Docket No. 2013-1545
DYK, WALLACH, CHEN
August 21, 2014
Brief Summary: Post-URAA patents susceptible to obviousness-type double patenting challenge where there is overlapping subject matter and, for instance, extended term due to PTO delays and/or applicant’s choice of different priority dates.
Summary: Kennedy appealed SDNY DC grant of DJ that its US 7,846,442 was invalid for obviousness-type double patenting in view of its US 6,270,766 (expired), both relating to treating rheumatoid arthritis using a combination of methotrexate and an anti-TNFα antibody. Abbvie et al. are licensees of the ‘766 patent but not the ‘442 patent. The ‘766 patent was filed on August 1, 1996, claimed priority to October 8, 1992 and expired in 2012. The ‘442 patent claimed priority to August 1, 1996 (the ‘766 filing date) but would expire in 2018 (with 750 day 154(b) extension). The ‘766 claims were directed to “individual[s] in need” and “co-administering” the drugs while the ‘442 claims are directed to “individuals with ‘active disease’” and “adjunctively administering” the drugs. The DC concluded that the meaning of “co-administering” and “adjunctively administering” overlapped and that “active disease” referred to “all patients suffering from rheumatoid arthritis and requiring treatment”. It concluded the ‘442 claims were invalid over the ‘766 claims because “a person of ordinary skill in the art would not consider there to be a substantial difference between the patient populations”. Kennedy argued that “statutory and policy rationales underlying the obviousness-type double patenting doctrine no longer exist and the doctrine should be discarded” with the 20-year period of patent protection provided by the URAA (effective June 8, 1995). The FC disagreed since, in cases like this one, “[p]atents claiming overlapping subject matter that were filed at the same time can have different patent terms due to examination delays at the PTO” and the applicant may choose “to claim different priority dates for” such patents (“We now make explicit what was implicit in Gilead…” (FC 2014)). The FC panel agreed with the DC construction of “co-administration” in the ‘766 claims based on the specification (e.g., it does not “discuss the discontinuation of methotrexate as a form of co-administration or as part of the invention” and “claim 9 says nothing about the discontinuation of the methotrexate”). The FC panel also “assume[d], without deciding, that Kennedy’s proposed construction of ‘active disease’ was correct” and “the genus claimed in the ‘766 patent…is broader than the species claims in the ‘442 patent”. The opinion noted “obviousness is not demonstrated merely by showing that an earlier patent dominates and later expiring patent”. However, “not every species of a patented genus is separably patentable” where the skilled artisan can “at once envisage each member” of a limited genus (In re Gleave, FC 2009; Pfizer, FC 2007) and, here, “a reader of the ‘766 patent could have easily envisioned a species limited to sicker patients” (as in the ‘442 claims). And, while “the nonclaim portion of [an] earlier patent ordinarily does not qualify as prior art”, it “may be used…to answer the question of whether claims merely define an obvious variation of what is earlier disclosed and claimed” (e.g., whether there were any unexpected results; citing In re Basel, FC 2008; Geneva Pharms., FC 2003; Pfizer, FC 2007). In this situation, no unexpected results were found. The DC decision was therefore affirmed.