Judge Koeltl Grants Summary Judgment of Intervening Rights

Scott Daniels | March 6, 2012

The patent infringement case brought by Dey and Mylan against Sepracor (now Sunovian) came to an abrupt end last week when Judge John Koeltl of the Southern District of New York granted two summary judgments in favor of the accused infringer.  Sepracor was accused of infringing two families of patents – the claims were for compositions and methods for treating certain pulmonary diseases with the drug formoterol.  First, Judge Koeltl granted summary judgment that the claims of one family of patents were invalid because of an anticipatory public use.  What will interest reexamination practitioners, however, is the Judge’s grant of summary judgment that the accused infringers are entitled to intervening rights with respect to the second family of patents.

After commencement of the infringement action, Sepracor requested reexamination of the patents in the second family.  Reexamination was granted, the claims rejected, but then confirmed in light of the patentees’ arguments and the following representative claim amendment:

A pharmaceutical composition, comprising formoterol, or a derivative thereof, in a pharmacologically suitable fluid [aqueous solution], wherein the composition is stable during long term storage, the fluid comprises water, and the composition is formulated at a concentration [effective for bronchodilation by nebulization, and the composition is] suitable for direct administration to a subject in need thereof [without propellant and without dilution of the composition prior to administration].

Thus, the claims were amended in five respects: by precluding a propellant, by limiting the composition to one suitable for a nebulizer, by precluding dilution prior to administration, by removing the requirement that fluid be an aqueous solution, and by narrowing the possible concentrations. 

Judge Koeltl first analyzed each of the five amendments individually to determine whether any created “a substantive change” to the scope of the claims.  Not surprisingly, he found that four of the amendments did constitute a substantive change in claims scope, and concluded that the accused infringer was entitled to intervening rights, removing any potential liability for acts of infringement occurring before the October 2011 issue date of the reexamination certificates.  (Only for the “dilution” amendment did the Judge determine that there was no substantive change).

Judge Koeltl also made a comment that could be significant in closer cases, specifically that the claim amendments could be considered collectively to determine whether there had been a substantive change. 

The interplay between the various additions and amendments-the addition of “by nebulization,” “aqueous solution,” and without propellant, and the narrowing of the concentration ranges-highlights the broader substantive change effected by the amendments in combination: taken together, these changes reduced the scope of the independent claims from a ready-to-use formoterol composition that might be administered in a number of ways and forms, to a more specific invention that was for administration by nebulization only. The scope of the independent claims was narrowed substantially in the process. Sunovion is therefore entitled to partial summary judgment precluding any damages for any alleged infringement of the ‘344 and ‘953 patents that occurred before October, 2011, when the reexamination certificates were issued for those patents.

(Emphasis added). 

Judges facing intervening rights issues must, of course, look at amendments of individual limitations, but they must also consider the general scope of the claims.


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