Justia Drugs & Biotech Opinion Summaries

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Apicore owns, and Mylan Is the exclusive licensee of, the 992, 616, and 050 patents, which relate to isosulfan blue (ISB), a triarylmethane dye used to map lymph nodes. The 992 and 616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting isoleuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. In response to Aurobindo’s FDA application to market a generic version of Myland’s drug, Lymphazurin®, Apricore and Myland obtained a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused ISB product that allegedly infringes the patents. The Federal Circuit affirmed. While the district court’s “equivalents analysis” was deficient and there remains a substantial question concerning infringement, so that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion, the injunction stands under the 050 patent. View "Mylan Institutional LLC v. Aurobindo Pharma Ltd." on Justia Law

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The First Circuit affirmed the district court’s dismissal of this putative class action alleging violations under sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The district court concluded that the initial amended complaint failed to meet the heightened pleading requirements of the Private Securities Litigation Reform Act (PSLRA). Thereafter, the court denied Plaintiffs’ subsequent motion to vacate the judgment and for leave to file a second amended complaint to include purportedly new evidence. The First Circuit held, on de novo review, that (1) the initial amended complaint failed to plead particularized facts giving rise to a strong inference of scienter, as required by the PSLRA; and (2) the district court did not abuse its discretion in denying the motion to vacate the judgment and for leave to file a second amended complaint. View "In re Biogen Inc. Securities Litigation" on Justia Law

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The Supreme Court's opinion in CRST Van Expedited Inc. v. E.E.O.C., 136 S. Ct. 1642, 1646 (2016), effectively overruled Branson v Nott's holding that when a defendant wins because the action is dismissed for lack of subject matter jurisdiction he is never a prevailing party. In this case, Amphastar filed a qui tam action against Aventis under the False Claims Act (FCA), 31 U.S.C 3730, alleging that Aventis obtained an illegal monopoly over the drug enoxaparin and then knowingly overcharged the United States. The district court dismissed the suit based on lack of subject matter jurisdiction. The Ninth Circuit held that Amphastar's allegations were based on publicly disclosed information, and it lacked the direct and independent knowledge needed to be an original source. Therefore, the panel upheld the district court's judgment on the merits. However, the panel held that the district court erroneously concluded that it could not award attorneys' fees, because the FCA's fee-shifting provision contained an independent grant of subject matter jurisdiction and because a party who wins a lawsuit on a non-merits issue is a "prevailing party." The panel remanded for resolution of the attorneys' fees issue. View "Amphastar Pharmaceuticals v. Aventis Pharma" on Justia Law

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The Eighth Circuit affirmed the dismissal of relator's False Claims Act (FCA), 31 U.S.C. 3729 et seq., suit based on the public disclosure bar. Relator alleged that CSL Behring conspired with pharmacies to submit false claims to the United States for reimbursement for prescription drugs. The Eighth Circuit concluded that, viewed collectively, the public disclosures provided enough information about the participants in the scheme to directly identify the defendants and the subject drugs; the disclosures would have set the government squarely on the trail of the defendants' participation in the purported fraudulent reporting; and the essential elements of relator's claims -- the purported fraud -- were publicly disclosed prior to him filing suit. View "Lager v. CSL Behring" on Justia Law

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The Cervenys sued the manufacturer of Clomid (Aventis, Inc.), asserting various tort claims under Utah law: failure to warn under theories of strict liability and negligence, breach of implied warranty, negligent misrepresentation, and fraud. They presented two theories, pointing to two types of warning labels that Aventis had allegedly failed to provide: (1) a label that warned of risks to the fetus when a woman takes Clomid before becoming pregnant; and (2) a label that unmistakably warned about harm to the fetus when Clomid is taken during pregnancy. The district court rejected the Cervenys’ claims based on preemption. The Tenth Circuit held that the district court ruling was correct on the Cervenys’ first theory, because the undisputed evidence showed that the FDA would not have approved a warning about taking Clomid before pregnancy. But on the second theory, the Tenth Circuit found the district court did not explain why a state claim based on the FDA’s own proposed language would be preempted by federal law. The district court also erred in failing to distinguish the remaining claims (breach of implied warranty, negligent misrepresentation, and fraud) from the failure-to-warn claims. These claims are based at least partly on affirmative misrepresentations rather than on a failure to provide a warning. The district court failed to explain why claims involving affirmative misrepresentations would have been preempted. View "Cerveny v. Aventis, Inc." on Justia Law

