Justia Drugs & Biotech Opinion Summaries

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

Amgen’s patents relate to antibodies that help reduce low-density lipoprotein cholesterol (LDLC), or “bad cholesterol.” Typically, high LDL-C is treated using small molecules (statins), which sometimes have adverse side effects or cannot reduce a patient’s LDL-C to a healthy level, requiring an alternative treatment, such as a PCSK9 inhibitor. PCSK9 is a naturally occurring protein that binds to and causes the destruction of liver cell receptors (LDL-Rs) that are responsible for extracting LDLC from the bloodstream. Amgen began studying PCSK9 in 2005 and developed the drug Repatha™ with the active ingredient “evolocumab,” a monoclonal antibody that targets PCSK9 to prevent it from destroying LDL-R proteins.The FDA approved Repatha in 2015. In 2007, Appellants started exploring antibodies targeting PCSK9, resulting in the development of Praluent. Praluent's active ingredient is a monoclonal antibody that targets PCSK9 to prevent it from binding to and destroying LDL-R proteins. The LDL-R proteins then extract LDL-C, lowering overall LDL-C levels. In 2011, Appellants obtained a patent that claimed Praluent by its amino acid sequence. The FDA approved Praluent in 2015. Amgen sued Appellants. Appellants stipulated to infringement. The district court enjoined the sale of Praluent. The Federal Circuit reversed in part. The district court erred by excluding Appellants’ evidence regarding post-priority-date evidence of enablement and improperly instructed the jury on written description. View "Amgen Inc. v. Sanofi" on Justia Law

Dr. David Jang, M.D., is the named inventor of the patent, which is directed to a coronary stent. Jang assigned the patent to BSC. BSC agreed to pay a royalty if it ever produced a product that would infringe the patent. Jang sued, based on BSC’s “Express stent.” BSC sought ex parte reexamination, then sought to include invalidity defenses in Jang’s suit. The district court denied the motion, deeming invalidity defenses “irrelevant” as to whether BSC owed royalties for past sales. The Patent and Trademark Office subsequently cancelled the asserted claims as unpatentable. The court denied BSC’s motion in limine to preclude Jang from presenting a doctrine of equivalents theory, finding that Jang’s experts sufficiently explained his doctrine of equivalents theory in their expert reports. The jury ultimately found no literal infringement, but found infringement under the doctrine of equivalents. Following through on its earlier decision, the district court conducted an evidentiary hearing on ensnarement. Concluding that Jang did not meet his burden of persuasion, which includes providing a proper hypothetical claim that does not ensnare the prior art, the district court vacated the jury verdict and entered judgment of non-infringement. The Federal Circuit affirmed the entry of judgment of non-infringement. View "Jang v. Boston Scientific Corp." on Justia Law

The Fifth Circuit affirmed defendant's sentence for methamphetamine-related offenses. The court held that the district court did not clearly err by denying a mitigating-role adjustment under USSG 3B1.2 where defendant certainly understood that she was illegally transporting contraband into the United States and that she was being paid for her participation. The court also held that the district court did not impermissibly rely on her integral role to the exclusion of all else, and remand was not warranted where the district court need not weigh each USSG 3B1.2 factor on the record. View "United States v. Bello-Sanchez" on Justia Law