Justia Drugs & Biotech Opinion Summaries

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

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

The counties filed suit in the Northern District of Ohio against manufacturers and distributors of prescription opioids. More than 2,700 other opioid cases have been transferred there by the Judicial Panel on Multidistrict Litigation (MDL). The first Case Management Order put the Counties’ cases on “Track One,” with a March 2019 trial date, setting a deadline in April 2018 for the Counties to amend their complaints. The Counties then asserted claims against 12 Pharmacies as “distributors” of pharmaceuticals to their own retail pharmacies, expressly declining to bring "dispenser" claims. Distributors ship pharmaceuticals wholesale; dispensers fill prescriptions. The Track One parties engaged in massive discovery.Rather than ruling on summary judgment motions, the district court granted the Counties’ motion to sever all but one Pharmacy (Walgreens) from Track One. Trial had been rescheduled for October 2019. The 11 Pharmacies settled with the Counties, agreeing to pay $260 million. The district court canceled the trial, then allowed the Counties to amend their complaints to add “dispenser” claims and ordered discovery to proceed anew. The court refused to rule on dismissal motions and ordered the Pharmacies to produce data on every prescription that they had filled for any opioid medication, anywhere in the U.S., dating back to 2006. The Sixth Circuit ordered that the amendments to the complaints be stricken, noting that the Federal Rules of Civil Procedure apply in MDL under 28 U.S.C. 1407 and had been disregarded in several instances. View "In re National Prescription Opiate Litigation" on Justia Law

This case arose when Amgen submitted a price increase notice to CCHCS and other registered purchasers. Reuters News made a request under the California Public Records Act, seeking the price increase notices. Amgen then filed a petition for writ of mandamus blocking disclosure. Amgen also moved for a preliminary injunction, which the trial court granted. While this appeal was pending, the trial court sustained CCHCS's demurrer to the mandamus cause of action with leave to amend, and then Amgen chose to dismiss the action instead.The Court of Appeal held that the appeal was not barred by the mootness doctrine where the issues raised are capable of repetition because there will be future price increase notices. Furthermore, the issues are likely to evade review because a pharmaceutical manufacturer has little reason to continue to prosecute a mandamus action after obtaining a preliminary injunction for the 60-day period before a price increase becomes public.On the merits, the court held that the trial court abused its discretion by concluding that Amgen had sufficiently shown that its price increase notice pursuant to Senate Bill No. 17 was a trade secret despite its disclosure to the registered purchasers. In this case, Amgen failed to explain how its purported trade secret maintained its confidentiality and concomitant value to Amgen when it was disclosed to over 170 purchasers who had the incentive to use the information to their benefit and Amgen's detriment, and were not subject to any restrictions on using or further disseminating the information. Likewise, the court held that the trial court abused its discretion in finding that the balance of harms favored Amgen. Therefore, the court reversed the trial court's order granting a preliminary injunction in favor of Amgen. View "Amgen Inc. v. Health Care Services" on Justia Law

In this complaint alleging that Defendants intentionally or recklessly misled investors about Ocular Therapeutix, Inc.'s manufacturing problems the First Circuit affirmed the judgment of the district court dismissing Plaintiffs' complaint for failure to state a claim, holding that Plaintiffs failed to allege facts giving rise to a strong inference of scienter as required by the Private Securities Litigation Reform Act (PSLRA), 15 U.S.C. 78u-4, 78u-5.In 2015, Ocular submitted a new drug application to the FDA for approval of Dextenza. In 2017, the FDA published its observations of issues at Ocular's manufacturing facility, which resulted in a drop in the company's stock price. Plaintiffs, several shareholders, brought this securities fraud action on behalf of themselves and a putative class of investors alleging violations of section 10(b) of the Securities Exchange Act, 15 U.S.C. 78j(b) and section 20(a) of the Exchange Act, 15 U.S.C. 78t(a). The district court dismissed the complaint pursuant to Fed. R. Civ. P. 9(b) and 12(b)(6), the Exchange Act, and the PSLRA. The district court granted the motion and dismissed the complaint with prejudice. The First Circuit affirmed, holding that Plaintiffs did not allege facts giving rise to a strong inference of scienter as required by the PSLRA. View "In re Ocular Therapeutix Inc." on Justia Law

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

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

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

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