Abbvie Inc., et al. v. Kennedy Trust for Rheumatology Research

Case Number: 1:13-cv-01358-PAC

The court had previously determined that The Kennedy Trust’s U.S. Patent No. 7,846,442 (the “parent patent”) was invalid for obviousness-type double patenting (“ODP”) to U.S. Patent No. 6,270,766 (“the grandparent“). At issue in this case was whether U.S. Patent No. 8,383,120 (“the ´120 patent“) is similarly invalid. The ´120 patent is a continuation of the parent patent.

Judge Crotty found that, at summary judgment, collateral estoppel applied here, and that the ´120 patent is invalid. While he refused to simply compare the claims of the ´120 patent to the claims of the parent patent, when he considered the differences between the ´120 patent and the grandparent, he found no patentable distinction. Prior determinations of ODP are preclusive, he said, when “the differences revealed by a comparison of the claims do not vary the relevant issues bearing on obviousness.” The patentee, the court said, offered three grounds under which the claims of the ´120 patent were not obvious under the grandparent’s claims:

• The ´120 patent defines the “disease activity element” in a manner that is “substantially more specific, specifically requiring ‘the presence of six or more swollen joints plus at least three of the following four secondary criteria. . .’”
• The ´120 patent “require[s] a specific level of therapeutic benefit . . . greater than fifty percent (50%) according to the Paulus criteria for a significant duration of time,” whereas the parent patent claims require only “reduction of the signs and symptoms of the disease [rheumatoid arthritis]”
• The ´120 patent claims explicitly recite the biological mechanism by which the claimed antibody must act, whereas the parent patent’s claims were not so explicit

Turning first to the “disease activity element,” the court characterized this as the level of disease in the patient population. In the prior litigation, the court had already rejected the argument that it would be nonobvious to treat sicker patients. Accordingly, the new limitation of the ´120 patent, which is directed to patients having more rather than less disease, was not non-obvious.

The court characterized the second limitation, requiring a specific level of benefit, as the “treatments benefit.” At the prior trial, the court had already heard evidence relating to treatments benefit as measured by the Paulus criteria. There, the court found no unexpected results. As “[m]erely discovering and claiming a new benefit of an old process cannot render the process again patentable,” (King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1275 (Fed. Cir. 2010)), the new limitation was not non-obvious.

Finally, with respect to the newly-claimed biological mechanism, the court made two findings, each of which it said made the element not non-obvious. First, the patentee pointed to one reference and said that the mechanism “was not established in this study.” Failing to allege that the mechanism was not known (rather than that it was not known to one author) failed to raise a genuine issue of fact. Second, the court found that the claimed mechanism is inherent, and that “[m]erely describing an inherent property or mechanism of the prior art, without more, does not render a claim patentably distinct.” Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012).

In finding the ´120 patent invalid, the court summarized its position as follows:

Taking the differences between the ´120 Patent and the [parent patent] in the context of their importance to the invention as a whole, it is clear that they raise no new issue bearing on the ODP analysis. Not only does the ´120 Patent merely limit its claims to those that were already clearly covered by the prior two patents, it has done so in ways that the Court actually considered in the Prior Action. A patentee like Kennedy may seek to adjust its claims in response to actions by a patent examiner or by a court, but Kennedy has failed to do so here in any way that would materially affect the Court’s prior ODP analysis. In essence, Kennedy has claimed the same treatment as a new invention—but with limitations to treat sicker patients, for a specific outcome, and by a specific mechanism that was inherent in the prior art. As with the narrowed claims of the [parent patent], this is precisely the kind of insubstantial tinkering on a previous patent that the ODP doctrine renders unpatentable.