Justia Drugs & Biotech Opinion Summaries

The State of Mississippi brought a civil action against generic pharmaceutical provider Sandoz, Inc., alleging that Sandoz impermissibly exploited Mississippi’s Medicaid reimbursement program by routinely and exponentially reporting fictitious “Average Wholesale Prices,” a key data factor in the federally supervised formula used by the Mississippi Division of Medicaid to reimburse pharmacies serviced by Sandoz. The trial court, sitting as fact-finder, found Sandoz in violation of the Mississippi Consumer Protection Act and liable for common-law fraud. Sandoz appealed, and the State cross-appealed. On a deferential standard of review, the Supreme Court affirmed the trial court in full. View "Sandoz, Inc. v. Mississippi" on Justia Law

Whether a third-party payer (TPP) will cover the cost of a member’s prescription depends on whether that drug is listed in the TPP’s formulary. Pharmacy Benefit Managers prepare TPPs’ formularies of drugs approved for use by TPP members by analyzing research regarding a drug’s cost effectiveness, safety and efficacy. In 1999, the FDA approved Avandia as a prescription for type II diabetes. TPPs included Avandia in their formularies and covered Avandia prescriptions at a favorable rate. GSK downplayed concerns about Avandia’s heart-related side effects. In 2010, the FDA restricted access to Avandia in response to increasing evidence of its cardiovascular risks. TPPs (union health and welfare funds) sued GSK on behalf of themselves and similarly situated TPPs. asserting that GSK’s failure to disclose Avandia’s significant heart-related risks violated the Racketeer Influenced and Corrupt Organizations Act based on predicate acts of mail fraud, wire fraud, tampering with witnesses, and use of interstate facilities to conduct unlawful activity. They also claimed unjust enrichment and violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law and other states’ consumer protection laws. The Third Circuit affirmed the district court’s finding that the TPPs adequately alleged the elements of standing. View "In Re: Avandia Mktg.,Sales Practices & Prod. Liab." on Justia Law

Leucovorin is a compound used to ameliorate the toxic effects of methotrexate, a chemotherapy treatment; to treat folate deficiency; and to enhance the efficacy of a 5-fluorouracil cancer treatment. Spectrum, the exclusive licensee of the 829 patent, holds the approved New Drug Application for a levoleucovorin formulation, and listed the patent as claiming the drug product in the Food and Drug Administration publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), and markets Fusilev®. Sandoz submitted an Abbreviated New Drug Application (ANDA) in 2011, seeking FDA approval for a drug product that will be imported in the form of single-use vials with 175 mg or 250 mg of levoleucovorin, indicated for methotrexate rescue at doses of 7.5–75 mg per dose. Its ANDA contained a certification that the 829 patent was invalid or would not be infringed by the ANDA product, 21 U.S.C. 355(j)(2)(A)(vii)(IV). After receiving notice of that certification, Spectrum filed suit. The district court found certain claims invalid as obvious and others not infringed. The Federal Circuit affirmed, rejecting Spectrum’s argument that an aggregation of Sandoz’s approved product—that is, the total amount of levoleucovorin drug product to be imported—would infringe the claims. View "Spectrum Pharma., Inc. v. Sandoz Inc." on Justia Law

NiGen, manufacturer and distributor of dietary supplements, Isodrene and The HCG Solution, appealed the dismissal of its constitutional and state law claims against the Attorney General based on state sovereign immunity. NiGen had filed suit under 42 U.S.C. 1983 after the AG sent letters to NiGen and its retailers, intimating that formal enforcement was on the horizon for both NiGen and its retailers. The retailers pulled the products from their shelves in Texas and other states, allegedly costing NiGen millions of dollars in lost revenue. The court concluded that it is at least partially correct that NiGen’s claims are not barred from federal jurisdiction on the basis of Ex parte Young; federal jurisdiction plainly exists over most of the constitutional claims pled; and NiGen has standing to sue. Accordingly, the court affirmed in part, and vacated, remanding in part for further proceedings. View "NiGen Biotech, L.L.C. v. Paxton" on Justia Law

Shire’s patents are directed to derivatives of amphetamines, used to treat various disorders, including attention deficit hyperactivity disorder. A drawback to the use of amphetamines is their potential for abuse. The patents describe modifying amphetamine to decrease its activity when administered in high doses—as when the drug is being abused—but to maintain activity similar to that of unmodified amphetamine when delivered at lower doses. Shire’s FDA-approved capsules are distributed under the brand name Vyvanse®. The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists all the Vyvanse® patents. Defendants filed Abbreviated New Drug Applications (ANDAs) for generic versions of Vyvanse® before expiration of the patents The ANDAs included Paragraph IV certifications, 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patent claims are invalid or not infringed. Shire sued under 35 U.S.C. 271(e). The court found certain claims not invalid, denied defendants’ motion to amend their invalidity contentions to include an on-sale bar claim, and found that Johnson induced infringement by providing the active pharmaceutical ingredient to the ANDA defendants. The Federal Circuit affirmed in part, finding that defendants failed to raise a genuine issue of material fact that the asserted claims are obvious and that court did not abuse its discretion in denying the motion to amend. In the circumstances of this case Johnson cannot be liable for induced infringement before FDA approval of the ANDA application. View "Shire LLC v. Amneal Pharma., LLC" on Justia Law

