Federal Circuit’s Initial Reaction to Teva: “Clearly Erroneous” Review Standard Not Implicated In Most Cases

In the nearly three months since the U.S. Supreme Court ruled that subsidiary factual findings in claim construction proceedings must be reviewed for clear error, the U.S. Court of Appeals for the Federal Circuit has decided a handful of cases requiring it to review claim construction rulings by a district court or the U.S. Patent and Trademark Office. The Federal Circuit has declined to extend deference in any of those cases, and by all indications it is unlikely to do so in many future cases.

Prior to January 20, 2015, the Federal Circuit reviewed claim construction rulings – including subsidiary factual findings – de novo, without affording any deference to the findings or reasoning of the lower court. See Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc). In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., ___ U.S. ___ (Jan. 20, 2015), the Supreme Court held that district court factual findings based on extrinsic evidence are subject to “clearly erroneous” review under Fed. R. Civ. P. 52(a)(6). This more deferential standard applies even if the fact finding is “nearly dispositive” of the ultimate legal question of claim interpretation.

The Teva Court indicated that in reviewing claim construction rulings, the Federal Circuit should review the ultimate ruling on claim construction de novo. If the district court only considered intrinsic evidence (the claim language, specification, and prosecution history), then the entire question of claim construction is subject to de novo review. If, however, the district court ventured into extrinsic evidence (such as expert or inventor testimony), then those specific factual findings are entitled to deference and must be reviewed for clear error. Despite that deference, however, the Federal Circuit still reviews the ultimate claim construction ruling de novo.

In practice, Teva’s effect on Federal Circuit review of claim construction rulings may prove to be limited. The appeals court has held that extrinsic evidence – the only type of finding now afforded any deference – is much less significant in the claim construction analysis than intrinsic evidence. See Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (“We have viewed extrinsic evidence in general as less reliable than the patent and its prosecution history in determining how to read claim terms”). In fact, the Federal Circuit has rarely, if ever, expressly relied on extrinsic evidence when interpreting a claim. It is not likely to start relying on extrinsic evidence following Teva. A review of Federal Circuit cases since Teva illustrates the decision’s limited impact to date.

PTAB Ex Parte Proceedings

The Federal Circuit has addressed Teva in two cases arising from ex parte appeal proceedings before the USPTO Patent Trial and Appeal Board. In In re Imes, 778 F.3d 1250 (Fed. Cir. Jan. 29, 2015), the Federal Circuit reversed a PTAB ruling cancelling claims in a reexamination. The court rejected the USPTO’s construction of the term “wireless” based on an express and unambiguous definition of the term provided in the specification. As a result, the court noted that, “Nothing in this case implicates the deference to fact findings contemplated by the recent decision in Teva[.]” 778 F.3d at 1252 n.1.

In a more recent case involving an ex parte appeal from a final rejection, the Federal Circuit also stated that its review of the USPTO’s claim interpretation did not implicate the Teva standard. In re Bookstaff, No. 2014–1463 (Mar 26, 2015). The court reversed the USPTO’s construction of the term “data that is indicative of a gratuity to be charged” based on the specification and disclosed embodiments, without considering any extrinsic evidence.

PTAB AIA Proceedings

The Federal Circuit addressed the standard for reviewing claim interpretation during an AIA post-grant proceeding in one case, In re Cuozzo Speed Technologies, LLC, 778 F.3d 1271 (Fed. Cir. 2015). After holding that the Teva decision is applicable to PTAB trial appeals, the Federal Circuit proceeded to exercise de novo review. The PTAB based its interpretation of the challenged claim on the patent specification and prosecution history. As a result, the Federal Circuit noted that, “Because there is no issue here as to extrinsic evidence, we review the claim construction de novo.”

District Court Actions

In two appeals from district court judgments, the Federal Circuit also declined to apply Teva’s clearly erroneous standard. In Fenner Investments, Ltd. v. Cellco Partnership, 778 F.3d 1320 (Fed. Cir. 2015), the court noted the Teva standard, but affirmed the district court’s construction of the term “personal identification number” based on the specification and statements made in the prosecution history.

