Justia Drugs & Biotech Opinion Summaries

Plaintiffs filed three separate class action suits alleging that defendants violated Missouri law and conspired with unknown third parties to deceive customers into throwing away medications after their expiration dates, knowing that the medications were safe and effective beyond the expiration date. Defendants appealed the district court's remand order holding that defendants failed to establish the amount in controversy requirement under the Class Action Fairness Act (CAFA), 28 U.S.C. 1332(d)(2). The court concluded that each defendant's affidavit detailing the total sales of their respective medications in Missouri met the amount in controversy requirement; even if it was highly improbable that plaintiffs would recover the amounts defendants have put into controversy, this did not meet the legally impossible standard; defendants were not required to provide a formula or methodology for calculating the potential damages more accurately, as the district court held; and defendants' affidavits were not inadmissible hearsay. Therefore, the court reversed the district court's finding that it lacked subject matter jurisdiction and remanded for further proceedings. View "Raskas, et al. v. Johnson & Johnson, et al." on Justia Law

Plaintiff filed a complaint seeking damages and injunctive relief, alleging that defendants violated, inter alia, the Lanham Act, 15 U.S.C. 1125(a)(1), and New York General Business Law 349 when defendants published a scientific article reporting research results related to plaintiff's production of surfactants. The court concluded that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate could not give rise to liability for damages sounding in defamation. The court also concluded that the secondary distribution of excerpts of such an article could not give rise to liability, so long as the excerpts did not mislead a reader about the conclusions of the article. Therefore, the district court correctly concluded that plaintiff failed to state a claim based on publication of the article itself because the challenged statements were protected scientific opinion and plaintiff failed to adequately allege that defendants Chiesi and Cornerstone distributed misleading excerpts of the article. Accordingly, the court affirmed the judgment.View "ONY, Inc. v. Cornerstone Therapeutics, Inc." on Justia Law

Wyeth’s patents relate to the use of rapamycin for treatment and prevention of restenosis, the renarrowing of an artery. To open a blocked artery, a doctor guides a balloon catheter to the site of accumulated plaque and inflates the balloon to crush the plaque. As the balloon inflates it may cause injury to the arterial wall that leads to restenosis. The claims recite a method of treating or preventing “restenosis ... which comprises administering an antirestenosis effective amount of rapamycin.” In general, “rapamycin” may refer to a class of compounds; the parties agree that the specification discloses only one rapamycin species, sirolimus. In Wyeth’s infringement action, the district court adopted Wyeth’s proposed construction of “rapamycin,” but entered summary judgment, finding the patents invalid for nonenablement. The Federal Circuit affirmed, finding that the specification does not enable one of ordinary skill to practice the asserted claims without undue experimentation. View "Wyeth & Cordis Corp. v. Abbott Labs." on Justia Law

Proveris owns the 400 patent, for a mechanism to evaluate aerosol spray plumes. The apparatus evaluates delivery of drugs by inhalers or nasal sprays, by triggering a spray and collecting data on the plume with an illumination device and an imaging device. Innova made and sold the Optical Spray Analyzer (OSA). Proveris sued, alleging that OSA infringed the 400 patent. Innova conceded infringement of certain claims (including claim 3), but disputed infringement of others. The district court ruled in favor of Proveris on invalidity. A jury found that Innova did not infringe the disputed claims and that no damages had been proven. Based on the conceded infringement, the district court enjoined Innova from making or selling OSA. Innova modified OSA and began selling the new Aerosol Drug Spray Analyzer (ADSA). Proveris filed a contempt motion. Innova argued that OSA allowed a user to identify what range of images he wanted to analyze before activating the spray, while ADSA requires the user to first activate the spray and later determine what he wants to analyze. The district court ruled that, because Innova could have raised claim construction issues in the underlying infringement action, the court would not construe claim 3; Innova could not raise new invalidity arguments in contempt proceedings. The court entered a contempt order against Innova, found that the violation had been willful, and ordered disgorgement of profits. The Federal Circuit vacated, holding that the court erred in failing to construe the disputed claim language. View "Proveris Scientific Corp. v. Innovasystems, Inc." on Justia Law

Plaintiff brought claims of negligence, strict liability, breach of warranty, misrepresentation and fraud, and negligence per se against defendants, alleging that she developed tardive dyskinesia after taking generic metoclopramide manufactured by Defendant Teva for a period of greater than 12 weeks, contrary to administrative guidance issued by the FDA. The court affirmed the district court's dismissal of plaintiff's claims against Teva as preempted by federal law and because, preemption aside, the learned intermediary doctrine prevented her from stating a claim upon which relief could be granted under Florida law; affirmed the district court's grant of summary judgment in favor of Defendant Brand Manufacturers because Florida law did not permit an injured consumer to recover from the brand manufacturer of a prescription drug if the consumer is known to have ingested only the generic form of that drug; and noted that, insofar as plaintiff sought redress for her injuries, such redress lies with Congress or the Florida legislature. Accordingly, the court affirmed the judgment.View "Guarino v. Wyeth, et al." on Justia Law

