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

Molon sued Merkle-Korff, for infringement of the 785 patent. Merkle-Korff filed counterclaims relating to Molon’s 915 and 726 patents. Molon unilaterally executed the 2006 Covenant, agreeing not to sue Merkle-Korff for infringement of the 915 and 726 patents. After the dismissal of the counterclaims, the parties entered into the 2007 Settlement. Merkle-Korff agreed to pay a lump sum for an exclusive license to multiple Molon patents including the 785, 915, and 726 patents, within the Kinetek Exclusive Market. The Settlement granted Merkle-Korff “the right, but not the duty, to pursue an infringement claim” and contains a statement that all prior covenants “concerning the subject matter hereof” are “merged” and “of no further force or effect.” Merkle-Korff later became Nidec. Molon sued, alleging that Nidec is infringing the 915 patent outside the licensed Market. Nidec argued that Molon is barred from enforcing the patent under the 2006 Covenant. Molon responded that the Covenant was extinguished by the 2007 Settlement.The court granted Nidec partial summary judgment after comparing the subject matters of the agreements. The Federal Circuit affirmed; the agreements concern different subject matter and do not merge. The 2006 Covenant gives Nidec a right to avoid infringement suits on two patents. The 2007 Settlement is in some ways broader, as an exclusive license, covering multiple patents and applications and providing Nidec with some enforcement rights, and in other ways narrower, being limited to a defined market. The 2006 Covenant remains in effect because it does not concern the same subject matter as the 2007 Settlement. View "Molon Motor & Coil Corp. v. Nidec Motor Corp." on Justia Law

Farmos developed and patented Dexmedetomidine, a compound that is effective as a sedative, in the 1980s, and conducted human studies using intravenous administration of 20 µg/mL dexmedetomidine hydrochloride. Farmos abandoned its testing based on adverse effects. In 1994, Farmos’s successor granted Abbott an exclusive license to make, use, and sell dexmedetomidine in the U.S. In 1999, Abbott received FDA approval for “Precedex Concentrate,” a 100 µg/mL concentration too strong to be directly administered to patients; the label provides dilution instructions. In 2002, the European Medicines Evaluation Agency authorized the use of Dexdomitor, a ready-to-use 500 µg/mL formulation of dexmedetomidine hydrochloride. Hospira’s 106 patent, entitled “Dexmedetomidine Premix Formulation,” is directed to a liquid for parenteral administration, “wherein the composition is disposed within a sealed container as a premixture.” Fresenius sought FDA approval for a generic ready-to-use dexmedetomidine product. Hospira sued for infringement. Fresenius stipulated to infringement of the 106 patent. The Federal Circuit upheld a finding that a claim in that patent is invalid as obvious over prior art. The patent states that the invention was based on “the discovery that dexmedetomidine prepared in a premixed formulation . . . remains stable and active after prolonged storage.” It does not recite any manufacturing limitations related to stability or an added component that enhances stability; it recites a composition, with a “wherein” clause that describes the stability of that recited composition, a result that was inherent in prior art. View "Hospira, Inc. v. Fresenius Kabi USA, LLC" on Justia Law

Amgen holds an approved New Drug Application for Sensipar®, a formulation of cinacalcet hydrochloride used to treat secondary hyperparathyroidism in adult patients with chronic kidney disease who are on dialysis and to treat hypercalcemia in patients with parathyroid cancer and primary and secondary hyperparathyroidism. Amneal, Piramal, and Zydus each filed an Abbreviated New Drug Application (ANDA) seeking to enter the market with a generic version of Sensipar®. Amgen sued each ANDA filer, alleging that the proposed ANDA products would infringe its 405 patent, which is directed to a rapid dissolution formulation of cinacalcet. The district court entered a judgment of non-infringement. The Federal Circuit vacated in part, finding that the district court construed the claims incorrectly and erred in its analysis of infringement by Amneal. The court affirmed with respect to Piramal and Zydus, finding that the district court properly applied prosecution history estoppel to Amgen’s arguments regarding Piramal and otherwise did not err in its factual findings for Zydus. View "Amgen Inc. v. Amneal Pharmaceuticals LLC" on Justia Law

