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PhRMA and GPhA disagree on ‘first to file’ US patent law plan

By Gareth Macdonald, 27-Jun-2011

Related topics: Regulatory & Safety, Globalisation, Lifecycle management

The Pharmaceutical Research and Manufacturers of America (PhRMA) has welcomed proposed changes to US patent laws that would alter the basis for patent awards.

The potential revision, detailed in a bill passed by the House of Representatives last week, would no longer see patents awarded to the first to invent but to the “first inventor to file”.

The modification would benefit the pharmaceutical industry by make the filing process less complex and more efficient according to PhRMA VP Karl Uhlendorf.

This would bring us in line with the patent systems of other developed nations, creating efficiencies for inventors seeking patent protection in the US and other markets.

“It would also provide a more-objective measure of determining patentability, thereby providing inventors with more certainty and potentially limiting costly and time-consuming litigation over who was the first to invent.

Uhlendorf also backed the plan to include a ‘supplemental examination’ procedure designed to encourage patent holders to ask the US Patent and Trademark Office (USPTO) to review the documents.

It would allow affirmation of valid patents, establishing greater certainty for the research-based patent holders who rely on them, while allowing for clarification of potentially questionable patents.

“This procedure has the potential to greatly limit frivolous litigation, all while spurring the innovation that is stimulated by strong patent protection.

GPhA response

However, while PhRMA welcomed the revisions, the Generic Pharmaceutical Association (GPhA) reiterated its opposition, focusing its criticism on the proposed ‘supplemental examination’ mechanism.

The organisation said the bill grants patent holders that knowingly falsify information in their original patent application a mechanism to retroactively correct their filing without any consequences.

Executive director Bob Billings said: “This legislation offers a free ride for those looking to mislead and misrepresent the PTO.”

“While proponents may try to argue that the mechanism provided in the bill merely allows patent holders to correct inadvertent mistakes, what we are talking about here is purposeful lying and any claims to the contrary are simply disingenuous.”

The US Congress is due to vote on the “The America Invents Act” later this year.