Posts Tagged: "Dr. Kristina Lybecker"

Trans-Pacific Partnership – What do IP practitioners need to know?

Trade partners negotiating the Tans-Pacific Partnership trade deal have reached an agreement. The agreement details have not been released, and likely will not be submitted to Congress for a mandatory review for at least a month, perhaps longer… Presently the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years. While the term of data exclusivity is not one in the same with reducing the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

Protecting Data Exclusivity, Protecting the Future of Medicine

Traditionally, “small molecule” drugs are patent protected for a twenty-year term. Biologic medicines, however, are more difficult to comprehensively protect with patents due to their size, complexity, and numerous similar effective variants. This comprehensive protection is critical given the investment and risk associated with biologics. Estimates are that the pre-approval cost of developing a biologic approaches $1.2 billion and that the time needed to recover the pre-approval R&D costs be between 12.9 and 16.2 years. In the United States, the Biologics Price Competition and Innovation Act of 2009 (“Biologics Act”) provides for 12 years of exclusivity for the drugs. Through this, Congress endeavored to fill the void left by patents and trade secrets in the protection of biologics.

The Importance of Protecting Incremental, Improvement Innovation

Innovation provides new therapies and breakthrough treatments that extend and enhance life. The scientific and financial resources required for these advances are an investment worth making and an important precedent for global health. Patents encourage those innovations, making cutting-edge treatments a reality. Patents give innovation life. Current efforts to amend existing intellectual property legislation to “fix” the patent system will only undermine the incentives that encourage innovation. All innovation, both breakthrough discoveries and incremental improvements, is valuable and should be protected and rewarded. India, Brazil, South Africa and other emerging economies should take note. Their proposed changes, aimed at weakening intellectual property rights protections, are misguided and potentially very damaging to public health.

Are Pharmaceutical Patents A Barrier to Access to Medicines? The Importance Economic Development and Growth

Critics argue that pharmaceutical patents are a barrier to wide-reaching access to medicines, especially for vulnerable populations in the developing world. They cast their argument in the phrase, “Patents Kill” and advocate against intellectual property (IP) protection for medical innovation and the trade agreements that incorporate them… Not surprisingly, barriers to access are more prevalent in less developed nations and access to medicine is a function of the level of economic development. Not surprisingly, higher-income nations benefit from greater access to medicines.

Economics of Access to Medicines: The Challenges of Pharmaceutical Patents, Innovation and Access for Global Health

While it is easy to point to patents and blame the industry and international trade agreements for barriers to access to medicines in developing nations, the reality of the situation is more nuanced and not nearly so straightforward.  In the debate over barriers to access, the focus must be broadened to include other important factors such as poverty, taxes and tariffs, corruption and pharmaceutical counterfeiting.  Each of these elements inhibits access to medicines, through financial challenges, higher prices, shortages, and spurious products.  For the most vulnerable populations it is essential to address all of the key barriers to access, and improve procurement and monitoring systems.  Without a wider focus and a solution to these problems, it is unlikely that efforts to improve access will succeed.