Shealey served on active duty in Vietnam. He sought service connection for a cervical spine disability and major depressive disorder. The Board of Veterans’ Appeals held that Shealey was dishonorably discharged. Before Shealy filed his third motion for reconsideration, the Army Board for Correction of Military Records upgraded his discharge to “under honorable conditions.” The Board denied reconsideration. Shealey sought assistance from Veterans Legal Advocacy Group (VetLAG), a nonprofit law firm; VetLAG would not charge a fee and if the Veterans Court granted attorney’s fees, VetLAG could keep the full amount. Shealey agreed that VetLAG could apply for attorney’s fees and litigation expenses under the Equal Access to Justice Act, 28 U.S.C. 2412(d) (EAJA), and he would provide assistance. VetLAG represented Shealey before the Veterans Court for three months until a pre-briefing conference, where the government stated its intent to move for dismissal. The attorneys advised Shealey to file a new claim to reopen his case. Shealey disagreed, discharged them, and obtained new counsel. The court vacated the Board’s decision. The government did not dispute that Shealey was the “prevailing party” and did not oppose VetLAG's EAJA motion seeking $4,061.60. Shealey opposed the application. The court determined that VetLAG lacked standing. The Federal Circuit affirmed. Under EAJA’s plain text, the attorneys lack any substantive rights sufficient to confer standing. Affording standing to the attorneys over Shealey’s objections would contravene the policies on which the third-party standing doctrine is based. The fee agreement did not constitute an assignment. View "Shealey v. Wilkie" on Justia Law

The Kreizenbecks sought compensation under the National Vaccine Injury Act, 42 U.S.C. 300aa-1–34, alleging that vaccinations administered to their son aggravated an underlying mitochondrial disorder and caused him to suffer immune system dysfunction and other medical problems. They submitted 1,500 pages of medical records, medical literature, Mrs. Kreizenbeck's affidavit, and reports from three medical experts. The government submitted reports from three experts. The Special Master determined that “a ruling on the papers was preferable to a hearing,” expressed “serious misgivings about the claims’ substantive validity,” and explained that if the parties proceeded to a hearing, he was unlikely to compensate the Kreizenbecks for costs. The Kreizenbecks chose to forgo a hearing but objected to a ruling on the record. The Master allowed the parties to submit final briefs, then determined that nothing in the record and expert reports suggested that the outcome would be different after a hearing. He found the government’s mitochondrial expert “reliable and persuasive,” the Kreizenbecks’ expert reports “conclusory or unsubstantiated” and Mrs. Kreizenbeck’s affidavit uncorroborated and inconsistent with the medical records. The Kreizenbecks did not dispute the substance of the claim denial but challenged the dismissal of their petition on the written record.The Claims Court affirmed, finding that the Master provided ample opportunity to support the claims with written material. The Federal Circuit affirmed, noting the Master’s broad discretion to rule on the record and rejecting a due process argument based on evaluating the credibility of the experts and Mrs. Kreizenbeck without live testimony or cross-examination. View "Kreizenbbeck v. Secretary of Health and Human Services" on Justia Law

In 2006-2010, the U.S. Agency for International Development (USAID) awarded DAI developmental services contracts for Afghanistan. DAI subcontracted with EI, which employed over 1,000 individuals to provide security services. Afghanistan imposed a $2 million fine on EI based on the size and composition of EI’s private security workforce. EI paid the fine, allocating the expense among DAI’s contracts. In May 2017, DAI submitted EI’s claims to USAID. DAI’s cover letter characterized itself as a certification. DAI also included EI’s certifications stating that each claim was in good faith; 70 days after DAI submitted its claims, the contracting officer notified DAI that the submission did not contain a contractor certification. DAI filed appeals. The Board dismissed DAI’s claims for lack of jurisdiction based on DAI’s failure to certify the claims (41 U.S.C. 7103(a)(1)), stating that DAI’s May 2017 certification bore no resemblance to the required statutory language, that DAI made its certification with reckless disregard for the requirements, and that nontechnical mistakes in the certification and DAI’s recklessness rendered DAI’s purported certification unsalvageable.The Federal Circuit reversed. The statute provides that “[a] defect in the certification of a claim does not deprive a court or an agency board of jurisdiction over the claim.” EI’s certifications, which mirror the certification language of 48 C.F.R. 33.207(c), evidence an intent to certify the claims. Because the contracting officer failed to issue a decision within the statutory period, DAI’s claim was deemed denied and became appealable, 41 U.S.C. 7103(f)(5). View "DAI Global, LLC v. Administrator of United States Agency for International Development" on Justia Law

