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Published by: James Yang

Process Claims Directed To New Purpose

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  • Posted on: November 17th, 2006 by James Yang

In Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368 (Fed. Cir. 2001), Bristol-Myers patented a method of administering the drug Paclitaxel for antitumor purposes. A competing drug manufacturer (i.e., Ben Venue Labs, Inc.) challenged the validity of the patent based on a prior art reference by Kris which disclosed the method of administering the drug Paclitaxel but did not recognize the antitumor benefits of Paclitaxel.

Bristol-Myers contended that although the method of administering the drug Paclitaxel is old, the method for administering the drug Paclitaxel for antitumor purposes is new and thus patentable. The Federal Circuit disagreed, stating that “the claimed method is not directed to a new use; it is the same use, and it consists of the same steps as described by the Kris reference. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” Id. (emphasis added). Accordingly, the patent claims were invalidated.

In Abbott Laboratories v. Baxter Pharmaceutical Products, Inc., Fed. Cir., No. 06-1021, 11/10/06, the patentee patented a composition (i.e., product claim) comprising water and Sevoflurane to prevent degradation of the Sevoflurane in the presence of Lewis acid. Sevoflurane is an inhalation anesthetic. A prior art reference disclosed the water and the Sevoflurane composition but did not appreciate the benefit of water to prevent the degradation of Sevoflurane in the presence of Lewis acid. The patentee contended that the prior art reference did not anticipate their claims because the claimed composition is directed to a newly discovered result of a known process directed to a different purpose citing Bristol-Myers Squibb for support. Even though Bristol-Myers Squibb involved only method claims, the patentee attempted to extend the holding of Bristol-Myers Squibb to product claims. The Federal Circuit disagreed by narrowing the holding of Bristol-Myers Squibb to method claims and did not retain the broad reading of Bristol-Myers Squibb to include product claims as desired by the patentee. Hence, the composition claims at issue were anticipated, and thus, invalid.

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