Tuesday, June 23, 2009

Hatch Continues Patent Reform Work

As staffers for Senate Judiciary Chairman Patrick Leahy resume negotiations with stakeholders who are divided over sections of his bill to overhaul the U.S. patent system, (see CongressDaily's AM Edition for coverage), aides for Sen. Orrin Hatch, R-Utah, are trying to build support for a proposal that would essentially let the Patent and Trademark Office examine information that was not considered during an earlier patent review. Officials from the generic and brand pharmaceuticals industries as well as biotechnology interests met with Hatch's team on Monday. Under the longtime intellectual property crusader's plan, if a patent is issued, the information in question may not be used to hold the patent unenforceable.

Language that Hatch prepared to introduce when Leahy's panel marked up the broader bill in April also clarifies that requesting the reissue (or the decision not to) cannot alone be the basis of an "inequitable conduct" challenge. The proposal would leave untouched the underlying doctrine, which generic drug makers believe is vital to ensure timely market entry of medicines. Hatch, an original cosponsor of Leahy's bill, announced during the mark up that he could no longer support the final product and was one of four members who voted against the measure. "[The bill] has the very real potential to undermine the stimulatory effects of not only our patent system but those abroad," he said at the time.

Generics manufacturers previously argued Hatch's proposal would incentivize deception before the PTO. It's a back door "but for" test that would do away with the inequitable conduct defense, they said. But the senator's office is trying to engage in good faith negotiations with key players and hopes to reconvene the group for further talks after the Independence Day recess, sources said. One individual who attended the Monday meeting said there was "a great deal of positive interaction," with all parties trying to understand each others concerns. If the patent reissue problem can be solved, Hatch is more likely to rally his GOP colleagues in support of Leahy's bill as it heads toward the Senate floor.