Justia Drugs & Biotech Opinion Summaries

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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

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The DC Circuit affirmed the district court's grant of summary judgment in favor of Eagle, in an action brought by Eagle, alleging that the Orphan Drug Act's (ODA), 21 U.S.C. 360aa–360ee, plain language required the FDA to automatically grant Eagle marketing exclusivity upon designating its drug as an orphan drug and approving it for marketing. The court held that the district court correctly determined at Chevron step one that the FDA's post-approval clinical superiority requirement was forbidden and that Eagle was automatically entitled to a seven-year period of exclusive approval when it approved Bendeka for marketing. View "Eagle Pharmaceuticals, Inc. v. Azar" on Justia Law

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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

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Dolin was prescribed Paxil, the brand-name version of the drug paroxetine, to treat his depression. The prescription was filled with a generic paroxetine product. Six days later, Dolin died by suicide. Federal law preempted an "inadequate labeling" state-law claim against the generic manufacturer. Mrs. Dolin sued GSK, the manufacturer of brand-name Paxil, arguing that GSK was responsible for the labeling for all paroxetine, no matter who made and sold it, and had negligently omitted an adult suicide risk. The Seventh Circuit reversed her jury verdict, based on preemption, citing the complex regulation of drug labels and of Paxil/paroxetine’s label in particular. GSK had attempted to change the Paxil label in 2007 to add an adult suicide warning. The FDA rejected that change. The court concluded that GSK lacked new information after 2007 that would have allowed it to add an adult-suicidality warning under the existing regulations. Eight days after denying Dolin certiorari, the Supreme Court decided another case, further explaining the “clear evidence” standard for impossibility preemption for prescription drug labels. Dolin filed an unsuccessful motion under FRCP 60(b)(6), arguing that the 2018 judgment should be set aside based on a change in law so that GSK could not establish its defense of impossibility preemption. The Seventh Circuit affirmed and did not impose sanctions. The Supreme Court provided important guidance but did not break new ground that would change the result in Dolin’s case. Her motion was not frivolous. View "Dolin v. GlaxoSmithKline LLC" on Justia Law

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In this action asserting claims for breach of contract and fraud the Supreme Court granted Defendants' motion to stay proceedings under N.C. Gen. Stat. 1-75.12 on forum non conveniens grounds and denied as moot all other requested relief, holding that the balance of all relevant factors showed it would be more convenient for the parties to litigate these claims in England. Plaintiff, a Swiss biopharmaceutical company, sued an English contract research organization and its North Carolina-based parent, asserting claims for, inter alia, breach of contract and fraud. Defendants filed, among other pre-answer motions, a motion seeking to stay the proceedings under section 1-72.12. The Supreme Court granted Defendants' motion to stay and denied as moot all other requested relief, holding that, after considering the convenience of witnesses, ease of access to sources of proof, applicable law, and local interest factors, this case should be stayed on forum non conveniens grounds because Defendants showed that a substantial injustice would result if this case were to proceed in North Carolina and that England was a convenient, reasonable, and fair place of trial. View "Cardiorentis AG v. Iqvia Ltd." on Justia Law

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The First Circuit reversed the judgment of the district court dismissing this qui tam action under the False Claims Act (FCA) against PharMerica, Inc. under the public disclosure bar, holding that relator James Banigan fell within an exception to that bar as an "original source of the information." Banigan and Richard Templin, former employees of the pharmaceutical company Organon, brought this action under the FCA and several of its state law equivalents alleging that PharMerica committed fraud by participating in a Medicaid scheme that rewarded it financially for incentivizing physicians to change patients' antidepressant prescriptions to Organon's medications. The district court dismissed the action under the public disclosure bar, which excludes from the subject matter jurisdiction of federal courts qui tam actions that are based upon the public disclosure of allegations in a civil hearing and other sources. The First Circuit reversed, holding that where the allegations of fraud were based upon Banigan's direct knowledge, Banigan's sources met the statutory requirement of "direct and independent knowledge of the information on which the allegations are based," see 31 U.S.C. 3730(e), to qualify as an original source. View "United States, ex rel. Banigan & Templin v. Pharmerica, Inc." on Justia Law

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The patent for Lexapro, an anti-depressant, was expiring, creating a potentially lucrative opportunity to sell a generic version, escitalopram. BioPharm, a generic drug manufacturer, and Antrim planned to sign an updated version of the terms for a previous venture, but never signed a contract for the escitalopram venture. The FDA approved Antrim’s Abbreviated New Drug Application for escitalopram. Bio-Pharm manufactured the first batch but never shipped it to Antrim because the companies never signed a new agreement. Antrim sued Bio-Pharm for breaching an oral contract. Bio-Pharm counterclaimed, arguing promissory estoppel or breach of the claimed oral contract. Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert on how the FDA regulates ANDA holders. BioPharm successfully argued the court should preclude testimony by Antrim’s expert on industry practices and how Bio-Pharm’s alleged breach impaired the value of Antrim’s business. The court rejected Antrim’s proposed Jury Instruction that under FDA policy an ANDA holder owns the product underlying that ANDA and denied Antrim’s motion to bar Bio-Pharm from requesting lost profits in its counterclaim, despite missing the Rule 26(a)(1) disclosure deadline. A jury ruled in favor of Bio-Pharm on Antrim’s claim and in favor of Antrim on Bio-Pharm’s counterclaim. Neither party was awarded damages. The Seventh Circuit affirmed, rejecting Antrim’s challenges to the jury instructions, evidentiary rulings, and allowing Bio-Pharm to request lost profits. View "Antrim Pharmaceuticals LLC v. Bio-Pharm, Inc." on Justia Law

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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

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Kaiser had surgery to implant the Prolift Anterior Pelvic Floor Repair System, a transvaginal mesh medical device that supports the pelvic muscles. A few years later, Kaiser began experiencing severe pelvic pain, bladder spasms, and pain during intercourse. Her physician attributed these conditions to contractions in the mesh. Kaiser had surgery to remove the device, but her surgeon could not completely extract it and informed her that the complications she was experiencing were likely permanent. Kaiser sued Ethicon, Prolift’s manufacturer, under the Indiana Products Liability Act. A jury found Ethicon liable for defectively designing the Prolift device and failing to adequately warn about its complications and awarded $10 million in compensatory damages; the judge reduced a punitive award to $10 million. The Seventh Circuit affirmed, rejecting Ethicon’s claim of federal preemption. The requirements of the FDA’s premarket-notification process do not directly conflict with Indiana law. A reasonable jury could conclude that Prolift was unreasonably dangerous and could credit the physician’s assertion that additional warnings about complications would have led him to choose a different treatment plan. The court rejected challenges to the damages and to jury instructions. Seventh Circuit precedent interprets the Indiana Product Liability Act to require a plaintiff in a design-defect case to produce evidence of a reasonable alternative design for the product but the Indiana Supreme Court disagreed in 2010. The state supreme court’s decision controls on a matter of state law. View "Kaiser v. Johnson & Johnson and Ethicon, Inc." on Justia Law

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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