Justia Drugs & Biotech Opinion Summaries

The patent claims methods for preparing multi-cryopreserved hepatocytes (a type of liver cell), used for evaluating drug candidates. The owner claimed infringement and obtained a preliminary injunction. The Federal Circuit affirmed. The district court acted within its discretion in finding likelihood of success on the merits, considering defenses of non-infringement, obviousness, written description, and inequitable conduct. The court considered and properly addressed the public's interest in obtaining an adequate supply of pooled multi-cryopreserved hepatocyte products. View "Celsis In Vitro, Inc. v. Cellzdirect, Inc." on Justia Law

The 2006 patent, entitled "Surgical Devices Having a Polymeric Material with a Therapeutic Agent and Methods for Making Same" and the 2007 patent, entitled "Surgical Devices Containing a Heat Bondable Material with a Therapeutic Agent" have identical specifications and are directed to a surgical implant in which a polymeric material is bonded by heat to an expandable implant, where the polymer includes a therapeutic agent such as an antibiotic. The owner of the patents sued. The district court made a finding of noninfringement. The Federal Circuit affirmed the finding and construction of the term "bonded." The district court then declared the case exceptional under 35 U.S.C. 285 and awarded defendant attorney and expert witness fees totaling $4,683,653.03. The Federal Circuit affirmed. The district court opinion indicates its finding that plaintiff acted in bad faith in filing a baseless infringement action and continuing to pursue it despite no evidence of infringement and engaged in vexatious and unjustified litigation conduct that unnecessarily prolonged the proceedings and forced defendant to incur substantial expenses. View "MarcTec, LLC v. Johnson & Johnson" on Justia Law

Defendants, who operated what purported to be online pharmacies, were convicted on a 42-count indictment alleging crimes arising from a multi-national, internet-based, controlled-substance-distribution scheme. They have appealed multiple decisions of the trial court and appealed their conviction. The Third Circuit affirmed. Among other challenges, the court rejected arguments: that the money-laundering convictions impermissibly merge with underlying predicate felonies; that the district court should have suppressed evidence from untimely-sealed surveillance records; that the indictment, evidence, and jury instructions were insufficient to sustain a Continuing Criminal Enterprise conviction; and that the court erred in calculating sentences; the the alleged conduct, distribution of controlled substances via the internet, was not illegal at the time charged; that the money laundered was obtained by lawful means; and that certain convictions were misdemeanors, not felonies. View "United States v. Mullinix" on Justia Law

Plaintiff's 502 patent for a statin drug is a reissue of a patent that claims the benefit of a provisional application filed on April 10, 2000. The earliest date by which plaintiff asserts that it conceived and reduced to practice its claimed invention is December 1, 1999. In 2008 plaintiff sued for infringement by the drug Crestor. The district court found the 502 claims invalid, based on defendant's showing that it had conceived and reduced its drug to practice prior to plaintiff's first conception of the claimed subject matter (35 U.S.C. § 102(g)(2)). The Federal Circuit affirmed. View "Teva Pharm. Indus., Ltd. v. Astrazeneca Pharm., LP" on Justia Law

Defendant was the pharmacy director of a medical center and had influence over decisions concerning which drugs to stock. Levato was the local business manager of a pharmaceutical company. Levato agreed to pay defendant $18,000 not to switch away from his company's drug, and made computer entries recording nine nonexistent speeches given by defendant for the pharmaceutical company; defendant later received another $14,000 for more fictitious speeches. After investigation by an FDA agent, Levato and defendant were indicted. Levato plead guilty and testified against defendant. Defendant was convicted of solicitation and receipt of kickbacks and sentenced to 22 months in prison. The Seventh Circuit affirmed. Memoranda prepared by the Department of Health and Human Services, discovered by the prosecution after trial, did not constitute exculpatory material withheld by the prosecution. The court noted that the documents would have strengthened the prosecution case. View "United States v. Muoghalu" on Justia Law

