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

Pirfenidone is a drug used to treat idiopathic pulmonary fibrosis (IPF), a chronic, irreversible lung disease. There is no cure for IPF. Patients living with the disease face an average survival of two-five years. The FDA has approved two drugs for the treatment of IPF, pirfenidone, and nintedanib; differences center on side effects and metabolism. Pirfenidone was first studied as an investigational new drug in 1973. In 2004, the FDA granted pirfenidone orphan drug status for treatment of IPF. In 2014, pirfenidone was approved to treat IPF in the U.S. as Esbriet®, sold by Genentech. Sandoz submitted two Abbreviated New Drug Applications, seeking FDA approval to market a generic version of pirfenidone. Genentech then brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would induce the infringement of its patents. The asserted patents do not claim pirfenidone itself, or the use of pirfenidone to treat IPF but claim methods for managing side effects when using pirfenidone to treat IPF.The Federal Circuit affirmed district court holdings that the claims of Genentech’s Liver Function Test patents are unpatentable as obvious, sales of Sandoz’s generic product would not induce infringement of the LFT patents, and sale of Sandoz’s generic product would not directly infringe Genentech’s Drug-Drug Interaction patents. View "Genentech, Inc. v. Sandoz Inc." on Justia Law

Hanser served in the Army from 1979-1999. In 2012, he was assigned 20% service-connected disability ratings, effective July 2011, for his left leg radiculopathy and his bilateral arm radiculopathy. In 2014 and 2015, lumbar and cervical spine examinations showed improvement in his conditions. in March 2016, the VA reduced his disability ratings to 0% for both his left leg and bilateral arm radiculopathy, effective June 2016. Hanser timely filed a notice of disagreement. Following examinations in October 2017, the VA confirmed the ratings reductions in December 2017.The Board of Veterans’ Appeals and the Veterans Court concluded that the procedural protections of 38 C.F.R. 3.344 did not apply to Hanser and affirmed. The Federal Circuit affirmed. Section 3.344(c) applies the procedures of sections 3.344(a) and (b) only to disability ratings that have continued at the same level for five years or more. Hanser’s ratings do not satisfy this condition. Section 3.344(c) guides the VA’s determinations as to whether procedures that make it more difficult to reduce a rating must be followed, and provides that such procedures apply when a rating has been in place, unchanged, for a long period, parenthetically defined as five years. View "Hanser v. McDonough" on Justia Law

Mosaic manufactures a money-clip wallet called the Smart Money Clip II (SMCII). Ridge makes the Ridge Wallet, which is nearly identical to the SMCII. Each company accused the other of patent infringement. Mosaic also claimed infringement of trade dress. Following claim construction of the terms “lip,” and “of varying thickness,” the parties stipulated that Mosaic cannot prove infringement of its patent. The district court then granted summary judgment of invalidity of Ridge’s patent, based on anticipation, and denied Mosaic’s motion for summary judgment that Ridge had obtained its patent through inequitable conduct. The district court also granted Ridge summary judgment on Mosaic’s trade dress claim, finding the trade dress invalid on multiple grounds.The Federal Circuit upheld the claim construction and affirmed the dismissal of Mosaic’s infringement claim. The court found genuine disputes of material fact as to whether Mosaic’s SMCII product is prior art to Ridge’s patent and reversed the grant of summary judgment of invalidity of Ridge’s patent. The court vacated the denial of summary judgment on Mosaic’s inequitable conduct defense and affirmed the grant of summary judgment that Mosaic’s trade dress is invalid because the design is functional. View "Mosaic Brands, Inc. v. Ridge Wallet LLC" on Justia Law

Plastipak’s patents, each entitled “Lightweight Plastic Container and Preform” claim priority to U.S. Application 11/749,501, filed in 2007, which was a continuation-in-part of Application 11/368,860, filed in 2006. Each patent lists Darr and Morgan as inventors. Plastipak sued Premium Waters for infringement. Premium argued that the patents should have included a third co-inventor, Falzoni, an employee of SACMI, an Italian company. Darr had communicated with Falzoni in 2005.The district court entered summary judgment, rejecting the suit as invalid for nonjoinder under pre-AIA (America Invents Act) 35 U.S.C. 102(f). The Federal Circuit reversed, finding that genuine issues of material fact precluded summary judgment. A reasonable fact-finder, taking the evidence in the light most favorable to Plastipak as the nonmoving party, could reject Premium’s position on Falzoni’s status as a joint inventor. View "Plastipak Packaging, Inc v. Premium Waters, Inc." on Justia Law

