the patenting of publicly funded research. Such a study ought not be restricted to studying the existence and extent of publicly funded patents, but their impact and the rate of influence on innovation and knowledge spill overs/technology transfer more broadly. Where possible, the study also ought to find ways ways to foster more transparency and accountability in publicly funded research and provide incentives to influence the course of such research to yield more socially optimal innovations. Since India is considering the prospect of regulating publicly funded patents for the first time, it may be more sensible to attempt this flexible policy measures that can be changed relatively easily, rather than freeze any norms through legislation, as such norms, if proved wrong, could take a long time to amend through Parliamentary processes. Lastly, in the event that the current framework underlying the bill cannot be strayed from, we recommend that certain specific changes be made to the current wordings of the Bill. Most such changes are with a view to incorporating more public interest safeguards into such a legislation. II TESTING THE ASSUMPTIONS UNDERLYING THE INDIAN BILL As with any other piece of proposed legislation, it is important to investigate the purported aims of the Bay Dole legislation and whether it is likely to achieve those aims. The statement of objects and reasons of the bill state thus: 1. To compete in a global environment, it is necessary for India to innovate and promote creativity. For promoting creativity and innovation, India needs to protect and utilise the intellectual property created out of public funded research and development. Over the years, the Government has invested large funds in research and development. To provide incentives for creativity and innovation, it is necessary to develop a framework in which the protection and utilisation of intellectual property is put in place. The ultimate objective, however, is to ensure access to such innovation by all stakeholders for public good. 2. The proposed legislation imposes obligations and creates rights to optimise the potential of public funded research and development, provides incentive to create intellectual property and the mechanism for its protection and utilisation, encourages innovation in small and medium enterprises, promotes collaboration between Government, private enterprises and non-Government organisations, commercialisation of intellectual property created out of public funded research and development and the culture of innovation in the country. 3. The proposed legislation will enhance awareness about intellectual property issues, especially in universities, academic and research institutions. It will also increase the responsibility of universities, academic and research institutions to encourage students, faculty and scientists to innovate. Such innovations can be utilised for raising financial resources of these establishments, through royalties or income. The income from intellectual property will promote self-reliance and will minimise dependence of universities, academic and research institutions and other recipient organisations for Government funding. 4. The proposed legislation seeks to achieve the above objects. From this statement, as also the text of the legislation and various other statements made by the government to the media, the following objectives emerge: i) Encouraging institutes to commercialise their patents and make money. The natural corollary of this wealth creation objective is that government funding to institutes would gradually reduce. ii) Bring more accountability to institutes that use public funding iii) Providing incentives for creativity and innovation and encouraging more technology transfer and commercialisation. vii) Promoting the culture of innovation in India. And enhancing awareness about intellectual property issues, especially in universities, academic and research institutions. vi) Provision of appropriate royalty shares for scientist Inventors This paper explores each of the above goals with a view to examining the efficacy or otherwise of the present bill in achieving them. However, prior to this, it undertakes a historical jaunt to expose a faulty assumption regarding patent title that underlies the bill. A Indian BD: A Historical Misunderstanding Although the Indian Bayh Dole bill draws its inspiration from the US Bayh Dole Act, the Indian drafters appear to have missed an important context that informed the drafting of the US Bayh Dole Act. Prior to the Act, there was considerable uncertainty regarding patent ownership of publicly funded inventions; on the one hand were institutes and their researchers who came up with the inventions; and the other was the government agency that funded the inventive process. Needless to state, while in some cases, the government let the institute own the patent, in other cases, it retained title with itself. It was believed that in cases where title vested with the government agency, the rate of commercialisation of inventions was insignificant. Therefore, the Bayh Dole Act 1980 was enacted to provide publicly funded institutes (PFIs) with a clear patent titled. Given that Indian government agencies rarely retain patent title whilst doling out public funds for R&D, the very need for a separate law to specifically vest title in publicly funded institutes (PFIs) is questionable. The Indian Patent Act, 1970 stipulates that the right to apply for patent vests with the scientist/inventor who came up with the invention. However, should an employer institute wish to apply for such patents in its own name, it can do so through an agreement of assignment with its employee. Typically, most leading PFIs in india have employment contracts providing for such assignments. Others must be encouraged to work out such employment contracts. In short, given that there is no legal bar to patenting by PFIs, the need to vest clear patent title through a separate legislation is questionable. One may argue that the Bill sets out to do more than merely reiterate an existing freedom. It imposes a positive obligation to patent, under threat of sanction. While this rationale may give the bill a better footing to stand on, it is clearly problematic, as discussed below: 1. Need for More Circumspect Patenting The bill forces all publicly funded institutions to patent any and all inventions without any regard to the costs of patenting or the individual worth of such inventions: i) Section 9 of the Bill mandates the scientist (IP creator) to make a disclosure to his/her employer institution (recipient of the public funds) immediately after the creation of any intellectual property. ii) The recipient institution is, in turn, obligated to disclose the same to the government within 60 days of actual knowledge of such creation. iii) The recipient institution has to elect to retain title to such invention within 90 days of such disclosure. Else the title vests with the government. iv) Section 6 of the Bill prohibits public disclosure or exhibition of the public-funded IP, unless steps have been taken to protect the IP. In any case, the recipient should intimate the government at least 15 days before such disclosure is made so as to allow the government to file applications in countries, where the prospects of a patent grant may be prejudiced by such disclosure. Failure to comply with the above provisions may attract severe penalties, including a fine amounting to 50% of the grant amount received by the recipient for R&D.  The bill assumes that patents are always the best way to incentivise innovation and that they must be applied for in all cases. There is a growing recognition of the fact that whilst patents may help in some cases, they may not in others. Leading IP scholars, Eisenberg and Rai note: Although intellectual property rights may sometimes be necessary to motivate private firms to develop and disseminate university-based discoveries, the trend towards assertions of intellectual property rights by universities might also impede the progress of science. The challenge lies in distinguishing discoveries that are better developed and disseminated through open access from discoveries that are better developed and disseminated under the protection of intellectual property rights. Under the Bayh-Dole Act, institutions that perform funded research enjoy largely unfettered discretion to determine when intellectual property rights are appropriate. Therefore, the bill must make it incumbent on the institute concerned to evaluate as best as possible whether or not the said invention must be patented or rather subjected to other kinds of knowledge transfers. In fact, given the traditional reluctance of pharmaceutical companies to invest in R&D for neglected diseases, Indias premier lab (or network of labs) CSIR is currently attempting to discover a cure for TB through an open source drug discovery model. Further, in some cases, the costs of patenting are very high and a blind push towards patenting all inventions may end up in tremendous wastage of resources. Consider the example of CSIR, a network of government labs and Indias biggest patentee. While it generated 4 crore rupees (approximately $1 million) in licensing revenues, it spends over twice that much on patenting/licensing costs (10 crore rupees). The CSIR example illustrates the need to be cautious whilst advocating a blind patenting spree or in promoting the assumption that a Bayh Dole like structure is likely to help Universities transition to cash cows overnight. No doubt, it may be impossible to determine ex-ante which inventions are more likely to benefit from a patent centric approach and which ones are not; therefore one cannot articulate a strict legal obligation in this regard. Nonetheless, we urge that the Bill make it obligatory on part of the publicly funded Institute (PFI) to review each disclosure and assess which ones are worth patenting. Although such an obligation would, at best, be recommendatory and not strictly enforceable, it serves a signalling function and advises technology transfer offices (TTOs) to be more cautious. In this regard, we also urge the government to vest more discretion in the hands of the scientist inventor, as discussed in a later section in this paper. B. Creating Wealth The bill aspires to make Indian universities wealthy and selfsufficient. However, the ability of Bayh Dole type models to generate cash may be vastly exaggerated. Empirical data from the United States shows that most universities do not make significant sums of money by licensing their technology. In fact, the cost of operating a technology transfer office (TTO) often exceeds the money made from technology licensing. Lita Nelson, the head of the technology licensing office at MIT (and former President of the Association of University Technology Managers) notes that the direct economic impact of technology licensing on the universities themselves has been relatively small (a surprise to many who believed that royalties could compensate for declining federal support of research) [M]ost university licensing offices barely break even. As noted earlier, the amount spent by CSIR (Indias largest network of publicly funded labs) on patenting was twice as much as it earned through licensing. Within the framework of a pure monetary cost benefit analysis, CSIR appears to be making losses on its patents. Of course, this could be owing to the fact that CSIRs aggressive patenting strategy is hardly about a decade old and one needs to give it more time. India's BayhDole attempt will come to naught if it ignores this important fact regarding CSIR and its rather impressive patent numbers. The Indian government must therefore have a more realistic expectation from the proposed Bill in terms of its ability to generate wealth. C. Promoting Accountability A key motivating factor behind the Indian bill appears to be a desire to foster accountability in publicly funded institutes (PFIs). In other words, the bill assumes that the imposition of an obligation to patent would ensure that better account is made of public moneys received by such institutions. Using patent numbers to promote accountability is akin to killing an ant with an elephant gun. Surely, there are better ways of achieving this than forcing publicly funded institutions to patent any and all inventions that are generated. Illustratively, institutes could be subjected to rigorous record keeping and accounting obligations and audits. D. Promoting technology transfer This is the only justification that qualifies as somewhat persuasive. However, the law, as currently drafted is myopic and merely forces PFIs to patent any and all inventions, without independently inducing better prospects of commercialization or licensing of the patent to create valuable products for society. It bears reiteration that PFIs do have the freedom to patent even under existing laws. And many of the leading PFIs boast numbers that are clearly more than negligible However, the current framework of the bill provides