Justia Drugs & Biotech Opinion Summaries

Since 2014 Par has manufactured and sold Vasostrict®, an FDA-approved vasopressin injection product used to treat patients with critically low blood pressure. The Orange Book identifies Par’s 785 and 209 patents as encompassing Vasostrict®. Both patents require the vasopressin composition to have a rounded pH between 3.7–3.9. In 2018, Eagle filed an abbreviated new drug application (ANDA) to manufacture and sell a generic version of Vasostrict® before those patents expired. Eagle represented in its release specification that the pH range would be between 3.4–3.6. Eagle’s ANDA also contained 35 U.S.C. 355(j)(2)(A)(vii)(IV) certification that Par’s patents are invalid or will not be infringed by Eagle’s proposed product.Par sued for infringement under 35 U.S.C. 271(e)(2). Eagle stipulated that its proposed product would meet all asserted claim limitations except the claimed pH range. Par argued that “real-world” evidence shows the pH of Eagle’s product drifts up over time and that Eagle sought authority to release products into the marketplace with a pH of 3.64, just 0.01 beneath the infringing range. The Federal Circuit affirmed the rejection of those arguments. Minor fluctuations in pH value identified by Par did not reveal any discernible trend and the stability specification imposed an additional constraint that Eagle’s proposed product maintain a pH between 3.4–3.6 from the time of its distribution through its entire shelf life. View "Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc." on Justia Law

The First Circuit affirmed in part and vacated in part the judgment of the district court granting Edge Pharma, LLC's motion to dismiss for failure to state a claim the allegations brought by Azurity Pharmaceuticals, Inc. under both the Lanham Act and Mass. Gen. Laws ch. 93A based on statements that Edge made on its website, holding that Azurity's claims cannot survive.Azurity's suit alleged that the statements at issue falsely represented that Edge was not in violation of the Food, Drug, and Cosmetic Act (FDCA) and that the statements falsely held out Edge's vancomycin drug as being superior to Azurity's. The district court concluded that the FDCA precluded Azurity's Lanham Act claim, which meant that the Chapter 93A likewise failed "as it is premised on the same allegations" as the Lanham Act claim. The First Circuit held (1) the district court properly dismissed the Lanham Act claim on the alternative ground that Azurity did not plausibly allege that some of the statements made a misleading representation of fact and that other statements at issue were in violation of the Lanham Act; and (2) insofar as no variant of Azurity's Lanham Act claim could survive, for the same reasons this Court vacates and affirms in part the dismissal of Azurity's Chapter 93A claim. View "Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC" on Justia Law

The Supreme Court affirmed the judgment of the district court dismissing the complaint in this case for failure to state a claim, holding that an employee discharged after testing positive at work based on recreational marijuana use does not have a common-law tortious discharge claim.Plaintiff was terminated from his employment based on a positive test result for marijuana. Plaintiff brought this complaint arguing that he did not use marijuana in the twenty-four hours before that shift and that his use complied with Nevada's recreational marijuana laws. The district court dismissed the complaint. At issue before the Supreme Court was whether adult recreational marijuana use qualifies for protection under Nev. Rev. Stat. 613.333. The Supreme Court answered the question in the negative, holding that because federal law criminalizes the possession of marijuana in Nevada, marijuana use is not lawful in the state and does not support a private right of action under Nev. Rev. Stat. 613.333. View "Ceballos v. NP Palace, LLC" on Justia Law

The First Circuit denied Petitioners' petition for review in this action challenging a final rule promulgated by the Drug Enforcement Administration (DEA) that set the framework through which applicants may register to lawfully manufacture and cultivate cannabis for research purposes, holding that Petitioners were not entitled to relief on their claims.Petitioners - Dr. Lyle Craker, a botany professor, and Scottsdale Research Institute (SRI), a clinical research company - brought this action raising two perceived procedural defects with the DEA's notice of proposed rulemaking that would demand that the final rule be set aside. The First Circuit denied relief, holding (1) Petitioners were not entitled to relief on their claim that the APA required the DEA to include more detail about the legal basis of the proposed rule; (2) the proposed rule did not exceed the DEA's rulemaking authority; (3) Petitioners' challenge to the DEA's definition of "medicinal cannabis" was unavailing; and (4) the DEA's new regulatory framework for registrations was not arbitrary, capricious, or otherwise contrary to law. View "Craker v. U.S. Drug Enforcement Administration" on Justia Law

The First Circuit affirmed the judgment of the district court dismissing this complaint against Karoypharm Therapuetics, Inc. and its corporate officers (collectively, Defendants) alleging securities fraud in violation of sections 10(b) and 20(a) of the Securities Exchange Act, 15 U.S.C. 78j(b) and 78t(a), and Securities and Exchange Commission (SEC) Rule 10-b, 18 C.F.R. 240.10b-5, holding that the district court correctly dismissed the complaint for failure to state a claim.Plaintiff-investors brought this action following a decline in Karyopharm's stock price, alleging that Karyopharm materially misled them as to the safety and efficacy of the company's cancer-fighting drug candidate selinexor. The district court dismissed the complaint for failure to state a claim, concluding that Plaintiffs failed adequately to plead scienter with respect to Defendants' statements about a certain study of the drug as a treatment for pinta-refractory multiple myeloma. The First Circuit affirmed on other grounds, holding that Plaintiffs did not plausibly allege an actionable statement or omission with respect to the trial disclosures, and therefore, dismissal was appropriate. View "Thant v. Karyopharm Therapeutics Inc." on Justia Law

