Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Since 2014 Par has manufactured and sold Vasostrict®, an FDA-approved vasopressin injection product used to treat patients with critically low blood pressure. The Orange Book identifies Par’s 785 and 209 patents as encompassing Vasostrict®. Both patents require the vasopressin composition to have a rounded pH between 3.7–3.9. In 2018, Eagle filed an abbreviated new drug application (ANDA) to manufacture and sell a generic version of Vasostrict® before those patents expired. Eagle represented in its release specification that the pH range would be between 3.4–3.6. Eagle’s ANDA also contained 35 U.S.C. 355(j)(2)(A)(vii)(IV) certification that Par’s patents are invalid or will not be infringed by Eagle’s proposed product.Par sued for infringement under 35 U.S.C. 271(e)(2). Eagle stipulated that its proposed product would meet all asserted claim limitations except the claimed pH range. Par argued that “real-world” evidence shows the pH of Eagle’s product drifts up over time and that Eagle sought authority to release products into the marketplace with a pH of 3.64, just 0.01 beneath the infringing range. The Federal Circuit affirmed the rejection of those arguments. Minor fluctuations in pH value identified by Par did not reveal any discernible trend and the stability specification imposed an additional constraint that Eagle’s proposed product maintain a pH between 3.4–3.6 from the time of its distribution through its entire shelf life. View "Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc." on Justia Law

In 2012, Click-to-Call sued several entities (including Ingenio) for infringement of its patent. Ingenio filed a petition for inter partes review (IPR) challenging the 16 asserted claims and one additional claim. While the petition was pending, the district court issued a Markman order construing certain claim terms and required plaintiffs to narrow their asserted claims to eight claims. Click-to-Call selected claims 1, 2, 8, 12, 13, 16, 26, and 27. The Board partially instituted IPR, found persuasive unpatentability grounds based on one reference, Dezonno, but refused to consider grounds based on another reference, Freeman. The Freeman grounds challenged asserted claim 27, whereas the Dezonno grounds did not. While appeal of the IPR was pending, the Supreme Court overruled the practice of partial institutions in “SAS” (2018). Ingenio never sought remand under SAS for the Board to consider Ingenio’s challenge to claim 27.In post-IPR district court proceedings, Ingenio moved for summary judgment, arguing that the only asserted claim not finally held unpatentable in the IPR, claim 27, was invalid based on the same reference that Ingenio had used against the other asserted claims in its IPR petition—Dezonno. Click-to-Call unsuccessfully argued that Ingenio was estopped from pressing this invalidity ground against claim 27, citing IPR estoppel, 35 U.S.C. 315(e)(2). The Federal Circuit reversed and remanded. The district court erred in not applying IPR estoppel to claim 27 based on Dezonno. View "Click-to-Call Technologies, LP- v. Ingenio, Inc." on Justia Law

Centripetal filed an infringement complaint against PAN, which then filed an inter partes review (IPR) petition for one patent and a post-grant review (PGR) petition for another. While the petitions were pending, the Patent and Trademark Office (USPTO) updated its interim guidance, noting that the agency “does not accept requests for Director review of decisions on institution.” The Patent Trial and Appeal Board denied institution. PAN filed Requests for Director Rehearing. The agency responded that USPTO "does not accept requests for Director review of decisions on institution ... parties may only request Director review of final written decisions" issued in IPR and PGR and that PAN’s “rehearing requests will not revert to the Board panel and there will be no further review of the Board’s decision.”PAN sought mandamus relief. A newly-appointed Director updated the interim guidance to state that “the Office does not accept requests for Director review of institution decisions” but that “the Director has always retained and continues to retain the authority to review such decisions sua sponte.” The Director has since exercised that authority. PAN argues that the Director’s current policy was contrary to the Appointments Clause, as interpreted by the Supreme Court in “Arthrex,” (2021). The Federal Circuit denied the petition. That the Appointments Clause requires that a Presidentially-appointed, Senate-confirmed officer have review authority does not mean that a principal officer, once bestowed with such authority, cannot delegate it to other agency officers. View "In Re Palo Alto Networks, Inc." on Justia Law

