Welcome to part three of our series of comments on ‘research priorities,’ drawn from the 2013 Global Congress Research Survey. This section focuses mostly on patents, health, and trade issues.
As before, if you’d like to submit a couple paragraphs about research priorities for the field, here’s the place to do so. We’ll publish them back out.
Amy Kapczynski, Yale Law School, USA
I think we need more serious conceptualization of the commons and of public alternatives to the market. Studies of actual existing innovation schemes — in the commons, or public — that work and that conceptualize why sharing is important are high priorities, as well as work that explores how to deal w/ the flaws of these modes (insularity, waste, political interference1. Also, there needs to be more work on local IP law, and implementation of international agreements locally. We are better at the international scale because it’s easier to access.
Jorge Contreras, American University, USA
There is a need for good empirical work that quantifies the impact of patenting structures on innovation and welfare across different jurisdictions. Do more or fewer patents fuel innovation? What is the impact of patent litigation on innovators? Are there migrations of talent, capital or funding across borders based on patent issuance or litigation?
Arlene Zank, Way Better Patents, USA
Significant effort needs to be dedicated to patent quality research and the dynamics of the patent marketplace. There are several “urban legend” patent studies that are informing policy discussions – the James Bessen and Michael Meurer work on the impact of non-practicing entities, Colleen Chien on patent litigation, for example. These studies are based on a proprietary dataset developed by a firm that stands to benefit from results of the study. More high-quality scientific examination of these types of findings is needed. Researchers and investigators need to see if they can replicate the results of these studies independently and document the quantitative and economic methods for measuring the impact of NPEs.
An extension of work done on the impact of asymmetric information in patent licensing discussions is needed. Earlier work by Mark Lemly and others that discuss the economic impact of the lack of information transparency on patent licensing discussions warrants significant academic scrutiny. Along the same lines, the impact of private transfer of intellectual property (or more accurately the transfer of IP in private1 should be examined in light of the disclosure requirements for patents.
At a very basic level, it would be interesting to enlist a pool of grad students to see if they can figure out how to figure out the owner of patents (Real Party in Interest1 and how to contact the appropriate person to enter into licensing discussions. This effort would be focused on determining the extent to which a group of patents enable entrepreneurs, inventors, investors, etc. can find the right people and how long it takes in light of the disclosure requirements conveyed by a patent. We suspect that such an effort would confirm the difficulty in actually finding patents and the failure to meet the disclosure requirements.
Peter Maybarduk, Public Citizen, USA
What are the health budget impacts of biologic medicines—i.e., new treatments derived from living organisms for cancer, heart disease and many other conditions. Most of these are extraordinarily expensive. Some industry groups are pressing hard for the longest and broadest possible monopoly protections for these drugs, including via new rules we expect to see introduced around in the world in the coming few years. Can we measure some of the health budget impacts of these rules, particularly for developing countries?
How much do we know about research and development budgets for pharmaceuticals? What gaps remain in the literature, and are there generalizations we can make? Medicines, Innovation Models
What are the particular patented clean energy or other environmental technologies that could bring benefits if transferred to developing countries through licensing?
Brook Baker, Northeastern Law School, USA
Concerning access to medicines, this is now a world in which patent and potentially data barriers are going to be increasingly pronounced. As a consequence, licensing – voluntary and involuntary – will become increasingly important. In the context of private licensing, we need more researches in patterns of voluntary licensing, both commercial arms-length and quasi-humanitarian (forced in part by activism). In this regard, we need an appraisal of medicines patent pools and what they have and haven’t accomplished. We need to know more about the terms of such licenses, mechanisms for increasing transparency concerning their terms, and options for regulating such licenses, including their extraterritorial features. In terms of compulsory licensing, we need new research on the production-for-export CL problem, including the best work-arounds for the August 30 System as well as new options, including an Article 30 limited exception. We need research on mechanisms for coordinating the issuance of compulsory licenses in multiple jurisdictions in order to aggregate markets that incentivize generic entry. Finally, with respect to licenses, we need better theoretical and empirical research on the complementarity of voluntary and compulsory licensing approaches.
Access to medicines to medicines for poor populations in middle-income countries is a growing problem. Two strategies need further development. First, we need better analyses of market sector segmentation (public/NGO vs. private) as a partial solution to access needs. Second, we need better economic modeling of the impacts of tiered royalties on profitability for right holders and access for patients in need. The cost structures and efficiencies of generic producers suggest that there is ample “space” between the alleged no-profit and discount/tiered prices of right holders and the modest profit prices of generic companies. Using realistic models of manufacturing costs over time and differential cost structures, how could tiered royalties become a value proposition for right holders while still securing substantially lower prices for middle-income country patients.