The three patents at issue share the same written description and explain that medical implements, such as catheters and luer ports, are common sites for transmissions of pathogens into patients. To prevent such transmissions, medical staff traditionally swabbed a site before making connections to medical implements. Swabs came in a small pad of cotton gauze soaked in a cleaning agent (e.g., isopropyl alcohol) and packed in a foil package to prevent evaporation. After swabbing, the site is allowed to dry, killing any pathogens. In practice, these swabbing procedures were often “overlooked” or “poorly executed.” The inventors provided a cleaning device that includes a cap that twist on to the medical implements and, when used, reliably disinfects a medical implement. In an infringement suit, the district court granted summary judgment of invalidity, finding the asserted claims obvious under 35 U.S.C. 103. The Federal Circuit reversed. The patent holder established a genuine dispute over whether one of ordinary skill in the art would have been motivated to add a vent to the disinfecting cap described in prior art. View "Ivera Med. Corp. v. Hospira, Inc." on Justia Law

Dome owns a patent for making contact-lens materials that are rigid and gas permeable. On reexamination, the U.S. Patent and Trademark Office found that the claimed method at issue was obvious and therefore unpatentable. The district court found that a person of ordinary skill would have been motivated to combine the prior art and that the prior art did not teach away from the claimed invention, so that the claims were unpatentable under 35 U.S.C. 103. The court found that Dome’s proffered evidence of objective indicia did not indicate nonobviousness. The Federal Circuit affirmed. View "Dome Patent L.P. v. Lee" on Justia Law

In 2000 and 2002 the FDA issued warnings to Caraco, a Michigan pharmaceutical manufacturer, stating that failure to correct violations promptly could result in enforcement action without further notice. After follow-ups in 2005, the FDA sought a definitive timeline for corrective actions. The FDA issued notices of objectionable conditions in 2006, 2007, and 2008. A consultant audited Caraco’s facilities and stated that it was “likely that FDA will initiate some form of seizure action.” Caraco executives thought the consultant “alarmist.” Later, the FDA issued a formal warning, determining that Caraco products were adulterated and that its manufacturing, processing, and holding policies did not conform to regulations and noting its poor compliance history. The letter stated that failure to promptly correct the violations could result in legal action without further notice, including seizure. A new consultant warned of likely enforcement action. Caraco followed some of its suggestions. In 2009, Caraco issued a nationwide drug recall, constituting “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” The FDA filed a complaint, served Caraco, and seized products. Days later, Caraco began a mass layoff, indicating that it did not “reasonably foresee" the FDA action. A certified class of former Caraco employees alleged that Caraco violated the Worker Adjustment and Retraining Notification (WARN) Act, 29 U.S.C. 2101, by failing to provide 60 days notice. The Sixth Circuit affirmed that the FDA action was not an unforeseeable business circumstance that would excuse WARN Act compliance. View "Calloway v. Caraco Pharma. Lab., Ltd." on Justia Law

Plaintiffs, including Jack and Nancy Cooper, filed suit against Takeda, manufacturers of the prescription drug Actos, which is used to treat type 2 diabetes mellitus. The Coopers appealed the trial court's grant of Takeda's motion for judgment notwithstanding the verdict and Takeda's alternative motion for new trial on the grounds that without the testimony of plaintiffs’ expert, Dr. Smith, the evidence was insufficient to support the verdict, and that the trial court should not have instructed the jury regarding concurrent causation. The court concluded that the trial court erred in striking the expert’s testimony. The court concluded that, by requiring that the expert rule out all other possible causes for Jack Cooper’s bladder cancer, even where there was no substantial evidence that other such causes might be relevant, the trial court exceeded the proper boundaries of its gatekeeping function in determining the admissibility of the complex scientific testimony. The court also concluded that the evidence supported giving a jury instruction on multiple causation. Accordingly, The court reversed the judgment notwithstanding the verdict and the order granting a new trial, as well as the subsequent judgment entered in favor of Takeda, and remanded the matter to the trial court with directions to enter a new judgment based on the jury’s verdict. View "Cooper v. Takeda Pharmaceuticals" on Justia Law

Glaucoma is an eye disease associated with elevated intraocular pressure (IOP). Treatments that effectively reduce IOP can slow the progression of the disease. In 2001, the FDA approved Lumigan 0.03%®, a topical solution developed by Allergan, for treating open angle glaucoma and ocular hypertension. Although Lumigan 0.03% was effective at lowering IOP, it also caused frequent, severe hyperemia. Many patients stopped using it without consulting their physicians, causing gradual vision loss. Allergan explored alternative formulations and developed Lumigan® 0.01%, which has a three-fold lower bimatoprost concentration than Lumigan 0.03%, and a four-fold higher concentration of a preservative for inhibiting bacterial growth. In 2010, the FDA approved Allergan’s New Drug Application for Lumigan 0.01% for the same approved uses as Lumigan 0.03%. Allergan’s patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as claiming Lumigan 0.01% and its approved uses. Generic manufacturers submitted Abbreviated New Drug Applications to the FDA, for generic versions of Lumigan 0.01% before expiration of the patents. Allergan sued, asserting infringement. The district court held, and the Federal Circuit affirmed that, the patents were not shown to be invalid for obviousness under 35 U.S.C. 103, and that claims of two patents were not shown to be invalid for lack of an adequate written description under 35 U.S.C. 112. View "Allergan, Inc. v. Sandoz, Inc." on Justia Law