Kamstrup’s 957 patent describes ultrasonic flow meters and housings. The specification discloses that the meters are used for “calculating a consumed quantity of water, heat, cooling, gas or the like.” Ultrasonic flow meters include “housing” to protect electronic components, such as a display or battery. The patent is directed to “an ultrasonic flow meter housing in the form of a monolithic polymer structure being cast in one piece.” It explains that “the present invention can be fabricated with a reduced number of steps compared to existing meters.Axioma petitioned for inter partes review of all 15 claims. The Federal Circuit affirmed the Patent Trial and Appeal Board in finding the challenged claims unpatentable as obvious or anticipated, construing “cast in one piece” as a product-by-process claim element. Kamstrup did not present any evidence showing that the claim element provided structural and functional differences distinguishing it from the prior art. View "Kamstrup A/S v. Axioma Metering UAB" on Justia Law

In 2006, LaBonte went absent without leave (AWOL) from the Army for six months. He voluntarily returned to his base, pleaded guilty to desertion in a court-martial proceeding, and received a Bad Conduct Discharge. In 2012, LaBonte was diagnosed with post-traumatic stress disorder (PTSD), stemming from his combat service in Iraq. In 2014, he was found eligible for VA benefits for service-connected PTSD, traumatic brain injury, depression, headaches, back pain, tinnitus, a painful scar, and ulcers. In 2016, LaBonte received a 100% service-connected disability rating.In 2015, LaBonte applied to the Army Board for Correction of Military Records (ABCMR), seeking retroactive medical retirement. He alleged that, while in the Army, he had permanent disabilities incurred during service that rendered him unfit for service before his absence without leave. In 2020, on remand, ABCMR again denied LaBonte’s claim. The Claims Court dismissed an appeal, finding that, in order for ABCMR to grant LaBonte disability retirement, it would have to correct LaBonte’s DD-214 Form to show that he was separated due to physical disability rather than due to a court-martial conviction and that 10 U.S.C. 1552(f), prohibited such a correction. The Federal Circuit reversed. ABCMR was not required to change LaBonte’s DD-214 in order to grant him disability retirement. The 214 is a record of events, not intended to have any legal effect on the termination of a soldier’s service. View "LaBonte v. United States" on Justia Law

Meyer imports cookware. Each cookware item manufactured in Thailand began as a steel disc imported from China. In Thailand, the manufacturer transforms the discs into finished cookware and sells finished cookware to distributors in Macau and Hong Kong. The manufacturers, distributors, and Meyer have a common parent/shareholder.Meyer requested duty-free treatment for the cookware produced in Thailand, based on Thailand’s status as a beneficiary developing country under the Generalized System of Preferences. Meyer also asked Customs to value its cookware based on the first-sale price that its affiliated distributors paid to the manufacturers. Customs denied duty-free treatment and assessed duties based on the second-sale price that Meyer paid to its distributors. The Court of International Trade ruled that raw materials from nonbeneficiary developing countries must undergo a “double substantial transformation” in the beneficiary developing country to count toward duty-free treatment and the manufacturer did not substantially transform the input a second time by converting the shell into a finished pot; Meyer failed to show that an unfinished shell is a “distinct article of commerce.”The Federal Circuit affirmed in part. The Trade Court properly found only one substantial transformation but erred in requiring Meyer to prove that the first sales were at arm’s length and also unaffected by China’s status as a non-market economy. The court remanded for reconsideration of whether Meyer may rely on its first-sale prices. View "Meyer Corp., U.S. v. United States" on Justia Law

