The U.S. Patent Office does not have substantive rulemaking authority. Thus, the office cannot change the meaning of “novelty” or “obviousness” even through a formal process of notice and comment rulemaking. The Office does, however, have the power to make rules that govern procedures within the office that are “not inconsistent with [the] law.” 35 USC 2.
GlaxoSmithKline has now sued the Patent Office to stop implementation of two new sets of PTO rules — arguing that the scope and effect of the new rules extend well beyond the PTO’s limited rulemaking authority. The main thrust of the rules is to limit the number of follow-on applications that can be filed that somehow relate to an original patent application and to limit the number of claims filed in each patent application.
Glaxo can easily show that these rule changes will harm its business — especially because the rules retroactively impact the UK company’s already pending patent applications.
The rules hit innovator pharmaceutical companies especially hard. Pharmaceutical companies typically file large original patent applications early in the drug development process. Those original applications typically disclose many variations of a class of drug along with various methods of manufacturing and using the drug. As development continues, follow on continuation applications are used to specify and claim particular subgroups. The continuations also typically include further information to prove utility and nonobviousness of the particular subgroups. These rule changes will severely limit GSK’s ability to file these continuations and, as a consequence, will hurt its position.
GSK notes that the PTO’s exceptions to the rule is primarily mythical because it requires a strict “could not have” limitation.
- Read the Complaint
- The complaint was filed by my old firm of Kirkland & Ellis. This is perhaps odd since Kirkland does no patent prosecution.