Novartis Pharms. Corp. v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. June 21, 2022)

In this week’s Case of the Week, the Federal Circuit granted panel rehearing of and vacated its prior decision in Novartis Pharms. Corp. v. Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir. 2022).  Our write-up of that opinion can be found here.  Previously, the Court had affirmed the district court’s decision that Novartis’s patent claims directed to sclerosis treatments were supported by adequate written description, and its subsequent bench trial ruling that the claims were infringed by petitioners HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (HEC).  As relevant to the issues on rehearing, the Court had found that a negative limitation excluding use of a “loading dose” in the claimed treatment regime was supported by adequate written description, notwithstanding that the patent’s specification was silent as to the presence or absence of a loading dose.  (A “loading dose” is a typically higher dose administered initially to elevate the patent’s medication levels.)  In reaching this conclusion, the Court credited expert testimony that a skilled artisan would understand the specification to disclose a regime excluding a loading dose.

On rehearing, Circuit Judge Hughes replaced Judge O’Malley on the panel assigned to the case following Judge O’Malley’s retirement in March 2022.  Judge Hughes joined Chief Judge Moore (who had previously dissented) in finding that the “no loading dose” negative limitation was not adequately supported by the patent’s written description.  The opinion of the Court explained that as with positive claim limitations, “the hallmark of written description is disclosure.”  The Court held that “[s]ilence is generally not disclosure,” and while a negative limitation need not be recited in haec verba, there must be something in the specification conveying to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages of the excluded element or distinctions between the element and alternatives.  Absent such disclosures, the Court held that a skilled artisan must understand the excluded element to be necessarily absent from the claimed method or apparatus.

Here, loading doses were not mentioned at all in the specification, and the Court found that the district court clearly erred in finding the “no loading dose” limitation to be adequately supported.  In support of its conclusion, the Court noted that the negative limitation was added in an amendment during prosecution to overcome prior art, which should not have been needed if the limitation was necessarily understood to be present by a skilled artisan, and that HEC’s expert testimony did not otherwise establish that a skilled artisan would understand the specification to necessarily preclude a loading dose.  The Court also noted tension in the district court’s conclusion that the limitation was disclosed in the patent but not in asserted prior art that was similarly silent as to the presence of a loading dose.  On this latter point, the Court rejected the district court’s rationale that unlike prior art, a patent “is presumed complete,” holding that “[a] patent is not presumed complete such that things not mentioned are necessarily excluded.  We presume only that a patent has adequate written description, not that it is complete.”

Because the asserted claims were not supported by adequate written description, the Court reversed the district court’s judgment that the claims were not invalid.  Judge Linn dissented, disagreeing with the majority’s adoption of a “necessarily excluded” standard and arguing that a patentee should need only show that a skilled artisan would understand it had possession of the claimed invention as of the claimed priority date.

The opinion can be found here.

By Jason Wrubleski


Centripetal Networks, Inc. v. Cisco Systems, Inc., Appeal No. 2021-1888 (Fed. Cir. June 23, 2022)

In this case, the Court of Appeals for the Federal Circuit found a judge disqualified from a dispute between Centripetal Networks, Inc. and Cisco Systems, Inc.  After the judge realized his wife owned $4,687.99 in Cisco stock, he deposited the stock in a blind trust.  First, the Federal Circuit found that although placing stock in a blind trust deprived the judge’s wife of control, it did not deprive her of ownership, and therefore was not “divestiture” under 28 U.S.C. § 455(f), as would be needed to cure a § 455(b)(4) impermissible financial interest.  Second, turning to the appropriate remedy, the Federal Circuit found vacatur appropriate.  Among other factors, the court considered the risk that would be caused by allowing the judge’s prior decision to stand, both in signaling to other judges that sitting on a case where a family member had a financial interest was not a serious issue, and in undermining public confidence in the judicial process—particularly given increasing concern within the public and judiciary caused by reports of judges hearing cases in which they have a financial interest.  Thus, the Federal Circuit found the judge’s violation of § 455(b)(4) was not a harmless error, and vacated and remanded all orders and opinions entered after the date the judge became aware of his wife’s financial interest.

The opinion can be found here.

By Tyler Hall 

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This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.

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