Justia Drugs & Biotech Opinion Summaries

Sanofi’s patents describe and claim compositions and uses of the cardiovascular (antiarrhythmic) drug dronedarone. The 800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The 167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. In 2009, Sanofii received New Drug Application approval for 400 mg tablets of dronedarone, sold as Multaq®. Both patents are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as patents claiming either Multaq® or a method of using Multaq®. Defendants, hoping to market generic versions of Multaq®, filed abbreviated new drug applications with the FDA, certifying under 21 U.S.C. 355(j)(2)(A)(vii)(IV), their beliefs that both patents were invalid and/or that the manufacture, use, and sale of the proposed generic drugs would not infringe either patent. Sanofi sued for infringement under 35 U.S.C. 271(e)(2)(A). The district court ruled, and the Federal Circuit affirmed, that as to the 167 patent, Sanofi proved that sale of the proposed generic drugs, with the proposed labels, would induce physicians to infringe, and defendants did not prove that any asserted claims were invalid for obviousness. As to the 800 patent, the courts rejected the non-infringement argument. View "Sanofi v. Watson Laboratories Inc." on Justia Law

To seek redress for an opioid epidemic, characterized by the Court of Appeal as having placed a financial strain on state and local governments dealing with the epidemic’s health and safety consequences, two California counties sued (the California Action) various pharmaceutical manufacturers and distributors, including the appellants in this matter, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”). The California Action alleged Watson engaged in a “common, sophisticated, and highly deceptive marketing campaign” designed to expand the market and increase sales of opioid products by promoting them for treating long-term chronic, nonacute, and noncancer pain - a purpose for which Watson allegedly knew its opioid products were not suited. The City of Chicago brought a lawsuit in Illinois (the Chicago Action) making essentially the same allegations. The issue presented by this appeal was whether there was insurance coverage for Watson based on the allegations made in the California Action and the Chicago Action. Specifically, the issue was whether the Travelers Property Casualty Company of America (Travelers Insurance) and St. Paul Fire and Marine Insurance Company (St. Paul) owe Watson a duty to defend those lawsuits pursuant to commercial general liability (CGL) insurance policies issued to Watson. Travelers denied Watson’s demand for a defense and brought this lawsuit to obtain a declaration that Travelers had no duty to defend or indemnify. The trial court, following a bench trial based on stipulated facts, found that Travelers had no duty to defend because the injuries alleged were not the result of an accident within the meaning of the insurance policies and the claims alleged fell within a policy exclusion for the insured’s products and for warranties and representations made about those products. The California Court of Appeal concluded Travelers had no duty to defend Watson under the policies and affirmed. View "The Traveler's Property Casualty Company of America v. Actavis, Inc." on Justia Law

Petitioner, by and through her mother and next friend, was one of nineteen minor plaintiffs who alleged that they sustained birth defects as a result of their mothers’ use of the prescription medication Zoloft. The Mass Litigation Panel granted summary judgment to Respondents - Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC - upon concluding that there existed no genuine issue of material fact and that Pfizer was entitled to judgment as a matter of law. The Supreme Court affirmed, holding that the Panel correctly concluded that (1) Michigan law governed Petitioner’s claims; (2) federal law operated to preempt the exception to Michigan’s failure to warn immunity where Zoloft has received FDA approval; (3) no genuine issues of material fact remained in the case; and (4) Respondents were entitled to judgment as a matter of law. View "M.M. v. Pfizer, Inc." on Justia Law

In 2003, the FDA granted Bayer approval to market vardenafil hydrochloride trihydrate to treat erectile dysfunction (ED) under the name Levitra. Vardenafil belongs to a class of ED drugs called phosphodiesterase inhibitors. When the FDA approved Levitra, two other phosphodiesterase inhibitors were already on the market: Pfizer launched Viagra in 1998, and Eli Lilly launched Cialis in 2003. Each is formulated as immediate-release tablets that are swallowed whole. Bayer’s 950 patent issued in 2013, claiming priority to 2005; it is directed to a formulation of vardenafil as “an uncoated tablet which disintegrates rapidly in the mouth,” vardenafil ODT, which Bayer markets as Staxyn. Watson filed an FDA Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Staxyn. Bayer alleged infringement. The Federal Circuit reversed the district court’s holding Watson failed to prove by clear and convincing evidence that two claims would have been obvious, 35 U.S.C. 103. The district court clearly erred in finding a skilled artisan would not have been motivated to use the claim elements to formulate an ED drug as a fast-dissolving tablet; the claims would have been obvious. View "Bayer Pharma AG v. Watson Laboratories, Inc." on Justia Law

Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." on Justia Law

Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." on Justia Law

Merck owns the 150 patent, which is directed to a process for preparing a stable formulation of ertapenem, an antibiotic compound, and claims a manufacturing process for a final formulation of the antibiotic that purportedly minimizes both dimerization and hydrolysis degradation pathways. Hospira notified Merck that it had filed an abbreviated new drug application, seeking FDA approval to engage in the commercial manufacture, use, or sale of generic versions of Merck’s Invanz® product, the principal component of which is the carbon dioxide adduct of ertapenem. Merck sued Hospira for infringement of two patents—the 150 patent and the 323 patent. The Federal Circuit affirmed a holding that certain claims of the 150 patent are invalid under 35 U.S.C. 103, for obviousness. It was reasonable for the district court to deduce from the evidence that the order and detail of the steps, if not already known, would have been discovered by routine experimentation while implementing known principles. View "Merck Sharp & Dohme Corp. v. Hospira, Inc." on Justia Law

This products liability lawsuit centered on Risperdal. Louise Taylor began suffering psychotic episodes when she was seventy-one years old, in early 1998. From March 1998 to January 2001, Psychiatrist Richard Rhoden prescribed Risperdal to Taylor for the treatment of her recurrent psychotic manifestations. In February 2001, Taylor developed tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements in patients treated with antipsychotic drugs. In 2002, Taylor filed a complaint against Ortho-McNeil Janssen Pharmaceuticals, the manufacturer, seller, and distributer of Risperdal, and its parent company Johnson & Johnson (collectively “Janssen”), claiming that Risperdal caused her to develop tardive dyskinesia. Taylor also named her treating physician, Dr. Richard Rhoden, as a defendant in her complaint. Taylor settled her claims against Dr. Rhoden prior to trial. The case went to trial oin 2014. The jury, in a nine to three decision, found that Taylor was harmed by Risperdal due to: (1) Janssen’s “failure to provide adequate warnings/instructions” and (2) Janssen’s “negligent marketing/misrepresentation.” The jury awarded Taylor $650,000 in actual economic damages and $1.3 million in noneconomic damages, for a total damages award of $1,950,000. On review, the Mississippi Supreme Court held that, as a matter of law, the Risperdal in question contained an adequate warning; the Court reversed and rendered the statutory inadequate warning judgment. Furthermore, the Court held that various errors in the jury instructions required reversal of the plaintiff’s verdict that sounded in negligent misrepresentation, and the Court reversed and remanded the negligent misrepresentation claim. View "Johnson & Johnson, Inc. v. Fortenberry" on Justia Law

Defendants manufacture and distribute FDA-approved prescription eye drop medications for treating conditions such as glaucoma. Bottles are pre-packaged with a fixed volume of medication; labeling does not indicate how many doses or days of treatment a patient can extract from the bottle. The dimensions of the bottle’s dropper tip dictate the size of the drop dispensed. Scientific research indicates that a normal adult’s inferior fornix – the area between the eye and the lower eyelid – has a capacity of approximately 7-10 microliters (µLs) of fluid. If a drop exceeding that capacity is placed into an eye, excess medication is expelled, providing no pharmaceutical benefit to the patient. Expelled medication also may flow into a patient’s tear ducts and move into his bloodstream, increasing the risk of certain harmful side effects. These studies conclude that eye drops should be 5-15 µLs. Defendants’ products emit drops that are considerably larger so that at least half of every drop goes to waste. The Third Circuit reversed dismissal of a putative class action (Class Action Fairness Act, 28 U.S.C. 1332) under state consumer protection statutes. The consumers’ allegations of injury were sufficient to confer standing. Plaintiffs claim economic interests in the money they spent on medication that was impossible for them to use; their concrete and particularized injury claims fit comfortably in categories of “legally protected interests” readily recognized by federal courts. View "Cottrell v. Alcon Laboratories" on Justia Law

The FDA approved Depakote for treating seizures, migraine headaches, and conditions associated with bipolar disorder. Physicians may prescribe it for other "off-label" uses, but a drug’s manufacturer can promote it only as suitable for uses the FDA has found safe and effective. Abbott, which makes Depakote, encouraged intermediaries to promote Depakote’s off-label uses for ADHD, schizophrenia, and dementia, hiding its own involvement. Abbott pleaded guilty to unlawful promotion and paid $1.6 billion to resolve the criminal case and False Claims Act suits, 31 U.S.C. 3729–33. Welfare-benefit plans that paid for Depakote’s off-label uses sought treble damages under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1964, for a class comprising all third-party payors. Following a remand, the court dismissed the suit on the ground that the plaintiffs could not show proximate causation, a RICO requirement. The Seventh Circuit affirmed, reasoning that the Payors are not the most directly, injured parties. Patients suffer if they take Depakote when it is useless and may be harmful and costly. Physicians also may lose, though less directly. Because some off-label uses of Depakote may be beneficial to patients, it is hard to treat all off-label prescriptions as injurious to the Payors; if they did not pay for Depakote they would have paid for some other drug. In addition, some physicians were apt to write off-label prescriptions whether or not Abbott promoted such uses. Calculation of damages would require determining the volume of off-label prescriptions that would have occurred absent Abbott’s unlawful activity. View "Sidney Hillman Health Center of Rochester v. Abbott Laboratories, Inc." on Justia Law