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Expiration of Patent Does Not Divest a Court of Jurisdiction in a § 291 Interference Proceeding

10-1264
August 23, 2011
Hendrix, Justin A.

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Last Month at the Federal Circuit - September 2011

Judges: Lourie (author), Plager, Dyk (concurring-in-part and dissenting-in-part)

[Appealed from: D. Del., Judge Robinson]

In Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., No. 10-1264 (Fed. Cir. Aug. 23, 2011), the Federal Circuit affirmed the district court’s dismissal of an interference action under 35 U.S.C. § 291 for lack of an interference in fact.

Genetics Institute, LLC (“Genetics”) is the assignee of U.S. Patent No. 4,868,112 (“the ’112 patent”). Novartis Vaccines and Diagnostics, Inc. (“Novartis”) is the assignee of U.S. Patent Nos. 6,228,620 (“the ’620 patent”) and 6,060,447 (“the ’447 patent”) (collectively “the Novartis patents”). The patented technology-at-issue relates to truncated forms of a protein called Factor VIII, which is an essential blood-clotting protein that circulates freely in the blood in an inactive state. The Factor VIII protein contains several regions, or domains, including an A, B, and C domain. Each domain folds into a three-dimensional structure independent of the other domains. The C domain contains an acidic region, a3, as well as domains A3, C1, and C2.

Genetics sued Novartis to determine priority of invention under 35 U.S.C. § 291, alleging that an interference in fact existed between certain claims of the ’112 patent and the Novartis patents. Genetics asserted that all three patents are directed to the same subject matter, truncated Factor VIII proteins lacking all or part of the B domain while retaining procoagulant activity. Novartis moved to dismiss, arguing that (1) the district court lacked subject matter jurisdiction because a 35 U.S.C. § 156 patent term extension of the ’112 patent did not apply to all of its claims; and (2) there was no interference in fact between the asserted claims because the Novartis patents—unlike the ’112 patent—are directed to truncated Factor VIII proteins that preserve the functional a3 acidic region. The district court granted Novartis’s motion to dismiss, holding that while the patent term extension under § 156 applied to all of the ’112 patent claims, there was no interference in fact as to any of the allegedly interfering claims. Genetics appealed.

The Federal Circuit rejected Novartis’s argument, initially raised in a motion to dismiss Genetics’ appeal, that expiration of the ’112 patent divested the Court of jurisdiction over the appeal. In so doing, the Court declined to extend Albert v. Kevex Corp., 729 F.2d 757 (Fed. Cir. 1984), where the Court found that a patent disclaimer, directed to the patent claims addressed in a § 291 action, mooted the action and required dismissal for lack of jurisdiction to circumstances involving expired patents. The Court explained that disclaiming claims under 19 U.S.C. § 253 “effectively eliminate[s] those claims from the original patent,” and the patent is treated “as though the disclaimed claim(s) had ‘never existed.’” Slip op. at 13 (alteration in original) (citation omitted). “Unlike a disclaimed claim, however, an expired patent is not viewed as having ‘never existed’ . . . [and] ‘. . . does have value beyond its expiration date.’” Id. (citation omitted).

Additionally, the Federal Circuit found that the expiration of the ’112 patent did not deprive the appealed § 291 action of meaning because the outcome directly impacts a pending district court infringement suit. Finally, the Court noted that, unlike 35 U.S.C. § 135, which requires one pending application and “any pending application, or . . . any unexpired patent,” id. at 14 (alteration in original) (citation omitted), § 291 simply requires two “interfering patents,” indicating “one essential difference between these two statutes,” id. Accordingly, the Federal Circuit held that it had jurisdiction over the appeal.

The Federal Circuit also rejected Novartis’s assertion that the district court lacked jurisdiction over the interference proceeding because a § 156 patent term extension applies on a claim-by-claim basis, and thus did not apply to the ’112 patent claims asserted in the interference. Relying on the plain language of § 156 and its legislative history, the Court found that “[a] patent as a whole is extended even though its effect may be limited to certain of its claims.” Id. at 17. The Court additionally rejected Novartis’s related argument that patents extended under § 156 cannot form the basis of a § 291 interference action, finding that neither the statutory text nor the legislative history of § 156 supported such a conclusion. Accordingly, the Federal Circuit held that the district court properly had jurisdiction over the proceeding.

Turning to the substance of the appeal, the Federal Circuit reiterated that an interference in fact under § 291 exists “if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa.” Id. at 19 (citation omitted). Thus, each leg of the “two-way test” must be satisfied.

The Federal Circuit agreed with the district court, finding no interference in fact between the asserted patent claims of the ’112 patent and the ’620 patent because, in analyzing the first leg of the test, the Court concluded that if the claims of the ’112 patent had been prior art, they would not have rendered obvious the claims of the ’620 patent. In reaching that conclusion, the Court first cited structural differences between the proteins claimed in the ’112 and ’620 patents. In particular, the claimed truncated Factor VIII proteins differed (1) in terms of the size of the permitted amino acid deletions; (2) the location of the permitted amino acid deletions; and (3) the degree of allowable amino acid substitutions.

