Justia Drugs & Biotech Opinion Summaries

Bard and AngioDynamics both manufacture vascular access ports, devices implanted underneath a patient’s skin that allow the injection of fluid into the patient’s veins on a regular basis without starting an intravenous line each time. Vascular access ports were traditionally used to administer injections at low pressure and flow rates. Certain procedures, like computed tomography (CT) imaging, required the injection of fluids into patients at high pressure and high flow rates (power injection). As of 2005, vascular access ports were not FDA-approved for power injection but certain medical providers were using existing ports for power injection; in some cases, the pressure ruptured the port, seriously injuring the patient. Bard obtained FDA approval for PowerPort as the first vascular access port labeled for power injection and obtained the patents-in-suit. AngioDynamics then obtained FDA approval to market its own vascular access port products as suitable for power injection.Bard sued AngioDynamics for infringement. During the trial, the court granted judgment that the asserted claims were not infringed, were not willfully infringed, and were invalid as directed to printed matter. The Federal Circuit reversed. There was substantial evidence to support a jury finding of infringement and willfulness; the asserted claims are not directed solely to printed matter and are patent-eligible under 35 U.S.C. 101. A genuine dispute of material fact precludes summary judgment as to anticipation. View "C R Bard Inc. v. AngioDynamics, Inc." on Justia Law

Quidel Corporation (Quidel) petitioned for a writ of mandate and/or prohibition to direct the trial court to vacate its order granting summary adjudication. Quidel contended the trial court incorrectly concluded a provision in its contract with Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of Business and Professions Code, section 16600. Quidel argued the trial court improperly extended the holding from Edwards v. Arthur Andersen LLP, 44 Cal.4th 937 (2008) beyond the employment context to a provision in the parties’ 2003 BNP Assay Agreement (the Agreement). In its original, published opinion, the Court of Appeal concluded it was not, granted the petition and issued a writ instructing the trial court to vacate the December 2018 order granting summary judgment on the first cause of action. The California Supreme Court then granted review of the Court of Appeal's opinion and ordered briefing deferred pending its decision in Ixchel Pharma, LLC v. Biogen, Inc., S256927. On August 3, 2020, the Supreme Court issued Ixchel Pharma, LLC v. Biogen, Inc., 9 Cal.5th 1130 (2020), which held “a rule of reason applies to determine the validity of a contractual provision by which a business is restrained from engaging in a lawful trade or business with another business.” The Quidel matter was transferred back to the Court of Appeals with directions to vacate its previous opinion and reconsider the case in light of Ixchel. The appellate court issued a new opinion in which it concluded the trial court’s decision was incorrect. The trial court was directed to vacate the December 7, 2018 order granting summary adjudication on the first cause of action. View "Quidel Corporation v. Super. Ct." on Justia Law

The Supreme Court affirmed the judgment of the trial court in favor of Defendants, Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim International, GmbH, on claims brought by Plaintiff, the executrix of the decedent's estate, that an oral anticoagulant medication wrongfully caused the decedent's death, holding that the trial court did not err.Specifically, the Supreme Court held that the trial court did not improperly (1) preclude evidence and arguments related to spoliation; (2) prevent Plaintiff from using an excerpt from a particular deposition on rebuttal; (3) grant Defendants' motion for summary judgment on a design defect claim relating to the absence of a reversal agent; and (4) issue a curative instruction to the jury after closing arguments. View "Boone v. Boehringer Ingelheim Pharmaceuticals, Inc." on Justia Law

The Valeant plaintiffs reside in Japan, Ireland, and Delaware. The defendants are incorporated and have principal places of business in West Virginia, Pennsylvania, and India. The brand-name FDA-approved drug Jublia® has nine patents listed in the Orange Book. Defendant, a generic drug company, executed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Jublia®, sending the ANDA from its West Virginia office to the FDA in Maryland. Valeant sued for infringement in the District of New Jersey, alleging that the district is a likely destination for the generic solution; each defendant does business in New Jersey and is registered to do so; each defendant has previously submitted to the court's jurisdiction and has a place of business in New Jersey; the generic drug will be “purposefully directed at … New Jersey. The district court dismissed for improper venue, finding that the ANDA was submitted from West Virginia, rendering venue proper there, while acknowledging that MLL, a foreign entity, was subject to venue in every judicial district.The Federal Circuit affirmed in part, citing the 2017 Supreme Court “TC Heartland” holding: the general venue provision in 28 U.S.C. 1391, which provides that a corporation is deemed to “reside” in any judicial district in which it is subject to personal jurisdiction, does not modify the term “resides” in 28 U.S.C. 1400, the specific patent venue statute; “resides” refers only to a corporation’s state of incorporation. A corporation may be sued for patent infringement in districts in the state of its incorporation and those in which it has a regular and established place of business and an act of infringement has occurred. In Hatch-Waxman Act, 35 U.S.C. 271(e)(2)(A) infringement cases, section 1400 “acts of infringement” occur only in districts where actions related to the ANDA submission occur, not in all locations where future distributions of the products specified in the ANDA is contemplated. The court remanded the dismissal of the foreign defendant. View "Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc." on Justia Law

In this lawsuit brought against Johnson & Johnson, Inc. and other entities (collectively, Defendants) alleging state tort claims due to injuries caused by a Class III medical device the Supreme Court reversed the judgment of the trial court granting Defendants' motion for judgment on the pleadings based on federal preemption of all claims, holding that, under Kentucky's notice pleading standards, the motion for judgment on the pleadings should have been denied.In their complaint, Plaintiffs asserted claims for, inter alia, strict liability negligence, and lack of informed consent. Defendants moved for judgment on the pleadings based on federal preemption of all claims. The trial court granted the motion and dismissed all of Plaintiffs' claims. The court of appeals affirmed. The Supreme Court reversed, holding that, under Kentucky's notice pleading standard, Plaintiffs' complaint sufficiently put Defendants on notice of parallel claims under Kentucky law that may not be preempted. View "Russell v. Johnson & Johnson Inc." on Justia Law

