Justia Drugs & Biotech Opinion Summaries

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Baxalta sued Genentech, asserting that Genentech’s Hemlibra® product used to treat the blood clotting disorder hemophilia infringes claims of its 590 patent. The 590 patent relates to preparations used to treat hemophilia patients who have developed factor VIII inhibitors. After the district court issued a claim construction order, construing the terms “antibody” and “antibody fragment,” the parties stipulated to non-infringement of the asserted claims. The Federal Circuit vacated, finding that the district court erred in construing the terms by selecting a narrower construction, which is inconsistent with the written description and the plain language of the claim. View "Baxalta Inc. v. Genentech, Inc." on Justia Law

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The Supreme Court held that the Arizona Department of Health Services' (ADHS) interpretation of Arizona Administrative Code R9-17-303, which governs ADHS's allocation of marijuana dispensary registration certificates, violated Ariz. Rev. Stat. 36-2804(C).On June 16, 2016, ADHS announced that, because every county had at least one dispensary, it would allocate new registration certificates based on other factors set forth in R9-17-303. Saguaro Healing LLC timely applied for a certificate for its dispensary in La Paz County. During the application period, the only dispensary in La Paz County relocated out of the county. ADHS, however, did not consider the vacancy when prioritizing registration certificates and did not issue a certificate to Saguaro, leaving La Paz County without a dispensary. Saguaro filed a complaint for special action. The trial court dismissed the complaint because R9-17-303(B) "does not say when, during the process of issuing new certificates, [ADHS] must determine how certificates will be allocated." The Supreme Court reversed, holding (1) Ariz. Rev. Stat. 36-2804(C) requires ADHS to issue at least one medical marijuana dispensary registration certificate in each county with a qualified applicant; and (2) ADHS's interpretation of R9-17-303 contrary to this statutory mandate violates section 36-2804(C). View "Saguaro Healing LLC v. State" on Justia Law

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Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out.The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim.The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation. View "Cottingham v. Secretary of Health and Human Services" on Justia Law

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The Ninth Circuit affirmed the district court's judgment for plaintiff in an action alleging product-liability claims based on injuries she sustained from a medical device -- the G2 intravascular filter -- designed and manufactured by Bard. The jury found Bard liable for negligent failure to warn, awarding $1.6 million in compensatory damages and $2 million in punitive damages.The panel held that, because Bard's preemption defense presented a purely legal question, it would consider the merits of the district court's denial of its motion for summary judgment. The panel held that the preemption argument fails because Booker's claim rests on an asserted state-law duty to warn of the risks posed by the particular design of Bard's G2 Filter, and the FDA has not imposed any requirements related to the design of that device or how a device of that design should be labeled. In regard to the failure-to-warn claim, the panel held that Georgia courts had not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning, and the district court correctly allowed the jury to decide the adequacy of the warning. Finally, the panel held that the evidence was adequate to support the jury's award of punitive damages. View "Booker v. C.R. Bard, Inc." on Justia Law

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The Ninth Circuit affirmed in part and reversed in part the district court's dismissal of a third amended complaint (TAC) brought by plaintiffs, a putative class of former NFL players, alleging that the NFL negligently facilitated the hand-out of controlled substances to dull players' pain and to return them to the game in order to maximize profits. The NFL allegedly conducted studies and promulgated rules regarding how Clubs should handle distribution of the medications at issue, but failed to ensure compliance with them, with medical ethics, or with federal laws such as the Controlled Substances Act and the Food, Drug, and Cosmetic Act.The panel agreed with the district court that two of plaintiffs' theories of negligence, negligence per se and special relationship, were insufficiently pled. However, the panel held that plaintiff's voluntary undertaking theory survives dismissal, given sufficient allegations in the TAC of the NFL's failure to "use its authority to provide routine and important safety measures" regarding distribution of medications and returning athletes to play after injury. Furthermore, if proven, a voluntary undertaking theory could establish a duty owed by the NFL to protect player safety after injury, breach of that duty by incentivizing premature return to play, and liability for resulting damages. View "Dent v. National Football League" on Justia Law

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Granny Purps grows and provides medical marijuana to its 20,000 members, in compliance with state laws governing the production and distribution of marijuana for medical purposes. Santa Cruz County’s ordinance prohibits any medical cannabis operation from cultivating more than 99 plants; Granny’s dispensary was growing thousands of marijuana plants. The sheriff’s office went to the dispensary in June 2015, seized about 1,800 plants, and issued a notice of ordinance violation. Several months later, officers again went to the dispensary and took about 400 more marijuana plants. Granny sued, alleging conversion, trespass, and inverse condemnation and sought an order requiring the county to return the seized cannabis plants, The trial court dismissed.The court of appeal reversed. A government entity does not have to return seized property if the property itself is illegal but the Santa Cruz ordinance ultimately regulates land use within the county; it does not (nor could it) render illegal a substance that is legal under state law. View "Granny Purps, Inc. v. County of Santa Cruz" on Justia Law

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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

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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

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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

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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