Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the Federal Circuit
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Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells, which are responsible for processing information to develop an immune response in the body using receptors on their surfaces. The named inventor Dr. Honjo, a professor at Kyoto University, had shared information with Drs. Wood and Freeman until about 2001. In 2002, Honjo filed his patent application in Japan. Each patent at issue case claims priority from that patent application; none include Freeman and Wood as inventors. The Federal Circuit affirmed that Drs. Freeman and Wood should be deemed inventors of the subject matter of the patents alongside Dr. Honjo, 35 U.S.C. 116(a). The inventorship of a complex invention may depend on partial contributions to conception over time, and there is no principled reason to discount genuine contributions made by collaborators because portions of that work were published prior to conception for the benefit of the public. Earlier publication of an invention is obviously a potential hazard to patentability, but the publication of a portion of a complex invention does not necessarily defeat joint inventorship of that invention. View "Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd." on Justia Law

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Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin. Amgen filed a biologics license application, 42 U.S.C. 262(k) to market a biosimilar version of Avastin—Mvasi. Mvasi received FDA approval effective September 2017. In October, Amgen notified Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. In August 2018, Amgen filed a third supplement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label. By July 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech filed motions, seeking to preclude Amgen from commercially marketing Mvasi until Amgen “provides notice of its intent to commercially market such product” pursuant to 42 U.S.C. 262(l)(8) and 180 days have elapsed,” arguing that Amgen’s third and fourth supplements resulted in new and distinct applications that require new notices. The Federal Circuit affirmed the denial of the motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements. View "Genentech, Inc. v. Immunex Rhode Island Corp." on Justia Law

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In July 2010, L.M. was born at full-term and developed normally for six months. In February 2011, L.M. received childhood vaccines, including the diphtheria-tetanus-acellular pertussis vaccination. By that evening, L.M. had a fever, was lethargic, had poor muscle tone, and would not eat., Any disturbance caused L.M. to scream. L.M. began to have several seizures a day. At seven years of age, L.M. could crawl and walk with the assistance of a walker. She had a poorly coordinated grasp, suffered cortical visual impairments, and was nonverbal, though she could use a few signs to express ideas such as “yes,” and “no.” Testing revealed that L.M. had a genetic mutation. In a claim under the National Vaccine Injury Compensation Program, L.M. alleged that the vaccinations administered to L.M. in February 2011, significantly aggravated L.M.’s pre-existing condition under two alternative theories. The Special Master denied the petition, finding that L.M.’s genetic mutation was “the most compelling explanation for her predisposition to develop a seizure disorder.” The Federal Circuit affirmed the denial of an “on-table” claim, finding no support for an argument that most encephalopathies do not become acute until after vaccination. The court vacated and remanded the denial of an “off-table” claim, which requires determining whether the child’s receipt of vaccinations significantly aggravated her seizure disorder in the face of an underlying genetic mutation. View "Sharpe v. Secretary of Health and Human Services" on Justia Law

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The patents at issue are directed to the fusion protein etanercept and methods of making the same. Etanercept is the active ingredient in Immunex’s biologic drug Enbrel®, which is primarily indicated for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis, an autoimmune disorder. Sandoz filed an abbreviated Biologics License Application (aBLA), seeking approval to market Erelzi, a biosimilar version of Enbrel®. In a patent infringement suit under the Biologics Price Competition and Innovation Act, Sandoz stipulated to infringement of the asserted claims of the patents-in-suit. The district court held that Sandoz had failed to prove that the asserted claims of the patents-in-suit were invalid. The Federal Circuit affirmed, rejecting claims of obviousness-type double patenting; failure to meet the written description requirement; and obviousness. View "Immunex Corp v. Sandoz Inc." on Justia Law

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Cochlear’s patent describes a hearing aid with several parts. A vibration-producing component is implanted and mechanically anchored into a patient’s skull on the patient’s deaf side. An external component, which includes a microphone, picks up sound on the patient’s deaf side, processes the sound, and generates vibrations in the implanted part, which are transmitted through th skull to the patient’s non-deaf ear, which then perceives sound originating from the deaf-ear side. The Patent and Trademark Office instituted two inter partes reviews, 35 U.S.C. 311–319, and concluded that claims 4–6 and 11–12 had been proven unpatentable; claims 7–10 were not unpatentable. Cochlear disclaimed claims 1–3 and 13. The Federal Circuit affirmed except with respect to claim 10, as to which it vacated. The Board correctly held that the preamble phrase “for rehabilitation of unilateral hearing loss” is not a limitation on the scope of the apparatus claims. The court upheld obviousness determinations concerning claims 4-6 and found claims 11-12 anticipated by prior art. On remand with respect to claim 10, the Board should consider whether the directivity-dependent-microphone alternative is outside the scope of 35 U.S.C. 112, because it recites a structure (the directivity dependent microphone) that sufficiently corresponds to the claimed directivity means. View "Cochlear Bone Anchored Solutions AB v. Oticon Medical AB" on Justia Law

