Patent office loses fight to introduce rules that pharma said would harm innovation
A US district court has said that the US patent office cannot introduce new rules that drug firms argued were a threat to innovation.
The US Patent and Trademark Office (PTO) rules would have limited the number of times companies could file changes to existing patent applications (’continuations’) to three, while also restricting the number of claims they could make about an invention to 25. Currently, applicants can file as many continuations and claims as they want.
But on 1 April a Virginia district court ruled in favour of the plaintiffs - pharmaceuticals giant GlaxoSmithKline (GSK) and Triantafyllos Tafas, an inventor with multiple patents pending who co-founded the US medical technology company Ikonisys. Judge James Cacheris said the PTO had overstepped its authority when it tried to introduce the regulations in November 2007.
The ruling was hailed by GSK and the Biotechnology Industry Organization (BIO) as a major victory.
’We are pleased that the court has considered our arguments and decided that the PTO lacks the necessary authority to implement the proposed rule changes,’ GSK said. ’This is a judgment in support of innovation across all industries. It reaffirms that all who want to patent their inventions in the United States will be allowed to seek protection on the full scope of their discoveries.’
Jim Greenwood, BIO’s chief executive, welcomed the ruling as ’a sound decision’. Had the regulations gone into effect, he noted, they would have ’inhibited the ability of biotechnology innovators to obtain adequate patent protection on their technologies, significantly decreasing their ability to attract the financing necessary to bring innovative, life-enhancing and life-saving products to market’.
The PTO says it is disappointed with the court’s decision. According to agency spokeswoman Jennifer Rankin, the rules are consistent with existing statutes and would have streamlined the US patent system for all stakeholders. Applicants currently have to wait 32 months on average before their patents are reviewed.
The agency has two months to appeal the Cacheris decision. Meanwhile, patent reform legislation pending in the US Congress could override the court’s ruling. The measure, which is expected to see movement this summer, includes language that would substantially beef up the PTO’s rulemaking powers.
However, some lawyers accuse the PTO of simply trying to lessen its own workload. ’PTO wanted less work,’ says John White, a patent attorney practicing in Virginia. ’It was very much a statutory revision which the office was trying to pass off as a mere regulatory footnote. They were trying to legislate from their own little conference room.’
Rebecca Trager, US correspondent for Research Day USA