A bipartisan group of lawmakers has accused the U.S. Patent & Trademark Office of “weakening” the system for challenging patents and, as a result, encouraging abuses by drug makers that seek to thwart the availability of lower-cost generic medicines.
At issue is the inter partes review, or IPR, which went into effect in 2012 as a result of the America Invents Act. This type of patent challenge, which is heard by the Patent and Trials Appeal Board, was intended to provide an easier and faster alternative to patent infringement lawsuits filed in federal courts. For this reason, the IPR process has irked brand-name pharmaceutical companies.
Yet the PTO has increasingly denied a growing number of IPR petitions as the result of a discretionary rule implemented three years ago by a former agency director. Basically, the rule says the PTAB can deny an IPR challenge if it is not brought within a year of federal court litigation in which the same brand-name drug maker is fending off would-be generic rivals seeking to invalidate its patents.
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