BIOGEN INTERNATIONAL GMBH V. MYLAN PHARMACEUTICALS INC.

Before O’Malley, Reyna, and Hughes. Appeal from the United States District Court for the Northern District of West Virginia.

Summary: A specification may not describe “possession” of an invention in satisfaction of the § 112 written description requirement even though the specification lists dosage ranges encompassing the claimed limitation.

MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

Before Lourie, O’Malley, and Stoll. Appeal from the Patent Trial and Appeal Board.

Summary: Sublicensee’s theory of royalty-based injury was too speculative to support standing on appeal. Later changes in factual basis cannot support standing where the original basis for standing is not shown to be continuous.

MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

Before Lourie, O’Malley and Stoll. Appeal from the Patent Trial and Appeal Board.

Summary: A presumption of obviousness based on overlapping ranges requires showing that the overlapping range is actually taught by the prior art.

INDIVIOR UK LIMITED v. DR. REDDY’S LABORATORIES S.A.

Before Lourie, Linn, and Dyk. Appeal from the Patent Trial and Appeal Board.

Summary: Claims of a continuation application were anticipated because they were not entitled to the filing date of a parent application that failed to support the ranges of numerical values claimed in the continuation.

ROHM SEMICONDUCTOR USA, LLC v. MAXPOWER SEMICONDUCTOR, INC.

Before Lourie, O’Malley, and Chen. Appeal from the U.S. District Court for the Northern District of California.

Summary: An arbitration agreement, which incorporated the California Code of Civil Procedure by reference, delegated determining arbitrability and supported dismissal of a district court action.

GALPERTI, INC. v. GALPERTI S.R.L.

Before: Moore, Prost, Taranto. Appeal from the Trademark Trial and Appeal Board.

Summary: Evidence of use of a term even without a showing of secondary meaning, by any third party, is relevant to demonstrate that an assertion of substantially exclusive use was false.

APPLE, INC. v. QUALCOMM, INC.

Before Newman, Prost, and Stoll. Appeal from the Patent Trial and Appeal Board.

Summary: Apple lacked standing to appeal an IPR decision upholding patents that Apple licenses from Qualcomm, in light of a prior decision with identical operative facts

On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” originally released in May 2005.

CELGENE CORP. v. MYLAN PHARM. ET AL.

Before Prost, Chen, and Hughes. Appeal from the District of New Jersey.

Summary: In Hatch-Waxman litigation: (1) infringement occurs where the ANDA is submitted and not where the patentee received notice of the ANDA submission; (2) the presence of an affiliated entity or employees in the district is insufficient to show a regular and established place of business; and (3) pleadings must explain how a defendant was involved in the ANDA submission to support a claim for infringement.

UNIVERSITY OF STRATHCLYDE v. CLEAR-VU LIGHTING LLC

Before Reyna, Clevenger, and Stoll. Appeal from the Patent Trial and Appeal Board.

Summary: The Federal Circuit reversed the PTAB’s obviousness decision because the inventors succeeded where the prior art failed and there could be no expectation of success based on the failed attempts of the prior art.