DiMasi, then a 47-year-old nurse-practitioner student, received an influenza vaccine on December 4, 2012. She was admitted to the hospital on December 5, 2012, released the next day, and then readmitted on December 8. Almost three years later, DiMasi sought compensation under 42 U.S.C. 300aa-10 to -34 (Vaccine Act). In 2019, a special master denied compensation, noting that the parties agreed on the post-vaccination conditions at issue, ultimately diagnosed in 2016 and 2017: “small fiber neuropathy” and “postural tachycardia syndrome” (POTS), which are related. He also noted that no claim of significant aggravation of a preexisting condition had been presented and found that the vaccine was not the cause in fact of the conditions. DiMasi had 30 days to seek Claims Court review.On September 15, 2020, within a year of the final judgment, DiMasi sent the special master a letter, with medical records and other attachments, requesting that she be allowed to proceed pro se and that her case be reopened. The special master allowed DiMasi to proceed pro se and construed her request to reopen her case as a motion for relief from judgment under Claims Court Rule 60. The special master ultimately vacated the denial. The Federal Circuit appointed counsel for DiMasi and requested additional briefing, noting that it had “more questions than answers” about the findings and proceedings concerning DiMasi’s former counsel’s submissions and choices. View "DiMasi v. Secretary of Health & Human Services" on Justia Law

In 2011, Cranford, on active duty in the Army, was charged with possessing and using Spice, an unregulated intoxicant, in violation of a lawful general order. Captain Lease recommended that Cranford be tried by general court-martial and forwarded the charges. Cranford requested to be discharged in lieu of trial by court-martial, acknowledging that the Uniform Code of Military Justice authorized the imposition of a bad conduct or dishonorable discharge for the charge. Cranford admitted guilt and acknowledged that he would qualify for an “other than honorable” (OTH) discharge, potentially barring him from receiving benefits. Cranford received an OTH discharge. Cranford later requested VA benefits. The regional office denied that request, reasoning that Cranford’s discharge status barred him from receiving benefits. The Board of Veterans’ Appeals affirmed the denial, applying 38 C.F.R. 3.12(d)(1), to conclude that Cranford had been discharged under dishonorable conditions and was ineligible for benefits as a non-veteran under 38 U.S.C. 101(2).The Veterans Court and Federal Circuit affirmed, rejecting arguments that the Board mischaracterized his discharge as being “in lieu of a general court-martial,” instead of a summary court-martial and that section 3.12(d)(1) did not apply to him because he had accepted an OTH discharge, not an “undesirable discharge.” An OTH discharge accepted in lieu of a general court-martial is equivalent to an undesirable discharge—despite the military service departments’ shift in terminology. View "Cranford v. McDonough" on Justia Law

ADASA’s patent relates to methods and systems for commissioning radio-frequency identification (RFID) transponders (RFID tags), which are used, like barcodes, to identify and track objects by encoding data electronically in a compact label. RFID tags can communicate the data they encode over a distance using a radio-frequency transmission. ADASA sued Avery for infringement. ADASA argued that the asserted claims are neither anticipated by the Kuhno patent or the book RFID for Dummies nor rendered obvious by RFID for Dummies in combination with Electronic Product Code standards.The district court found the patent was directed to eligible subject matter. 35 U.S.C. 101 and valid under 35 U.S.C. 102, 103. The Federal Circuit affirmed as to eligibility but reversed as to anticipation and obviousness. There is a triable issue of fact regarding the scope of disclosures in RFID for Dummies. While Kuhno discusses the relevant concepts in different terms, with different points of emphasis than ADASA's patent, the court erred in interpreting these linguistic differences as fatal to a finding of anticipation. The district court was within its discretion to impose discovery sanctions and did not violate Avery’s due process rights but erroneously tied the monetary award to the “number of infringing tags determined to exist as of the date of the verdict.” View "ADASA, Inc. v. Avery Dennison Corp." on Justia Law