Finally, LMICs are enamored with the prospects of local production of medicines, but there is very little economic or IP related research on the economic viability of local production in regions plastered with patents. In regional contexts where there are expected battles over where “regional” capacity should be located. How do patterns of patenting interact with clear-headed assessments of pharmaceutical capacity and eventual market efficiency and siting decisions?
Koichi Kameda, UAEM-Brazil
I think it is important to conduct research related to the implementation of the recommendations by WHO’s consultative expert working group in 2012 (the already classic CEWG report1. One topic is to understand concretely advantages and challenges for using open knowledge approaches in the research and development of health technologies.
We need research that can draw lessons from negotiations on the ‘Least Developed Countries’ TRIPS extension concluded this year. These could be very useful in forthcoming discussions on the TRIPS pharmaceutical exemption, which due to expire at the end of 2015. The target would be LDC negotiators.
Peter Drahos, Australian National University, Australia
My current work revolves around a project called ‘Global Energy Governance’—a study of G20 countries focusing on the variables that affect the transition from a high carbon to a low carbon economy. It would be very useful to look at how intellectual property rights affect specific energy sectors such as nuclear power.
A topic that is of huge fiscal significance for states but that has received little attention in the literature is the link between transfer pricing and intellectual property rights.
Ante Wessels, FFII (Germany1 and Vrijschrift (The Netherlands)
Investor-state dispute settlement (ISDS) allows foreign investors (multinationals) to circumvent domestic courts and bring claims against host governments before an international tribunal. The definitions of investment in investment treaties often include intellectual property rights. This gives investors the possibility to challenge reforms of copyright, patent, database and trade mark law. Investors may demand repeal of the measure concerned or high damages.
Regarding the total cost of ownership of investment treaties, besides the duration of a treaty, the investment agreements’ provisions may continue to be effective for up to 20 years after termination (survival clause1. To understand the risks of ISDS, a best and worst case scenario assessment of the total costs of ISDS for the full duration of the obligations is needed with regards to threats to use ISDS (as they have a chilling effect1, number of cases (rising sharply1, claims, damages, legal costs and lost opportunities, including lost opportunities to solve crucial problems such as climate change and the euro crisis.
ISDS involves a transfer of sovereignty, it gives investors equal standing to states, and arbitrators the power to decide in conflicts between investors and states. ISDS takes away “sovereign immunity”: states can be sued only under limited circumstances – ISDS leaves states limited defense. As it is a critical step to transfer sovereignty (especially for a long period in a fast changing world1, proponents have to provide sufficient evidence regarding necessity (as insurance and state-state dispute settlement are alternative ways to protect investments1, safeguards (the present system is riddled with conflicts of interest) and total costs of ISDS. An inventory of missing evidence would provide oversight.
EU member states signed many bilateral investment treaties containing ISDS clauses. The 2009 Lisbon Treaty gave the EU competence to conclude such treaties, in time, nationally concluded investment treaties will be phased out. The EU competence is not fully exclusive, there is partly a mixed competence with the EU member states (mixed agreement1. The EU treaties do not contain provisions on how to withdraw from international agreements. Will an EU member state be allowed to withdraw from a mixed (competence) investment treaty? Will EU withdrawal from investment treaties involve qualified majority voting in the Council? The complexity of the EU decision making process may make withdrawal from investment treaties difficult, close to a locked-in situation. An element to consider is that the EU single market is much bigger, with higher expected profits, than the individual member states’ markets. The EU may be a more attractive subject to challenge than individual EU member states. For civil societies to participate meaningfully in the decision making process a good understanding of the processes and the scope of the EU competence is needed. This may include an assessment of the compatibility of proposed investment treaties with human rights (including social, economic and cultural rights1 and the EU treaties. Much attention goes to the EU – US trade agreement (TTIP / TAFTA), but other trade agreements, like with Canada and Singapore, will probably go into a ratification process earlier, setting a precedent.
Glyn Moody, journalist, UK
Investor-state dispute resolution is the greatest threat to, well, everything. It allows multinational companies to override local laws, include those on health, safety, labour and intellectual monopolies. And yet few know about it. So a key aim would be to make the public and politicians aware of its huge threat.
Maira Sutton, Electronic Frontier Foundation, USA
We need a better picture of how lobbying from the copyright and patent industries are influencing innovation policy around the world, through various trade fora, WIPO, and any other means.
What kind of evidence, from papers or reports, are being used to justify such policies? There are several papers that are floating around that have been funded by the IP industries, that are used to support restrictive copyright and patent rules. The objectivity of such reports are highly questionable and thus should be exposed. This could lead to some baseline transparency standards over IP policy research.
What is the impact of the revolving doors between the IP industries and national/international rulemaking bodies? The lack of accountability over policy is no where more apparent than in the way public officials take high-paying jobs in the industries that they were previously authorized to regulate. There are several (possibly dozens more) examples of this in the IP space.