for an unduly bureaucratic structure which is likely to breed huge transaction costs and bottlenecks and hamper the effective filing of patents by even those publicly funded institutions that have impressive numbers. In any case, the lack of patenting per se may not be as much of a problem, as the sheer inability to convert publicly funded patents to useful products for society. Consider the case of CSIR, which has a huge patent portfolio, but has been unable to license or commercialise a number of its patents. As of 2008, CSIR had 1926 patents in force, of which only 5.7% were commercialised or licensed. Contrast this with more established academic patent players such as Stanford University, which licensed out more than 37% of its inventions. Given that CSIR is a much newer player in this game, it is unfair to compare its successes or lack thereof with an established player such as Stanford. However, the above figure underscores the importance of the fact that more important than the act of patenting is the translation of such patents to useful products for society. And this is the challenge that the legislation should have ideally set out to achieve. Had this been the objective, the provisions may have taken a different shape. Perhaps the government may have also found that rather than legislation, this could be achieved through a slew of policy measures. However, since the bill wrongly assumes that patenting itself is a problem, it seeks to address this. And it does so with a vengeance, by not only insisting that every invention be disclosed, but also that a non-compliance with reporting and patenting obligations would attract severe penalties, a point that we discuss in detail later in this paper. E.Promoting the Culture of Innovation in India The bill assumes that forcing institutions to patent would somehow engender a better innovation culture. There is enough literature that casts doubt on the direct nexus between patents and innovation; in any case, patents are but one spoke in the wheel of innovation and will not by itself, promote innovation. Further, a blind patenting spree may simply result in huge costs, with no attendant benefits; as opposed to a more evolved knowledge transfer approach. If the reasons for patenting in India are low, the government must study this in more detail and aim to specifically redress the conditions that account for low patenting numbers. It would appear that the lack of patenting stems from a lack of awareness, expertise and/or finances. These reasons ought to be investigated and redressed separately. F. More Royalties to Scientists The Bill stipulates that the inventor employee who comes up with the invention be paid at least 30% of any royalties stemming from the licensing of the patent. While this is perhaps the most commendable part of the Bill, it bears noting that there are no documented cases in India that suggest that universities or institutes use their superior bargaining power to disadvantage scientists and give them lower royalties than is due to them. In fact, evidence suggests that most leading institutions in India provide fair royalty rates, with some of them exceeding the 30% benchmark outlined by the Bill. Therefore, this provision, by itself cannot be reason enough to support an otherwise badly conceptualised bill. Even assuming that there is a need to create a legally enforceable claim for such minimum royalties, the said provision can be added as an amendment to the existing patent regime; rather than instituting an altogether new regime for this purpose. III. TEASING OUT SPECIFIC CONCERNS IN THE INDIAN BD BILL Assuming the current framework underlying the bill cannot be derogated from, we offer some specific suggestions to help improve the Bill: A. Vesting More Discretion in the Hands of the Scientists The most laudable aspect of the Bill is that it stipulates that the individual inventor who came up with the invention be paid at least 30% of any royalties stemming from the licensing of the patent. Such a provision empowers individual inventors considerably and helps them reap the benefits of their creativity. However, despite this guarantee of a share in the profits, the individual inventor is left with little discretion to determine how his/her invention is likely to be used/commercialised. Even if such inventor wishes to place her invention in the public domain and not patent it, she cannot do sorather, the bill vests such discretionary power in the technology transfer office of a university/research institution. This legislative oversight assumes further significance in some critical areas of science, wherein it may make sense to encourage more open science as opposed to a closed-door proprietary model. An example from India may be illustrative in this regard. Dr. Samir K. Brahmachari, the current Director General of CSIR, had in the recent past initiated a move to put the SARS genome in a publicly available database, instead of patenting it. He also launched a drive for an open source model relating to Pharmacogenomics and drug discovery for infectious diseases (especially TB). Unfortunately, under the Indian Bayh Dole Bill, Dr Brahmachari may find that he has less of a say in the matter and it is the PFI, and more specifically the technology transfer office (TTO) within the PFI that will be the sole determinant of whether or not the invention ought to be patented. This can have adverse consequences in the long run, since TTOs are generally well known for their aggressive drive towards patents and their relative insensitivity to alternative ways of achieving knowledge transfers and knowledge spillovers. Therefore the Bill ought to mandate that the scientist inventor be mandatorily made part of any committee set up to evaluate the worth of inventions and the most optimal way in which to appropriate such inventions and achieve significant technology and knowledge spillovers. Secondly, and perhaps more importantly, the inventor scientist ought to be vested with the secondary right to patent. Under the Bill as it stands now, if the recipient institution fails to patent within a specified time, the right transfers to the government funding agency. We urge that this right be transferred in the name of the scientist(s) who came up with the invention. Not least because the scientists have more of a stake in the invention and are relatively more likely to patent than government agencies, which may not appreciate the invention well enough. More importantly, governments are relatively less likely to spend the