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Federal Circuit Review - Provided by Patterson, Belknap, Webb & Tyler LLP

The following is are reviews of Federal Circuit intellectual property cases decided the week ending January 10, 2003.



Amgen, Inc. v. Hoechst Marion Roussel, Inc. et al., Nos. 01-1191, -1218 (January 6, 2003).

Opinion by Michel, joined by Schall. Dissenting opinion by Clevenger.

Defendants Hoechst and Transkaryotic Therapies, Inc. (collectively "TKT") appealed the decision of the district court, after a bench trial, on Amgen’s U.S. Patent Nos. 5,547,933 (the "’933 patent"), 5,618,698 (the "’698 patent"), 5,621,080 (the "’080 patent"), 5,756,349 (the "’349 patent"), 5,955,422 (the "’422 patent") relating to a naturally-occurring protein called EPO. The Federal Circuit affirmed (1) the district court's claim construction; (2) the enforceability of the patents; (3) the invalidity of the '933 patent under §112 ¶2 for indefiniteness; (4) the infringement of the '422 patent claim 1; (5) the determination that the '080, '933, '349 and '698 patents were not invalid for anticipation; and (6) the determination that the '349 patent claims are infringed. The Federal Circuit vacated and remanded for further consideration the following issues: (1) whether the '080, '349, and '422 patents obvious in light of a prior art reference (Sugimoto) or anticipated or obvious in light of another prior art reference (Goldwasser); (2) whether the '422 patent is anticipated by Sugimoto (unless Amgen can prove its nonenablement); (3) whether the '698 and '349 patent claims are infringed by the accused method; and (4) whether the '080 patent is infringed under the doctrine of equivalents.

For inequitable conduct, the Federal Circuit affirmed the district court's finding of no intent to deceive.

Claim Construction

TKT's principal argument on claim construction was that the claims should have been limited to EPO produced with exogenous DNA, in contrast to the TKT process using endogenous DNA. The Federal Circuit rejected this argument, citing the plain meaning of the claims, as well as claim differentiation. The Federal Circuit also rejected TKT's other attempts to narrow the plain meaning of other claim terms, and recognized the scope of negative limitations, such as "non-naturally occurring," as simply excluding specific subject matter.


The Federal Circuit affirmed the district court's determination that all the patents were valid under 35 U.S.C. §112¶1 for adequate written description and enablement. For written description, the Federal Circuit (1) affirmed the district court's conclusion that the written description need not describe methods of making the claimed composition arising after the application was filed, and (2) found that the written description requirement could be satisfied as to known structures ("mammalian" and "vertebrate" cells) if those of skill understood the disclosed function sufficiently correlated to the known structures. The Federal Circuit also confirmed again that Gentry Gallery did not announce a new "essential element" test.

For enablement, the Federal Circuit affirmed the district court's decision because (1) failure to disclose later-developed technology cannot invalidate the patent; (2) the specification need teach only one mode of making and using the claimed composition; and (3) the district court's findings of fact supported enablement of the broad genus through disclosure of one or two species.

The Federal Circuit affirmed the district court's determination that the '933 patent is invalid for indefiniteness because the limitation "glycosylation which differs" is insolubly ambiguous, and thus vacated the district court's determination that TKT does not infringe the '933 patent.

Judge Clevenger, in dissent, would remand for further findings with respect to written description and enablement, and whether the broad scope of the claims is fully described and enabled.

With respect to the Goldwasser prior art, the Federal Circuit remanded for further findings because the district court had not properly construed "therapeutically effective" as part of the Markman hearing (it was not selected as in dispute at that time), but the interpretation is central to whether the Goldwasser prior art was enabled, and thus a potentially invalidating reference.

With respect to the Sugimoto prior art, the Federal Circuit stated that claimed and unclaimed subject matter in prior art patents are presumed enabled. The Federal Circuit affirmed the district court's determination that Sugimoto did not anticipate any asserted claims of the '080, '349 or '698 patent, but remanded on obviousness because the district court erroneously disregarded Sugimoto as not enabled. The Federal Circuit noted that, for obviousness, a reference qualifies as prior art regardless of whether it is enabled.


