Justia Drugs & Biotech Opinion Summaries

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

Under the Biologics Price Competition and Innovation Act (BPCIA), 124 Stat. 119, an abbreviated biologics license application (aBLA) requires proof that a product is “biosimilar” to an approved reference product, plus information regarding the FDA’s determination that the reference product is safe. ABLA approval may not take effect until 12 years after licensing of the reference product. BPCIA allows patent infringement suits before approval: the applicant provides confidential access to its aBLA within 20 days after the FDA accepts its application. The parties negotiate a list of patents that would be subject to an immediate infringement action. Under subsection 262(l), the applicant gives notice at least 180 days before commercial marketing, to allow a suit for preliminary injunction. If the applicant discloses information, neither may bring suit based on non-listed patents before notice of commercial marketing. Amgen has marketed Neupogen® since 1991. Sandoz filed an aBLA, for a Neupogen biosimilar. Sandoz notified Amgen that intended to launch its biosimilar upon approval and that it “opted not to provide” its aBLA, so that Amgen was entitled to sue under section 262(l). In 2015, the FDA approved Sandoz’s aBLA. Sandoz gave a “further notice” of commercial marketing. Amgen sued, asserting state law claims of unfair competition based on BPCIA violations; conversion for wrongful use of Amgen’s approved license; and patent infringement. The court held that BPCIA permits an applicant not to disclose its aBLA; that such a decision alone does not permit the reference product owner to obtain relief; and that the applicant may give notice of commercial marketing before FDA approval. The Federal Circuit affirmed dismissal of Amgen’s state law claims, but otherwise vacated and directed the court to consider the patent infringement claims. View "Amgen, Inc. v. Sandoz, Inc." on Justia Law

Plaintiffs acquired shares of K-V Pharmaceutical stock during the period in which the company launched and marketed Makena, its new prescription drug, designed to reduce the risk of pre-term labor for at-risk pregnant women. It had acquired rights to the drug from the FDA, under the Orphan Drug Act, 21 U.S.C. 360. In a putative class action, the plaintiffs alleged that K-V and three of its officers made materially false or misleading statements or omissions related to the product launch. The district court dismissed, holding the challenged statements were protected by the safe-harbor provision of the Private Securities Litigation Reform Act of 1995 (PSLRA), 15 U.S.C. 78u-4(b), and that the plaintiffs failed to adequately plead scienter under the PSLRA. The district court also denied the plaintiffs the opportunity to amend the complaint as it related to allegations from confidential witnesses. The Eighth Circuit affirmed. K-V’s statements fell within the PSLRA’s safe-harbor provision as forward-looking statements accompanied by meaningful cautionary language and are not actionable as a basis for a securities fraud action. View "Anderson v. K-V Pharma. Co." on Justia Law

TMC owns patents relating to the drug bivalirudin, a synthetic peptide anti-coagulant. TMC sells the drug for injection under the Angiomax® brand and, from 1997 to 2006, purchased pharmaceutical batches from BV Laboratories. In 2005, BV created batches of bivalirudin with levels of impurity that exceeded the FDA approved maximum. TMC hired a consultant, who discovered that certain methods of adding a pH-adjusting solution during the compounding process minimize the impurity. In 2008, TMC filed two patent applications, describing this discovery. A year before filing these applications, TMC hired BV to prepare batches of bivalirudin using the patented method. Each was released to TMC for commercial packaging. In 2010, TMC sued Hospira, alleging infringement by Hospira’s ANDA filings. The district court found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar under 35 U.S.C. 102(b), which applies when, before the critical date, the claimed invention was the subject of a commercial offer for sale and was ready for patenting. The court found that the claimed invention was ready for patenting but not commercially offered for sale. The Federal Circuit reversed, finding that the batches prepared by BV were sold to TMC and not prepared primarily for experimental purposes. View "The Medicines Co v. Hospira, Inc." on Justia Law