The Trans-Pacific Partnership and Innovation in the Bioeconomy: The Need for 12 Years of Data Protection for Biologics
Earlier this week, BIO submitted a letter and white paper (PDF) to the U.S. Trade Representative outlining recommendations for policies to pursue with TPP negotiating partners to ensure intellectual property protection for innovative biologic products. Standards that enable biotechnology companies to protect and leverage their intellectual property are of critical importance to companies seeking breakthrough treatments and cures for patients in need worldwide.
Implementing standards of protection that effectively protect innovation for biological products within the TPP region is an important issue for BIO and its members. The realities of modern research and development in this industry demonstrate that each TPP member has the potential to participate in the discovery and development of new biological products, or new uses of existing products.
The highly leveraged and disseminated nature of the biotechnology industry enables research institutions and small start-up companies in any TPP country to be the seed of this process of discovery, innovation and development. Indeed, there are numerous examples of an individual or small group of scientists, often located in a university or publicly funded research institution, starting a chain of events that make possible discovery and development of a new biological product. There is no reason why a scientist in any one of the TPP countries cannot become that seed of innovation and development.
This innovative potential requires an IP infrastructure that is certain and consistent throughout the TPP region. As we move to more tightly integrate the economies of the TPP countries and to promote collaborations throughout this region, discrepancies in the IP infrastructure will become substantial obstacles to collaboration. For this reason, it is imperative that the TPP create a set of strong intellectual property standards – particularly those governing data protection, patents and trade secret protection – that are relevant to biological products. BIO believes this approach will help achieve the TPP’s vision of promoting high standards that integrate the trade and investment climate in the region.
In addition to strong IP protections, an extended period of regulatory data protection – beyond that given to traditional, small molecule drugs in the generic drug context – is essential to properly incentivize the development of new biological products and new uses of those products.
The existing standards found in agreements between the U.S. and its trading partners provide a good foundation to build upon, but must be updated to reflect the realities and challenges facing developers of new biological products. In particular, given the challenges of securing broad patent rights that can cover variations of innovative biological products, and the need to ensure that investors see the potential to secure commercial success of these products, a period of data protection of not less than 12 years of duration is necessary. That was the period that the U.S. Congress found to be the minimum necessary to provide continued incentives to the biotechnology industry, and the investment communities upon which that industry depend, to develop new biological products.
The biotechnology industry is a dynamic, job-creating industry, and presents opportunities for every country in the TPP region. Indeed, the vast majority of biotechnology companies are small- and medium-sized enterprises. What these companies share is a philosophy that is critical to the task of developing biotechnology products – a willingness to take huge risks and invest in development of new technologies that will lead to new products and services that will improve peoples’ lives.
BIO and its members believe a successful TPP Agreement will create an environment that promotes collaboration and innovation throughout the trans-Pacific region. With this letter and white paper, we hope to provide a better sense of the challenges biotechnology companies face in developing new biological products, and how those challenges translate into the need for effective intellectual property standards within the TPP region.
Download white paper (PDF)