American Journal of Law & Medicine

The global health licensing program: a new model for humanitarian licensing at the university level. (Symposium)

INTRODUCTION

Disparities in health outcomes and access to the essential medicines that affect health outcomes are two of the most pressing issues facing the world today. (1) The lack of adequate health care in developing countries is rooted in a number of systemic problems, including insufficient health infrastructure, lack of medical personnel, government corruption and incompetence, and the high price of pharmaceuticals. These problems are not mutually exclusive. Instead, they are mutually reinforcing, particularly in least developed and developing countries. (2)

The high cost of drugs and vaccines is undoubtedly one of the driving forces in disparate health outcomes, (3) and partial solutions to poor health in the developing world rightly focus on lowering the cost of health products, while preserving the financial incentive for innovation. (4) The high cost of many medicines is largely due to the international patent system, codified by the Trade Related Intellectual Property Rights (TRIPS) Agreement, which grants a monopoly to the innovator and allows it to completely control pricing for a period of years. The result is an access gap, whereby patients in low- and middle-income countries (LMI) cannot afford expensive patented drugs, while patients in wealthy countries can afford and do have access to such treatments. In response to this, the most explored means for lowering drug prices thus far has been the introduction of generic competition in the drug market, whether accomplished through licensing provisions or through public pressure on pharmaceutical companies. (5)

An access gap also exists, however, with respect to medical and preventative technologies, so that persons in developing countries are at higher risk of acquiring certain diseases, such as cervical cancer, that can be prevented by regular screenings or vaccination. (6) Generic production of some of these technologies, particularly biologics such as vaccines, is not always possible, and thus finding solutions to this access gap can be difficult. (7) Advocating for generic competition to service developing country markets has been one successful way of dealing with lack of access to drugs, but may not be the best approach to facilitating affordable access to biologics and devices. As such, advocates seeking to bridge the access gap have had to look at all available options for doing so, and have looked to university licensing as one viable solution for enhancing access to drugs, biologics, devices, and other health products.

UNIVERSITIES' ROLE IN THE GLOBAL ACCESS GAP

Since the 1980 Bayh-Dole Act allowed universities and government agencies to patent and capitalize on their own research, universities have played a central role in the development of health products under our current system. (8) Universities now own significant intellectual property rights that are licensed to pharmaceutical and biotech companies and are developed into lifesaving health innovations. This influential role continues to increase, as the number of patents filed and licensing agreements signed by universities nearly doubled between 1993 and 2003. (9)

Universities also have a unique duty. They do not have a profit motive, but rather have missions to educate and conduct research to enhance the global good. Universities have a distinctive obligation to use their role in the development and licensing of health technologies to further global health and narrow the gap between rich and poor. Many research universities are at a turning point, making the transition from national to truly global universities, and addressing today's global health inequalities is a key part of this transition. (10)

Universities' role in promoting global health has been comprehensively addressed elsewhere, particularly by the advocacy organization Universities Allied for Essential Medicines. (11) Practical approaches to university humanitarian licensing have most recently been proposed by technology transfer experts April Effort and Ashley Stevens of Boston University. (12) This article seeks to build on and synthesize their excellent work into a practical program that can harness the unique position and mission of universities in health research.

I. OVERVIEW

Various approaches have been proposed to maximize universities' role in enhancing access to medicines for the global poor. Academics, practitioners, and activists have, at different times, proposed non-assertion agreements, reservation of rights provisions, white knight provisions, patent pools, open-source licensing, sublicensing requirements, the Equitable Access License, at-cost pricing, milestones, non-exclusive licenses, restrictions on patenting of future innovations, and public-private partnerships.

As discussed below, however, it is apparent from the application of these approaches, from the experiences of public-private partnerships seeking to facilitate access, and from our experience working with a university to implement a comprehensive humanitarian licensing program, that there are pros and cons to each of these techniques. No single approach will meet the needs of every negotiating partner or every type of licensed intellectual property, and there is no silver bullet to bridge the access gap.

Therefore, we propose a comprehensive approach to humanitarian licensing for universities--a Global Health Licensing Program. It would have two formal components: a committee to review innovations ready for licensing and a toolbox of access licensing options for technology transfer offices to use during licensing negotiations. Our program incorporates a transparent procedure for licensing innovations with developing country potential, while simultaneously meeting standards identified in the leading technology licensing literature. (13) To be as effective as possible, such a program should have an articulated mission statement, involve all relevant stakeholders, utilize all available licensing approaches, and be a formal, standing component of the technology transfer office.

The next Part of this article will discuss the current options universities could use to enhance access to medicines, either alone or working in partnership. It will then address why each of these options alone is not a sufficient solution, and why each one's effectiveness will vary by health technology, university position in the licensing negotiation, and other variables. The final Part of the article will outline the program and process we propose and the standards that should be utilized.

II. CURRENT OPTIONS FOR ENHANCING ACCESS TO MEDICINES VIA UNIVERSITY LICENSING

To date, a variety of approaches have been devised and recommended for universities seeking to license intellectual property and the fruits of university research in a humanitarian way. We argue in this article that none of these offers a one-size-fits-all approach to enhancing access to essential medicines through university licensing. That said, these approaches could be utilized in tandem, or, as we propose in Part III, as part of a comprehensive approach to humanitarian licensing, in which the most appropriate and effective licensing strategy for each innovation is selected from a toolbox of options held by the university.

