Federal Circuit

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 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.

The Federal Circuit applied the Kessler doctrine — a nineteenth-century rule of preclusion in patent law — to bar PersonalWeb from relitigating patent infringement claims against Amazon Web Services customers after PersonalWeb had previously lost in a suit against Amazon directly, holding that customers of an adjudicated non-infringer are protected from subsequent patent suits on the same technology.

The Federal Circuit granted Google’s writ of mandamus and held that cache servers leased inside third-party ISP facilities do not create a “regular and established place of business” for patent venue purposes unless an employee or agent of the defendant is conducting business there.

The Federal Circuit held that the Patent Trial and Appeal Board cannot cancel patent claims as indefinite in inter partes review proceedings, since the IPR statute limits the Board to invalidity grounds based on prior art under Sections 102 and 103.

The Federal Circuit held that the Patent Trial and Appeal Board exceeded its authority by instituting inter partes review on an obviousness ground that was not raised in the petition, violating the statutory requirement that the Board limit its review to grounds asserted by the petitioner.

The Federal Circuit reversed a PTAB obviousness ruling, holding that a patentee cannot presume a nexus between commercial success and a patent when the successful product contains significant features not covered by the patent claims.

The Federal Circuit vacated a bench-determined FRAND royalty award, holding that a standard-essential patent holder is constitutionally entitled to a jury trial on “release payments” for an implementer’s past unlicensed use of the patented technology.

The Federal Circuit affirmed invalidity of Idenix’s broad nucleoside compound patent for lack of enablement and written description, ruling that a claim covering a vast genus of chemical compounds is invalid when the specification does not teach how to make most of them.

The Federal Circuit vacated a $145 million patent damages award against Apple, holding that Wi-LAN’s expert improperly used entire smartphone sales as the royalty base for cellular standard-essential patents — applying the entire market value rule without adequate apportionment to the patented features — and requiring retrial on damages.

The Federal Circuit affirmed that patents covering the Contrave weight loss drug were obvious, rejecting arguments that unexpected synergistic effects between bupropion and naltrexone saved the claims from invalidity.

The Federal Circuit clarified the scope of IPR estoppel under § 315(e)(2), holding that IPR estoppel applies only to grounds based on patents or printed publications — the types of prior art available in IPR — and does not bar district court invalidity challenges based on prior art that could not have been raised in IPR, such as prior public use or on-sale evidence.

The Federal Circuit held that applying inter partes review (IPR) proceedings to patents issued before the America Invents Act does not constitute an unconstitutional taking under the Fifth Amendment, rejecting a major constitutional challenge to the PTAB system.

The Federal Circuit affirmed dismissal of Amgen’s doctrine of equivalents infringement claim, holding that arguments made during patent prosecution create estoppel bars even when those arguments were not strictly necessary to secure allowance of the claims.

The Federal Circuit affirmed invalidity of Enzo’s nucleotide labeling patents for lack of enablement, holding that claims covering tens of thousands of possible labeled polynucleotide embodiments were not enabled when the specification disclosed only a few working examples.

The Federal Circuit held that state sovereign immunity does not apply in inter partes review proceedings, following the logic of its earlier St. Regis Mohawk Tribe ruling and closing the gap between tribal and state immunity claims at the PTAB.

The Federal Circuit held that the USPTO cannot reduce patent term adjustment by a period during which the applicant could not have taken any action to advance prosecution, limiting PTA deductions to periods of actual applicant delay.

The Federal Circuit held that the judicially created doctrine of obviousness-type double patenting cannot be used to cut short a patent term extension lawfully granted by statute, affirming Novartis’s extended patent protection for its multiple sclerosis drug Gilenya.