Home > IP Topics Index > Putting Intellectual Property to Work: Experiences from Around the World > Patent Consolidation and Equitable Access: PATH’s Malaria Vaccines > Editor's Summary, Implications and Best Practices

Malaria is one of the most widespread and deadly tropical diseases. There are more than 300 million cases and more than one million deaths each year. No safe, effective vaccine for malaria exists. A vaccine could greatly reduce the effects of the disease in terms of suffering and lives lost. It also could prevent the spread of malarial more cost effectively than any existing treatment. Developing a malaria vaccine, however, presents several major challenges:

1. Technical challenges—malarial parasites are difficult to target with a vaccine. During each stage of the parasite’s life cycle, it produces a number of different antigens, some of which may be useful for developing a vaccine. However, these antigens number in the thousands.
2. Commercialization challenges—different populations need different vaccine products. For example, children livening in malarial endemic regions will require a vaccine having properties different from a traveler’s vaccine. In addition, funding mechanisms and delivery channels are needed.
3. IP challenges—many patents, some with overlapping claims, cover malaria antigens that may be needed for vaccine development. Such a patent thicket is challenging because it is likely that more than one antigen will be needed fro an effective vaccine.

The Rockefeller Foundation provided a grant to the PATH Malaria Vaccine Initiative (MVI) to analyze whether consolidation of patents in the malaria vaccine field could streamline access by advancing, and accelerating, the development of vaccines. In addition, the project was designed to ensure market access for the malaria vaccine candidates that are most likely to receive regulatory approval and be developed as products. This chapter provides the results of this study, which assessed the current status of the relevant patents, determined their availability for license, and explored the possible role for some form of patent consolidation or technology trust for pooling patents and technology for general access on behalf of the field. The chapter does not recommend developing a broad-based technology trust for existing malaria antigen patents. Instead, several other steps are recommended to consolidate available rights and improve access for future patent families.

Before this study, MVI had identified some potentially obstructive IP issues for the development of a malaria vaccine for developing country markets. Public and academic institutions—institutions with missions that in many cases include some form of public benefit—hold many of the patents in the malaria antigen field. As the study’s findings reveal, with few exceptions the patents held by public and academic institutions have been assigned or exclusively licensed to private companies, and are therefore currently are unavailable for licensing from the original public institution patent holders.

While sublicensing of these malarial antigen patents from the current private holders of the technology may be possible, it is likely to be more difficult and costly; engaging them in contributing to a patent pool or clearinghouse also might be challenging. However, a patent pool for a malaria vaccine might generate further obstacles: potential anti-trust issues, whether real or perceived, might trigger interest and scrutiny by the U.S. Department of Justice and the Federal Trade Commission. And while the concept of a technology trust or patent pool may still be useful for patents filed in the future, even some of those would be under option for license by the private companies holding the current patents. Finally, the number of high-priority cases for any malaria antigen is small, as is the number of entities likely to seek access to any given patent family. This makes the expense of a patent pool even less justifiable.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Patent pools can be instrumental in accelerating the introduction of novel technologies. They are not cartels, provided they are properly regulated. National anti-competition law typically contain the necessary grounds for governments to issue guidelines for patent pool arrangements and determine possible misuse.
• Participation in product development partnerships (PDPs) by national public sector and academic institutions may represent the best route for accelerating access to products, especially vaccines. PDPs can facilitate assembling essential patents.

For Senior Management (university president, R&D manager, etc)

• In the past, patent pools have sometimes been used for anti-competitive purposes, such as collusion and price fixing. To prevent this, the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) have set up guidelines to ensure that patent pools are “pro-competitive.” Any patent pool must follow these guidelines, but it is unclear how or whether this would work for vaccine antigens.
• For companies currently developing vaccines covered by their patents, the patents are likely part of a core business strategy and, hence, participation in a patent pool may not be an option.
• A clearinghouse approach, with IP rights accessible by multiple potential partners or licensees in a “pick-and-choose” fashion, could be a strategy for avoiding potential antitrust scrutiny often triggered by patent pools. However, there are many other forms mechanisms that facilitate both in- and out-licensing.

For Scientists

• Scientific investigations are necessary to establish precisely how different antigens from different phases of the malarial parasite (plasmodium) life cycle might work together in concert within a vaccine. This will then instruct how complementary technologies are to be combined in a patent pool or other suitable mechanism of IP assembly.

For Technology Transfer Officers

• One feasible approach for obtaining access to patents for malaria vaccines in developing countries is to work directly with the owner when it is clear that access will be needed to their specific technology. The relationship may include not just straightforward licensing but also co-development agreements, manufacturing contracts, or marketing partnerships. It may make sense to develop such a relationship only when the needed technological inputs are more clearly understood and defined.