Justia U.S. Federal Circuit Court of Appeals Opinion SummariesArticles Posted in Drugs & Biotech
Bio-Rad Laboratories, Inc. v. 10X Genomics Inc.
Bio-Rad’s patents are directed to systems and methods for forming microscopic droplets (plugs) of fluids to perform biochemical reactions. Microfluidic systems—often called “labs-on-a-chip”—allow scientists to conduct microscale chemical and biological reactions. For example, the technology allows scientists to analyze and compare DNA, RNA, and proteins within large numbers of individual cells. This technology has applications in medical diagnostics and high-throughput screening. In an infringement suit, the jury found all three patents valid and willfully infringed and awarded damages of $23,930,716. The court granted Bio-Rad’s motion for a permanent injunction. The Federal Circuit affirmed the judgment of infringement of one patent (which covers all six accused products) and the entire damages award. Prosecution history estoppel does not apply and 10X’s challenges concerning the infringement under the doctrine of equivalents fail. The court reversed the district court’s construction of the asserted claims of two patents, vacated the judgment of infringement of those patents, and remanded for a new trial on the issue of whether 10X’s accused products infringe those patents under the proper claim construction. The court also vacated the injunction with respect to 10X’s Linked-Reads and CNV product lines. View "Bio-Rad Laboratories, Inc. v. 10X Genomics Inc." on Justia Law
Takeda Pharmaceuticals U.S.A. v. Mylan Pharmaceuticals, Inc.
Takeda sued Mylan for patent infringement based on Mylan’s Abbreviated New Drug Application (ANDA) for a generic version of Takeda’s Colcrys® version of the drug colchicine. The parties settled, entering into a License Agreement that allows Mylan to sell a generic colchicine product on a specified date or under circumstances defined in Section 1.2, which refers the date of a final court decision holding that all unexpired claims of the licensed patents that were asserted and adjudicated against a third party are not infringed, invalid, or unenforceable. The parties stipulated that Mylar's breach of Section 1.2 “would cause Takeda irreparable harm.”Takeda also sued Hikma based on Hikma’s FDA-approved colchicine product Mitigare®. The district court granted summary judgment of non-infringement. After Mylan launched its product, Takeda sued, alleging breach of contract and patent infringement.The Federal Circuit affirmed the denial of a preliminary injunction. Takeda failed to show it is likely to succeed on the merits or that it will suffer irreparable harm. Section 1.2(d) was triggered by the third-party litigation; all unexpired claims of the three patents that were “asserted and adjudicated” were held to be not infringed. An objective, reasonable third party would not read Section 1.2(d) to be limited to generic equivalents of Colcrys® excluding section 505(b)(2) products like Mitigare®. Because Takeda had not established that Mylan breached the Agreement, the irreparable harm stipulation did not apply. Money damages would remedy any harm Takeda would suffer as a result of Mylan launching its generic product. View "Takeda Pharmaceuticals U.S.A. v. Mylan Pharmaceuticals, Inc." on Justia Law
XY, LLC v. Trans Ova Genetics, LC
XY sued Trans Ova for infringement of seven patents relating to technology for sex selection of non-human mammals. Its 559 patent is titled “Enhancing Flow Cytometry Discrimination with Geometric Transformation.” Flow cytometers can be used as “high-speed jet-in-air sorters to discriminate particles and cells that are only subtly different.” The patent relates to “apparatus and methods for real-time discrimination of particles while being sorted by flow cytometry . . . resulting in enhanced discrimination between populations of particles” and “can be used to separate X from Y bearing sperm,” an application useful in animal husbandry to “guarantee the sex of offspring.”The district court found asserted claims 1–23 of the 559 patent-ineligible under 35 U.S.C. 101 and that XY’s patent-infringement allegations with respect to certain claims of other patents were claim-precluded based on a prior lawsuit filed by XY against Trans Ova. The Federal Circuit reversed. The asserted claims of the patent are directed to a patent-eligible improvement to a method of sorting particles using flow cytometry technology, not to an abstract idea. The district court did not apply the proper legal standard to its claim-preclusion analysis. The court vacated the claim-preclusion judgment. View "XY, LLC v. Trans Ova Genetics, LC" on Justia Law
IBSA Institut Biochimique v. Teva Pharmaceuticals USA
IBSA's patent, entitled “Pharmaceutical Formulations for Thyroid Hormones,” provides “pharmaceutical formulations based on thyroid hormones enabling a safe and stable oral administration in the framework of the strict therapeutic index prescribed in case of thyroid disorders.” It is listed in the FDA’s “Orange Book” for IBSA’s Tirosint® product, a soft gel capsule formulation containing the active ingredient levothyroxine sodium. Teva sought to market a generic version of Tirosint® and filed an Abbreviated New Drug Application (ANDA) that included a “Paragraph IV certification” that the 390 patent is invalid, unenforceable, or will not be infringed by Teva’s generic product. IBSA filed suit, alleging infringement.The Federal Circuit affirmed a holding that certain claims are invalid as indefinite under 35 U.S.C. 112. The intrinsic evidence fails to establish the boundaries of the claim term “half-liquid” and there was no clear error in the court’s determination that the extrinsic evidence does not supply “half-liquid” with a definite meaning under section 112. View "IBSA Institut Biochimique v. Teva Pharmaceuticals USA" on Justia Law
Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd.
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
Genentech, Inc. v. Immunex Rhode Island Corp.
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
Immunex Corp v. Sandoz Inc.
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
Sharpe v. Secretary of Health and Human Services
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
Cochlear Bone Anchored Solutions AB v. Oticon Medical AB
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
Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC
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