Justia Drugs & Biotech Opinion Summaries

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

Plaintiff alleged various causes of action against the maker of the generic drug (Pliva), brand defendants, and others after she was injured by the prescription medication metoclopramide. On appeal, plaintiff challenged the district court's grant of summary judgment in favor of brand defendants and dismissal of her claims against Pliva. The court denied plaintiff's motion to supplement the record, finding no compelling reason to allow plaintiff to do so; the district court did not err in determining plaintiff's claims against brand defendants failed as a matter of law because she stipulated that she had not ingested a product manufactured by brand defendants; reversed the district court's dismissal of plaintiff's non-warning design defect and breach of implied warranty claims and remanded for further consideration; and because there was no causal link between Pliva's failure to incorporate the 2004 labeling change and plaintiff's injury, the district court's dismissal of that claim was not error. Accordingly, the court affirmed in part, reversed in part, and remanded for further proceedings.View "Bell v. Pfizer, et al." on Justia Law

Johnson, a Louisiana citizen, and Lucier, a Pennsylvania citizen, suffer from birth defects allegedly caused by their mothers’ use of thalidomide. They claim that newly-accessible evidence revealed that the defendant companies were aware of the drug’s risks while marketing it to pregnant women, and that they have been engaged in a 60-year cover-up to avoid liability. After defendants removed their suit for damages to federal court, the plaintiffs moved to remand the action to state court because four of the defendants are Pennsylvania citizens. The district court denied the motion. The Third Circuit affirmed, concluding that the district court correctly analyzed the citizenship of the companies, examining the principal place of business of one company and the fact that a limited liability company assumes the citizenship of its owner.View "Johnson v. SmithKline Beecham Corp." on Justia Law

Tolmar’s filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Differin® Gel, 0.3%, a topical medication containing 0.3% by weight adapalene approved for the treatment of acne. Galderma sued Tolmar, alleging that Tolmar’s ANDA product infringed its patents. The district court ruled against Tolmar, finding the Galderma patents not invalidity for obviousness under 35 U.S.C.103. The Federal Circuit reversed, after examining prior art. While the comparable tolerability of 0.1% and 0.3% adapalene was unexpected in view of the prior art, a skilled artisan would have expected that tripling the concentration of adapalene would have resulted in a clinically significant increase in side effects, so the result does not constitute an unexpected result that is probative of nonobviousness. The commercial success of Differin® is of “minimal probative value.” View "Galderma Labs, L.P. v. Tolmar, Inc." on Justia Law

The plaintiffs allege that they ingested metoclopramide, the generic equivalent of the prescription drug Reglan, and, as a result, developed a serious neurological disorder, tardive dyskinesia. The labeling for the drugs recommends short-term use for heartburn and acute and recurrent bloating: up to 12 weeks in adults for heartburn. Reglan and metoclopramide have not been shown to be either efficacious or safe for long-term treatment; the drugs affect the brain’s movement center, typically causing involuntary, repetitive movements. Overuse can result in symptoms including tardive dyskinesia, dystonia, and akathisia, Parkinsonism, and Reglan-induced tremors. Reglan and metoclopramide have also been associated with central nervous system disorders, depression with suicidal ideation, visual disturbances, and other problems. The plaintiffs sued both the generic and brand-name manufacturers, alleging various product-liability claims. The district court dismissed, finding the metoclopramide claims preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399f, and that the brand-name manufacturers are not liable because none of the plaintiffs ingested Reglan. The Sixth Circuit affirmed and denied the plaintiffs’ motion to certify a proposed question to the Tennessee Supreme Court. View "Speed v. Wyeth Pharm., Inc." on Justia Law

Volkman, an M.D. and a Ph.D. in pharmacology from University of Chicago, was board-certified in emergency medicine and a “diplomat” of the American Academy of Pain Management. Following lawsuits, he had no malpractice insurance and no job. Hired by Tri-State, a cash-only clinic with 18-20 patients per day, he was paid $5,000 to $5,500 per week. After a few months, pharmacies refused to fill his prescriptions, citing improper dosing. Volkman opened a dispensary in the clinic. The Ohio Board of Pharmacy issued a license, although a Glock was found in the safe where the drugs were stored. Follow-up inspections disclosed poorly maintained dispensary logs; that no licensed physician or pharmacist oversaw the actual dispensing process; and lax security of the drug safe. Patients returned unmarked and intermixed medication. The dispensary did a heavy business in oxycodone. A federal investigation revealed a chaotic environment. Cup filled with urine were scattered on the floor. The clinic lacked essential equipment. Pills were strewn throughout the premises. Months later, the owners fired Volkman, so he opened his own shop. Twelve of Volkman’s patients died. Volkman and the Tri-State owners were charged with conspiring to unlawfully distribute a controlled substance, 21 U.S.C. 841(a)(1); maintaining a drug-involved premises, 21 U.S.C. 856(a)(1); unlawful distribution of a controlled substance leading to death, 21 U.S.C. 841(a)(1) and 841(b)(1)(C), and possession of a firearm in furtherance of a drug-trafficking crime, 18 U.S.C. 24(c)(1) and (2). The owners accepted plea agreements and testified against Volkman, leading to his conviction on most counts, and a sentence of four consecutive terms of life imprisonment. The Sixth Circuit affirmed. View "United States v. Volkman" on Justia Law

OWW owns related patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. Some of the patents have been asserted in patent infringement suits and many have been involved in reexamination proceedings before the Patent and Trademark Office. OWW sued Alps for infringement of the 237 patent, entitled “Gel and Cushioning Devices,” lists Kania as the sole inventor and has an application date of 1996. The district court issued its claim construction order. Alps subsequently initiated the first of two consecutive ex parte reexaminations of the 237 patent. After a stay was lifted, the district court granted summary judgment to Alps, finding certain claims invalid due to the collateral estoppel effect of parallel litigation and other claims invalid for obviousness. The district court also granted OWW summary judgment of no inequitable conduct. The Federal Circuit affirmed on the issues of collateral estoppel and obviousness, but reversed and remanded on the issue of inequitable conduct. Issues of material fact regarding whether OWW committed inequitable conduct during the reexamination proceedings by withholding information preclude summary judgment.View "Ohio Willow Wood Co. v. ALPS South, LLC" on Justia Law