When ‘Any Patent’ Means No Patent: Federal Circuit Reverses Non-Specific Verdict
In Ollnova Technologies Ltd. v. Ecobee Technologies ULC [Opinion], Appeal No. 25-1045, the Federal Circuit held that a verdict form that asks a single question as to whether the defendant infringed any asserted claim is improper because it does not ensure a unanimous jury finding of infringement as to each asserted patent.
Ollnova sued ecobee for infringement of four patents relating to wireless communications systems. The district court’s verdict form included only a single infringement question covering all asserted patents:
“Did Ollnova, the Plaintiff, prove by a preponderance of the evidence that ecobee, the Defendant, infringed ANY of the Asserted Claims of the Asserted Patents?”
The jury returned a verdict answering Yes to the infringement question, but it did not identify which patent or patents were infringed. ecobee moved for a new trial, arguing the verdict form improperly allowed the jury to find liability without a unanimous finding that ecobee infringed any particular claim of any patent. The district court denied ecobee’s motion, and ecobee appealed.
The Federal Circuit reversed, holding that the verdict form created a substantial risk that the verdict did not reflect unanimous agreement as to any particular patent. Because the verdict form asked a single infringement question encompassing multiple patents, it required a “Yes” answer even if individual jurors believed that different patents were infringed without unanimous agreement on any one patent. The Federal Circuit explained that because a patent infringement verdict must be unanimous as to each asserted patent, the verdict form “needed to have included … separate infringement questions for each asserted patent” to ensure unanimity. Accordingly, the Federal Circuit vacated the infringement judgment and the associated damages award and remanded for a new trial on infringement and damages.
Reap What You Sow: Industry-Specific Applications of Data Processing Do Not Survive § 101
In AGI Suretrack LLC v. Farmers Edge Inc., Appeal No. 24-1730, the Federal Circuit held that patents claiming data collection, processing, and transmission using generic computer components are patent-ineligible abstract ideas under § 101, even when narrowed to a specific industry or use.
AGI alleged Farmers Edge infringed five patents related “to automated systems and methods for capturing, processing and sharing farming data.” The district court granted summary judgment for Farmers Edge, holding the patents invalid under § 101 because the claims “use generic (‘off the shelf’) computers and sensors to collect data from standard farm implements” and were “directed to software that collects, processes, and shares data” without transforming the abstract idea into an inventive concept. AGI appealed, arguing its claims were patent-eligible as a “solution to the interoperability problem” between different farm equipment brands using an unconventional hardware and software system. The Federal Circuit disagreed.
At Alice step one, the court found the claims were directed to an abstract idea. The specification described the invention as simply a computer-implemented method for gathering and processing farm data, and the claims “invoke[d] the use of generic computer components to collect, analyze, and transmit farming data” without any specific improvement to computer functionality. At Alice step two, the court found that the claims did not disclose any specific inventive technology. The claims relied on generic computer components (microprocessor, bus connector, GPS receiver, memory storage area) used conventionally, and the improved speed inherent with applying an abstract idea using a computer was insufficient to establish an inventive concept. Accordingly, the Federal Circuit affirmed the district court’s determination that the asserted patents were not directed to eligible subject matter.
Skinny Labels at the Supreme Court: Carving out Room for Generics to Breathe
In Hikma Pharmaceuticals USA Inc. Et Al. v. Amarin Pharma, Inc., et al., Appeal No. 23-1169, the Federal Circuit held that to be adequately pled, induced infringement claims must rest on affirmative acts encouraging infringement, not omissions, inactions, roundabout theories, or vague statements.
Amarin Pharma, Inc. (Amarin) obtained FDA approval for its drug Vascepa® (icosapent ethyl), which was originally indicated for the treatment of severe hypertriglyceridemia. The original Vascepa® label included a use limitation stating that its effect “on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.” The FDA later approved Vascepa® for a second, much more common treatment—to reduce cardiovascular risk in hypertriglyceridemia patients who already take statins. Amarin then removed the use limitation from its label. Though Amarin had obtained method-of-use patents for both indications, a district court invalidated the patents covering the original, narrower indication. In response to these developments, drug manufacturer Hikma Pharmaceuticals USA, Inc. (Hikma), which had an Abbreviated New Drug Application (ANDA) for a generic version of Vascepa® pending with the FDA, supplemented its ANDA with a section viii statement, seeking a “skinny label” limited to the original, narrower, and no-longer-patented indication. Hikma also removed the use limitation from its skinny label and, after obtaining FDA approval, began marketing its drug. Amarin then sued Hikma under 35 U.S.C. § 271(b), alleging induced infringement of the method-of-use patent for the newer, broader indication.
