Models For Change

Wright, BD. The Economics of Invention Incentives: Patents, Prizes, and Research Contracts. The American Economic Review. 1983 September; 73(4): 691-707.
The author analyzes the choice between three of the most common alternative means of public intervention in the research market, namely, patents, prizes, and direct contracting for research services. He attempts to illustrate why any of the three can be preferred using a model that pays explicit attention to differences in the informational roles of each of these alternatives. He concludes that different areas will be favorable depending on how quickly and to what degree researchers respond to incentives. On the whole, Wright argues that the range of situations in which a practical patent system dominates other feasible alternatives may be narrower than is commonly believed, while the relative advantages of contractual research and of prizes may be undervalued.

Merz JF. Intellectual property and product development public/private partnerships. Final report to the WHO Commission on Intellectual Property Rights, Innovation and Public Health, May 2005.
The author presents an interview study of US-based product development public/private partnerships (PDPPPs) focused on the development of new drugs, vaccines, and other products for diseases that disproportionately affect developing countries. The study aims to describe the range of models used to organize and fund each effort; the nature and comprehensiveness of intellectual property faced in the area, and the strategies and experiences of PDPPPs in IP issues; the number and nature of collaborative and licensing arrangements used to gain access to necessary IP and technologal know-how; and any problems faced and solutions developed to ensure freedom to use. The authors conclude that the PDPPPs studied are all actively engaged in dealing with the fundamental questions regarding the relationship between intellectual property and drug and vaccine development, yet it is too early to tell which model, if any, works better than the others and whether aggressive patenting and ownership strategies are effective in achieving their charitable goals more effectively than alternatives.

Moran M, Ropars AL, Guzman J, Diaz J, Garrison C. Executive Summary For The New Landscape Of Neglected Disease Drug Development. Pharmacetical  R&D Policy Project. 2005 September. (Executive Summary)
The authors of this report take a strongly empirical approach to investigating known neglected disease drug R&D from 1975 to the end of 2004. Using a framework that suggests Pharmaceutical R&D’s aim is to improve health outcomes for developing country neglected disease patients, the authors focus specifically on policies and incentives that Western governments could implement to achieve this aim. After an analysis of private companies, multinational corporations, and a mixture of private and public sectors the authors offer recommendations for the future.  Full Report

Ridley DB, Grabowski HG, Moe JL. Developing Drugs For Developing Countries. Health Affairs. 2006; 25(2): 313-324.
The authors propose that developers of treatments of neglected disease receive a “priority review voucher.” The voucher could save an average of one year of U.S. Food and Drug Administration (FDA) review and be sold by the developer to the manufacturer of a blockbuster drug. In a well-functioning market, the voucher would speed access to highly valued treatments. Thus, the voucher could benefit consumers in both developing and developed countries at relatively low cost to the taxpayer

Hynek P. The Hyper-commons: how open science prizes can expand and level the medical research playing field. Rejuvenation Research, 2008; 11(6):1065-1073.
The author proposes a program of voluntary Open Science Prizes that would draw large numbers of new players, who would in turn produce much new medical innovation, provide academic priority recognition, and develop a growing body of patent-beating prior art that would serve as public domain firewalls on a new supranational Hyper-Commons. He argues that such a commons would welcome thousands more entrants, thwart the over-fencing of private patents, speed innovation, and reduce costs.

Chandrasekharan S, Kumar S, Valley CM, Rai A. Proprietary Science, open science, and the role of patent disclosure: the case of zinc-finger proteins. Nature Biotechnology, 9 Feb. 2009: published online.
The authors examine the large patent estate now covering the engineering and use of zinc-finger proteins. Sangamo Biosciences owns the majority of patents in this area and has given the company a powerful monopoly. Although one would predict that Sangamo would license its technology in a manner that is both profit maximizing and enhances social benefit, they have tolerated an open-science alternative to its proprietary platform. Regardless, the authors conclude that the patents in this area may be posing a barrier to academic research in the field, and that even though resolving deficiencies in patent disclosure might mitigate some access problems the patent may nonetheless be failing to fulfill its goal in promoting the progress of the useful arts.

Maturano, A. When Speed Truly Matters, Openness Is The Answer. Bioethics. 2009; 23(7):385-393.
The author analyzes the ethical implications of the two main competing methodologies in genomic research: J. Craig Venter’s “patent-and-publish regime” and John Sulston’s “open source” methodology. He concludes that while the patent-and-publish method is a transactional method based on the exchange of extrinsic goods, the free and open-source methodology is a transformational method based on a visionary ideal of science, which leads to prioritizing intrinsic goods in scientific research over extrinsic goals.