After the district court granted summary judgment in favor of two government agencies and a pharmaceutical company in this Freedom of Information Act ("FOIA") case. Plaintiff, a science writer and journalism professor, sought records from the government agencies relating to the pharmaceutical company's successful application for accelerated approval of a drug for the treatment of a neuromuscular disease. The agencies produced over 45,000 pages of documents, some of which were redacted under Exemption 4 of FOIA. The district court granted summary judgment for the agencies and the pharmaceutical company on the basis that the redacted information fell within Exemption 4 and publication would either cause foreseeable harm to the interests protected by Exemption 4 or was prohibited by law.Plaintiff appealed and the Second Circuit affirmed the district court’s ruling. The court held that the interests protected by Exemption 4 are the submitter's commercial or financial interests in the information that is of a type held in confidence and not disclosed to any member of the public by the person to whom it belongs. Defendants' declarations show that the release of the information Plaintiff seeks would foreseeably harm the pharmaceutical company’s interests and Plaintiff does not raise a genuine dispute as to that showing. View "Seife v. FDA, et al." on Justia Law

The Third Circuit vacated in part the order of the district court denying OptumRX's (Optum) motion to compel arbitration in the underlying action alleging breaches of contract and breaches of duties of good faith and fair dealing and violations of certain state statutes, holding that the district court erroneously applied the incorrect standard in ruling on Optum's motion.More than 400 pharmacies brought suit against Optum, a pharmacy benefits manager responsible for administering prescription drug programs on behalf of health-insurance plans. Optum moved to compel arbitration based on arbitration agreements found in various contracts covering the majority of the pharmacies. The district court denied the motion in full, concluding that compelling the pharmacies to proceed with arbitration would be procedurally unconscionable. The Sixth Circuit vacated the judgment in part, holding that the district court erred by not adhering to Guidotti v. Legal Helpers Debt Resolution, LLC, 716 F.3d 764 (3d Cir. 2013). View "Robert D. Mabe, Inc v. OptumRX" on Justia Law

Plaintiff Sanofi-Aventis U.S., LLC (“Sanofi”) sued Defendants Mylan, Inc. and Mylan Specialty, LP (collectively “Mylan”) under Section 2 of the Sherman Antitrust Act. Sanofi, one of the world’s largest pharmaceutical companies, alleged Mylan, the distributor of EpiPen, monopolized the epinephrine auto-injector market effectively and illegally foreclosing Auvi-Q, Sanofi’s innovative epinephrine auto-injector, from the market. The parties cross-moved for summary judgment. The district court, holding no triable issue of exclusionary conduct, granted Mylan’s motion for summary judgment. After careful consideration, the Tenth Circuit agreed and affirmed the district court. View "Sanofi-Aventis U.S. v. Mylan, et al." on Justia Law

Petitioners Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia, LLC (“Vapetasia”) sought to market flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. Section 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products. FDA denied the requested marketing authorizations, finding that Petitioners failed to offer reliable and robust evidence (such as randomized controlled trials or longitudinal studies) to overcome the risks of youth addiction and show a benefit to adult smokers. Petitioners sought review of those marketing denial orders (“MDOs”), and prior to the consolidation of the two cases. Petitioners argued that the FDA lacks the authority to impose a comparative efficacy requirement and that FDA acted arbitrarily and capriciously by “requiring” scientific studies.   The Eleventh Circuit denied the petitions for review. The court explained that Congress passed the Family Smoking Prevention and Tobacco Control Act (“TCA”) in an active effort to protect public health. Relevant here, the Deeming Rule subjected e-cigarette manufacturers to the TCA’s prior authorization requirement—manufacturers of “new tobacco product[s]” must submit premarket tobacco product applications (“PMTAs”). The court held that the FDA’s consideration of the lack of cessation as a risk and comparing that risk between new tobacco products and old tobacco products “fall[s] squarely within the ambit of the FDA’s expertise and merit[s] deference.”  As such, the court cannot say that FDA acted arbitrarily and capriciously by disagreeing with Petitioners as to the significance of the evidence they presented. View "Wages and White Lion Investmen v. FDA" on Justia Law

The patents share the same specification and are entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients.” They discuss diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. These increased levels of donor cfDNA—which occur naturally as the organ’s condition deteriorates—can be detected and then used to diagnose the likelihood of an organ transplant rejection.In an infringement action, the district court found the patents ineligible under 35 U.S.C. 101. The Federal Circuit affirmed. The court applied the Supreme Court’s two-part “Alice” test to determine whether the claims were patent-eligible applications of laws of nature and natural phenomena or claims that impermissibly tie up such laws and phenomena. The claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, including PCR, identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a potential rejection, none of which was inventive. This is not a case involving a method of preparation or a new measurement technique. View "CareDx, Inc. v. Natera, Inc" on Justia Law