time and money to register such patents. B. Achieving Wider Knowledge Spill-Overs and Evaluating Performance Section 10 of the Bill prescribes the creation of an Intellectual Property Management Committee. This nomenclature is likely to endorse what has been a problematic characteristic of most TTOs: an aggressive patenting and licensing approach as opposed to a more nuanced approach focused on optimal ways of achieving knowledge spillovers and technology transfers. It might therefore be more optimal to label this as a technology transfer office or knowledge transfer office. The performance of scientists and TTOs ought to be evaluated, taking into account not just the number of patents, but the number of publications and other ways that the scientist/institute in question has worked towards achieving knowledge transfer. The bill must expressly provide for these different measures of success and in the process promote all kinds of knowledge transfer, without necessarily prioritizing one over the other. To this extent, the Bill must explicitly state that the goal of university research is to create useful goods for society and to enable knowledge transfer overall. Such norm setting by the Bill, even if only recommendatory would have a strong signalling function and help research move in more socially optimal direction. C. Providing for more Public Interest Provisions Since all the intellectual property covered by this Bill has been generated with the help of the tax-payers money, such IP must be subjected to more public interest safeguards than is the case with purely private IP rights. Illustratively, the Bill must make clear that whilst PFIs license their patents to third parties, the default option ought to be in favour of non-exclusive licensing. Exclusive licensing vests the entire gamut of rights over the invention with one entity and this may lead to a relative stultification in technological progress, than would have been the case, had the technology been licensed out to multiple parties. In other words, the rate of technological development is likely to be greater with multiple competitors, as opposed to a single monopolist player. Further, increasing competition is more likely to result in greater variety and lower prices, thereby benefiting consumers. The aforementioned concerns assume further significance in the context of technologies that qualify as platform technologies. Illustratively, consider the recombinant DNA (hereinafter rDNA) patents held by the Stanford University, which were fortunately, widely licensed to interested parties by Stanfords TTO. But for this, biotechnological developments may not have progressed as quickly as it did. One cannot expect all patentees to be as evolved in their approach as Stanford is, and most TTOs are likely to favour an exclusive license that brings in more licensing fees upfront, as that is the standard measure of their success today. In order to prevent this possibility, the Bill must state upfront that non-exclusive licensing is the preferred default rule. As an exception, institutes may consider exclusive licensing by a prospective licensee, if she/she petitions that substantial sums would have to be invested to commercialise the patent and create a valuable product for society and that such sums cannot be invested without some assurance of market exclusivity. Upon receiving such a petition, the PFI must advertise it and call for objections from interested parties. Any interested party may challenge the grant of an exclusive license; and volunteer to either license the invention in a non-exclusive manner or offer a higher price for the exclusivity. Such a procedure is built into the NIHs technology transfer program and it may help to study this and incorporate it within the Indian regime as well. D. Affordable Pricing Another public interest provision that ought to be incorporated in the Bill is that of affordable pricing i.e. there must be a mandate that all PFIs and/or putative licensees are to implement affordable pricing policies with respect to any patented products that are created using public funds. History is replete with instances of patented university research being licensed to pharmaceutical majors, who then use these patents to create and sell drugs at very high prices in poor economies. Illustratively, an anti HIV drug Zerit (based on the molecule d4t) created by BMS came out of an exclusive license from Yale University. Despite a stipulation that such license shall be used for the benefit of society in general, BMS sold the drug for extremely high prices in Africa. Subsequent to a protest from Yale (led by students), BMS backed down and agreed to sell the drug at affordable prices in Africa. They also agreed to not enforce their patents against Aspen, a generic manufacturer from South Africa. While it would be impossible to determine prices ex ante, nonetheless, the government could introduce a clause urging that any products that are created using public funded patents (hereafter PFPs) must be made available at affordable prices. It is pertinent to note that the Bill itself states that [t]he ultimate objective, however, is to ensure access to such innovation by all stakeholders for public good. Besides, normative statements within the text of a statute have a powerful signaling function and considerable moral force. Naturally, the question is: what is an affordable price? At least in the context of pharmaceutical drugs, one might consider roping in the National Pharmaceutical Pricing Authority (NPPA) to make such a determination. Further, the bill must insist that any products that come out of publicly funded research are not sold at one global price, but are subjected to tiered pricing, as far as possible. The Indian Patents Act stipulates that a compulsory licence can be granted if a patented product is sold at an excessive price. However, this ground for compulsory licensing kicks in only after three years from the date of grant of the patent. In the context of publicly funded IP, there is no reason to maintain this 3 year window. Rather, all publicly funded IP should be subject to a compulsory license immediately after the patent grant, if products corresponding to that IP are sold at excessive prices. E. Normatively Encouraging Socially Relevant Innovation The Bill ought to encourage innovations that have maximal social impact. Consider the plight of villagers from the Sunderbans, where a furious Aila polluted agricultural lands with a massive infusion of salt water. Traditional wisdom holds