In a divided decision, the Federal Circuit affirmed that Biogen’s multiple sclerosis drug patent lacked adequate written description because the specification’s single passing reference to a 480 mg/day dose of dimethyl fumarate did not demonstrate the inventors actually possessed that specific therapeutic method.
The Federal Circuit granted mandamus to compel transfer from the Western District of Texas, holding that a district court’s faster time to trial cannot alone outweigh other venue factors that favor transfer.
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.
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.
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.
The Federal Circuit held that a forum selection clause in a non-disclosure agreement requiring disputes to be litigated in New York courts does not preclude the counterparty from filing inter partes review petitions at the PTAB, because the connection between the IPR and the NDA was too attenuated.
The Federal Circuit held that the USPTO acted arbitrarily by ordering ex parte reexamination based on arguments substantially identical to those the same requester had already raised and lost in IPR proceedings, affirming the agency’s discretion to reject repetitive patent challenges.
The Federal Circuit clarified that willful patent infringement requires only deliberate or intentional infringement — no heightened standard applies — and reinstated a doubled damages award against Cisco for its litigation conduct and disdain toward the patent holder.
The Federal Circuit affirmed that a patent is unenforceable for inequitable conduct when a company’s chief science officer withheld from the USPTO material information about a competitor’s epinephrine product that he disclosed to the FDA during the same period.
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.
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.
The Federal Circuit reversed a $1.2 billion jury verdict for Juno, holding that patent claims covering a broad functional genus of CAR-T cell receptor constructs lacked adequate written description because the specification disclosed only a few examples that could not support the full claimed scope.
The Federal Circuit held that a generic drug company can be liable for inducing infringement of a brand-name patent even when it used a “skinny label” carving out the patented indication, affirming a $235 million jury verdict against Teva.
The Federal Circuit held that a corporate affiliate’s physical stores in a district cannot establish patent venue for related web-only entities that have no employees, offices, or physical presence there.
The Federal Circuit held that a university employment agreement providing that patents “shall be the property” of the university is a statement of future intent, not an automatic present assignment, and therefore did not strip the inventor of standing to sue.
The Federal Circuit vacated PTAB decisions in Qualcomm’s IPR proceedings against Qualcomm patents, holding that the Board’s sua sponte adoption of a new claim construction — without giving the parties an opportunity to address it — violated the Administrative Procedure Act and due process.
The Federal Circuit reversed PTAB obviousness findings, clarifying that prior art references that merely warn of tradeoffs do not categorically teach away from a claimed invention, and that commercial success nexus cannot be assessed element-by-element.
The Federal Circuit granted mandamus and ordered transfer out of the Western District of Texas, holding that courts must disregard a plaintiff’s transparent pre-litigation scheme to manufacture venue by assigning limited patent rights to a newly-formed affiliate days before filing suit.
The Supreme Court held 5-4 that assignor estoppel — the doctrine preventing a patent inventor who has assigned their patent from later claiming the patent is invalid — remains a valid doctrine, but only applies when there is a direct conflict between the invalidity position and what the inventor warranted in making the assignment.
The Supreme Court held 5-4 that the appointment of Administrative Patent Judges without Senate confirmation violated the Appointments Clause — but remedied the violation by making APJ decisions reviewable by the USPTO Director, rather than striking down the entire IPR system.
The Federal Circuit affirmed that an applicant’s clear statements during prosecution disclaiming hierarchical category relationships narrowed the claim scope, and that later prosecution statements could not be used to walk back that unambiguous disavowal.
The Federal Circuit held for the first time that the USPTO can assert prosecution laches as a defense in a § 145 civil action, blocking Gilbert Hyatt’s decades-delayed patent applications from issuing based on his unreasonable and prejudicial delays.
The Federal Circuit reversed a PTAB finding of obviousness, holding that prior art disclosing ambitious performance parameters for a gas turbine engine cannot render claims obvious when the prior art relies on non-existent materials that a skilled artisan could not have made.
The Federal Circuit held that the § 314(d) bar on appealing institution decisions does not extend to post-institution estoppel rulings under § 315(e)(1), giving patent owners a path to challenge PTAB estoppel determinations that arise after an IPR is already underway.
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.
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.
The Federal Circuit affirmed that Amgen’s patents claiming a broad functional genus of anti-PCSK9 antibodies were invalid for lack of enablement, because the specification failed to teach skilled artisans how to make the full range of claimed antibodies without undue experimentation.
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).
