This morning, GlaxoSmithKline prevailed in the District Court for the Eastern District of Virginia and succeeded at enjoining the USPTO from making the Final Rules on claims and continuations effective. The Rules were intended to go into effect on November 1, 2007.
GSK argued that the new rules will compromise their ability to fully prosecute patent applications and obtain patents on their inventions. They went on to state that the rules are procedurally defective and unconstitutional, and represent an arbitrary and capricious taking of GSK's patent and patent application property rights.
Under the present system, usually submit broad patent applications in order to stake their intellectual property claim as soon as possible. As more and more information about a potential new drug, for example, becomes available, companies then file continuations and add extra claims to the original application, all which must then be reviewed by the PTO.
The PTO argued that, as there is currently no limit on the amount of continuation applications, the review process is getting out of hand, with a 32-month backlog of applications. Under the new rules, applicants would be limited to two continuation applications with up to 25 claims, and would have to petition the PTO if they decide to exceed the limit. The PTO claims that these rules are designed to make the patent-application process more "efficient by encouraging applicants to use greater precision in describing the scope of their inventions." GSK, on the other hand, believes that "the changes in place go beyond the authority of the PTO and have the potential to stifle innovation."
In the days leading up to the hearing, a number of companies filed amici briefs in support of GSK, including HEXAS LLC, Elan Pharmaceuticals, and the American Intellectual Property Law Association. Elan opined that "the Final Rules will improperly and unfairly shift the burden onto patent applicants to evaluate patentability in the first instance in many cases," while AIPLA stated that the final rules will compel owners of intellectual property to"abandon pending patent claims, abandon entire patent applications, and surrender currently existing claim scope without adequate opportunity for consideration by the [Office]." While the PTO has disagreed with AIPLA's claims, many patent attorneys have been finding themselves narrowing applications and canceling pending claims to comply with the new rules.
As of today, the District Court has granted a preliminary injunction to GSK and maintained the status quo. A full decision should arrive in several months' time.