that their livelihoods are doomed, as nothing ever grows in salt water. However, one might be able to come up with creative solutions to solve this problemperhaps by eliminating salt water in a cost-effective manner or identifying crops or plants that are likely to be salt resistant? The government must use the opportunity afforded by the current Bill to encourage R&D tailored towards such socially relevant innovation. Illustratively, it could insist that PFI performance be measured in accordance with the social impact of their innovations and that PFIs that score higher earn the prospect of higher funding from the government. By this yardstick, any PFI inventing a valuable drug for tuberculosis (TB) would be rated higher than a PFI that comes up with the next version of Viagra and adds to the woes of a country that is already choking under the yoke of a rapidly exploding population. F. Intramural vs. Extramural Research (and the place of CSIR) It is not clear whether the present bill strikes a distinction between intra mural and extra mural research. Section 3 notes that Any recipient interested to take a grant from the Government for the purpose of research and development shall enter into an agreement with the Government before receipt of such grant. One could read the above clause as excluding CSIR, since CSIR does not get a specific grant, but has a budget allocated to it by the government. In other words, this is akin to the government performing research of its own accord i.e. intra mural research. If the aim of the legislation is to regulate the patenting of publicly funded research, we see no principled reason for the exclusion of CSIR, Indias largest beneficiary of R&D funds and largest patentee as well. However, CSIR cannot be treated the same way as any other patentee that receives public funds as a separate grant. Therefore we may need differential policies to address these two kinds of publicly funded institutions. The range and kind of publicly funded institutions in India are as diverse as its populace and one size cannot fit all. It is pertinent to note in this regard that the US has two kinds of legislations covering publicly funded patents. One titled Stevenson Wydler regulates intra mural research performed internally by the government. The other is the Bayh Dole Act that regulates research performed by outside institutes using government money. Rather than having two separate legislations, the Indian bill could simply make a distinction between intra mural and extra mural research within the same legislative framework. G. Creation of a Nodal Authority Although the Bill has comprehensive provisions to regulate the creation and use of publicly funded IP, it does not provide for a nodal authority to oversee the functioning of this Bill. We therefore propose the creation of such a nodal authority within the Bill. Such authority could perhaps consist of: Secretary, DST Controller General, Indian Patent Office Representative from IIT Representative from Industry Representative from UGC Legal Expert This committee ought to review the working of this Bill periodically and propose solutions to make it work better. IV. OTHER ASPECTS Apart from the above, there are plenty of technical aspects that the Bill must take care of: A. Title of Bill The title of the bill (Protection and Utilisation of Public Funded Intellectual Property Bill, 2008) is extremely long and dreary and ought to be shortened. We therefore recommend that it be shortened to Publicly Funded Intellectual Property Bill. If however, the government uses this opportunity to regulate publicly funded research more generally, it might be more optimal to label the bill as the Regulation of Publicly Funded Research Bill. B. Questioning the Application to Trademarks and Copyrights The Bill currently covers all forms of intellectual property rights including patents, trade marks, designs, plant varieties, copyrights, and semi conductor chip layouts. Since there is no credible nexus between publicly funded research and innovation on the one hand, and trademarks on the other, we argue that trademarks be excluded. Trademarks are source indicators for goods/services and is not a natural output of R&D. Given that the Indian Bay Dole bill seeks to regulate intellectual property coming out of R&D activities, one fails to see how trademarks can legitimately form part of such a bill. Secondly, some of the obligations under the bill, particularly in relation to disclosure and registration do not make sense in the context of copyrights. A legally enforceable copyright come into being the moment a work is created and does not depend for its validity upon registration. Therefore, the disclosure obligation (section 4) and the registration obligation (sections 5 and 7) in relation to copyright is meaningless. Further, the timing of scientific publications might be impacted if non-disclosure obligations (section 6) are included within the ambit of this Bill. Therefore the disclosure, registration and non-disclosure obligations should not apply to copyrights. The only key obligation that makes sense in relation to copyrights is the royalty sharing arrangements under section 11 of the Bill. It is pertinent to note in this connection that under current law, copyright in any works created during the course of employment by an employee belong to the institutional employer. By way of clarification, the bill should also have a clause clearly stating that only that intellectual property that is generated using public funds and is created during the course of employment ought to be covered. We recommend the following clause: Only that IP which is created using public funds and by an employee of a publicly funded institution within the course of his/her employment is covered by this legislation. If the person/s creating the IP are not employees of the publicly funded institution, then the relevant IP shall be covered by this Bill only if the IP has been created under a contract for service. C. Problematic Definition of Intellectual Property Intellectual property is defined in section 2 (c) as below: intellectual property means any right to intangible property, including trade mark, patent, design, and plant variety as defined under the Copyright Act, 1957, the Patents Act, 1970, the Designs Act, 2000, the Semiconductor Integrated Circuits, Layout-Design Act, 2000, and the Protection of Plant Varieties and Farmers Rights Act, 2001; Section 4 then goes on to require that The recipient shall within a period of sixty days of actual