For the '080 patent, the Federal Circuit agreed that TKT did not literally infringe because the reference in the claims to "amino acid sequence of FIG. 6" is limited to the exact 166 amino acid sequence depicted, despite a mistake discovered that Fig. 6 should have only 165 amino acids. The Federal Circuit remanded on doctrine of equivalents under Festo to allow Amgen to attempt to rebut the presumption of estoppel.

For the '698 patent, and for claim 7 of the '349 patent, the Federal Circuit vacated the district court's grant of summary judgment of noninfringement, finding that the district court improperly compared the accused device to a commercial embodiment, and remanded for proper comparison to the claims. For asserted claims 1, 3, 4, and 6 of the '349 patent, the Federal Circuit affirmed infringement of, rejecting TKT's argument under the reverse doctrine of equivalents. For the '422 patent, the Federal Circuit rejected TKT's interpretation of the claims as it would exclude a preferred embodiment of the patent, and thus the district court's finding of infringement was proper.

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Oakley, Inc. v. Sunglass Hut International, et al., No. 02-1132 (January 9, 2003).

Opinion by Lourie, joined by Newman and Dyk.

The Federal Circuit affirmed the decision of the United States District Court for the Central District of California granting a preliminary injunction in favor of Oakley concerning defendants’ (collectively, "Sunglass Hut") sunglass lenses that were likely to infringe Oakley’s U.S. Patent No. 5,054,902 ("the ‘902 patent"). The '902 patent is directed to a 3-layer sunglass lens that, due to an interference "differential effect" of light reflected from the lens, has a "vivid colored appearance."

The Federal Circuit assessed Oakley’s likelihood of success on the merits and made the following findings: (1) because patentee’s specification provided mathematical formula and values of differential effect that corresponded with the "vivid colored appearance," that term was not indefinite to one skilled in the art; (2) the USPTO twice allowed the ‘902 claims (once during prosecution of the original application and once during reissue) over the prior art Apfel patent, and thus the Apfel patent was not likely to anticipate the claims of the ‘902 patent; (3) Sunglass Hut’s declarations, submitted as evidence of prior art sales, were deficient and did not prove that the alleged sales anticipated the claims of the ‘902 patent; and (4) defendants’ other prior art arguments were unpersuasive. With respect to infringement, the Federal Circuit held that the structural similarity between the accused device and the patentee’s disclosed embodiments constituted indirect evidence of a sufficiently high differential effect, and the accused device was likely to infringe the ‘902 patent.

Because Oakley made a sufficiently strong showing of likelihood of success on the merits, the Federal Circuit held that Oakley was entitled to a presumption of irreparable harm. The Court also found that the balance of hardships favored Oakley.

Sunglass Hut also argued that the wording of the issued injunction was indefinite under Fed. R. Civ. P. § 65(d). Having reviewed the record, the Federal Circuit found that Sunglass Hut understood the scope of the injunction. As a result, the Federal Circuit did not find legal error in the district court’s wording of the preliminary injunction.



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The following is a review of Federal Circuit intellectual property cases decided the week ending January 17, 2003.


Plant Genetic Systems, N.V., et. al., v. Dekalb Genetics Corp., No. 02-1011 (January 13, 2003). Opinion by Michel, joined by Newman and Prost.

The district court found some claims of a transgenic plant cell patent invalid for lack of enablement and others not infringed. The patent lacked enablement because undue experimentation was required at the time of the experiment to practice the claimed stable gene transformation for monocot cells. Whether the patent was pioneering or not was irrelevant to the lack of enablement inquiry. The other claims of the patent were not infringed because the accused infringer's cells were monocot, i.e. corn, while the prosecution history and the ordinary and objective meaning of those claims limited them to dicots, i.e. tomatoes, potatoes, and tobacco. The Federal Circuit affirmed both of the district court's holdings and the all of the reasoning therefor.