Jude Andrews: "Purified and Isolated" Does Not Exclude Excipients

In Bayer v. Aurobindo (1:15-cv-902) (NDA Drug: Xarelto), the ANDA defendants argued that the claim term “purified and isolated,” in claim 14 of U.S. Patent 7,157,456, should be narrowly construed to exclude, in addition to impurities, pharmacologically acceptable auxiliaries and excipients:

6. The compound having the following formula [structure] or a pharmaceutically acceptable salt or hydrate thereof.

14. The compound of claim 6 that is purified and isolated.

18. A pharmaceutical composition comprising the compound of claim 14 and one or more pharmacologically acceptable auxiliaries or excipients.

Based on the construction that claim 14 excludes excipients, defendants further argued that claim 18 is an improper dependent claim since it includes within its scope excipients that are excluded in claim 14.

Judge Andrews (District of Delaware) disagreed, holding that the claim term purified and isolated “does not exclude a pharmaceutical composition that contains . . .one or more pharmacologically acceptable auxiliaries or excipients."  Judge Andrews emphasized construing claim 14 to be consistent with the other claims.  Judge Andrews also relied on the specification for using the term purified and isolated in relation to purification of a compound obtained from a reaction process:

For example, the patent teaches a method for preparing a compound, specifying that the product of the reaction "can be isolated by silica gel chromatography" from "the reaction mixture." ('456 patent at 53:35-36). This usage is inconsistent with Defendants' much more restrictive limitation that the compound must be kept isolated and separate from any other compounds. Rather, it seems clear to me that the patent uses the word "isolated" to mean separated from synthesis-related compounds existing in the reaction mixture. Furthermore, the very same example uses the word "purified" in a similar context, specifying that, "The product is purified by silica gel chromatography."

The court construed claim 6 to mean: "The compound of claim 6 that is sufficiently free of impurities and any synthesis-related compounds to permit its use in a pharmaceutical composition. The claim does not exclude a pharmaceutical composition that contains the compound of claim 14 and one or more pharmacologically acceptable auxiliaries or excipients.”