US patent reform legislation may delay generics

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US patent reform legislation may delay generics

Home/Policies & Legislation | Posted 06/05/2011 0 Post your comment

Generic drugmakers have been dealt a blow in Congress now that the Senate has passed patent-reform legislation despite efforts by the generics industry to remove a provision in the bill.

The America Invents Act, S23, was passed by the Senate on 8 March 2011, a major step forward for a bill that has been under consideration for several years and has reached the full Senate three times since 2008. The legislation overhauls the US patent system by changing it from a ‘first-to-invent’ to a ‘first-to-file’ system, and gives courts more influence in determining patent dispute damages, among other things.

Pharmaceutical Research and Manufacturers of America (PhRMA), the industry groups representing innovator companies, welcomed the decision saying that it represents a ‘commitment to innovation’.

However, the Generic Pharmaceutical Association (GPhA) is not too pleased. Their main issue is with section 11 of the bill, which relates to supplemental examination of patents. The GPhA is worried that this would allow a patent holder to ‘cleanse’ its patent, thus preventing patent challenges from generics manufacturers and delaying access to cheaper generic medicines.

The GPhA strongly supports current law and is urging the House to keep the current inequitable conduct provisions as they exist or improve the language currently in the bill. This, they believe, ‘will help preserve the duty of honesty and good faith that is essential to the proper functioning of the patent system’ and ‘will also help assure that affordable generics can come to the market.’

What happens next?

The bill was introduced to the House of Representatives on 30 March 2011 with a few small changes to the Senate version. It is believed that those few changes may, however, jeopardise the bill’s chances of being passed by the House this year.

Source: Genetic Engineering and Biotechnology News, GPhA, PhRMA