The Debate over Inequitable Conduct
Among key provisions of the America Invents Act:
• Grace period—Current law protects inventors for a year from describing their invention in a printed publication, making public use of the invention, or offering the invention for sale. America Invents would narrow the grace period to one year from disclosure, a term undefined in the bill.
• Post-grant review—S.23 authorizes a new court-like proceeding pitting challengers against owners within nine months of a patent being issued.
• Priority technologies—The amended bill lets the PTO give priority to technologies deemed important to the national economy or national competitiveness, including biofuels.
• Inequitable conduct—Under current law, the failure to disclose relevant information or submission of false information to the PTO has led to patents being declared unenforceable. America Invents allows patent owners to request “supplemental examination” prior to litigation, during which time the owners could submit what they deem relevant information to the patent office for consideration. Patentees that survive the scrutiny would be found exempt from inequitable conduct.
The Generic Pharmaceutical Association contends that the change to the inequitable conduct standard would let big pharma perpetuate patents of dubious value, “thus unjustly extending monopolies for branded drugs.”
But Clark G. Sullivan, a partner in the intellectual property and food and drug practices of the law firm Arnall Golden Gregory, told GEN that the bill will bring much-needed reform to the inequitable conduct standard.
“It is very easy to accuse somebody after the fact of hiding the ball or playing games with experimental data. And it really has made the system practically unworkable. There are patents that should not be challenged that are. The generic always knows they can create some argument for inequitable conduct,” Sullivan said.
With provisions like these, no wonder the Pharmaceutical Research and Manufacturers of America (PhRMA) and its biotech counterpart, the Biotechnology Industry Organization, support S.23. These organizations have successfully persuaded senators to rewrite earlier versions of the patent-reform bill dating back to 2007.
“Initially, the life sciences industry was more opposed to the early patent reform bills, since it was promulgated mainly by the IT industry, which had different agendas such as an emphasis on limiting damages for multicomponent systems and patent troll cases,” Bill Warren, partner with the intellectual property practice of the law firm Sutherland Asbill & Brennan, told GEN.