In this Part, we lay out the landscape and summarize the humanitarian licensing strategies proposed to date, providing a short--and by no means comprehensive--analysis of their advantages and disadvantages. Wherever possible, we present sample language for these strategies to demonstrate how they have been used in practice. Then we provide a simple chart that illustrates graphically how each of these strategies can be employed. The idea is that a truly comprehensive approach to socially responsible licensing would utilize each of these strategies, or a combination of these strategies, when they are appropriate for the innovation being licensed. A university seeking to take such a comprehensive approach would collect information and samples of all these options, as part of their toolbox of approaches. They would then select from this toolbox the most appropriate option for innovations that could have significant potential in low- and middle-income countries.

At the outset of this Part, it must be noted that a variety of terms are used in the access debate, often to describe the same approach. This list is not intended to be exhaustive, but rather a summary of the approaches we found in our research. We adopt the terms that seemed most widely utilized and group them together based on similarity of underlying approach. Another caveat is that many of these approaches cannot be neatly categorized, as they incorporate some of the same elements. Thus, we recognize that our categorization is somewhat artificial and that these categories are not necessarily mutually exclusive. To aid universities seeking to implement a humanitarian licensing program that makes use of all available approaches, however, we felt it would make the task less arduous to group similar methods together for purposes of explaining the approaches.

A. APPROACHES UTILIZING MARKET SEGMENTATION

Many recommended strategies take an approach that is based on market segmentation. The overall idea is to segment markets essentially by a country's income level, and then give licenses for specific markets only. Alternatively, a licensee's responsibilities could change based on which market it is serving. Non-exclusive licensing often implicates this approach: a licensee has exclusive rights to market and sell a technology resulting from university research in high-income countries, but does not have exclusive rights in low- to middle-income countries. As such, generic competitors could also obtain a license to operate in these developing markets, reducing costs and increasing access to medicines, while still allowing the original licensee exclusive rights in the lucrative developed-world markets. We found three types of licensing strategies that utilize this type of approach:

1. Non-Assertion of Rights Agreements

These agreements "grant permission to third parties to practice a patent they would otherwise infringe." (14) A non-assert agreement is an implied license. The patent-holder agrees not to prosecute infringement of the patent by a certain organization or agrees not to produce drugs/vaccines for a specified developing country market. Under this approach, a university would prevent its primary licensee from prosecuting infringement in certain markets (which would have to be identified at the outset). These non-assert agreements can come in three forms: (1) a bilateral agreement between a primary licensee and a company seeking to serve the developing world (or a university and a primary licensee), or (2) a multilateral agreement between many interested parties, or (3) simply by proclamation of the patent holding university. (15)

One of the main benefits of a non-assert agreement is that it is self-executing, and a university does not have to expend significant time or effort drafting multiple licenses for a given innovation. Another benefit is that a non-assert can be used to facilitate both generic drug and vaccine manufacture in developing countries, if the non-assert is related to certain processes or manufacturing "know-how." (16) There are also some drawbacks to using non-asserts, however. For example, the university has to use very specific language and carefully identify which rights will not be enforced and determine whether any field of use restrictions will apply. (17) It may have a difficult time utilizing a non-assert when the licensed innovation is early stage research, requiring significant downstream innovation. In such an instance, the university would have to include further language ensuring access to, or non-assertion of rights in, downstream innovations, which could require more bargaining power than a typical university would have. Additionally, a non-assert agreement may not effectively allow generic manufacturers to make a drug/biologic if the university owns only some of the intellectual property needed to produce the drug/biologic. For instance, while the university may own the patent to the key protein used in a vaccine, if another entity has patented the production process or other elements required to produce the vaccine, the non-assert alone will not be effective.

Boston University has drafted some model non-assert language that could be used in university licensing agreements. This is excerpted in the box on the following page. The Massachusetts Institute of Technology has also drafted a non-assert proclamation, which is excerpted in the box following Boston University's model non-assert language:

Non-Assertion of Rights Agreements: Examples Boston University Non-Assert License

1. Include in the "WHEREAS" clauses:

WHEREAS, University and Licensee acknowledge that it may serve the public good to make certain drugs available at affordable prices to Non-Market Countries in certain circumstances, with appropriate safeguards to Licensee's economic interests in other markets.

2. Include in the "Definitions":

Market Countries shall mean:

a. All current and future member countries of the Organisation for Economic Cooperation and Development (OECD), presently consisting of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, the United Kingdom, and the United States; and

b. All current and future members of the European Union; and

c. Russian Federation, Republic of China (Chinese Taipei), Korea, Malaysia and Singapore

Non-Market Countries: shall mean all countries other than Market Countries.

Public Sector shall include:

a. The sovereign government of a country;

b. Agencies of the United Nations, the World Health Organization, and the World Bank;

c. Organizations which are members of the International Committee of the Red Cross and Red Crescent;

d. …

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