The district court granted Hikma’s motion to dismiss for failure to state a claim. The Federal Circuit reversed, however, holding that it was “at least plausible that a physician could read” Hikma’s label, website, and press releases as encouragement to prescribe Hikma’s drug for the still-patented use. The Supreme Court granted certiorari.
The Supreme Court concluded that Amarin’s allegations failed to plausibly plead that Hikma took affirmative steps to encourage infringement. First, Hikma’s removal of the use limitation and retention of information about a clinical study in which some patients were on statins was done to satisfy the statutory requirement that Hikma’s label be identical to the Vascepa® label except for the carved-out use. Second, Amarin’s allegations based on a patient-information leaflet warning of possible side effects for people with cardiovascular disease was too “roundabout” to plausibly state a claim for inducement. Third, Hikma’s categorization of its drug as a “hypertriglyceridemia” drug on its website was akin to describing a drug for leukemia as “a cancer drug”—a broad category, not an instruction to prescribe the drug for a specific type of cancer. Fourth, though Hikma described its product as “generic Vascepa” or the “generic equivalent” of Vascepa® in its press releases, the Supreme Court found those statements to be truthful and consistent with normal industry practice. Fifth, while Hikma did not specify in its investor-focused press releases that its drug was limited to the original, narrower indication, the Court explained that such an alleged omission or inaction does not plausibly state a claim for active inducement.
Thus, the Supreme Court reversed the judgment of the Federal Circuit and remanded the case for further proceedings consistent with the opinion.
Typos Cause Alkanes of Trouble
In Enanta Pharmaceuticals, Inc. v. Pfizer Inc., Appeal No. 25-1427, the Federal Circuit held that a patentee could not argue that its provisional application provided written description support for its issued claims by arguing that the provisional contained an obvious typographical error.
Enanta Pharmaceuticals sued Pfizer, alleging patent infringement. Enanta’s provisional disclosed a compound with an alkyl group containing between two and twelve carbon atoms. Pfizer later publicly disclosed a compound with a one-carbon alkyl group. Subsequently, Enanta filed a non-provisional application, which led to the asserted patent, whose claims encompassed one-carbon alkyl groups. Pfizer moved for summary judgment of invalidity, asserting that the patent could not claim priority from the provisional and was thus anticipated. Enanta argued that its provisional contained an obvious typographical error by reciting a “C2-C12-alkyl” rather than a “C1-C12-alkyl,” and it asked the district court to correct the error. The district court declined Enanta’s request and found that the patent was invalid as anticipated. Enanta appealed.
The Federal Circuit affirmed the district court’s grant of summary judgment, holding that the patent could not claim priority from the provisional. The court first held that its precedent did not authorize the district court to correct an error in the provisional application. That precedent only permits (i) the USPTO to correct certain errors in reissue proceedings, and (ii) district courts to correct errors in issued patents when “the correction is not subject to reasonable debate.” The Federal Circuit noted that the dispute was not before the USPTO, that the alleged typographical error was in a provisional application rather than an issued patent, and that “a change from C2 to C1 has not been shown here to be a correction of an obvious error.” Thus, the district court did not have the authority to correct the provisional application. However, as the district court ultimately declined to correct the provisional application, it properly considered whether the uncorrected provisional application provided written description support for the issued patent’s claims.
The Federal Circuit affirmed the district court’s written description decision. Enanta’s expert had argued that the provisional must have conflated C2 and C1 in the relevant portion of the specification because it made the same mistake elsewhere in the provisional. The Federal Circuit disagreed. It held that “C1-alkyl was simply not disclosed in the ’048 provisional” and that “an expert opinion on a typographical error contained elsewhere in the ’048 provisional does not render the former fact disputed.” The court therefore affirmed the district court’s ruling that there was no genuine dispute that the provisional’s disclosure of compounds with a two-carbon alkyl group did not provide written description support for compounds with a one-carbon alkyl group. Because Enanta’s patent could not claim priority to its provisional, it was anticipated by Pfizer’s public disclosure of a compound with a one-carbon alkyl group.
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