knowledge of the public funded intellectual property make a disclosure thereof to the Government in such form and manner as may be prescribed. Barring copyrights which do not need to be registered (an aspect dealt with earlier), all the other intellectual property rights come into being only after being registered. Therefore section 4 may end up with a rather illogical reading: that a recipient is bound to disclose IP only after the said IP has been registered in the first place. To cater to this paradox, we recommend that intellectual property be defined as: intellectual property includes any invention, work or subject matter capable of being registered or protected as one of the following categories: patents under the Patents Act 1970, Copyrights under the Copyright Act 1957, Design under the Designs Act 2000, Plant Varieties under the Protection of Plant Varieties and Farmers Rights Act, 2001 and semiconductors under the Semiconductor Integrated Circuits, Layout-Design Act, 2000. D. Exclusion of Private Parties: Section 2 (e) defines Recipient to include a university or institution of higher education established for research purposes which has entered into an agreement with the Government under section 3, and includes an organization established by an Act of Parliament or a non-profit scientific or educational organization registered under the Societies Registration Act, 1860. The above definition excludes private entities that receive money from the government. There is no principled reason for this exclusion and therefore we recommend that the clause be reworded as below: Recipient includes a university or any other institution or legal entity, whether public or private which has entered into an agreement with the Government under section 3. E. Harsh Fines As mentioned earlier, the Bill in the present form provides for disproportionately high penalties for non-compliance. Illustratively, section 20 provides that where a publicly funded institute fails to comply with its obligations, the government shall: (a) recover the amount of grant already released with interest at the rate of ten per cent. per annum thereon in such manner as may be prescribed; and (b) bar such recipient for future grants for those purposes which were subjects of initial funding agreement. Further section 22 carries additional penalties and notes that any non compliant institute shall be punishable with fine which may extend to fifty per cent of the amount of the grant received by him for research and development under section 3. Section 21 applies to the individual inventor/creator and states that such creator, shall, upon violating his/her disclosure obligations under section 9: (a) not be given his share of income or royalty; and (b) be punishable with fine which may extend to twenty-five per cent. of the amount of grant received by the recipient for research and development. We recommend that the penalties be tempered. Illustratively, any failure to comply with the letter of the Bill could lead to a lower ranked performance, which might impact the quantum of funds to be received by the Institute in question the next time round. However, given that Institutes often consist of several departments, the Bill ought to ensure that only that department that actually flouts the relevant norms be penalized and not the Institute as a whole. F. More Transparency The Bill has commendable provisions with respect to ensuring transparency in the registration and licensing of publicly funded IP. In addition to existing provisions, this paper recommends that the following provisions be added: that all patent applications for publicly funded inventions state in the application that the invention has been made with public funding. To this extent, it is necessary to amend current patent rules to specifically mandate the inclusion of this information in the application to be submitted to the Indian patent office. That a separate list of all IP created using public funds ought to be maintained by the nodal authority under this legislation G. Relationship with other IP Legislations In order to minimise the scope for conflict, we would recommend the insertion of a clause as below: Subject to the provisions of this Act, all the provisions in the IP legislations (such as the Patents Act, Copyright Act) shall apply to publicly funded IP as well. Where there is a conflict between the provisions of this Act and any of the existing IP or other existing laws in India, the provisions of this Act shall prevail. V CONCLUSION As currently worded, the Indian Bayh Dole bill is short sighted in several respects. In fact, the very raison dtre of the bill is flawed in that it attempts to solve a false patenting problem. There is no legal bar to the patenting of publicly funded research; rather any institution receiving public funds is free to patent. However, many institutions may not be patenting, owing to lack of funds or lack of awareness. The government must therefore find ways to address these specific bottlenecks. Rather than assuming that a strong mandate to patent any and all inventions, under threat of severe sanctions will solve the problem. Such a mandate to patent will not help India achieve more commercialisation and technology transfer. Indias premier technology lab, CSIR has plenty of patents, but the rate of commercialisation is low. Solutions need to be found to address this specific bottleneck. The bill as currently drafted appears to have been drafted, sans any substantial study, empirical or otherwise of the specific circumstances governing patenting and knowledge transfer activities in Indian institutes. Prior to arriving at any policy framework in this regard, India must first undertake a comprehensive study of the public funding, regulation thereto, patenting activities and technology transfer. It is only such a study that can enable a better understanding the nuances of public funding and how best to regulate it. India must use this opportunity to regulate public funding more broadly than merely limiting it to patenting activities. For the moment, it might be more optimal for India to regulate the patenting of publicly funded research through a policy and not a law that creates binding legal rights and obligations. When compared to a flexible national science and innovation policy, an enacted statute will be far more difficult to cure or change as the years go by. In any case, absent any compelling reasons to create legally binding rights and obligations, one should experiment with a flexible and easily amendable national science and innovation policy.  