Google previously petitioned for inter partes review (IPR) of Hammond’s 483 patent, which is related to and shares the same specification as the 816 patent, disclosing a communication system that allows a communication device to execute one or more applications remotely. The Patent Trial and Appeal Board determined that all challenged claims of the 483 patent would have been obvious based on prior art combinations that included Gilmore and Dodrill. Hammond did not appeal and the decision became final.Google petitioned for IPR of all claims of the 816 patent but did not assert the same grounds against all claims. The Board held claims 1–13 and 20–30 would have been obvious over combinations of prior art, including Gilmore and Dodrill; Google failed to show claim 14 would have been obvious in view of prior art (Gilmore and Creamer) and also failed to show dependent claims 15–19 were unpatentable.The Federal Circuit reversed in part. The Board’s determination that claim 18 of the 483 patent is unpatentable renders claim 18 of the 816 patent unpatentable based on collateral estoppel. Claim 14 of the 816 patent rises and falls with claim 18 and is, therefore, unpatentable. The court rejected Google’s argument that dependent claims 15–17 and 19 would have been obvious based on the Board’s findings as to parallel dependent claims. View "Google, LLC v. Hammond Development International, Inc." on Justia Law

The Department of Energy (DOE) issued a solicitation for Technical Security, Communications Security, Cyber, Analysis, and Security Administration, designated as a small business set-aside. The size limit for interested businesses was a maximum of $20.5 million in average annual receipts. Obsidian submitted a bid proposal and self-certified as a small business based on its five-year average of annual receipts ($17.5 million). DOE notified Obsidian that it was the apparent successful offeror but submitted a request to the Small Business Administration (SBA) to confirm Obsidian’s size status before making the award. The SBA determined Obsidian did not qualify as a small business. Rather than use the five-year average of receipts, the SBA used Obsidian’s three-year average (roughly $21.8 million)The Office of Hearings and Appeals affirmed. Obsidian filed a bid protest under the Tucker Act, 28 U.S.C. 1491(b), arguing that the BA was required to start using five years of annual receipts. Obsidian cited the Runway Extension Act (REA), an amendment to the Small Business Act (15 U.S.C. 632(a)(2)), including a requirement to use a five-year average of receipts for purposes of size determinations. The Federal Circuit affirmed judgment on the administrative record in favor of the government. The REA unambiguously did not apply to the SBA. There are two subsections discussing size factors. The SBA has its own, broader limitations on establishing size standards than other agencies. View "Obsidian Solutions Group, LLC v. United States" on Justia Law

In 2005, the Defense Logistics Agency (DLA) awarded Supreme a contract to provide food to U.S. forces in Afghanistan. During negotiations concerning deliveries to forward operating bases, Supreme submitted inflated cost proposals. Supreme threatened to withhold payments to subcontractors (potentially cutting off supplies to troops), The parties executed a Modification, including Supreme’s proposed rates, subject to verification. The Defense Contract Audit Agency concluded that Supreme’s documentation was not adequate and questioned more than $375 million of claimed costs. The contracting officer, in 2011, determined that DLA had overpaid Supreme by $567,267,940. DLA withheld $540 million from Supreme’s monthly payments. Supreme submitted unsuccessful “reverse image” claims. In 2014, Supreme pled guilty to fraud and entered into a civil settlement in a False Claims Act suit. During the investigations, with Supreme’s contract expiring, the parties entered into two extensions. In 2015, based on Supreme’s guilty plea, DLA demanded the return of all money paid under the contract. In 2020, the Armed Services Board of Contract Appeals concluded that Supreme’s contract claims against the government were barred by Supreme’s prior material breach.The Federal Circuit affirmed. The government did not waive its prior material breach defense. While DLA had some notice of Supreme’s fraudulent behavior in 2009, it had no “known right” until Supreme’s guilty plea, after which DLA never extended Supreme’s contract. Supreme cannot treat the bridge contracts as separate only to evade the government’s affirmative defenses. The parties treated the original contract and the extensions as inextricably intertwined; DLA’s prior material breach defense applies to those contracts. View "Supreme Foodservice GmbH v. Director of the Defense Logistics Agency" on Justia Law