Justia Intellectual Property Opinion Summaries

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

VVV appealed the district court's dismiss of its trademark claims based on three marks and the denial of leave to amend its complaint. The Ninth Circuit assumed, without deciding, that the district court correctly applied the elements of claim preclusion to this case, but found that an exception to claim preclusion applied.The panel explained that an interparty proceeding before the TTAB is a limited proceeding involving registration of a trademark, and the TTAB has no authority to determine the right to use, or the broader questions of infringement, unfair competition, damages or injunctive relief. In this case, TTAB had no power to decide VVV's claims of infringement, dilution, and unfair competition or to grant either injunctive relief or damages. Therefore, the panel held that it would be unfair to preclude VVV from litigating these claims and seeking relief when barriers existed that prevented it from doing so in the first action. The panel reversed and remanded for the district court to consider, in the first instance, whether issue preclusion applied. The panel also reversed the denial of leave to amend the complaint, and affirmed the dismissal of plaintiff's claims as to the second and third marks. View "V.V.V. & Sons Edible Oils v. Meenakshi Overseas" on Justia Law

The Ninth Circuit affirmed the district court's dismissal, for failure to state a claim, of an action brought by Great Minds, publisher of math curriculum Eureka Math. The complaint alleged a claim of copyright infringement against Office Depot.The panel held that Office Depot did not itself become a licensee of the "Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International Public License" or otherwise infringe Great Minds' copyright by making copies of Eureka Math materials for a profit on behalf of school and school district licensees. In this case, there was no dispute that, if Office Depot were itself a licensee, commercial copying of Great Minds' material would fall outside the scope of the license and infringe Great Minds' copyright; under California law, the school and school district licensees' exercise of their rights under the license through the services provided by Office Depot did not result in Office Depot becoming a licensee; and the district court not abuse its discretion in denying leave to amend the complaint. View "Great Minds v. Office Depot, Inc." 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

Chamberlain’s 611 patent, entitled “Barrier Movement Operator Human Interface Method and Apparatus,” is directed to improved methods of human interaction with “barrier movement operators,” such as garage door operator systems. Claims 18–25 of the patent are directed to an “interactive learn mode” that “guide[s] a user through installation and learn mode actions.” On inter partes review, the Patent Trial and Appeal Board found those claims anticipated, 35 U.S.C. 102(b) and 103(a). The Federal Circuit affirmed the findings as supported by substantial evidence. The disclosure, in prior art, of transmitting the signals in sequence, one after the other in response to the previously-completed steps of identifying the garage door operator’s present status and activities to be completed teaches the “responsive to” step in the challenged claim. View "Chamberlain Group, Inc. v. One World Technologies, Inc." on Justia Law

Amgen’s patents relate to erythropoietin (EPO) isoforms and aspects of their production. EPO is a glycoprotein hormone that regulates red blood cell maturation and production. Recombinant human EPO is an important therapeutic protein for the treatment of anemia. Amgen manufactures and markets recombinant human EPO as Epogen. Hospira submitted its Biologics License Application (BLA) to the FDA, seeking approval for a biosimilar to Amgen’s Epogen product. Amgen sued Hospira for infringement under 35 U.S.C. 271(a) and 271(e)(2)(C). A jury found the asserted claims not invalid and infringed. Of the 21 accused drug substance batches, the jury found seven batches entitled to the Safe Harbor defense. The jury awarded Amgen $70 million in damages. The Federal Circuit affirmed, upholding the district court’s claim construction and finding substantial evidence of infringement. Section 271(e)(1) carves out a "Safe Harbor” exception to patent infringement liability when otherwise-infringing activities are solely for uses reasonably related to obtaining FDA approval. Substantial evidence supports the jury’s finding that the 14 batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA. View "Amgen Inc. v. Hospira, Inc." on Justia Law