Maxmen, A. Driving Innovation: Ready, Set, Go! Cell. 2010 January; 140: 171-173.
The author reports on the role of prizes in driving innovation. Maxman explains that prizes are on the rise, and have been steadily increasing in the past decade in science, engineering, environmental research, and space exploration. After presenting some of the background for prizes, she analyzes the challenges and advantages a prize system brings to the proprietary landscape.

Bentwich M. Changing the rules of the game: addressing the conflict between free access to scientific discovery and intellectual property rights. Nature Biotechnology, Feb. 2010; 28(2)137-140.
The authors present a novel and relatively easy solution to the secrecy threat entailed in patents and their undesired effects on the free access to scientific knowledge and to the advancement of biotechnological research. They suggest a mandatory provisional patent paper application procedure, largely based on the already available and internally recognized PPA procedure to mitigate secrecy threats. They also illustrate how PPPAs may promote earlier and fuller disclosure of novel scientific knowledge and provide an example justification for requiring patents to grant inexpensive licenses for use of their inventions by other parties.

Munos B. Can open-source drug R&D repower pharmaceutical innovation?  Clinical Pharmacology & Therapeutics, May 2010; 87(5):534-536.
The author attempts to answer whether open innovation is the answer to a system that remains in crisis. He argues that although open innovation may be part of the solution, significant cultural, scientific, and regulatory barriers can prevent it from delivering on its promise. Munos concludes that while the drug industry shows remarkable growth in the networked R&D models, open-source research by itself is unlikely to repower innovation unless it is accompanied by concurrent changes in corporate culture and the behavior of other stakeholders.

Moran N. Seeking the biotech eBay. Nature Biotechnology. 2010; 28(3): 200-202.
The author analyzes whether licensing of biomedical research over the internet in an eBay style fashion would be feasible. He argues that most people believe biotech intellectual property is not amenable to being packaged and sold on the internet. This being said, given some consolidation and a greater number of users, many think such a system could be useful eventually. If the websites worked, most feel they would be especially useful for buying and selling some categories of technology, such as materials, culture media, mouse models of diseases or biomarkers—areas in which the product is relatively simple.

Alic J, Sarewitz D, Weiss C, Bonvillian W. A new strategy for energy innovation. Nature, 2010; 466:316-317.
The authors argue that the US government must make the Department of Defense a key customer for energy technology and make greenhouse-gas reductions a public good. They argue that the US government must include in its energy policy the nature of how innovation works. Instead of focusing money on R&D programs and financial subsidies, the government needs to treat innovation as a system, with a portfolio of policies adapted to the many technologies needed and their many evolutionary stages.

Melese T, Salima ML, Chang JL, Cohen NH. Open innovation networks between academia and industry: an imperative for breakthrough therapies. Nature Medicine. 2009 May; 15(5): 502-507.
The authors present an imperative they believe will help facilitate collaboration through an open innovation network between academia and industry. They provide a strategy that encourages the adoption of new attitudes about sharing information, managing the industry-academic collaborations as they would an investment portfolio, and creating new innovation models. They conclude that such interaction will continue to have an important role in developing better treatments, and any private company that wants to fully capitalize on such partnerships will need to take into account the interests of both parties. However, is it only by identifying areas of precompetitive research and pooling their resources that private companies will ultimately be able to develop therapeutics and testing technologies that break completely new ground.

Fini R, Nicola L, Shane S. Inside or outside the IP system? Business creation in academia. Research Policy. 2010; 39: 1060-1069.
The authors analyze a sample of 11,572 professor and found that, contrary to belief, much academic entrepreneurship occurs outside the university intellectual property system. About 2/3 of businesses started by academics were found to be not based on disclosed and patented inventions. The authors also illustrate that individual characters, departmental and organizational affiliations, and time allocation of academics that have started business outside the IP system are different from those of academics that have started businesses to exploit disclosed and patented inventions. The authors conclude that a sizeable portion of academic entrepreneurs engage in commercial activity that lies outside the formal university IP system and that characteristics of the academics that start non-patent-based companies are not well represented by their colleagues who start businesses based on patents. The implications of their study on policy are discussed.

Joly Y. Open biotechnology: licenses needed. Nature Biotechnology. 2010 May; 28(5): 417-419.
The author discusses several innovation models and explains why open biotechnology, while idea, has ultimately failed to deliver on its promises. One of the main obstacles that stands in the way is the need to develop simple, efficient, and legally valid open licenses to support projects. The author concludes that with time and the increasing number of projects that favor open innovation, new models can be developed that address the existing challenges.