Sustained biopharmaceutical innovation is demanding, with companies facing a myriad of challenges including those associated with initial drug discovery, developmental lead times and satisfying the regulatory conditions required to introduce novel therapeutics onto the market. IP is considered to be a biopharmaceutical company’s most valuable resource in meeting such challenges and driving innovation.
In a recent publication, Professor David Taylor at University College London School of Pharmacy and his colleagues at London School of Economics, present the view that protecting and strengthening IP rights is essential in facilitating continued private and public investment in biopharmaceutical innovation. Such innovation is responsible for the ongoing increase in global life expectancy at birth and the authors noted that coupling this with extended health care provisions could eradicate premature mortality by 2050.
However, this publication comes at a time when some parties perceive IP rights to be under challenge by governments, particularly those in developing countries with a domestic generic pharmaceutical manufacturing sector. For example, in 2013, the Indian Supreme Court controversially refused to grant Novartis a patent for its anticancer drug imatinib (Glivec), with the Court ruling that imatinib was an updated variant of a pre-existing drug. Furthermore, in 2012, the Indian government granted a compulsory licence for a generic drug manufacturer to produce a pharmaceutical comparable to that of Bayer’s liver and kidney cancer drug sorafenib (Nexavar).
Taylor and his colleagues believe these are not equitable long-term solutions for future innovation and discourage investment into high risk biopharmaceutical research and development. Price differentials, where drugs are sold at a fraction of the price in poorer countries compared to wealthier ones, may provide a potential solution to the problem. However, a downward pressure on pricing levels could negatively impact on the sustainability of research and development activities within the industry.
At the launch of the publication, Sir Robin Jacob, a former Lord Justice of Appeal and a leading expert in IP law, held that whilst the patent system does not provide real incentives to carry out research into diseases of the third world, the focus should not be on diminishing the current patent system, but making improvements where it does not work as well.
Balancing medical innovation with affordable universal access to drug treatments requires fine tuning and there are no quick solutions. Nevertheless, the view of Taylor and his colleagues is that a strong, transparent and equitable IP portfolio is essential for a robust global biopharmaceutical industry.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.