The Federal Circuit held that technical documents submitted to video coding standards bodies and distributed at widely attended conferences qualify as prior art “printed publications” based on public accessibility, even without formal library indexing.
The Federal Circuit held that a patent owner’s disclaimer of its right to pursue infringement damages in a parallel district court proceeding could moot a challenger’s appeal of an adverse IPR final written decision, giving patent owners a powerful procedural tool.
The Federal Circuit held that Google forfeited its claim construction arguments by failing to raise them before the examiner or the PTAB, clarifying the important procedural distinction between waiver and forfeiture in patent appeals.
The Federal Circuit granted Apple’s mandamus petition, holding that district courts must resolve venue transfer motions before proceeding on the merits, and issued a writ ordering the Western District of Texas to transfer the case to Northern California.
The Federal Circuit held that venue in Hatch-Waxman patent infringement cases is proper only where the defendant’s ANDA submission occurred, not in any district where the generic drug might eventually be sold, resolving a split among district courts.
The Federal Circuit upheld TecSec’s multi-level document security patents as patent eligible under § 101 and reversed the district court’s exclusion of inducement evidence, finding that the claimed data-encryption system represented a specific technical improvement rather than an abstract idea.
The Federal Circuit affirmed PTAB’s invalidity ruling on Immunex’s IL-4 receptor antibody patent, upholding a broad claim construction of ‘human antibodies’ that encompassed humanized antibodies and finding the claims obvious over prior art.
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.
The Federal Circuit held that the inter partes review statute does not permit a petitioner to join itself to its own existing IPR proceeding or to add new issues through joinder, closing a widely-used PTAB practice that had allowed parties to work around the one-year filing deadline.
The Federal Circuit vacated a judgment of noninfringement in a dispute over Genentech’s Hemlibra hemophilia drug, holding the district court’s narrow construction of ‘antibody’ was inconsistent with the patent’s written description, which disclosed bispecific, chimeric, and humanized antibodies.
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.
The Federal Circuit granted a writ of mandamus directing transfer of a patent case from the Western District of Texas to the Northern District of California — the first such order against Judge Albright’s court — holding that the district court abused its discretion by improperly weighing transfer factors.
The Federal Circuit held that a state university’s sovereign immunity barred its involuntary joinder as a co-plaintiff, but permitted an exclusive patent licensee to proceed with infringement litigation without the patent owner, because the licensee had identical interests and no risk of multiple suits.
The Federal Circuit affirmed the PTAB’s invalidation of EMC’s data storage system patents on obviousness grounds — holding that the PTAB properly weighed secondary considerations of non-obviousness including commercial success and industry praise, but found them insufficient to overcome the strong prima facie case of obviousness established by the prior art.
The Federal Circuit held that Roche’s patents on etanercept (Enbrel) were not subject to obviousness-type double patenting by Immunex, because Roche’s license to Immunex was not an effective assignment — Roche retained substantial patent rights that prevented common ownership.
The Federal Circuit held that direct competitors have Article III standing to appeal an IPR final written decision even without a specific threat of patent infringement litigation, so long as their commercial activities risk infringement and the patent owner has refused to grant a covenant not to sue.
The Federal Circuit held that claim preclusion and the Kessler doctrine barred PersonalWeb from re-suing Amazon’s customers for infringement of the same patents, after PersonalWeb had previously settled a lawsuit against Amazon itself without expressly reserving its rights to sue downstream customers.
The Federal Circuit addressed whether a standard-essential patent holder’s injunction request against a licensee who rejected a FRAND license offer was properly denied — examining the standards for determining whether a license offer was FRAND-compliant and whether refusal to accept a FRAND offer could support injunctive relief.
The Federal Circuit held that assignor estoppel bars a patent assignor from challenging claim validity in district court, but does not prevent the same assignor from filing inter partes review petitions at the PTAB — a critical distinction with major implications for post-grant strategy.
The Federal Circuit held that a patent term extension under the Hatch-Waxman Act covers only the active ingredient actually approved by the FDA—and its salts and esters—but does not extend to a metabolite of that ingredient, even if the metabolite is what is pharmacologically active in the body.
The Supreme Court held 7-2 that § 314(d)’s bar on judicial review of IPR institution decisions extends to determinations about the § 315(b) one-year time bar — meaning courts cannot review whether the PTAB incorrectly concluded that a petition was timely filed within the statutory one-year period after service of a complaint alleging infringement.
The Federal Circuit reversed a district court preliminary injunction that barred a patent holder from alleging infringement, holding that a finding of bad faith—including objective baselessness—is a necessary predicate before such an injunction may issue.