Plaintiff filed suit against Novartis alleging that Novartis negligently failed to provide adequate warnings for two drugs she took, Aredia and Zometa, after having two of her teeth extracted. Plaintiff developed osteonecrosis of the jaw (ONJ) after the extraction. Plaintiff was awarded $225,000 in compensatory damages and Novartis appealed. The court concluded that a jury could reasonably find that plaintiff's injury was the natural and probable consequence of Novartis's behavior and rejected Novartis's arguement that plaintiff did not establish that her injuries were proximately caused by inadequate warnings; the district court did not err in applying Missouri law where Missouri had the most significant relationship to the punitive damages claim; and Novartis correctly reasoned that the MedWatch checkmarks were inadmissible hearsay, out-of-court assertions offered for their truth but Novartis failed to demonstrate the prejudice required for a new trial. The court concluded, however, that the district court abused its discretion in awarding plaintiff full costs for depositions conducted as part of multi-district litigation. Accordingly, the court affirmed in Case No. 12-3121 and vacated in Case No. 12-3409. View "Winter v. Novartis Pharmaceuticals Corp." on Justia Law

OMJP appealed from the district court's denial of its motion for relief from judgment under Federal Rule of Civil Procedure 60(b)(2) and (3). In Levaquin I, the court upheld a jury award in compensatory damages against OMJP for Achilles tendon injuries plaintiff suffered while taking OMJP's prescription antibiotic Levaquin. In this appeal, OMJP contended that the district court abused its discretion in denying OMJP relief under Rule (60)(b)(2) based on the delinquent and belated disclosure of an expert's calculation regarding the relative risk of Achilles tendon rupture to certain patients. The court concluded that the district court did not abuse its discretion in denying relief based on OMJP's claim of "newly discovered evidence" where the evidence was merely cumulative or impeaching and OMJP had not demonstrated that it was probable it would produce a different result. In regards to OMJP's misconduct claim under Rule 60(b)(3), the court concluded that the district court did not abuse its discretion in finding that the lack of the expert's calculation did not prevent OMJP from mounting a vigorous defense and that any misconduct did not warrant a new trial. Accordingly, the court affirmed the judgment of the district court. View "Schedin v. Ortho-McNeil-Janssen Pharmaceuticals" on Justia Law

The products at issue in this appeal are formulations of Athena’s RevitaLash, all of which contain a prostaglandin derivative as an active ingredient. The FDA has not taken enforcement action against, or otherwise regulated, the products. Allergan sells a product called Latisse, which also contains a prostaglandin derivative. Latisse is an FDA-approved prescription drug used for the treatment of a condition that affects eyelash growth. Allergan sued Athena for patent infringement and a violation of the Unfair Competition Law (UCL), California Business and Professions Code 17200 by violating California’s Health and Safety Code 1115501 by “marketing, selling, and distributing [its] hair and/or eyelash growth products without [a new drug] application approved by the FDA or California State Department of Health Services.” The district court rejected Athena’s claim that the Federal Food, Drug, and Cosmetic Act preempts Allergan’s UCL claim and granted Allergan an injunction on its claim that the products at issue qualify as new drugs that lack the requisite approval. The Federal Circuit vacated and remanded. The FDCA did not preempt Allergan’s UCL claim and there is no genuine dispute that the products are drugs under California law, but the injunction was overbroad. View "Allergan, Inc. v. Athena Cosmetics, Inc." on Justia Law

Institut Pasteur owns three U.S. patents, which claim methods and tools for the site-directed insertion of genes into eukaryotic chromosomes. Precision requested inter partes reexamination of each. A Patent and Trademark Office examiner rejected a number of Pasteur’s claims for obviousness, under 35 U.S.C. 103.The Patent Trial and Appeal Board affirmed the rejections, concluding that the claimed inventions were obvious extensions of two prior-art references disclosing similar methods of targeting non-chromosomal DNA in prokaryotic cells. With respect to one patent, the Federal Circuit dismissed Pasteur’s appeal as moot, because Pasteur presented only substantively amended claims and amended claims cannot be entered after the patent has expired. With respect to another patent, the court reversed the Board’s conclusion as unsupported by substantial evidence and containing an erroneous obviousness analysis, including improper discounting of Pasteur’s objective indicia of non-obviousness. The court vacated the Board’s decision on the third patent and remanded for consideration of what motivation, if any, a skilled artisan at the relevant time would have had to pursue the claimed invention. View "Institut Pasteur & Universite v. Focarino" on Justia Law

In 1990 Novo began experimenting with the drug repaglinide in monotherapy treatement of Type II diabetes, conducted a study to determine whether repaglinide might be more effective in combination with metformin, and concluded that the combination obtained fasting plasma glucose levels more than eight times lower than typically achieved by metformin alone. Novo filed a provisional patent application for the combination in 1997. The examiner rejected the initial application as obvious. In its fifth response, Novo included the Sturis report, concluding that the combination has synergistic properties in type 2 diabetic human patients. The examiner withdrew her rejection, based solely upon the Sturis declarations and reconsideration of the synergistic effects. The 358 patent issued in 2004. In 2005, pursuant to the Hatch-Waxman Act, Caraco filed an Abbreviated New Drug Application requesting FDA approval to sell a generic version of repaglinide, and certifying that the 358 patent was invalid or would not be infringed. Novo responded with an infringement lawsuit. The district court held that claim 4 of the patent was invalid because of obviousness and that the patent was not enforceable because of inequitable conduct. The Federal Circuit affirmed with respect to obviousness but reversed with respect to inequitable conduct.View "Novo Nordisk A/S v. Caraco Pharma. Labs., Ltd." on Justia Law