Justia Drugs & Biotech Opinion Summaries

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

In earlier litigation, Teva challenged the validity and enforceability of GSK’s patents on lamotrigine, Lamictal’s active ingredient. Teva was first to file an FDA application, alleging invalidity or nonenforceability, and seeking approval to produce generic lamotrigine tablets and chewable tablets for markets alleged to be annually worth $2 billion and $50 million,. If the patent suit resulted in a determination of invalidity or nonenforceability—or a settlement incorporating such terms—Teva would be statutorily entitled to a 180- day period of market exclusivity, during which time only it and GSK could produce generic lamotrigine tablets. After the judge ruled the patent’s main claim invalid, the companies settled; Teva would end its patent challenge in exchange for early entry into the chewables market and GSK’s commitment not to produce its own, “authorized generic” Lamictal tablets. Plaintiffs, direct purchasers of Lamictal, sued under the Sherman Act, 15 U.S.C. 1 & 2, claiming that the agreement was a “reverse payment” intended to induce Teva to abandon the patent fight and eliminate the risk of competition in the lamotrigine tablet market for longer than the patent would otherwise permit. The district court dismissed. The Third Circuit vacated, citing Supreme Court precedent, holding that unexplained large payments from the holder of a drug patent to an alleged infringer to settle litigation of the patent’s validity or infringement (reverse payment) can violate antitrust laws. View "King Drug Co of Florence Inc, v. Smithkline Beecham Corp." on Justia Law

On the day the RE 048 patent issued, Pfizer filed suit against five generic drug manufacturers, alleging infringement. The district court granted the defendants summary judgment in part in part, finding that the RE 048 patent was not a valid reissue patent, because Pfizer’s asserted error of prosecuting a prior patent application as a continuation-in-part, rather than as a divisional, was not correctable by reissue under section 251. The court further found that the safe harbor provision of 35 U.S.C. 121 did not apply to the RE 048 patent, and that the relevant claims of the RE 048 patent were invalid for obviousness-type double patenting in light of an earlier patent. A final judgment of invalidity was entered against Pfizer. The Federal Circuit affirmed. The applications from which the two patents issued do not share “common lineage in the divisional chain,” they are not derived from the same restriction requirement. Restriction requirements (1994 and 1997) were not imposed on the same compound, composition, and method-of-use claims. View "G.D. Searle LLC v. Lupin Pharma., Inc." on Justia Law

In 1996, Drs. Lo and Wainscoat discovered cell-free fetal DNA (cffDNA) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery,they implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, they obtained the 540 patent, which does not claim cffDNA or paternally inherited cffDNA, but claims methods of using cffDNA to diagnose certain fetal characteristics based on the detection of paternally inherited cffDNA. The district court found that the asserted claims of the 540 patent are not directed to patent eligible subject matter and were invalid under 35 U.S.C. 101. The Federal Circuit affirmed. While the discovery regarding cffDNA was a significant contribution to the medical field, that alone does not make it patentable. View "Ariosa Diagnostics, Inc.v. Sequenom, Inc." on Justia Law

GE manufactures Omniscan, an FDA-approved gadolinium-based contrast agent that has been associated in some patients with development of nephrogenic systemic fibrosis (NSF), a rare and deadly condition that leads to the hardening (fibrosis) of the kidneys. Omniscan was administered to Wahl for two MRIs she received in Nashville in 2006. About one year later, she displayed the first symptoms of NSF. She was officially diagnosed with NSF in 2010. The Judicial Panel on Multidistrict Litigation consolidated all pre-trial litigation of Omniscan-related cases in the U.S. District Court for the Northern District of Ohio. In 2011, Wahl filed a complaint in that court. With the agreement of Wahl and GE, the MDL judge transferred the case, in 2013, to the Middle District of Tennessee, the “proper venue.” GE then moved for summary judgment, arguing that all Omniscan doses produced from 2004 to 2006 were marked with expiration dates two years after manufacture, so the Omniscan administered to Wahl must have expired no later than 2008; the Tennessee Products Liability Act’s statute of repose requires suits to be instituted within one year of the expiration date appearing on a product’s packaging. The Sixth Circuit affirmed summary judgment, favoring GE, applying Tennessee choice-of-law rules. View "Wahl v. Gen. Elec. Co." on Justia Law