Shamnad Basheer is the Ministry of HRD Professor of IP law at NUJS, Kolkata. Shouvik Guha is a research associate with the IP Chair at NUJS. We thank Shayonee Dasgupta for valuable research assistance.  The bill is likely to be introduced in Parliament in the budget session of February 2009.  United States Code (1980) The Patent and Trademark Act of 1980. Public Law 96-517. 6(a), 94 Stat. 3015, 3019-3028.  Economist Technology Quarterly, Dec. 14, 2002 .  See Mowery DC, Nelson RR, Sampat BN, Ziedonis AA (2004) Ivory tower and industrial innovation: University-industry technology transfer before and after Bayh-Dole. Stanford (CA): Stanford University Press. For a more recent review of the literature on this, see So Anthony et al (2008) Is Bayh-Dole good for developing countries? Lessons from the US experience. PLoS Biol 6(10): e262.  The bill is likely to be introduced in Parliament in the budget session of February 2009.  The committee carefully investigated the technological prowess of local industry, their ability to reverse engineer, the state of innovation in India, the exploitative use of the Indian patent regime by multinational patentees and most importantly, the history of patent regimes the world over and how nations incrementally improved upon their patent regimes to achieve their specific innovation and economic growth goals.  Although the paper refers specifically to patents, the arguments apply broadly to all IP covered by the Bill including plant varieties, semiconductor layouts etc.  See Kapil Sibal, Statement of Objects and Reasons, 3 December 2008.  See Law ministry moots penalty in R&D Bill to protect IPR, Economic Times, August 28, 2008>. See also PRS Legislative Brief The Protection and Utilisation of Public Funded Intellectual Property Bill, 2008, available at  See section 8 of the Bill.  Section 6 of the Patents Act, 1970 allows an application for a patent for an invention to be made by the true and first inventor or assignee or legal representative thereof.  Most leading institutions such as CSIR already do so. In fact, some government policies mandate institutions to take such rights from their employees. See the Department of Science and Technologys Guidelines for Technology Transfer and Intellectual Property provides that while the patent may be taken in the name(s) of inventor(s), the institution shall ensure that the patent is assigned to it and that the Institution shall take necessary steps for commercial exploitation of the patent on exclusive/ non-exclusive basis. [and] retain the benefits and earnings arising out of the IPR. Cited from M Kochupillai The Protection and Utilization of Public Funded Intellectual Property Bill, 2008: A Critique in the light of Indias Innovation Environment, JIPR.  Institutes already do this through their agreements.  As per Section 4 of the Bill.  See Section 21 and 22.  AW Torrance & B Tomlinson HYPERLINK "http://www.stlr.org/volumes/volume-x-2008-2009/torrance/"Patents and the Regress of Useful Arts 10 Colum. Sci. & Tech. L. Rev. 130 (2009).  See Arti K. Rai & Rebecca S. Eisenberg, Bayh-Dole Reforms and the Progress of Bio-Medicine, 66 Law & Contemp. Probs. 289 (Winter/Spring 2003).  Open Source for Cost Effective Drug Discovery, available at < HYPERLINK "http://spicyipindia.blogspot.com/2007/12/open-source-for-cost-effective-drug.html" http://spicyipindia.blogspot.com/2007/12/open-source-for-cost-effective-drug.html> (Last visited December 15, 2009)  Shamnad Basheer, Indian Patent Bill: Let's Not be Too Hasty, SciDev, 10 September 2008 <  HYPERLINK "http://www.scidev.net/en/opinions/indian-patent-bill-let-s-not-be-too-hasty.html" http://www.scidev.net/en/opinions/indian-patent-bill-let-s-not-be-too-hasty.html.  A recent study notes that, after deducting the costs of patent management, net revenues earned by US universities from patent licensing were on average, quite modest and concludes that universities should form a more realistic perspective of the possible economic returns from patenting and licensing activities See Bulut H, Moschini G. U.S. universities' net returns from patenting and licensing: A quantile regression analysis. 2006. Center for Agricultural and Rural Development at Iowa State University Working Paper 06-WP 432. Available at <HYPERLINK "http://ukpmc.ac.uk/redirect3.cgi?&&auth=0ZWgky0eF5LRoMfYxenfvzmKXRveH-h1FA5lBpQBW&reftype=extlink&article-id=1685459&issue-id=62717&journal-id=195&FROM=Article%7CCitationRef&TO=External%7CLink%7CURI&rendering-type=normal&&http://www.card.iastate.edu/publications/DBS/PDFFiles/06wp432.pdf"http://www.card.iastate.edu/publications/DBS/PDFFiles/06wp432.pdf>.  See Lita Nelsen The rise of intellectual property protection in the American university (1998) Science 279:1460-1461.  See footnote 19.  See Law ministry moots penalty in R&D Bill to protect IPR, Economic Times, August 28, 2008.  Section 14 and 15 impose obligations to maintain records and accounts, which could then be audited by the government. However, such record keeping obligations could be imposed independently, without tagging them along with a blind obligation to patent any and every invention that comes up in the course of R&D.  During a conference that sought to discuss the pros and cons of Indias Bayh Dole bill, Dr Premnath of NCL, one of the member labs of CSIR opined thus: The Act is likely to increase the administrative burden of the TTOs and make the process of patenting more bothersome for scientist. As and when an innovation is created the scientist is expected to inform the TTO or face penalties. Faced with this ultimatum it is likely that scientists will send anything and everything they create to the Technology Transfer Committees set up under this Act. Whether these committees will be able to review such large number of applications and identify the patentable innovations etc is a cause for concern.  An additional 3245 patents were under prosecution, of which 1.94% had been commercialised or licensed. Email from the CSIR office to Pranesh Prakash, CIS.  Between 1970 and 2008, Stanford had as many as 7500 disclosures (patents or otherwise). Of this, it was able to license out only 2800. And it received a total net worth of about 1.2 billion dollars from such licensing (cumulatively). See  One may refer to the considerable success that has been achieved in the Information Technology Sector not by way of law, but by way of creating a set of policies such as creation of Special Economic Zones to receive a wide range of developmental benefits.  