Cody Laboratories, Inc. and Lannett Co., Inc. (collectively, "Cody") appealed a district court's dismissal of their action for declaratory judgment against the Food and Drug Administration (FDA). Cody has been manufacturing and distributing morphine sulfate since 2005. At the time Cody filed its complaint, the company had not received FDA approval for its morphine sulfate product. Cody contends that the product falls under the "grandfather clause" of the Food, Drug, and Cosmetic Act (FDCA). The FDA claims that the grandfather clause is exceedingly narrow and applies only to drugs that have been marketed in essentially identical form since 1938. The FDA sent Cody a warning letter in March 2009 stating that Cody's manufacture and distribution of morphine sulfate was in violation of the FDCA. Meanwhile, in August 2009, Roxane Laboratories, Inc., Cody's main competitor, submitted a New Drug Application ("NDA") for its own morphine sulfate product. Following its policy of granting expedited review of an NDA if no approved alternative drug exists, the FDA quickly reviewed and approved Roxane's NDA in January 2010. Cody submitted an NDA for its product the following month. The company's requests for expedited review were denied. Cody brought suit claiming the FDA acted arbitrarily, capriciously and contrary to law in violation of the Administrative Procedure Act by: (1) improperly determining that Cody's product was a "new drug" and thus not entitled to grandfathered status under the FDCA; and (2) treating Cody disparately from Roxane in processing the companies' respective NDAs. The court subsequently dismissed Cody's complaint for lack of jurisdiction, holding that the FDA had yet to complete "final agency action" under section 704 of the APA. Upon review of the record, the Tenth Circuit concluded that one of Cody's claims was mooted by post-judgment events and that Cody failed to exhaust available administrative remedies with respect to its remaining claim. The Court affirmed the district court's dismissal for lack of jurisdiction on the grandfathering claim, and dismissed Cody's disparate treatment claim as moot. View "Cody Laboratories, Inc. v. Sebelius" on Justia Law

Plaintiff brought this securities fraud action against defendant, a biotechnology company and several of its officers, alleging that, by misstating and failing to disclose safety information about two of the company's products used to treat anemia, they violated the Securities and Exchange Act of 1934, 15 U.S.C. 78j(b), 78t(a), and Rule 10b-5, 17 C.F.R. 240.10b-5. At issue was what a plaintiff must do to invoke a fraud-on-the-market presumption in aid of class certification. The court joined the Third and Seventh Circuits in holding that plaintiff must (1) show that the security in question was traded in an efficient market, and (2) show that the alleged misrepresentation were public. As for the element of materiality, plaintiff must plausibly allege that the claimed misrepresentations were material. In this case, plaintiff plausibly alleged that several of defendants' public statements about its pharmaceutical products were false and material. Coupled with the concession that the company's stock traded in an efficient market, this was sufficient to invoke the fraud-on-the-market presumption of reliance. Therefore, the district court did not abuse its discretion in certifying the class. View "Connecticut Retirement Plans and Trust Funds v. Amgen Inc., et al." on Justia Law

Plaintiffs, citizens of New York, sued pharmaceutical companies (defendants) in New York state court claiming that defendants' hormone replacement therapy drugs caused plaintiffs to develop breast cancer. At issue was whether dismissal of plaintiffs' actions as time-barred under New York law precluded assertion of the same claims in a federal court diversity action in a State where the claims would not be time-barred. The court held that under New York claim preclusion law as articulated in Smith v. Russell Sage College and the many New York appellate decisions applying Russell Sage, the prior grant of summary judgment dismissing plaintiffs' New York claims as time-barred precluded the assertion of the same claims in these federal diversity actions in Minnesota. Therefore, the district court properly applied the Full Faith and Credit Statute in these cases, even if the New York Court of Appeals declined in the future to apply statute-of-limitations claim preclusion to more sympathetic plaintiffs. View "Rick, et al. v. Wyeth, Inc., et al." on Justia Law

Plaintiff, engaged in treatment and disposal of regulated biomedical waste, had trouble with its shredder and obtained approval from the Puerto Rico Environmental Quality Board to use autoclaves. After a few years, an inspector recommended that plaintiff's facility be shut down and ordered a landfill to stop accepting plaintiff's waste. Unable to resolve the matter with EQB, plaintiff sought a federal court injunction. The injunctions were denied, but plaintiff resumed handling waste. When a second shredder broke, an inspector again ordered the landfill to stop accepting waste and rejected several proposals for dealing with accumulated waste. Plaintiff's suit alleges more favorable treatment of a competitor and other constitutional violations. The district court dismissed for failure to link allegations to any particular defendant. The First Circuit affirmed, finding failure to meet minimal pleading standards. The complaint failed the plausibility test "spectacularly." View "Redondo Waste Sys., Inc.v. Lopez-Freytes" on Justia Law

In the first appeal in a case regarding clopidogrel bisulfate tablets, sold by plaintiff under the brand name Plavix®, the Federal Circuit affirmed the district court's grant of a preliminary injunction concerning defendants' generic product. In the second appeal, the court affirmed a judgment that the patent-in-suit is not invalid, was infringed, and not unenforceable. The district court then awarded prejudgment interest and denied defendants' motion for leave to file a supplemental answer, affirmative defenses, and counterclaims pleading patent misuse and breach of contract. The Federal Circuit reversed in part. The district court erred by awarding prejudgment interest in addition to actual damages specified in a settlement agreement. The court affirmed the district court’s holding that defendant is jointly and severally liable for all damages and denial of defendant's motion. View "Sanofi-Aventis v. Apotex" on Justia Law