Justia Drugs & Biotech Opinion Summaries

Valeant’s patent claims stable methylnaltrexone pharmaceutical preparations; methylnaltrexone, a quaternary amine opioid antagonist derivative, can be useful for reducing the side effects of opioids but is unstable in aqueous solution. The inventors discovered that when the pH of a methylnaltrexone solution is adjusted, the percentage of total degradants drops significantly. The patent is listed in the Orange Book for Relistor®, an injectable drug used to treat constipation as a side effect of taking opioid medication. Mylan filed an Abbreviated New Drug Application seeking FDA approval to market a generic version of Relistor®. Mylan conceded that its ANDA product would infringe claim 8 of the patent.The district court entered the parties’ stipulation to the construction of claim 8’s stability limitation: the phrase “the preparation is stable to storage for 24 months at about room temperature” means “the methylnaltrexone degradation products in the preparation do not exceed 2.0% of the total methylnaltrexone present in the preparation and the preparation is suitable for pharmaceutical use when stored for 24 months at room temperature” and granted summary judgment that claim 8 would not have been obvious. The court rejected Mylan’s expert testimony and cited references and Mylan’s theory that the claimed pH range would have been obvious to try.The Federal Circuit reversed. Mylar raised at least a prima facie case of obviousness. The district court’s obvious-to-try analysis is inconsistent with precedent. View "Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals Inc." on Justia Law

In 1996, two doctors discovered cell-free fetal DNA in maternal plasma and serum, previously discarded as medical waste. In 2001, they obtained a patent, claiming a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman. In 2015, the Federal Circuit (Ariosa) held that the patent's claims were invalid under 35 U.S.C. 101, as directed to “matter that is naturally occurring.” The patents at issue are unrelated to the Ariosa patent and begin by acknowledging the "Ariosa" natural phenomenon, then identify a problem that was the subject of further research: there was no known way to distinguish and separate the tiny amount of fetal DNA from the vast amount of maternal DNA. The patents use an additional discovery to claim methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA.The Federal Circuit concluded that the claims are patent-eligible. These inventors patented methods of preparing a DNA fraction. The claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps to selectively remove larger fragments of cell-free DNA to enrich a mixture in cell-free fetal DNA. Those steps change the composition of the mixture, resulting in a DNA fraction that is different from the naturally-occurring fraction in the mother’s blood. View "Illumina, Inc. v. Ariosa Diagnostics, Inc." on Justia Law

Kaken’s patent, titled “Method For Treating Onychomycosis,” describes and claims methods for topically treating fungal infections in human nails. On inter partes review under 35 U.S.C. 311–319, the Patent Trial and Appeal Board determined that all claims of the patent are unpatentable for obviousness. The Federal Circuit vacated. The Board erred in its claim construction of one claim limitation--“treating a subject having onychomycosis.” Kaken’s unambiguous statement that onychomycosis affects the nail plate, and the examiner’s concomitant action based on this statement, make clear that “treating onychomycosis” requires penetrating the nail plate to treat an infection inside the nail plate or in the nail bed under it. The Board’s obviousness analysis materially relied on its erroneous claim construction. View "Kaken Pharmaceutical Co., Ltd. v. Iancu" on Justia Law

Acetris obtains its pharmaceutical products from Aurolife, which makes them in a New Jersey facility, using an active pharmaceutical ingredient made in India. Acetris had contracts to supply the VA with several pharmaceutical products, including Entecavir (used to treat hepatitis B). The VA requested that Acetris recertify its compliance with the Trade Agreements Act of 1979 (TAA), which bars the VA from purchasing “products of” certain foreign countries, such as India. Ultimately, the VA requested that Acetris obtain a country-of-origin determination. Customs concluded that the Acetris products were products of India. Acetris agreed to cancel its Entecavir contract. The VA issued a new solicitation seeking proposals for Entecavir, indicating that it would continue to rely on the Customs determination. Acetris filed suit, challenging the VA’s interpretation of the TAA. The VA awarded the Entecavir contract to Golden, consistent with its policy to award contracts to the lowest-price technically acceptable bid. The government moved to dismiss the suit, arguing that Acetris lacked standing because Acetris would not have won the contract regardless of the interpretation of the TAA and that Acetris’ earlier-filed Court of International Trade suits divested the Claims Court of jurisdiction under 28 U.S.C. 1500.The Claims Court denied the government’s motions and rejected the government’s interpretation of the TAA. The Federal Circuit affirmed in part, holding that the suit is justiciable and agreeing with the Claims Court. The court remanded for the entry of a declaratory judgment and injunction. View "Acetris Health, LLC v. United States" 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

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

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

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

Pharma Tech sued LifeScan for infringement of two patents that concern blood glucose monitoring systems for home use by individuals with diabetes. The shared specification of Pharma Tech’s patents states that the claimed inventions improve on prior art blood glucose monitoring systems by “eliminat[ing] several of the critical operator depend[e]nt variables that adversely affect the accuracy and reliability” of these systems. The specification explains that the invention accomplishes this objective by performing multiple Cottrell current measurements and comparing the results. “In a system that is operating correctly, the results should agree within reasonable limits.” The Federal Circuit affirmed summary judgment of noninfringement. Pharma Tech agreed that the accused products do not literally infringe the claim. Prosecution history estoppel bars the claims for infringement under the doctrine of equivalents; the accused system falls within the claim scope surrendered by the inventors during prosecution of the patent. View "Pharma Tech Solutions, Inc. v. LifeScan, Inc." on Justia Law