One Difference from Senate Bill Remains
The House will also try to incorporate another amendment to the original that is intended to correct what the Generic Pharmaceutical Association (GPhA) termed a “fatal flaw” in the original House bill. GPhA also voiced its opposition to this part of the passed Senate bill.
It 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 amendment to the House bill, which passed the Judiciary Committee by 29–9 and was introduced by Goodlatte, bars the USPTO director or his successors from commencing supplemental examinations of patents in which fraud “was practiced or attempted.” The amendment also requires termination of supplemental exams in which fraud is discovered after they have begun. “We need to make very clear that any new proceeding we set forth incentivizes good faith submissions and punishes intentional misconduct and fraud,” Goodlatte asserted.
Current patent law already protects misuse of a patent, however: Courts have the authority to not enforce a patent whose patentee has been found to have engaged in inequitable conduct. By its own admission the USPTO is swamped just handling the current volume of applications, so its ability to handle the additional burden of enforcing the provision is debatable at best.
“The PTO isn’t well equipped to make these sorts of determinations,” Robert H. Underwood, Ph.D., a partner in McDermott Will & Emery’s Boston office, pointed out to GEN. “They’re not a judicial agency. They don’t have subpoena power so they can’t compel people to come forward with evidence to get all of the information necessary to determine if there is or is not fraud present.”
For these reasons the odds of the Goodlatte language surviving in its present form are also debatable at best. BIO objected to the amendment, arguing it would end up “creating disincentives for patent owners to use the new procedure by having the [PTO] act as a quasi-investigative body.”
Besides this most recent amendment stirring debate over inequitable conduct, most of the changes in the manager’s amendment are expected to find their way into the final America Invents Act this summer. The amended House bill has yet to be posted publicly but is expected to be by next week, along with a report by the House Judiciary Committee.
Underwood pointed out, “When it comes to patent reform, the biotech industry is in favor of any type of changes that improve patent quality, that improve business certainties based on the IP landscape. It wants to know: that the patents I have are valid and enforceable, and I don’t have to worry about very weak patents being asserted against me, or about having to get a bunch of licenses because I don’t want to litigate.”