After the State of Hawaii filed suit against several pharmaceutical companies in state court for allegedly deceptive drug marketing related to the medication Plavix, the companies turned to federal court, seeking an injunction against the state court litigation based on a violation of their First Amendment rights.The Ninth Circuit agreed with the district court that the state court litigation is a quasi-criminal enforcement proceeding and that Younger v. Harris, 401 U.S. 37 (1971), bars a federal court from interfering with such a proceeding. The panel explained that, even though the state proceeding is being litigated by private counsel, it is still an action brought by the State of Hawaii. The panel stated that what matters for Younger abstention is whether the state proceeding falls within the general class of quasi-criminal enforcement actions—not whether the proceeding satisfies specific factual criteria. Looking to the general class of cases of which this state proceeding is a member, the panel concluded that Younger abstention is appropriate here. In this case, the State's action has been brought under a statute that punishes those who engage in deceptive acts in commerce, and the State seeks civil penalties and punitive damages to sanction the companies for their allegedly deceptive labeling practices. Because the companies' First Amendment concerns do not bring this case within the scope of Younger's extraordinary circumstances exception, they have no bearing on the application of Younger. Accordingly, the panel affirmed the district court's dismissal of the action. View "Bristol-Myers Squibb Co. v. Connors" on Justia Law

The First Circuit affirmed Defendant's conviction of violating federal laws by conspiring to receive, and of receiving, kickbacks from the pharmaceutical company Insys in exchange for prescribing its synthetic opioid, Subsys, holding that there was no merit to Defendant's arguments on appeal.Specifically, the First Circuit held (1) the government introduced sufficient evidence to prove that Defendant participated in a conspiracy to receive kickbacks or to prove that he accepted those kickbacks in exchange for prescribing Subsys; (2) Defendant's conduct fell outside the Anti-Kickback Statute's safe harbor provision; and (3) the district court did not err in failing to instruct the jury about that same safe harbor provision. View "United States v. Clough" on Justia Law

The Court of Appeals answered questions certified to it by the United States Court of Appeals for the Second Circuit regarding whether New York recognizes so-called American Pipe tolling of the statute of limitations for absent class members of a putative class action filed in another jurisdiction.In 2012, Plaintiffs filed individual lawsuits alleging injuries based upon the manufacturing of a nematicide by Occidental Chemical Corporation. The cases were consolidated, and the action was transferred to the United States District Court for the Southern District of New York. Occidental moved for judgment on the pleadings, arguing that Plaintiffs' claims were time-barred under New York law. Plaintiffs argued in response that a putative class action originally filed in Texas state court in 1993 had tolled the applicable three-year statute of limitations. The New York District Court Judge denied the motion and certified an interlocutory appeal to the Second Circuit, which, in turn, certified questions to the Court of Appeals. The Court of Appeals answered (1) New York recognizes American Pipe & Construction Co. v. Utah, 414 US 538 (1974), tolling for absent class members of putative class actions filed in other state and federal courts; and (2) a non-merits dismissal of class certification, as occurred here in 1995, extinguishes tolling. View "Chavez v. Occidental Chemical Corp" on Justia Law

The Snyders patent describes and claims an artificial heart valve and a system for inserting the valve. In 2017, St. Jude filed two petitions under 35 U.S.C. 311–19, seeking inter partes reviews (IPR) of claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30. The Patent Trial and Appeal Board instituted two reviews, each addressing all the challenged claims. In IPR-105, the Board ruled that St. Jude failed to establish unpatentability of any of the challenged claims, rejecting the contention that all the challenged claims were anticipated by the Leonhardt patent and would have been obvious over Leonhardt plus either the Anderson patent or the Johnson and Imachi patents. In IPR-106, the Board found claims 1, 2, 6, and 8 anticipated by the Bessler patent, but it rejected St. Jude’s contentions as to all other claims, finding that St. Jude had not proved, as to all but claims 1, 2, 6, and 8, anticipation by Bessler or obviousness over Bessler combined with either Anderson or Johnson and Imachi. The Federal Circuit affirmed the decision in IPR-105; reversed the finding in IPR-106 that Bessler anticipated claims 1, 2, 6, and 8; did not reach the anticipation argument as to claim 28; and affirmed the obviousness rejection in IPR-106. View "St. Jude Medical, LLC v. Snyders Heart Valve LLC" on Justia Law

Immunex’s 487 patent is directed to antibodies that bind to the human interleukin-4 receptor, the resulting inhibition of which is significant for treating various inflammatory disorders, such as arthritis, dermatitis, and asthma. Amid infringement litigation, Sanofi filed three inter partes review (IPR) petitions challenging claims 1–17 of the patent. Two were instituted. In one final written decision, the Board concluded that claims 1–17 were unpatentable as obvious over two prior references. Immunex appealed, contesting the construction of the claim term “human antibodies.” In the other IPR, involving a subset of the same claims, the Board did not invalidate the patents for reasons of inventorship. Sanofi contested the Board’s inventorship determination. In consolidated appeals, the Federal Circuit upheld the Board’s claim construction, affirming the invalidity decision, leaving valid no claims at issue in the inventorship appeal. View "Immunex Corp v. Sanofi-Aventis U.S. LLC" on Justia Law