The 601 patent addresses error rates related to recording data to computer storage devices. Dr. Moon, a UMN professor, and Dr. Brickner, a UMN graduate student, developed maximum transition-run coding to reduce error-prone patterns; their work became the basis for the 601 patent. UMN sued LSI for infringement. On inter partes review, the Patent Trial and Appeal Board concluded that claim 13 was unpatentable in view of prior art (Okada) and that claims 14 and 17 were not unpatentable in view of either Okada or the Tsang prior art reference; the Tsang reference was not prior art because it was not “by another” under 35 U.S.C. 102(e).The Federal Circuit affirmed. The Board properly found that the material in the Tsang patent that exceeded the disclosure of the Seagate Report was not relevant to the anticipation challenge to claims 14 and 17 and that summarizing the Seagate Report in Tsang did not make Tsang an inventor of the material. There is no contention that the Seagate Report can be relied upon as prior art to the 601 patent since Dr. Moon and Dr. Brickner are both listed as the only authors of the Seagate Report and as the only inventors of the 601 patent. View "LSI Corp. v. Regents of the University of Minnesota" on Justia Law

The Federal Circuit previously affirmed summary judgment of no invalidity for claim 1 of the 348 patent in favor of Hologic, applying the doctrine of assignor estoppel against Minerva. The patent covers an endometrial ablation device for the treatment of uterine bleeding that eliminates the problem of “steam and liquid buildup at the ablation site.” The Supreme Court vacated, holding that assignor estoppel remains a valid doctrine, but that it comes with limits. On remand, the Federal Circuit again affirmed.Claim 1 is not “materially broader” than the claims assigned to Hologic such that assignor estoppel should not apply. Minerva is estopped from challenging the validity of claim 1. Minerva did not dispute that Truckai executed a broad assignment of his patent rights to NovaCept and later sold NovaCept to Hologic’s predecessor; that NovaCept received appreciable value for those patent rights; that Truckai founded Minerva and used his expertise to research, develop, and obtain FDA approval for Minerva’s Endometrial Ablation System; that his job responsibilities included bringing the System to market to compete with Hologic; and that he is in privity with Minerva. View "Hologic, Inc. v. Minerva Surgical, Inc." on Justia Law

In 2008, McDonald filed a patent application for methods and systems related to the display of search results. Several original claims did not recite a “processor” for conducting the claimed searches. The examiner rejected those claims as directed to patent-ineligible subject matter under 35 U.S.C. 101. McDonald amended the claims, adding a “processor” to certain claim limitations. The examiner withdrew the rejection. While the application leading to the 901 patent was pending, McDonald filed a continuation application, which resulted in the 111 patent; the claims in the continuation application included “processor” limitations. In 2015, McDonald filed a reissue application seeking to broaden the claims of the 111 patent, including amendments to remove the “processor” limitations. The examiner rejected multiple claims as obvious.The Patent Board affirmed, rejecting the reissue claims as being based on a defective reissue declaration lacking an error correctable by reissue and rejecting certain claims as impermissibly attempting to recapture subject matter that the patentee intentionally surrendered to overcome an eligibility rejection. The Federal Circuit affirmed. The Board properly applied the recapture rule; McDonald deliberately—not erroneously or inadvertently—added the “processor” limitations during the prosecution of the original claims to overcome the rejection. The error pinpointed in the Inventor Reissue Declaration—the existence of the allegedly unnecessary “processor” limitations—is uncorrectable because doing so would violate the recapture rule. View "In Re McDonald" on Justia Law

The United States Court of Appeals for the Federal Circuit held that the interim relief statute does not preclude a second removal action while a first removal action is still pending when the second action cures a procedural deficiency in the first action.The Department of the Treasury initiated a removal action against Petitioner charging him with misuse of government property. Treasury sustained the charge and removed Petitioner. A Board administrative judge (AJ) reversed based on a due process defect in the action. Treasury and Petitioner both petitioned for review. While that petition was pending, Treasury initiated a second removal action based on the same charge and specifications that cured the procedural deficiency in the first removal action. Treasury then removed Petitioner. An AJ upheld the second removal action, and that decision became the Board's decision. The Federal Circuit affirmed, holding that Treasury was not precluded from initiating the second action while the first action was still pending. View "Coy v. Dep't of Treasury" on Justia Law