Second, the Court agreed that Genetics failed to establish any such reason for “modifying the group of proteins claimed in the ’112 patent to produce the group claimed in the ’620 patent.” Id. at 23. The Court rejected Genetics’ arguments, finding that (1) it was not known prior to the filing of the ’620 patent that particular amino acids were critical to maintain a particular binding function of the truncated Factor VIII protein; (2) the mere existence of in vivo cleavage points between particular amino acid residues, without more, would not have motivated the skilled artisan to make the particular truncated proteins claimed in the ’620 patent; and (3) research objectives of those in the field of truncated Factor VIII proteins focused on finding a smaller protein that mimicked Factor VIII, not larger proteins, such as those claimed in the ’620 patent.

Third, the majority responded to Judge Dyk’s dissent, noting that the dissent (1) “selectively parses the prior art disclosure with impermissible hindsight,” id. at 25; (2) challenges “well-established law requiring the identification of some reason that would have prompted a researcher to substantially modify a prior art compound to produce the claimed compound” based on an “oversimplification” of the differences in the claimed proteins, id. at 25-26; and (3) like Genetics, erroneously “attempts to shoehorn the facts of this case into [the Court’s] holding in [In re] Peterson, [315 F.3d 1325 (Fed. Cir. 2003)],” slip op. at 27, where “[t]he facts here present a case where the ‘disclosed range is so broad as to encompass a very large number of possible distinct compositions’ thus ‘requir[ing] nonobvious invention,’ not a case, as in Peterson, where prior art ‘ranges that are not especially broad invite routine experimentation to discover optimum values,” id. at 28 (second alteration in original) (citation omitted).

Further, the Federal Circuit found that the district court did not err in crediting the unexpected results of the claimed invention of the ’620 patent as part of its obviousness analysis. First, the Court reiterated that “every property of a claimed compound need not be fully recognized as of the filing date of the patent application to be relevant to nonbviousness.” Id. at 29 (citation omitted). Thus, regardless of whether the importance of some of the binding ability of the proteins claimed in the ’620 patent were known at the time of filing, those effects may still be relied upon when considering unexpected results. Second, the Court rejected Genetics’ argument that the unexpected results were not commensurate with the full scope of the ’620 patent claims because one particular amino acid substitution at one particular position eliminates the unexpected binding function; rather, the Court held that there does not need to be an “absolute identity” of scope. Id. at 32. “Indeed, a rigid requirement of absolute identity that ignores relevant properties of claimed compounds would defy the mandate of § 103 requiring consideration of the claimed ‘subject matter as a whole.’” Id.

Accordingly, because the ’620 patent claims were not obvious in light of the ’112 patent claims, the first leg of the two-way test was not satisfied, and the Court did not need to consider whether the ’112 patent claims would not, if prior art, anticipate the ’620 patent claims or the second leg of the test.

The Federal Circuit next concluded that there was no interference in fact between the asserted claims of the ’112 patent and the ’447 patent. First, the Court noted that Genetics raised the same alleged errors by the district court that the Federal Circuit rejected in the context of the ’112 and ’620 patents. Moreover, the Court found that Genetics failed to show why one of ordinary skill would modify the protein claimed in the ’447 patent to make the three different proteins claimed in the ’112 patent. Without some reason for making the necessary chemical modifications to arrive at the claimed compound, the ’447 patent claims would not have rendered obvious the ’112 patent claims, and, thus, there was no interference in fact between the claims of the two patents.

Accordingly, the majority found that the expiration of the ’112 patent did not divest the Federal Circuit of appellate jurisdiction, and affirmed the district court’s judgment that (1) the patent term extension of the ’112 patent applied to all of the allegedly interfering claims; and (2) there was no interference of fact between the relevant claims of the ’112 patent and the ’620 and ’447 patents.

Judge Dyk concurred with the majority’s findings on jurisdiction, but dissented from the Court’s opinion regarding whether an interference in fact existed. Judge Dyk disagreed with the majority on four points: (1) there should be a requirement for a motivation to retain the binding region of the Factor VIII protein where, from an objective standpoint, no inventor—including the Novartis inventors themselves—could have been aware of the benefits of retaining the region at the time of the invention; rather, structural similarly was sufficient to establish prima facie obviousness; (2) the overlapping range of retentions in the Novartis patents and the ’112 patent was insufficient in and of itself to establish prima facie obviousness; rather, Judge Dyk would find the analysis analogous to In re Peterson and the claims prima facie obvious; (3) retention of amino acids in the region responsible for the beneficial binding was contrary to the teachings of the ’112 patent, where, in Judge Dyk’s view, the ’112 patent and the Novartis patents all taught some variants that retained the region and some variants that did not; and (4) later-discovered, undisclosed benefits should be considered as unexpected results; rather, Judge Dyk would require that unexpected properties be set forth in the specification or contemporaneously known to the inventors.

Summary authored by Justin A. Hendrix, Esq.