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Eage filed suit, alleging infringement of four patents under the doctrine of equivalents, stemming from Slayback’s new drug application for a generic version of Eagle’s branded bendamustine product, BELRAPZO®. Bendamustine is used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. The district court entered a judgment of non-infringement on the pleadings. The Federal Circuit affirmed, rejecting Eagle’s arguments that the district court erred when it concluded that the asserted patents disclose, but do not claim, ethanol—and therefore dedicated ethanol to the public and that the district court improperly applied the dedication disclosure doctrine at the pleadings stage, in the presence of factual disputes and without drawing all inferences in Eagle’s favor. The disclosure-dedication doctrine bars application of the doctrine of equivalents: “when a patent drafter discloses but declines to claim subject matter, . . . this action dedicates the unclaimed subject matter to the public.” The application of the doctrine is a question of law. The asserted patents disclose ethanol as an alternative to propylene glycol in the “pharmaceutically acceptable fluid” claim limitation. The only reasonable inference that can be made from the disclosures is that a skilled artisan would understand the patents to disclose ethanol as an alternative to the claimed propylene glycol. View "Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC" on Justia Law

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Biogen holds the New Drug Application for the active ingredient dimethyl fumarate (DMF), which was FDA-approved in 2013 as Tecfidera®, a twice-daily pill for the treatment of relapsing forms of multiple sclerosis at a daily dose of 480 mg. The 001 patent, “Utilization of Dialkylfumarates,” discloses that dialkyl fumarates may have therapeutic uses “in transplantation medicine and for the therapy of autoimmune diseases,” including multiple sclerosis. After the five-year data exclusivity for Tecfidera® expired, Banner submitted an application under 21 U.S.C. 355(b)(2) to market a twice-daily monomethyl fumarate (MMF) pill at a daily dose of 380 mg. Biogen alleged infringement of the 001 patent. Banner argued that section 156(b)(2) limits the scope of the patent’s extension to methods of using the approved product as defined in 156(f)—DMF, its salts, or its esters—and that MMF is none of those things. Biogen responded that section 156(b)(2) limits extension only to uses of any product within the original scope of the claims. The patent will expire in June 2020. The Federal Circuit affirmed the district court’s finding of non-infringement. The monomethyl ester, covered by claim 1, is not covered by the extension. The scope of a patent term extension under 35 U.S.C. 156 only includes the active ingredient of an approved product, or an ester or salt of that active ingredient; the product at issue does not fall within those categories. View "Biogen International GmbH v. Banner Life Sciences, LLC" on Justia Law

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CardioNet’s 207 patent, titled “Cardiac Monitoring,” claims priority to an application filed in 2004 and describes cardiac monitoring systems and techniques for detecting and distinguishing atrial fibrillation and atrial flutter from other various forms of cardiac arrythmia. The district court dismissed CardioNet’s patent infringement complaint against InfoBionic, finding that the asserted claims of the patent are ineligible under 35 U.S.C. 101. The Federal Circuit reversed, applying the Supreme Court’s two-step “Alice” framework and finding that the asserted claims of the 207 patent are directed to a patent-eligible improvement to cardiac monitoring technology and are not directed to an abstract idea. Nothing in the record suggests that the claims merely computerize pre-existing techniques for diagnosing atrial fibrillation and atrial flutter. View "CardioNet, LLC v. InfoBionic, Inc." on Justia Law

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Nevro sued, alleging infringement of 18 claims across seven patents that are directed to high-frequency spinal cord stimulation therapy for inhibiting pain. Conventional spinal cord stimulation systems deliver electrical pulses to the spinal cord to generate sensations, such as tingling or paresthesia, that mask or otherwise alter the patient’s pain. The claimed invention purportedly improves conventional spinal cord stimulation therapy by using waveforms with high-frequency elements or components, which are intended to reduce or eliminate side effects. The district court issued a joint claim construction and summary judgment order, holding certain claims invalid as indefinite. As to the remaining six claims, found not indefinite, the court granted summary judgment of noninfringement. The Federal Circuit vacated and remanded. The district court erred in holding invalid as indefinite the “paresthesia-free” system and device terms and in holding indefinite the claims reciting the term “configured to.” The Federal Circuit construed “configured to” to mean “programmed to” and construed “means for generating” as a means-plus-function term, having a function of “generating” and a structure of “a signal/pulse generator configured to generate” the claimed signals. The district court erred in its claim construction but correctly determined that the term “therapy signal” does not render the claims indefinite; a “therapy signal” is “a spinal cord stimulation or modulation signal to treat pain.” View "Nevro Corp. v. Boston Scientific Corp." on Justia Law

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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