In Enzo Biochem Inc. v. Applera Corp., ___ F.3d ___, (Fed. Cir. Mar 16, 2015), the court considered an appeal from a jury verdict of infringement. The district court ruled that the asserted claim covered both direct and indirect modes of detecting nucleotide probes, based in part on expert testimony that a figure in the patent specification disclosed an example of direct detection. On appeal, the Federal Circuit reversed in a 2-1 decision, relying on claim language and statements in the specification. The majority considered arguments based on the expert testimony to be waived on appeal, but noted that, “Nevertheless, even if we were to consider the district court’s finding, which would be subject to review for clear error under Teva, this sole factual finding does not override our analysis of the totality of the specification, which clearly indicates that the purpose of this invention was directed towards indirect detection, not direct detection.” In a dissent, Judge Newman argued that the district court’s construction was based on specific findings, including those based on expert testimony, and that, “These factual findings are entitled to deference, in accordance with the Court’s instruction in Teva[.]” She accused the majority of “ignoring the testimony and the district court’s findings and the jury verdict based on the evidence at trial.”

In Teva, the Court established that, when construing claims, appropriate deference must be given to the findings of the district court. The district court received some conflicting testimony, along with concessions on cross-examination, from which the court concluded that “at least one component” may include “the whole signaling moiety.” My colleagues show error of neither fact nor law in the court’s findings and conclusions.

Conclusion

 It is difficult to predict the long-term impart of Teva based on the limited number of Federal Circuit decisions applying it. The cases suggest, however, that the Federal Circuit likely will continue to apply de novo review when it resolves claim construction issues based on intrinsic evidence. In addition to situations where the USPTO or district court only considered intrinsic evidence, this approach may extend to situations in which courts considered extrinsic evidence, including expert testimony, but the Federal Circuit views the evidence to be insubstantial to the claim construction analysis.

Supreme Court Limits Federal Circuit’s Ability To Revise Claim Construction On Appeal

On January 20, 2015, the U.S. Supreme Court handed down its first patent decision of the current term, rejecting the U.S. Court of Appeals for the Federal Circuit’s long-standing practice of reviewing district court patent claim construction rulings, including subsidiary factual findings, without deference. The Supreme Court ruled that the Federal Circuit review all district court factual findings for “clear error,” even if the fact is nearly dispositive of the claim construction issue. The ultimate interpretation of the claim remains a legal conclusion, however, that the Federal Circuit will review de novo. Teva Pharmaceticals USA, Inc. v. Sandoz, Inc., Case No. 13-854 (Jan. 20, 2015). The slip opinion is available HERE. 

Background:

The interpretation of the asserted claims frequently is critical to the outcome of a patent dispute. The construction of disputed claim terms determines whether an accused product infringes the patent and is pivotal to most invalidity defenses. In Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), the Supreme Court ruled that claim construction is an issue delegated to the trial judge, even when it involves fact issues, such as the meanings of terms of art recited in a claim. Markman did not expressly state whether those factual findings subsumed in a claim construction ruling are subject to de novo review (as normally would be the case for legal rulings) or to review for “clear error” (as normally would apply to judicial fact findings).  In Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc), the Federal Circuit held that it would review district court claim construction rulings to de novo, reviewing the record without deference. Critics of the Cybor policy, including several Federal Circuit judges, have pointed out that the approach is inconsistent with the prevailing claim construction analysis, which requires district courts to consider a factual record consisting of both “intrinsic” evidence (the patent claims, specification, and prosecution history) and “extrinsic” evidence (such as expert testimony, treatises, art references, and other facts outside the patent and prosecution).

Teva Pharmaceuticals v. Sandoz Dispute

The Supreme Court ruling comes in a case involving drug patents under the Hatch Waxman Act. Teva Pharmaceuticals owns several patents covering its Copaxone® multiple sclerosis drug. Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the drug. In response, Teva filed an infringement action under the Hatch Waxman Act. 35 U.S.C. § 271(e)(2).

Sandoz argued that a group of claims in the Teva patents were invalid as indefinite, because the term “molecular weight” appearing in the claims was subject to multiple incompatible meanings, and the patents themselves and the relevant prosecution histories did not resolve the ambiguity. The United States District Court for the Southern District of New York ruled that the claims were not indefinite. Among other things, the district court based its determination on its construction of the disputed term, relying on expert testimony presented by Teva that the term "molecular weight" was not ambiguous.

On appeal, the Federal Circuit, reversed, ruling that the claims were indefinite. The Federal Circuit reviewed the conflicting expert testimony Teva and Sandoz presented to the trial court on the question whether the term “molecular weight” was ambiguous. The Federal Circuit concluded that “on de novo review of the district court's indefiniteness holding, we conclude that Dr. Grant's testimony [introduced by Teva] does not save Group 1 claims from indefiniteness." Teva appealed to the Supreme Court.

