Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010)
By a vote of 5-4, the Federal Circuit on Monday denied Eli Lilly's petition for panel rehearing or rehearing en banc from the court's July decision that affirmed the invalidity of Lilly's U.S. Patent No. 5,426,826 for obviousness-type double patenting. Judge Newman was joined by Judges Rader, Lourie and Linn in dissent.
In addition to the '826 patent, which claims the use of gemcitibine for treating cancer, Lilly owns U.S. Patent No. 4,808,614, which claims the gemcitibine compound. The '614 patent discloses, but does not claim, the anticancer utility of gemcitibine. The Federal Circuit panel decision in July, authored by Judge Prost and joined by Judges Bryson and Gajarsa, affirmed the invalidity of the '826 patent on grounds of obviousness-type double patenting, stating that "[t]he asserted claims of the later '826 patent simply claim the anticancer use disclosed in the specification of the '614 patent."
In dissent, Judge Newman cited numerous precedents of the Federal Circuit and its predecessor court for establishing the rule that "double-patenting is altogether a matter of what is claimed." She concluded, "Uniformly, unlike examination for obviousness based on prior art, the issue of obviousness-type double patenting is directed to whether the invention claimed in a later patent is an obvious variant of the invention claimed in an earlier patent. The panel opinion violates a vast body of precedent."
The case attracted the attention of several amici curiae, including BIO, PhRMA, Teva and Washington Legal Foundation. Judge Newman cited a portion of BIO's amicus brief to emphasize the importance of method-of-use patents to the pharmaceutical industry:
BIO's members routinely engage in continuing research on basic biotechnology inventions even after initial patent applications have been filed. Often, such research reveals something new about a basic invention, including better and unexpected new ways of using it that require patent protection for their commercial development.
Judge Newman concluded with a rebuke of the panel for changing the law of double patenting without en banc consideration. She stated:
If the majority of the court now believes, as a matter of policy, that the law should be changed in this new direction, en banc treatment is particularly appropriate, for the court's rule is that the earlier precedent prevails unless overruled en banc. A situation in which the court ignores this rule, and applies whatever law the panel prefers, is an indictment of the ability of this court to provide stable law in the areas entrusted to us.
Comments