Persion’s 760 and 499 patents, both entitled “Treating Pain in Patients with Hepatic Impairment” share a common written description and priority date and are directed to methods of treating pain in patients with mild or moderate compromised liver functionality, using extended-release hydrocodone-only formulations. Hydrocodone is an opioid, widely used to treat pain, and has been FDA-approved since 1943. The patents cover the formulation for Zohydro ER.4. Persion sued, alleging that Alvogen infringed the patents by filing an Abbreviated New Drug Application seeking to market a generic version of Zohydro ER.4. The Federal Circuit affirmed a finding that the patents are invalid as obvious. The district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims. Regardless of whether the court’s consideration of the FDA’s statement was proper, there was no clear error in the court’s finding that there was a motivation to combine prior art in light of the evidence as a whole. The district court considered Persion’s evidence of objective indicia together with the other evidence on the issue of obviousness and there is no inconsistency between the district court’s findings underlying its obviousness and lack of written description determinations. View "Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd." on Justia Law

IV alleged infringement of patents directed to filtering data files (such as email messages) based on content. The court severed the defendants. During claim construction in the Symantec action, IV’s expert consistently opined that a “characteristic” as used in asserted claims is “an attribute of the document such as whether it contains a virus or is SPAM or bulk email or includes copyrighted content.” The court adopted that construction. At the Symantec trial, IV’s expert changed his opinion, testifying that bulk email was not a characteristic. During a clarification hearing, IV’s counsel maintained that the expert had not changed his opinion and that bulk email “never was” within the scope of claim 9. The court clarified its claim constructions, stating that it “learn[ed] only at the last minute” that IV understood the construction to mean “that bulk email was excluded from claim 9 when it was clearly in the other claims ... a surprise inconsistent with the representations from” IV, and not what was intended. The court granted Micro judgment in part, holding the asserted claims invalid, canceled the Micro trial, and concluded that IV’s conduct was exceptional “solely with respect to” the changed testimony but that the case overall was not exceptional under 35 U.S.C. 285 and awarded Micro $444,051.14 in attorney fees.The Federal Circuit vacated. The district court should have determined whether the circumstances surrounding the expert’s changed opinion were such that, when considered as part of the totality of circumstances, the case stands out as exceptional, i.e., the case stands out among others with respect to the substantive strength of a party’s litigating position or the unreasonable manner in which the case was litigated. View "Intellectual Ventures I LLC v. Trend Micro Inc." on Justia Law

SRAM’s patent generally covers an improved bicycle chainring structure that better maintains the chain, obviating the need for extraneous structures. On inter partes review, the Patent Trial and Appeal Board found that the prior art references disclose all the limitations of the SRAM patent’s independent claims and that a skilled artisan would have been motivated to combine the asserted prior art. The Board nevertheless concluded, based on its analysis of secondary considerations, that the challenged claims would not have been obvious. The Federal Circuit vacated. In order to accord substantial weight to secondary considerations in an obviousness analysis, the evidence of secondary considerations must have a nexus to the claims; there must be a legally and factually sufficient connection between the evidence and the patented invention. The Board erred in presuming nexus between the independent claims and secondary considerations evidence pertaining to SRAM’s chainrings. On remand, SRAM will have the opportunity to prove a nexus between the challenged independent claims and the evidence of secondary considerations--that the evidence of secondary considerations is attributable to the claimed combination of wide and narrow teeth with inboard or outboard offset teeth, as opposed to, for example, prior art features in isolation or unclaimed features. View "FOX Factory, Inc. v. SRAM, LLC" on Justia Law

Syngenta sued Willowood, a Hong Kong company that sells fungicide to its Oregon-based affiliate, for infringement of patents directed to a fungicide compound and its manufacturing processes and infringement of copyrights for detailed product labels that provide directions for use, storage, and disposal, plus first-aid instructions and environmental, physical, and chemical hazard warnings. The district court dismissed the copyright claims as precluded by the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 135 and granted-in-part Syngenta’s summary judgment motion with respect to patent infringement. After a jury trial, the court entered a defense judgment on the patent claims. The Federal Circuit affirmed-in-part, reversed-in-part, and vacated in part. The district court did not provide an adequate analysis of the potential conflict between FIFRA and the Copyright Act. Because FIFRA does not, on its face, require a “me-too” registrant to copy the label of a registered product, FIFRA only conflicts with the Copyright Act to the extent that some particular element of Syngenta’s label is both protected under copyright doctrines and necessary for the expedited approval of Willowood’s generic pesticide. The court erred by imposing a single-entity requirement on the performance of a patented process under 35 U.S.C. 271(g); practicing a patented process abroad does not trigger liability under section 271(g) in the same manner that practicing a patented process domestically does under section 271(a). View "Syngenta Crop Protection, LLC v. Willowood, LLC" on Justia Law