The US Senate passed the historic legislation in an 89-9 vote, making this the first comprehensive reform to the nation’s patent system in nearly 60 years. Senate Judiciary Committee Chairman Mr Patrick Leahy and House Judiciary Committee Chairman Mr Lamar Smith first introduced the patent-reform bill to congress in 2005.

Biotechnology Industry Organization (BIO) President and CEO Mr Jim Greenwood, welcomed the decision saying it would ‘continue our nation’s global leadership in innovation while driving job growth throughout our economy.’ While the Pharmaceutical Research and Manufacturers of America (PhRMA), representing leading pharmaceutical research and biotechnology companies in the US, has previously welcomed the bill saying it represents a ‘commitment to innovation.’

However, this is not good news for the generics industry. The Generic Pharmaceutical Association (GPhA) has previously opposed the bill. Their main issue of the bill is with section 11, which relates to the supplemental examination of patents. The GPhA believes that the bill allows patent holders to knowingly falsify or omit information, since the bill allows for a mechanism to retroactively correct patents without any consequences. The GPhA is worried that this would allow a patent holder to ‘cleanse’ its patent so preventing patent challenges from generics manufacturers, thus delaying access to cheaper generic medicines [1].

What happens next?

This action by the US Senate paves the way for the Leahy-Smith America Invents Act to be sent to the President’s desk to be signed into law. This is expected to be a mere formality, as the US government strongly supports the bill.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. US patent reform legislation may delay generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 16]. Available from: www.gabionline.net/Policies-Legislation/US-patent-reform-legislation-may-delay-generics