Accountability in patenting of federally funded research

Bayh-Dole allows academic grantees to patent federally-funded research for purposes of promoting the commercialization of this research. To ensure commercialization goals are achieved, the Act requires grantees to report to funding agencies not only the existence of federally-funded patents but also utilization efforts they and their licensees/assignees are making. Although reporting is a cornerstone of accountability under Bayh-Dole, information about grantee compliance with reporting requirements is incomplete and dated. In fact, the last significant study of the question dates back to the late 1990s and analyzes only 633 patents. Since that time, concerns have emerged that federally-funded university patents are being asserted improperly against independent commercializers or even assigned to so-called “patent trolls.” This article provides fresh evidence indicating substantial under-reporting of the existence of federal funding in over 30,000 academic biomedical patents issued between 1980 to 2007. The article finds substantial under-reporting of federal funding even in the case of patents on FDA-approved drugs, which should presumably receive significant attention from universities. Grantees’ failure to report federal funding suggests similar, or even more significant, noncompliance with requirements to report utilization information. However, compliance with reporting requirements on utilization cannot be assessed because of secrecy associated with relevant government databases. Accordingly, the article makes a fresh argument that the Commerce Department, which has the requisite regulatory authority, work with funding agencies, to improve transparency. Greater transparency would not only motivate grantees to improve reporting but would also allow assessment of whether grantee patent management is actually achieving Bayh-Dole\u27s utilization goals

TRIPS implementation and secondary pharmaceutical patenting in Brazil and India

This article compares national approaches toward secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures countries have enacted policies to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyze the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications, and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches toward secondary patents need to be understood in the context of their broader approaches toward TRIPS implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s

Indian pharmaceutical patent prosecution: The changing role of Section 3(d)

India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of “secondary” pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against secondary applications in the years immediately following its enactment, and where it was, was redundant to other aspects of the patent law, raising concerns that 3(d) was being under-utilized by the Indian Patent Office. This paper uses a novel data source, the patent office’s first examination reports, to examine changes in the use of the provision. We find a sharp increase over time in the use of Section 3(d), including on the main claims of patent applications, though it continues to be used in conjunction with other types of objections to patentability. More surprisingly, see a sharp increase in the use of the provision against primary patent applications, contrary to its intent, raising concerns about potential over-utilization

Drug patenting in India: looking back andlooking forward

It has now been 20 years since the TRIPS Agreement, which established minimum standards for intellectual property (IP) regulation, came into force. Its implementation in India has been controversial, and in particular Section 3(d), a provision designed to restrict the grant of “secondary” patents, has been pinpointed as making it difficult to obtain pharmaceutical patents. Ken Shadlen and Bhaven Sampat suggest that paying so much attention to 3(d) may be misplaced. They argue that another, more fundamental, aspect of TRIPS implementation in India, the timing of the country’s adoption of pharmaceutical patents, is more important than 3(d) for understanding the current patenting landscape. And because the effects of timing are transitional, in the future it may be less difficult to obtain patents in India than is widely thought

Las instituciones como factor que regula el desempeño económico

There has recently been a resurgence of interest in how institutions affect economic performance. A review of this literature reveals that the concept of an ‘institution’ means different things to different scholars, both within economics and across the social sciences. This paper discusses what factors unify the different definitions of institutions, and develops a concept of institutions useful for the analysis of economic performance, and economic growth in particular. Specifically, it develops the notion of institutions as standard ‘social technologies’. Economic growth results from the co-evolution of physical and social technologies.institutions, economic growth, rutines, social technologies, physical technologies

The applied value of public investments in biomedical research

Scientists and policy-makers have long argued that public investments in science have practical applications. Using data on patents linked to U.S. National Institutes of Health (NIH) grants over a 27-year period, we provide a large-scale accounting of linkages between public research investments and subsequent patenting. We find that about 10% of NIH grants generate a patent directly but 30% generate articles that are subsequently cited by patents. Although policy-makers often focus on direct patenting by academic scientists, the bulk of the effect of NIH research on patenting appears to be indirect. We also find no systematic relationship between the “basic” versus “applied” research focus of a grant and its propensity to be cited by a patent

Patents, trade, and medicines: past, present, and future

This article analyzes the spread of intellectual property in trade agreements. We explain how the integration of intellectual property with international trade rules led to the globalization of pharmaceutical patenting, and then how additional provisions related to pharmaceutical products have been introduced by regional and bilateral trade agreements. We describe the additional ‘TRIPS-Plus’ rules contained in recent trade agreements, which go beyond the requirements of the World Trade Organization’s TRIPS Agreement, and explain the potential challenges that they may create for developing countries. We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again

University Software Ownership and Litigation: A First Examination

Software patents and university-owned patents represent two of the most controversial intellectual property developments of the last twenty-five years. Despite this reality, and concerns that universities act as “patent trolls” when they assert software patents in litigation against successful commercializers, no scholar has systematically examined the ownership and litigation of university software patents. In this Article, we present the first such examination. Our empirical research reveals that software patents represent a significant and growing proportion of university patent holdings. Additionally, the most important determinant of the number of software patents a university owns is not its research and development (“R&D”) expenditures (whether computer science-related or otherwise) but, rather, its tendency to seek patents in other areas. In other words, universities appear to take a “one size fits all” approach to patenting their inventions. This one size fits all approach is problematic given the empirical evidence that software is likely to follow a different commercialization path than other types of invention. Thus, it is perhaps not surprising that we see a number of lawsuits in which university software patents have been used not for purposes of fostering commercialization, but instead, to extract rents in apparent holdup litigation. The Article concludes by examining whether this trend is likely to continue in the future, particularly given a 2006 Supreme Court decision that appears to diminish the holdup threat by recognizing the possibility of liability rules in patent suits, as well as recent case law that may call into question certain types of software patents