This week, Science published a policy paper I wrote on the legal framework that governs patent protection for pharmaceuticals in the United States.
In the last 25 years, the cost of drug development has skyrocketed--from about $230 million to more than $1.2 billion. Pharmaceutical companies like GSK protect this huge investment with two kinds of protection: the exclusive ownership of our own clinical research and patents.
Intellectual property is undeniably vital to our industry. However, US law allows generic competition in some circumstances as early as five years after a product is introduced, leaving little time to recoup investment in innovative R&D. Further, US courts sometimes retroactively change standards for patent protection long after large R&D efforts have been started, which increases the risk to defend and rely on patent protection.
We believe it is time to update our legal system to take into account the rapidly increasing cost and time involved for drug development. Amendments to the Hatch Waxman Act, which dictates patent protection law for pharmaceuticals, could substantially increase the number of drugs in the R&D pipeline. Additionally, patent protection should be predictable and secure. Basing the patent system on a consistent set of laws will allow us to protect our investment and innovation over the long period of pharmaceutical R&D.
GSK supports reform of US patent laws, which we believe will encourage more research and, ultimately, result in more medications for patients.