See section 8.  Illustratively, the famed Indian Institute of Science (IISC) offers 40% of all royalty proceeds to the inventor (s). See section 6 of the policy, which is available at  See section 8.  See  See Open Source for Cost Effective Drug Discovery, available at < HYPERLINK "http://spicyipindia.blogspot.com/2007/12/open-source-for-cost-effective-drug.html" http://spicyipindia.blogspot.com/2007/12/open-source-for-cost-effective-drug.html> (Last visited December 15, 2009)  The number of universities with a technology transfer office (TTO) increased from 25 in 1980 to 200 in 1990, and by 2000 virtually every U.S. university had such an office (Nelson, 2001).  In the existing literature, knowledge transfer refers broadly to the intentional sharing of knowledge. Knowledge spillover however refers to the unintentional dissemination of knowledge. Illustratively, the maker of a pharmaceutical drug that can be reverse engineered facilitates a knowledge spill-over, in that a third party could break up the drug and gain knowledge of its constituent parts. The same manufacturer could also effectuate a knowledge transfer by entering into a technology transfer agreement with a third party and communicating the nuances of the drug and the process of manufacture to him/her. See Roger Smeets and Albert de Vaal An Integrated Framework of Knowledge Spillovers from FDI, NiCE Working Paper 06-103 October 2006: < HYPERLINK "http://www.ru.nl/economics/research/nice_working_papers" http://www.ru.nl/economics/research/nice_working_papers>. Our paper uses these terms interchangeably, since the net result of both an unintentional spillover and an intentional transfer is the same: knowledge is freed from the confines of the labs of PFIs scientists and reaches the general public.  Section 5(3) of The Protection and utilization of Public Funded Intellectual Property Bill, 2008 reads as: Where the recipient fails to apply for protection of public funded intellectual property within the period specified under section 7, the title of same, shall vest in the Government.  Considering the fact the performance of most TTOs are measured solely in terms of patents registered and licensed to industry, such aggressiveness, although undesirable, is not perhaps very surprising.  See RP Merges and RR Nelson On the Complex Economics of Patent Scope, Columbia Law Review, Vol. 90, No. 4. (1990).  See generally Licensing Policy, available at .  See University IP Policies and Access to Medicines, available at .  Following are the salient features of the NIH Licensing Policy in this context: NIH seeks to ensure that technologies commercialized under NIH licenses are brought to practical application, offered and maintained for sale, and made reasonably accessible to the public. NIH enhances public access to the benefits of its technology by fostering the development of competing products for the same or similar applications. For example, NIH currently has several CRADAs and licenses which combine the significant expertise of its scientists with the knowledge and resources of different private partners for the development of two types of therapy (gene therapy and recombinant enzyme replacement therapy) for an inherited disease. The only therapy currently on the market to treat this disease is an expensive enzyme replacement regimen derived from placental tissue.. See generally Licensing Policy, supra note 3.  See Statement of Objects and Reasons (Introduced by Kapil Sibal on December 2008).  Illustratively, BMS was pressured into dropping prices in Africa only because of the presence of a normative statement in the contract that the license be used for the benefit of society in general. A joint statement issued by universities like Harvard, Yale, Brown, Pennsylvania, Boston & Oregon reiterates such a norm by committing all these universities to make vigorous efforts to promote global access to drugs by way of licensing strategies that insist on lower prices. See Harvard Among Six Schools Urging Drug Access for Poor, Available at  HYPERLINK "http://www.bloomberg.com/apps/news?Pid=20601103&sid=aa23ahbwnxew" http://www.bloomberg.com/apps/news?Pid=20601103&sid=aa23ahbwnxew (Last visited on December 14, 2009).  In response to the growing controversy over the issue of access to medicines, the European Commission has also recently proposed a "tiered pricing" system that would work to offer lower drug prices to developing countries, whilst maintaining prices in the developed countries. The concept of differential pricing has also been taken up by the WHO and WTO Secretariats. See TRIPS, Patents and Access to Medicines: proposals for Clarification and Reform, Third World Network Briefing Paper, June 2001, available at (Last visited on July 31, 2009).  See Section 84(1) of the Patents Act, 1970.  An earlier version of the Bill stated that compulsory licensing provisions that are otherwise available under the Indian patents act would apply to publicly funded patents as well. Given that this amounted to a redundancy (even absent such a provision, publicly funded patents would anyway be covered by regular compulsory licensing provisions present in the Indian patents act), this provision was dropped in the final version of the Bill.  Shamnad Basheer Indias Innovation Tzar, December 6, 2009  See Glossary of NIH Terms, Office of Extramural Research, National Institutes of Health, available at http://grants.nih.gov/grants/glossary.htm, (Last visited September 9, 2009), wherein intramural research has been defined as research conducted by, or in support of, employees of the NIH and extramural research has been defined as research supported by NIH through a grant, contract, or cooperative agreement.  During a conference that sought to discuss the pros and cons of Indias Bayh Dole bill, Dr Premnath of NCL, one of the member labs of CSIR opined thus: The NCL experience has already shown that it is not a good idea to depend on these committees as they are likely to further delays and most of their decisions are ad hoc and not based on actual reviews of the applications received. This is likely to increase with government under this Act demanding more procedures to be followed at every step of the patenting and commercialization process. It may be better in this regard to only lay down a minimum set of guidelines that the public funded universities and institutions are to follow and have a one time approval of the institutions policy and by default vest the title with them. 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