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GSK Wins Injunction Against USPTO for Pending Patent Rule Changes

NEW YORK (GenomeWeb News) - The US District Court for the Eastern District of Virginia today issued a preliminary injunction that will delay recently proposed changes in US patent rules from taking effect tomorrow, GenomeWeb Daily News has learned.
A spokesperson from GlaxoSmithKline, which filed a complaint with the court earlier this month regarding the new rules, told GenomeWeb Daily News that the court has “granted a preliminary injunction that will delay implementation of the rules until such time that there can be a hearing on the merits of the case.”
John White, a patent attorney with Virginia-based patent law firm White and Quinn, was present at the hearing, and confirmed that the injunction had occurred. White was covering the hearing for the Patent Practice Center blog sponsored by the Practising Law Institute.
In August, the USPTO published new rules in the Federal Register designed to improve patent quality and improve the effectiveness and efficiency of patent examination. The rules were originally set to go into effect on Nov. 1. A timetable for hearings on the case had not yet been set as of the publication of this article.
Earlier this month, GlaxoSmithKline filed a complaint with the US Federal Court for the Eastern District of Virginia against the USPTO to challenge the published rules. Myriad organizations such as the Biotechnology Industry Organization, Pharmaceutical and Research Manufacturers of America, and the American Intellectual Property Law Association have also filed amicus briefs in support of the GSK complaint.
Under the new rules, patent applicants would have been able to file two new continuing applications and one request for continued examination as a matter of right. In addition, each patent application would have been allowed to contain no more than 25 separate claims, with no more than five of them independent, without any additional effort on the part of the applicant.
Beyond these thresholds, the rules would have required applicants to show why an additional continuation is necessary or to provide supplementary information relevant to the claimed invention to present additional claims.
“This would restrict the number of the claims that could be added to an open patent application, and you would then have to file an examination support document if you wanted to add any more than that,” the GSK spokesperson told GenomeWeb Daily News. “For the first time, they would require that you would do a far-reaching search across US and foreign patents and literature to prove that your claim deserves to be added. The problem is they don’t define what the scope of that search is, so it would be very hard to do that effectively.”
In its complaint, GSK argued that the rule changes were “not within the legal purview” of the USPTO, the spokesperson said. It also argued that the new rules would stifle innovation at GSK and other pharmaceutical companies.
The injunction is in particular a positive development for the pharmaceutical, biotech, and university communities, all of which depend on open applications to add new claims surrounding an invention as they are discovered over months or years.
The spokesperson told GenomeWeb Daily News that the new rules would have “severely limited” the pharmaceutical industry’s ability to claim inventions.
“We’re particularly vulnerable because we have a long discovery and development period for inventions, so it could be 10 to 12 years or more that we’re working with a medicine to bring it to market,” the spokesperson said.
“We learn a lot during that time frame, and [being able to] add your innovations on to a pre-existing application allows us to get the benefit of our invention,” she added. “Through that 10 or 12 years, or whatever it takes, we’re pouring a lot of money into the development process, and of course the assumption is that your invention is going to be protected so you can bring that to market. If we don’t have that confidence, you could potentially be in the situation of limiting the innovations that will then be available to patients.”
White told GenomeWeb Daily News that the new rules would have “absolutely gutted” innovation in the biomedical and university communities.
Following the injunction, the USPTO issued a statement of continued support for the rule changes.
“Interest shown by the US Supreme Court and the US Congress in patent modernization indicates that the system needs change,” the USPTO said. “The USPTO continues to believe that the rules are an important component of modernizing the patent system. They are part of a package of initiatives designed to improve the quality and efficiency of the patent process and move American innovation and our economy forward.
“This multi-pronged approach is already showing results,” the statement continued. “Patent examination quality is at a record high. Nearly 97 percent of the patents issued in [fiscal year] 2007 met stringent independent quality standards, up from about 93 percent in FY 2000. Additionally, last year USPTO’s board of patent appeals upheld examiners’ decisions to reject patents nearly 70 percent of the time, compared with only 51 percent of the time in FY 2000.”
As of the time of the publication of this article, the US District Court for the Eastern District of Virginia had not yet issued a written opinion on the injunction, but was expected to do so by the end of the day.

Further information about the injunction and the USPTO's response will appear in Monday's issue of Biotech Transfer Week.

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