Author name: Gary

Federal Circuit, Utility Patent

Celgene Corp. v. Mylan Pharmaceuticals — Federal Circuit Clarifies Hatch-Waxman Venue: It’s Where the ANDA Was Submitted, Not Where Drugs Will Be Sold

The Federal Circuit affirmed dismissal of Celgene’s Hatch-Waxman patent suit for improper venue, holding that for ANDA litigation venue purposes, the act of infringement is the submission of the ANDA itself — not the receipt of a notice letter or the state where future generic sales are anticipated.

Federal Circuit, Utility Patent

University of Strathclyde v. Clear-Vu Lighting LLC — Federal Circuit Reverses IPR Obviousness Finding for Lack of Reasonable Expectation of Success

The Federal Circuit reversed a PTAB obviousness determination, holding that the Board lacked substantial evidence for a reasonable expectation of success because the cited prior art references did not actually achieve the claimed result of inactivating antibiotic-resistant bacteria without photosensitizing agents.

Federal Circuit, Utility Patent

Intel Corp. v. Qualcomm — Federal Circuit Addresses IPR Estoppel Scope and ‘Could Have Raised’ Standard

The Federal Circuit addressed the scope of IPR estoppel under § 315(e)(2), holding that an IPR petitioner is estopped from raising in district court invalidity grounds based on prior art that could reasonably have been raised in the IPR petition — including prior art patents and publications the petitioner did not actually rely on in the IPR.

Federal Circuit, Utility Patent

Lubby Holdings LLC v. Chung — Federal Circuit Holds Corporate Officers Are Personally Liable for Patent Infringement Without Piercing the Corporate Veil

The Federal Circuit held that a corporate officer can be personally liable for actively participating in a corporation’s patent infringement even without any piercing of the corporate veil, and clarified that the patent marking statute limits pre-notice damages regardless of whether the infringer was aware of the patent.

Federal Circuit, Utility Patent

MLC Intellectual Property, LLC v. Micron Technology, Inc. — Federal Circuit Affirms Exclusion of Damages Expert for Insufficient Apportionment Analysis in Flash Memory Patent Case

The Federal Circuit affirmed the exclusion of a patent owner’s damages expert, holding that the expert’s reasonable royalty calculation failed to adequately apportion the royalty base to account only for the patented features, rather than the full value of the accused products.

Federal Circuit, Patent Subject Matter Eligibility

Universal Secure Registry LLC v. Apple Inc. — Federal Circuit Holds Multi-Factor Authentication Coordination Patents Are Abstract Ideas Ineligible Under § 101

The Federal Circuit held that four patents covering methods for coordinating multi-factor authentication across secure registries, PINs, biometrics, and universal devices are directed to abstract ideas and lack an inventive concept sufficient to confer patent eligibility.

Federal Circuit, Patent Subject Matter Eligibility

Yu v. Apple — Federal Circuit Holds Dual-Camera Patent Claims Directed to Abstract Idea

The Federal Circuit affirmed that Yu’s patent on a digital camera using two lenses and two image sensors to produce an enhanced digital image was patent-ineligible under § 101 — holding the claims were directed to the abstract idea of ‘taking two pictures and using one to enhance the other’ even though the claims recited physical camera components.

Federal Circuit, Patent Subject Matter Eligibility

In re Board of Trustees of the Leland Stanford Junior University — Federal Circuit Holds Haplotype Phasing Mathematical Algorithm Is Patent Ineligible Under § 101

The Federal Circuit affirmed that Stanford’s patent claims directed to a computational method for haplotype phasing — determining which genetic variants are inherited together on each chromosome — were patent ineligible as abstract mathematical calculations implemented on generic computer hardware.

Federal Circuit, Utility Patent

Edgewell Personal Care Brands, LLC v. Munchkin, Inc. — Federal Circuit Reverses Summary Judgment, Holds Apparatus Claims Defined by Structure Not Function

The Federal Circuit reversed summary judgment of noninfringement, reaffirming that apparatus claims must be construed according to what the device physically is rather than how it functions, and remanding genuine disputes about literal infringement and the doctrine of equivalents for jury resolution.

Federal Circuit, Utility Patent

Bayer Healthcare v. Baxalta Inc. — Federal Circuit Holds Knowledge of Infringement Alone Is Insufficient for Willfulness, Upholds 17.78% Royalty Award

The Federal Circuit affirmed a $155 million reasonable royalty award against Baxalta for infringing Bayer’s blood-clotting factor patent but reversed the willfulness finding, holding that mere knowledge of a patent and its infringement is not enough — willfulness requires wanton, malicious, or bad-faith conduct.

Federal Circuit, Utility Patent

Amgen v. Sanofi (Federal Circuit 2021) — Antibody Claims Fail Enablement for Genus Claiming Entire Functional Class

The Federal Circuit affirmed that Amgen’s antibody patents directed to an entire genus of antibodies binding to a specific PCSK9 epitope lacked adequate enablement — holding that claiming a broad functional genus of antibodies without enabling the full scope of the claim requires undue experimentation and is invalid under § 112(a).

Federal Circuit, Patent Subject Matter Eligibility

American Axle & Manufacturing v. Neapco Holdings — Federal Circuit Finds Driveshaft Tuning Method Directed to Natural Law

A divided Federal Circuit panel held that American Axle’s patent on a method for tuning a propshaft to reduce vibration was patent-ineligible as directed to the application of Hooke’s Law — drawing sharp dissents and a petition for rehearing that generated significant debate about the scope of § 101’s natural law exception for mechanical patents.

Federal Circuit, Utility Patent

Biogen MA Inc. v. EMD Serono, Inc. — Federal Circuit Holds Source Limitations Cannot Confer Novelty on Recombinant Proteins

The Federal Circuit reversed a judgment for Biogen and reinstated a jury verdict of invalidity, holding that a recombinant polypeptide cannot be distinguished from its native counterpart for novelty purposes when the molecules are structurally identical — a product-by-process analysis applies even within method of treatment claims.

Federal Circuit, Utility Patent

Bio-Rad Laboratories, Inc. v. 10X Genomics Inc. — Federal Circuit Affirms Willful Infringement but Partially Reverses Injunction Scope

The Federal Circuit affirmed a finding of willful patent infringement and the jury’s $23 million damages award in a droplet microfluidics case, but reversed claim construction on two of three patents and partially vacated the injunction as to product lines where 10X had not yet developed non-infringing alternatives.

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