Federal Circuit

The Federal Circuit sitting en banc overhauled the doctrine of inequitable conduct, holding that rendering a patent unenforceable requires both but-for materiality (the undisclosed information would have blocked the patent) and specific intent to deceive the USPTO — dramatically narrowing a defense that had become a routine litigation tactic.

The Federal Circuit addressed joint infringement in a healthcare IT patent dispute, holding that when patients and healthcare providers together perform steps of a patented method for online patient-provider communications, neither party alone is a direct infringer — applying the direction-or-control standard for divided infringement to electronic health record systems.

The Federal Circuit ruled that the widely used ’25 percent rule of thumb’ for calculating starting-point patent royalties is inadmissible as a matter of law, vacating a $388 million damages award against Microsoft and requiring that every patent royalty calculation be tied to the specific facts of the case.

The Federal Circuit reversed a summary judgment of obviousness in a deepwater drilling rig patent dispute, holding that the district court failed to give adequate weight to powerful objective evidence of non-obviousness — including commercial success, long-felt need, and failure of others — and remanded for proper analysis of the full record.

The Federal Circuit applied claim differentiation and rejected a narrowing construction of defibrillator patent claims, holding that independent claims cannot be read to require limitations found only in dependent claims — and affirmed the district court’s infringement finding on the broader interpretation.

The Federal Circuit held AstraZeneca’s patents on a once-daily budesonide inhaler formulation (Pulmicort Respules) valid and infringed in a Hatch-Waxman challenge, affirming the district court’s analysis of the complex obviousness record and reinforcing the significance of FDA-required labeling disclosures in constructive notice and § 101 analysis for pharmaceutical patents.

The Federal Circuit sitting en banc held that 35 U.S.C. § 112 contains a written description requirement that is distinct from the enablement requirement, and invalidated a broad genus patent covering all substances that inhibit NF-κB activity because the patent described the goal but not the means.

The Federal Circuit affirmed a $200 million jury verdict and permanent injunction against Microsoft for infringing i4i’s patent on a method for editing custom XML in word processing documents, rejecting Microsoft’s invalidity defense premised on a prior-sold product and upholding the clear-and-convincing evidence standard for patent invalidity claims.

The Federal Circuit vacated a patent damages award and held that a reasonable royalty calculation must rely on licenses that are technologically and economically comparable to the patent at issue — rejecting a royalty rate derived from re-bundling agreements that had no connection to the claimed invention.

The Federal Circuit affirmed summary judgment of invalidity of a patent on a method for bulk email delivery, holding the claims obvious under post-KSR standards where the claimed process involved only routine, predictable steps well within the common sense of a person with ordinary skill in email marketing.

The Federal Circuit largely affirmed that Roche’s pegylated erythropoietin product Mircera infringed four of Amgen’s EPO patents, but vacated the district court’s double-patenting rulings and remanded for additional analysis — a significant ruling in the long-running battle over the blockbuster anemia-treatment drug market.

The Federal Circuit vacated a $1.5 billion patent damages award against Microsoft, holding that the jury’s royalty base improperly relied on the entire market value of Microsoft’s products — including features unrelated to the patented invention — without proof that the patented feature drove demand for the whole product.

The Federal Circuit en banc held that the traditional four-factor preliminary injunction test applies in Hatch-Waxman patent cases — eliminating the prior practice under which a showing of validity and infringement created a presumption of irreparable harm — and remanded the preliminary injunction against generic clarithromycin for reconsideration under the corrected standard.

The Federal Circuit addressed the joint infringement problem in method patent claims — holding that when multiple parties each perform different steps of a claimed method, infringement requires that one party direct or control the actions of the other parties performing the remaining steps, setting an important standard for software and service patents with distributed functionality.

The Federal Circuit held that a patent application claiming an isolated DNA sequence encoding the NAIL protein receptor was obvious under KSR — where the prior art disclosed both the protein and routine methods of cloning its encoding gene — marking an important application of KSR’s flexible obviousness standard to biotechnology patent claims for genetic sequences.

The Federal Circuit struck down a controversial USPTO rule that would have limited patent applicants’ right to file continuation applications claiming priority to parent patents, holding the rule was inconsistent with 35 U.S.C. § 120 — while upholding other procedural rules in the contested rulemaking package.

The Federal Circuit affirmed the validity of Sanofi’s Plavix (clopidogrel) patent, holding that prior disclosure of a racemic mixture does not anticipate a claim to an isolated single enantiomer — particularly when the enantiomer exhibits unexpectedly superior properties not predictable from the racemate.

The Federal Circuit held that direct infringement of a method claim divided across multiple parties requires that a single defendant direct or control the performance of every claimed step — a ruling that made it significantly harder to prove infringement of internet-era method patents implemented through multi-party systems.

The Federal Circuit vacated a $78.9 million willful infringement verdict against DirecTV’s satellite broadcasting system, reversing on claim construction and holding that means-plus-function claims for software functions require more than a bare reference to software — the specification must disclose the specific algorithm performing each claimed function.

The Federal Circuit affirmed the invalidation of Aristocrat’s slot machine patent, holding that computer-implemented means-plus-function claims are indefinite under § 112 unless the specification discloses the specific algorithm that transforms a general-purpose computer into the claimed special-purpose device.

The Federal Circuit tightened the standards for inequitable conduct findings, requiring clear and convincing evidence of both materiality and intent to deceive before a patent may be rendered unenforceable — while also confirming that a patent examiner’s independent knowledge of withheld prior art does not excuse the patentee’s duty of disclosure.

The Federal Circuit addressed the interplay of written description and priority, holding that a claim amendment during prosecution that introduces new limitations must find support in the originally filed specification to maintain the benefit of the earlier filing date — a key ruling for patent drafters managing continuation and CIP application strategies.