Supreme Court Decision

In a 7-2 decision, the Supreme Court reversed the Federal Circuit, holding that it should have accepted the district court’s determination that “molecular weight” was not ambiguous unless the finding was clearly erroneous. Justice Breyer, writing for the majority, reasoned that Fed. R. Civ. P. 52(a)(6) mandates this more deferential standard of review and nothing in the Court’s jurisprudence or the rationales adopted by the Federal Circuit in Cybor permitted a different standard.

Breyer noted that although Markman gives the district judge sole responsibility to construe a patent claim, it recognizes that claim construction will require subsidiary factual findings. Analogizing a judge’s role in claim construction with a similar role in interpreting contracts or deeds, the Court observed that these subsidiary findings are subject to review for clear error, even when the ultimate interpretation of the documents receives de novo review. During the claim construction process, “courts may have to resolve subsidiary factual disputes. And . . . [Rule 52(a)(6)] requires appellate courts to review all such subsidiary factual findings under the ‘clearly erroneous’ standard.” Slip op. at 7.

The majority was not impressed with Teva’s policy argument that de novo review was important to ensure uniform interpretation of patents nationwide, preventing a “zone of uncertainty” that would discourage innovation. Instead, the Court stated that district court judges were reliable factfinders for scientific or technical disputes, noting that, “A district court judge who has presided over, and listened to, the entirety of a proceeding has a comparatively greater opportunity to gain that familiarity than an appeals court judge who must read a written transcript or perhaps just those portions to which the parties have referred.” Slip op. at 7-8. Moreover, it stated that inconsistent claim construction rulings by different trial courts would be infrequent and unlikely to cause uncertainty:

Neither the [Federal] Circuit nor Sandoz, however, has shown that (or explained why) divergent claim construction stemming from divergent findings of fact (on subsidiary matters) should occur more than occasionally. After all, the Federal Circuit will continue to review de novo the district court’s ultimate interpretation of the patent claims. And the attorneys will no doubt bring cases construing the same claim to the attention of the trial judge; those prior cases will sometimes be binding because of issue preclusion, see Markman, 517 U. S., at 391, and sometimes will serve as persuasive authority. Moreover, it is always possible to consolidate for discovery different cases that involve construction of the same claims. And, as we said in Markman, subsidiary fact-finding is unlikely to loom large in the universe of litigated claim construction.

Slip op. at 9.

Finally, the Court provided specific guidance on how to apply both review standards in claim construction appeals. First, in situations where the district court relies only on the intrinsic evidence (claim language, specification and prosecution history), its ruling is subject to de novo review. If the district court decision relies on factual underpinnings, however, such as evidence concerning the “background science or the meaning of a term in the relevant art during the relevant time period[,]” it should make specific factual findings and those findings are subject to review for clear error:

The district judge, after deciding the factual dispute, will then interpret the patent claim in light of the facts as he has found them. This ultimate interpretation is a legal conclusion. The appellate court can still review the district court’s ultimate construction of the claim de novo. But, to overturn the judge’s resolution of an underlying factual dispute, the Court of Appeals must find that the judge, in respect to those factual findings, has made a clear error. Fed. Rule Civ. Proc. 52(a)(6).

Slip op. at 13. The clear error standard applies even when the factual finding “is close to dispositive of the ultimate legal question of the proper meaning of the term in the context of the patent.” Id.

Applying this framework to the case on appeal, the Court held that the district court’s fact finding that a person skilled in the art would not have consider the “molecular weight” ambiguous was entitled to deference. “The Federal Circuit should have accepted the District Court’s finding unless it was “clearly erroneous.” Our holding today makes clear that, in failing to do so, the Federal Circuit was wrong.” Id. at 16.

Justice Thomas dissented, arguing that the entire claim construction issue was legal, notwithstanding any subsidiary facts, and should be subject to de novo review, just as a trial court’s interpretation of a statute is reviewed without deference. He added that he feared the ruling would lead to divergent decisions in patent cases, leading to uncertainty and, ultimately, suppression of innovation.

Although the Teva decision does not expressly alter the analytic framework used in claim construction proceedings since Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), it is likely to introduce important strategic issues in patent cases, especially relating to conduct of claim construction proceedings. The extent of those changes will depend on how the Federal Circuit applies the decision in subsequent cases.