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Qui tam relator failed to satisfy the False Claims Act’s materiality requirement in alleging that the manufacturer of a widely-prescribed cancer drug, Avastin, suppressed data that caused doctors to certify incorrectly that Avastin was “reasonable and necessary” for certain at-risk Medicare patients. Avastin is FDA-approved and has accounted for $1.13 billion a year in Medicare reimbursements. The relator, formerly the head of healthcare data analytics for the manufacturer, claimed the company ignored and suppressed data that would have shown that Avastin’s side effects for certain patients were more common and severe than reported and that such analyses would have required the company to file adverse event reports with the FDA, and could have resulted in changes to Avastin’s FDA label. He claimed the company caused physicians to submit Medicare claims that were not “reasonable and necessary.” The Third Circuit affirmed dismissal of the claim, stating the allegations may be true but a False Claims Act suit is not the appropriate way to address them. The manufacturer followed all pertinent statutes and regulations. If those laws and regulations are inadequate to protect patients, it falls to the other branches of government to reform them. View "Petratos v. Genentech Inc" on Justia Law

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The Leahy-Smith America Invents Act did not change the statutory meaning of “on sale” under 35 U.S.C. 102, in a case involving patents that were ready for patenting and subject to an invalidating contract for sale prior to the critical date of January 30, 2002. Teva had invoked the provision as a defense in a suit charging infringement based on Teva’s filing of an Abbreviated New Drug Application (ANDA). The district court upheld, as valid, Helsinn’s patents, directed to intravenous formulations of palonosetron for reducing chemotherapy-induced nausea and vomiting, and rejected Teva’s “on sale” defense. In reversing, the Federal Circuit noted that the invention worked for its intended purpose, that the evidence that the formulation was ready for patenting was “overwhelming,” and that there was no tenable argument that, before the critical date, Helsinn was unable to file a patent application that met the requirements of 35 U.S.C. 112. The district court clearly erred by applying too demanding a standard. The completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting. View "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

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Serena Kwan appealed the dismissal of her second amended complaint for failing to state a claim upon which relief can be granted. In 2014, Kwan, On Behalf of Herself and All Others Similarly Situated, filed a class action against Defendants-Appellees, SanMedica International, LLC (“SanMedica”), and Sierra Research Group, LLC (“Sierra”), alleging violations of California’s Unfair Competition Law (“UCL”) and California’s Consumers Legal Remedies Act (“CLRA”). The complaint was based on an allegation that the defendants falsely represented that their product, SeroVital, provided a 682% mean increase in Human Growth Hormone (“HGH”) levels, that it was clinically tested, and that “peak growth hormone levels” were associated with “youthful skin integrity, lean musculature, elevated energy production, [and] adipose tissue distribution." The Ninth Circuit concluded the district court correctly concluded that California law did not provide for a private cause of action to enforce the substantiation requirements of California’s unfair competition and consumer protection laws. Further, the district court did not err in concluding that Kwan’s second amended complaint failed to allege facts that would support a finding that SanMedica International’s claims regarding its product, SeroVital, were actually false. Accordingly, the Court affirmed dismissal. View "Kwan v. Sanmedica Int'l" on Justia Law

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The consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in an overarching monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed most of plaintiffs’ claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims. The court remanded one of the Lipitor appeals, brought by a group of California pharmacists and involving claims solely under California law, for jurisdictional discovery and determination of whether remand to state court was appropriate. View "In re: Lipitor Antitrust Litigation" on Justia Law

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Navartis’s 283 patent relates to a solid pharmaceutical composition suitable for oral administration, comprising a sphingosine-1 phosphate (S1P) receptor agonist and a sugar alcohol, which the patent explains is useful for the treatment of certain autoimmune diseases such as multiple sclerosis. According to the specification, S1P receptor agonists generally exhibit properties that make formulations suitable for oral administration of a solid composition difficult to create. However, “solid compositions comprising a sugar alcohol provide formulations which are particularly well suited to the oral administration of S1P receptor agonists." They also “provide a convenient means of systemic administration of S1P receptor agonists, do not suffer from the disadvantages of liquid formulations for injection or oral use, and have good physiocochemical and storage properties.” On inter partes review, the Patent Trial and Appeal Board found all original claims of the 283 patent and proposed substitute claims unpatentable as obvious. The Federal Circuit affirmed. The Board discussed independent grounds supporting the motivation to combine prior art, fingolimod and mannitol, in a solid oral composition. View "Novartis AG v. Torrent Pharmaceuticals, Limited" on Justia Law