GPhA, PhRMA weigh in on patent-reform legislation

WASHINGTON — A bill that would make the biggest changes to patent laws in more than half a century has drawn mixed responses from the drug industry.

The bill, S. 23, The Patent Reform Act of 2011, sponsored by Sen. Patrick Leahy, D-Vt., would make the first significant changes to patent laws in 60 years.

The Generic Pharmaceutical Association and the Pharmaceutical Research and Manufacturers of America, the respective lobbies for the generic and branded drug industries, both praised the bill on the whole, but the GPhA had reservations about a provision that it said would weaken the inequitable conduct clause.

Currently, a patent can be ruled unenforceable in a court of law if the court determines that the patent’s holder intentionally withheld information or deceived the Patent and Trademark Office in any way. For the generic drug industry, this has opened the opportunity for numerous challenges to patents covering branded drugs, allowing generic drug makers to launch their versions of the drugs ahead of patent expiration.

“Weakening current inequitable conduct standards will simply result in providing innovators with a greater incentive to be less than honest when seeking patents, thereby making it harder for companies to challenge dubious patents and bring affordable generic medicines to consumers,” a statement from the GPhA read.

Meanwhile, the PhRMA did not mention the inequitable conduct clause, but spoke in favor of the bill nonetheless. “Senator Leahy’s patent-reform bill would strengthen the patent system while protecting patent owners and maintaining incentives for innovation,” PhRMA SVP Wes Metheny said. “The bill balances the diverse interests of various stakeholders across American business sectors while maintaining strong and reliable intellectual property protection.”