Home > IP Topics Index > Putting Intellectual Property to Work: Experiences from Around the World > Specific IP Issues with Molecular Pharming: Case Study of Plant-Derived Vaccines > Editor's Summary, Implications and Best Practices

Molecular Pharming seeks to develop valuable new drugs and vaccines that can address important diseases in developed and developing countries. Government and foundation funding of Molecular Pharming represents a new generation of public sector initiatives for rectifying a widely acknowledged imbalance: lack of investment in R&D for health technologies for the poor. This chapter addresses IP issues that relate to Molecular Pharming, and presents a detailed analysis of the hepatitis B vaccine as a case study.

For an area such as Molecular Pharming, with many actors and a corresponding detailed landscape, there are three principal challenges to IP management:

1. Freedom to operate (FTO): For public sector support of Molecular Pharming to achieve its goals it will be necessary to undertake an in depth FTO assessment which will provide a clear picture about the patents may or may not be applicable. The chapter points out that this might entail third-party tangible and intangible property rights. Intangible property assets may be covered by several forms of IP rights, including patents, trade secrets and plant variety protection.
2. Securing new intellectual property: New research initiatives will develop new intellectual property. It is essential to the achievement of public sector goals that this intellectual property be identified and secured, for example by the filing of appropriate patent applications.
3. Deploying intellectual property: Public sector groups engaged in Molecular Pharming are often dedicated to achieving a social goal, that is, the availability of safe and effective health technologies for alleviating disease. To accomplish this, public sector institutions should consider reservation of rights and humanitarian licensing practices.

As the chapter makes clear, a wide array of technology is correlated to a wide array of intellectual property. Hence, as with most biotechnology products, the IP situation in plant-derived vaccines is complex. Managing intellectual property and tangible property rights presents added challenges—and expense, not least because plant-derived vaccines build on several distinct areas of innovation, including:

• Protein engineering and specific antigens (including immunogenicity, specific genes encoding antigenic proteins, etc.),
• Antigen production and accumulation in plants (including expression of foreign genes, optimization of genes, etc.),
• Genetic transformation of plants (including transformation protocols and equipment, marker technologies, etc.), and
• Bioprocess engineering for extraction and processing.

Nevertheless, despite the challenging complexity, the task is doable. The chapter points out, systematically, ways to surmount these challenges.

1. The work should take advantage of flexibilities, such as the freedom in the United States to undertake research without a license on patented technologies when the goal is to generate data for FDA regulatory requirements.
2. The goal of facilitating the availability of products for humanitarian uses is gradually becoming an integral part of the policies and strategies of many public institutions.
3. Though there is a thicket of patents for plant-derived vaccines in industrialized countries, very few of these patents have been filed in developing countries, simplifying matters with regard to humanitarian use.

The chapter applies many of these concepts to the real world case study of the hepatitis B vaccine, a good illustrative example of a complex biotechnology product with intellectual property attached. Associated intellectual property includes vaccine related patents, plant transformation and antigen production patents, PMP patents, bioprocess facility and cost implications. The example is presented clearly and concisely, so that the principles outlined in the chapter come to life for the reader, moving from abstract to concrete, from virus to antigen to plant to vaccine, and then to administration to those who so desperately need this type of innovation for their health. And, as the chapter clearly points out, best practices in proactive IP management plays a role throughout.

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

• Molecular Pharming is an emerging technology that holds great promise, particularly for developing countries. It is a scalable technology that allows for lower capital requirements and much faster upscaling of new vaccines.
• In developed countries, intellectual property is not a constraining factor in the development and potential introduction of plant-made pharmaceuticals and vaccines, at least not at the moment.
• The major constraints are regulatory, R&D capacity and production. This underscores the point that from a policymaker’s point of view, intellectual property should be seen as in the context of an innovation framework.

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

• Institutional capacity in IP management will likely facilitate, and indeed accelerate, access to complex biotechnological innovations embedded in vaccines produced via Molecular Pharming. This will involve commitment, training and serious investment. However, the outcome will be greater access to the types of products so needed by the poor.

For Scientists

• Molecular Pharming presents great promise and also great challenge. However, the promise can drive projects so as to overcome both the scientific and IP challenges. As a scientist, you will need to remain aware of these IP challenges throughout the complex process of developing applicable products. This will then assure access to those who need the end product … vaccines.

For Technology Transfer Officers

• Molecular Pharming will entail IP management and technology transfer, which your office will need to address. This will involve organization, skill, ongoing capacity building in both IP awareness and management and practical skills in licensing and technology transfer. Since this type of technology is so critically important to your country, prioritization of your office’s activities ought to focus on what needs to be done in order to move towards sustainable access of these important advances in biotechnology health innovation.