The Federal Circuit sitting en banc abandoned its 24-year-old willful infringement standard, adopting a new two-part objective/subjective recklessness test that raised the bar for enhanced patent damages and eliminated the automatic duty to obtain opinion-of-counsel letters.

The Federal Circuit reaffirmed that prosecution history estoppel bars application of the doctrine of equivalents when a claim was narrowed during prosecution to distinguish prior art — a landmark application of Festo’s flexible bar to a complex software patent dispute.

The Federal Circuit affirmed the validity of Forest Laboratories’ escitalopram (Lexapro) patent, holding the single-enantiomer antidepressant non-obvious over the known racemic citalopram — with the critical role played by unexpected superior pharmacological properties of the isolated (+)-enantiomer over the racemate as evidence of non-obviousness.

In one of the first major post-KSR Federal Circuit obviousness decisions, the court upheld the non-obviousness of Takeda’s pioglitazone (Actos) patent, applying the Supreme Court’s flexible obviousness framework while affirming that selection from a genus of prior art compounds requires specific motivation to choose the patented compound.

In one of the first post-KSR Federal Circuit obviousness decisions, the court invalidated Leapfrog’s patent on an electronic phonics learning toy as obvious, holding that it would have been obvious to combine the mechanical toy’s learning concept with electronic text-to-speech technology that was well-known in the prior art — a straightforward application of KSR’s flexible approach.

The Federal Circuit reversed a district court’s obviousness finding in a Hatch-Waxman pharmaceutical case, holding that the court had improperly defined the level of ordinary skill in the art — which significantly affected the obviousness analysis for an antibiotic ear drop formulation patent — underscoring the critical role of ordinary skill level determination in patent validity disputes.

The Federal Circuit reversed a district court’s validity ruling and held that Pfizer’s patent covering amlodipine besylate (Norvasc) was invalid for obviousness, finding that selecting the besylate salt of amlodipine was routine pharmaceutical testing that any skilled chemist would have performed.

The Federal Circuit addressed the requirements for functional claim limitations in software-implemented gaming machine patents, reinforcing that functional language in claims must be supported by adequate structural or algorithmic disclosure in the specification — a key ruling on the § 112 disclosure requirements for software-driven inventions.

The Federal Circuit sitting en banc resolved a circuit split and held that induced infringement under 35 U.S.C. § 271(b) requires proof that the defendant specifically intended to cause direct infringement — not merely that it intended to perform acts that happen to constitute infringement.

The Federal Circuit reversed a finding of obviousness in a spinal implant patent case, holding that the district court failed to identify a sufficient motivation or reason why a person of ordinary skill would have combined the cited prior art references — possibility of combination is not enough; there must be articulated reasoning grounded in the prior art as to why the skilled artisan would have made the combination.

The Federal Circuit held a textile dye process patent invalid as obvious, clarifying that the teaching-suggestion-motivation (TSM) test for obviousness is flexible and allows motivation to combine to be found in common knowledge, common sense, and efficiency goals — not just explicit documentary evidence.

The Federal Circuit invalidated Align Technology’s patents on incremental orthodontic aligners as obvious over prior art, holding that packaging convenience and commercial success driven by aesthetic and unclaimed features cannot overcome a prima facie case of obviousness.

The Federal Circuit held that the patent exhaustion doctrine does not give a purchaser the right to use replicated copies of a self-replicating patented technology, and that conditional sales of patented seed prevent exhaustion from arising in the first place.

The Federal Circuit invalidated a key Lipitor patent claim because the dependent claim attempted to claim subject matter outside the scope of the independent claim it depended on, violating 35 U.S.C. § 112, paragraph 4.

The Federal Circuit held that the sale of a licensed device does not exhaust a patent holder’s method claims, ruling that purchasers of Intel chips who used them in unauthorized combinations remained liable for infringement of LG Electronics’ method patents — a holding the Supreme Court later reversed in Quanta Computer v. LG Electronics (2008).

The Federal Circuit affirmed that Agfa’s patents were unenforceable due to inequitable conduct based on intentional withholding of material prior art, and confirmed that inequitable conduct claims may be tried to the court without a jury.

The Federal Circuit held in a poxvirus vaccine interference that there is no per se rule requiring a patent applicant to recite known structural information in the written description — an applicant may rely on publicly available scientific literature for what is well-known in the field.

The Federal Circuit held that when a patent defendant asserts an advice-of-counsel defense to willful infringement, it waives attorney-client privilege for all communications about the patent’s validity, enforceability, and infringement — but the waiver does not automatically extend to all attorney work product never communicated to the client.

The Federal Circuit reversed a finding of anticipation, holding that a prior art reference disclosing a broad temperature range of 100–500°C did not anticipate a claimed narrower range of 330–450°C — a genus does not anticipate every species, and a broader prior art range anticipates a narrower claimed range only when the prior art discloses the narrower range with sufficient specificity.

The Federal Circuit affirmed summary judgment of non-infringement, holding that a patent’s claim preamble is limiting when it recites essential structural elements of the claimed invention, and construed the asserted dental implant patent claims to require a complete emergence cuff and abutment combination.

The Federal Circuit affirmed invalidity of SmithKline’s Paxil patent, holding that product-by-process claims are anticipated by prior art that discloses the same product, even when the prior art used a different process to make it — because patents protect products, not processes, under such claims.

The Federal Circuit affirmed patent unenforceability for inequitable conduct, holding that pharmaceutical patent applicants who submitted declarations from scientists with undisclosed financial ties to the patent owner engaged in deceptive conduct that was material because the patent examiner had specifically requested independent, unbiased declarations to overcome obviousness rejections.