Law and Tech Research feed - Kapczynski http://law.berkeley.edu 11:12:55 -0400 09:00:00 -0400 Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of 'Secondary' Pharmaceutical Patents While there has been much discussion by policymakers and stakeholders about the effects of “secondary patents” on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.

We read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims (“independent” secondary patents).

We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.

Policies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active “life cycle management” or “evergreening” of patent portfolios in the industry. ]]> http://www.law.berkeley.edu/14908.htm http://www.law.berkeley.edu/14908.htm Wed, 10 Oct 2012 09:00:00 -0400 The Cost of Price: Why and How to Get Beyond Intellectual Property Internalism
We see, as I argue, that using price to guide scientific and cultural production — which is to say, using IP — may have costs not only for efficiency, but also for distributive justice and informational privacy. The IP approach is in tension with the value of distributive justice because reliance upon price may yield not only unjust distribution of existing information resources but also unjust production of future information resources. The IP approach is in tension with the value of information privacy because relying on price to generate information facilitates the desire, the demand, and perhaps the capacity for price discrimination. That, in turn, generates an impulse for the extensive collection of personal information. Both government procurement and commons-based production plausibly offer more promise than does IP in both distributive justice and privacy terms, and they may be no less efficient than IP. Giving full scope to all three of these values thus requires us to telescope out from the internalism that characterizes the field, and to countenance a broader role for commons-based production and government procurement. In the field of IP, I conclude, we should pay less attention to IP and more to the alternatives. ]]> http://www.law.berkeley.edu/14562.htm http://www.law.berkeley.edu/14562.htm Fri, 11 May 2012 09:00:00 -0400 Access to Knowledge: A Conceptual Genealogy http://www.law.berkeley.edu/11600.htm http://www.law.berkeley.edu/11600.htm Sat, 05 Feb 2011 09:00:00 -0400 Harmonization and its Discontents: A Case Study of TRIPS Implementation in India's Pharmaceutical Sector The paper also identifies compensating strategies that may facilitate the effective use of TRIPS flexibilities, responding to the transnationalized pressures that TRIPS implementation sets up. I call these strategies fragmentation, mimicry, and counter-harmonization. As I demonstrate, counter-harmonization shows the most promise for developing countries, because it offers countries safety in numbers, can lower the administrative costs of implementing an alternative patent law, and can generate a transnational legal counterculture.

Lastly, the paper engages with the literature about the implications of the legalization of the global trading regime. The case study offered here suggests that legalization cannot simply be identified, as some prominent trade law scholars have argued, with the substitution of politics for principle, and with the leveling of power differences between states. It also suggests a new perspective on the debate over whether the WTO has a “constitutional” form, and if so, what this means. To date, those who claim a constitutional nature for the WTO have identified that nature with a move beyond politics. The analysis offered here suggests that if the WTO has a constitutional nature, it lies in its capacity to mobilize and channel, rather than to suppress or transcend, political disagreement.

]]> http://www.law.berkeley.edu/10048.htm http://www.law.berkeley.edu/10048.htm Mon, 01 Mar 2010 09:00:00 -0400 The Story of the TAC Case: The Potential and Limits of Socio-Economic Rights Litigation in South Africa Commentators have noted the unusual strength of the court's order in this case, often attributing it to the fact that TAC was an "easy case." We show that the case was only easy because the Treatment Action Campaign spent years laying the groundwork for its legal success. Moreover, the court's order has largely depended on the Treatment Action Campaign for its implementation, such that its true promise still waits to be redeemed. The story of the TAC case thus exemplifies the importance of social movement organization and mobilization to constitutional litigation and constitutional meaning.

]]> http://www.law.berkeley.edu/10049.htm http://www.law.berkeley.edu/10049.htm Thu, 07 May 2009 09:00:00 -0400 Addressing Global Health Inequities: An Open Licensing Approach for University Innovations http://www.law.berkeley.edu/10051.htm http://www.law.berkeley.edu/10051.htm Tue, 03 Feb 2009 09:00:00 -0400 The Access to Knowledge Mobilization and the New Politics of Intellectual Property The frame-analytic perspective teaches that before a group can act it must develop an account of its interests and theorize how to advance these interests. These acts of interpretation are both socially mediated and contingent. Ideas can be a resource for those engaged in mobilization, but one that is not fully in their control. Frames thus can lay the scaffolding for a countermovement even as they pave the way for a movement's success. Law is a key location for framing conflicts because it provides groups with symbolic resources for framing, and because groups struggle within the field of law to gain control over law's normative and instrumental benefits. Law thus exerts a gravitational pull on framing processes. Engagement with law can influence a group's architecture, discourse, and strategies, and can also create areas of overlapping agreement and - as importantly - a language of common disagreement between opposing groups.

The Article closes by suggesting some implications of this point, which should be of interest to those who design legal institutions and who engage in social mobilization. Most intriguing, perhaps, is the role it suggests that law may play in the creation of global publics and polities.

]]> http://www.law.berkeley.edu/10050.htm http://www.law.berkeley.edu/10050.htm Wed, 21 Jan 2009 09:00:00 -0400