PhRMA Backing For US Patent Bill

Pharmaceutical Research and Manufacturers of America president AlanHolmer has told the US House Subcommittee on Courts and Intellectual Property that patent bill HR 400 will strengthen the Patent and Trademark Office by making it a government corporation, with resulting operational and fiscal flexibility. Also, he said, through incorporation it will underscore that user fees paid by patent and trademark applicants should be used solely to fund PTO operations.

HR 400 restores effective patent life lost through unusual administrative delays at the PTO under the new 20 years-from-filing patent system. Any patent term restoration in it will not, in combination with the Hatch-Waxman partial patent term restoration, provide longer patent term for drug patent holders than other innovators. It will only restore patent term loss at the PTO because of unusual administrative delay, which in any event ends with patent issuance. Hatch-Waxman's partial restoration of term lost due to lengthy Food and Drug Administration processes begins with patent issuance; these restoration periods do not overlap. The effect of both measures would reduce but not eliminate drug patent term lost by regulatory delays.

Mr Holmer said that as Hatch-Waxman provides only partial restoration, drug innovators will still be treated less favorably than others with respect to effective patent term, adding that both PTO and FDA delays warrant restoration to at least reduce the loss of drug patent term.