Immunex Corp. v. Sanofi-Aventis U.S. LLC, Appeal Nos. 2019-1749, -1777 (Fed. Cir. Oct. 13, 2020)

In our Case of the Week, the Federal Circuit addressed the construction of the term “human antibodies.” In doing so, the Court addressed a few principles and issues concerning claim construction, including the construction of terms following expiration of a patent.

Antibodies come in a few forms. Some antibodies come directly from animals. Over time, scientists learned how to modify those antibodies to make them more receptive by humans. These are sometimes called “humanized” antibodies. Then there are antibodies that come from humans. The patent claimed “human antibodies,” raising the question whether the term encompassed both “humanized” and fully human antibodies, or only the latter.

The patents at issue had previously been construed in litigation such that “human antibodies” meant only fully human antibodies. In IPRs, however, the PTAB construed them to include both “humanized” and fully human antibodies under the broadest reasonable interpretation—the standard applicable to the IPRs at the time of the Board’s decision. With that finding, the claim terms were found invalid over certain murine (mouse) antibodies in combination with a teaching of how to “humanize” those antibodies.

After the PTAB issued its final written decision and appellate briefing was complete, Immunex filed with the PTO a terminal disclaimer of the patent, disclaiming the patent as of May 26, 2020. Given that the patent had expired, Immunex sought a change of the claim construction standard applicable to its patent on appeal. That was based on law establishing that, for expired patents, Phillips was the correct claim construction approach.

The Federal Circuit first dispensed with that argument. Although the PTAB addressed claim construction of expired claims under Phillips, the Federal Circuit held that it would not change the claim construction approach at the late stage in the appeal. In two prior cases, the PTAB was directed to use a Phillips approach for expired claims. And the Federal Circuit had once applied the same logic to a claim that expired while on appeal. But the Court held that it would not shift claim construction approaches when the claim expired on appeal—after appellate briefing had concluded—as the result of a terminal disclaimer filed by the patent owner.

Under the BRI standard, the Federal Circuit agreed with the PTAB’s construction, based in large part on the use of the term “human antibody” in the specification. The Court also found the prosecution history to favor the broader construction.

Immunex submitted expert testimony concerning the term, and argued that this extrinsic evidence supported its narrower construction. However, the Court found this evidence uncompelling, providing a paragraph about the import of extrinsic evidence:

It is true that we seek the meaning of claim terms from the perspective of the person of ordinary skill in the art. The key, however, is that we look to how that person would have understood a term in view of the specification. … While extrinsic evidence may sometimes illuminate a well-understood technical meaning, … that does not mean that litigants can introduce ambiguity in a way that disregards language usage in the patent itself. The patent drafter controls the content of the specification, writes the claims, and responds to office actions. The drafter, then, is in the best position to anticipate ambiguity or questions of scope and to write the patent accordingly. Indeed, we give the intrinsic evidence “priority,” … over extrinsic evidence with which it is “inconsistent.”

The Court found the extrinsic evidence unavailing.

Finally the Court held that the PTAB was not required to elaborate on the specific reasons why it disagreed with the district court in terms of claim construction. It was sufficient that the PTAB acknowledged the district court opinion and yet provided a reasoned, supportable explication of the bases for its own construction.

The opinion can be found here.

By: Nika Aldrich


St. Jude Medical, LLC v. Snyders Heart Valve LLC, Appeal Nos. 2019-2108, -2109, -2140 (Fed. Cir. Oct. 15, 2020)

In this case, the Court addressed various issues in cross-appeals from two inter partes reviews of a patent directed to an artificial heart valve and a system for its installation, wherein the heart valve can be installed via catheter without invasive surgery to remove the damaged native valve. Notably, the Court found that based on the patent specification’s criticism of the prior art, the Board erred in its construction of a limitation requiring the valve’s frame to be “sized and shaped for insertion in a position between the upstream region and the downstream region” on either side of the native valve. The Board had found that the limitation required only that the frame be sized and shaped for insertion in a position between the upstream and downstream regions—and not necessarily insertion into a damaged heart valve—and was therefore disclosed by a prior art reference, Bessler, teaching the removal of the damaged heart valve before insertion. The Court disagreed, relying on claim and specification language indicating that the frame is inserted into a damaged heart valve, and particularly noting that the specification expressly described Bessler as presenting problems overcome by the claimed invention, including that Bessler’s procedure was too invasive because it included removal of the native valve. The Court found that these passages “go beyond stating a general preference for leaving the native valve intact,” and rendered the Board’s construction encompassing removal of the native valve to be unreasonable even under a “broadest reasonable interpretation” standard.

The Court also rejected as “meritless” petitioner St. Jude’s argument that the Board failed to apply its own construction of a limitation requiring “a band attached to the frame,” where the Board had essentially adopted St. Jude’s proposed construction of “band” as requiring “a structure generally in the shape of a closed strip or ring,” and found that it was therefore not disclosed in prior art teaching a structure extending over another structure like a sleeve. St. Jude argued that the term “band” does not imply any limitations on width, but the Court found that St. Jude failed to present any argument as to why some width constraint isn’t implied by “strip” or “ring,” which were key elements of its own proposed construction. The Court also found that the Board’s determination that St. Jude had failed to show motivation to combine in an asserted obviousness combination was supported by substantial evidence, where it had not demonstrated why a skilled artisan would modify certain elements of the prior art while leaving others intact, as would be required by the asserted combination.

The opinion can be found here.

By: Jason A. Wrubleski

Warsaw Orthopedic, Inc. v. Rick C. Sasso, M.D., Appeal No. 2019-1583 (Fed. Cir. Oct. 14, 2020)

At issue in this appeal was whether the United States District Court for the Northern District of Indiana’s abstention and dismissal of Warsaw Orthopedic, Inc.’s (“Medtronic”) declaratory judgement action without prejudice was an abuse discretion. The underlying dispute arose from a disagreement whether Medtronic was required to pay Dr. Sasso royalties for certain products under a licensing agreement. Dr. Sasso initially sued Medtronic for breach of contract in Indiana state court. Medtronic unsuccessfully attempted to remove that action to federal court. After the state court refused Medtronic’s defense of invalidity because the validity of the patents at issue was “irrelevant to royalty payments under the [license agreement],” Medtronic filed a declaratory judgement action in federal court seeking to invalidate the patents at issue. Meanwhile, the state court proceeding proceeded to trial where the court entered a jury verdict in favor of Dr. Sasso. That verdict was appealed by Medtronic and pending at the time of this decision. Since the district court did not act until after the verdict was entered, it relied in part on that verdict and pending appeal when abstaining and dismissing Medtronic’s claims. Medtronic appealed, arguing that the district court abused its discretion because “patent validity [was] essential to Dr. Sasso’s claim and was wrongly excluded from the state court trial, producing a fatal flaw in the state court proceeding.” The Court disagreed. “Under what is known as the Wilton/Brillhart abstention doctrine, district courts possess significant discretion to dismiss or stay claims seeking declaratory relief, even though they have subject matter jurisdiction over such claims.” In light of Medtronic’s failed attempt to remove the state court proceeding to federal court and the status of the state court proceeding, the Court found that “the district court exercised ‘common-sense accommodation of judgment,’ and did not abuse its discretion in abstaining and dismissing without prejudice.” Accordingly, the Court affirmed the decision of the district court.

The opinion can be found here.

By: Bazsi Takacs

Check out our searchable library of all Fresh from the Bench updates.

Sign up

Ideas & Insights