Rule Review - Obviousness-Type Double Patenting

The Uruguay Round Agreements Act (URAA), Pub. L. 103-465, 108 Stat. 4809 (effective June 8, 1995), installed a twenty-year U.S. patent term from the earliest-claimed priority date, modifying the previous seventeen-year term calculated from the date of patent issuance.1 That change eliminated a perceived abuse—sometimes called "submarine patenting" or "evergreening"—wherein the use of continuing applications allowed claiming of previously disclosed features many, many years later, since patent expiration was calculated from the date of issuance. In that former context, the prohibition against obviousness-type double patenting (OTDP) was a check ensuring that patentees could not obtain more than one patent based on merely unpatentable variations, effectively extending the monopoly on the same basic invention.

When OTDP, also known as "non-statutory double patenting," was raised by AbbVie Inc. as a defense in an infringement suit brought by The Mathilda and Terence Kennedy Institute of Rheumatology Trust ("Kennedy"), the policy justification for the doctrine post-URAA was questioned.2 Kennedy argued that the rationale for the rule no longer exists and that the doctrine should be discarded. The Federal Circuit, however, reaffirmed in its unanimous opinion that compelling reasons militate in favor of OTDP today:

It is designed to prevent an inventor from securing a second, later expiring patent for the same invention. That problem still exists. . . . [W]here, as here, the applicant chooses to file separate applications for overlapping subject matter and to claim different priority dates for the applications, the separate patents will have different expiration dates since the patent term is measured from the claimed priority date.3

In AbbVie, both patents at issue were directed towards methods of treating rheumatoid arthritis by co-administering two drugsa disease-modifying antirheumatic drug (methotrexate) and an antibody (anti-TNF antibodies). Kennedy sought and secured two patents on this combination therapy: it claimed the priority date of October 8, 1992 (the filing date of an earlier application), for U.S. Patent No. 6,270,766 ("the '766 patent"), and a later priority date, August 1, 1996 (the filing date of the '766 patent), for U.S. Patent No. 7,846,442 ("the '442 patent"), "so that the '422 patent would expire after the '766 patent."4 This timing made for a six-year difference in patent term. "When such situations arise," explained the...