AMGEN Wins Summary Judgment Against Genetics Institute

Amgen has won another victory over Genetics Institute (GI) in the seemingly perpetual war for patent rights to the red blood cell- stimulating factor, erythropoietin (Epo). On February 14, 1995, a federal district court in Massachusetts held in Amgen's favor on a motion for summary judgment, finding that a "purified Epo" patent owned by GI was unenforceable.

As reported in the November/December issue of BLR, GI filed suit in Delaware, asserting that Ortho Pharmaceuticals and Ortho Biotech, licensees of Amgen's recombinant erythropoietin (rEpo) patent, had infringed GI's recently issued U.S. Patent No. 5,322,837 to Hewick et al. (the '837 patent) (Genetics Institute v. Ortho Pharm. Corp., C.A. No. 94-342-JJF [D. Del.]). Amgen countersued in Massachusetts federal district court on September 9, 1994, asserting invalidity and noninfringement with respect to the '837 patent and urging that GI was bound by a settlement agreement that had ended an earlier, related litigation before the same Massachusetts court (Amgen v. Genetics Institute, 94-11818-WGY [D. Mass.]).

In the original Amgen/GI litigation, the U.S. Court of Appeals for the Federal Circuit concluded that a predecessor of the '837 patent, U.S. Patent No. 4,677,195 to Hewick et al. (the '195 patent), was invalid for failure to enable the purification of homogenous Epo from any means. While the '195 patent had purported to describe homogenous Epo with a (theoretical) specific activity of "at least" 160,000 IU/AU, the CAFC found that the patent specification in fact did not teach a workable method for obtaining Epo in such a purified state. The decision paved the way for a settlement agreement in May 1993 that seemed to take GI out of the Epo market.

The settlement agreement apparently was silent on the possibility of continuing applications, and GI did not disclose to Amgen the existence of a pending continuation application with a lineage linking it to the '195 patent. That application matured into the '837 patent on June 21, 1994. GI filed the Delaware action against Amgen the same day, effectively renewing the earlier litigation.

Thrust back into litigation over a matter that it had believed was settled, Amgen quickly filed suit in the Massachusetts court which held jurisdiction over the aforementioned settlement agreement. Shortly thereafter, Amgen followed with a motion for summary judgment on the issue or res judicata, contending that the holding which invalidated the '195 patent should control the validity of the '837 patent as well. GI countersued for summary judgment, and the two sides agreed on an April trial schedule.

It was last reported in BLR that the Massachusetts trial court might deny the motions for summary judgment, given the complexity of the issues at hand. Actually, the court reviewed Amgen's claim of res judicata and, as to claim preclusion, found an identity of claims between the '195 and '837 patents. Indeed, the court conducted a detailed comparison of the two patents, only to find that there were no real differences other than the absence from the '837 patent claims of an explicit requirement for a 160,000 IU/AU specific activity in the homogeneous Epo.

The court then considered whether the 160,000 IU/AU specific activity was an essential element of "homogenous Epo." Relying on the language of the CAFC's prior decision, the court found that the activity limitation was an essential element of homogeneity, and enablement of a homogenous preparation required enablement of 160,000 IU/AU specific activity. Thus, the court found that GI's new claims were identical to the prior claims.

The court thus held that, because there was identity of claims between the two patents, GI must be barred by the doctrine of claim preclusion from relitigating the question of whether the '837 patent specification enables a person skilled in the art to make and use a therapeutically effective, homogeneous Epo.4

Based on this rationale, the court found that GI was bound by the prior determination that the '195 patent specification does not enable the making of homogenous Epo. GI therefore was barred from asserting "virtually" the same claims, supported by the same specification, against Amgen's rEpo. With the essential dispute between the parties thus resolved, all other issues were rendered moot, prompting the court to dismiss them. An appeal by GI to the Federal Circuit would appear likely.