This is a fast turnaround. The US Senate only passed the Leahy-Smith America Invents Act and sent it to the President’s desk on 8 September 2011 [1]. However, maybe it is not surprising given that the US Government has stated on many occasions that it is strongly in favour of the bill, despite fears from the generics industry.

Biotechnology Industry Organization (BIO) President and CEO Mr Jim Greenwood said that ‘BIO is extremely pleased that the Administration recognises the potential of America’s biotechnology industry to provide jobs and grow the nation’s 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.’

Generics manufacturers, however, may not be taking the news so well. The US Generic Pharmaceutical Association (GPhA) has previously opposed the bill. 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 lead to patent ‘cleansing’, preventing patent challenges from generics manufacturers and ultimately delaying access to cheaper generic medicines [1].

Editor’s Comment

The signing of this legislation marks the end of a long road leading to patent reform in the US, but what will the consequences be for generics?

Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What are your views on the overhaul of patent legislation in the US? How do you think this will affect the generics industry?

References

1. GaBI Online - Generics and Biosimilars Initiative. US Senate approves patent reform [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 23]. Available from: www.gabionline.net/Policies-Legislation/US-Senate-approves-patent-reform

2. 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 23]. Available from: www.gabionline.net/Policies-Legislation/US-patent-reform-legislation-may-delay-generics