Justia Drugs & Biotech Opinion Summaries

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

Elan marketed metaxalone, a muscle relaxant, under the brand-name Skelaxin. Years after Skelaxin’s approval, Elan learned that another company conducted in vivo bioequivalence fasting studies and in vitro dissolution tests on metaxalone and that, based on the results, the FDA proposed to change the designation of metaxalone from “non bioproblem” to “bioproblem.” Elan initiated a study and observed a significant effect of food on bioavailability. Elan petitioned the FDA to require both fed and fasting data for any abbreviated new drug application for a generic version of Skelaxin and to revise its product label. The FDA granted both. Elan obtained patents based on its bioavailability data, which were later invalidated in light of prior art. Classen’s 472 patent is directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and commercializing that new use. Classen alleged that Elan infringed that patent when it studied the effect of food on Skelaxin’s bioavailability, used the data to identify a new use, and commercialized that use. The court entered summary judgment of noninfringement, finding Elan protected by the safe harbor provision of 35 U.S.C. 271(e)(1), for activities “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act. During ex parte reexamination of the 472 patent, the PTO cancelled 107 of the 137 originally issued claims. The Federal Circuit affirmed with respect to the 271(e)(1) exemption, but remanded an allegation that activities that occurred after the FDA submissions infringed the 472 patent and were not exempt. View "Classen Immunotherapies, Inc. v. Elan Pharma., Inc." on Justia Law

Takeda owns several asserted patents that cover several methods of administering colchicine products to treat gout. Colchicine itself, which has been used for centuries, is not covered by Takeda’s patents. Takeda has patents directed to treating acute gout flares and others directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors. In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares. It submitted an New Drug Application under the Hatch Waxman Act, 21 U.S.C. 355(b)(2). In 2014, the FDA granted Hikma approval to market its Mitigare colchicine capsule. Hikma launched Mitigare, and Takeda filed suit, asserting induced infringement under 35 U.S.C. 271(b) based on Hikma’s labeling of the Mitigare product. Hikma planned on launching an authorized generic version of Mitigare in October 2014. The district court granted Takeda’s request for a temporary restraining order, but later denied a preliminary injunction. The Federal Circuit affirmed. Takeda acknowledged that evidence of mere knowledge of infringing uses is not sufficient and did not establish a probability of success on the issue of infringement. View "Takeda Pharma., U.S.A. v. Hikma Am., Inc." on Justia Law

Madel sued the Department of Justice and Drug Enforcement Administration for a response to Freedom of Information Act, 5 U.S.C. 552, requests that sought information on oxycodone transactions in Georgia by five private companies. DEA withheld some documents as confidential commercial information. The district court granted summary judgment to DEA, finding it produced all non-exempt information. The court denied declaratory and injunctive relief and attorney fees. The Eighth Circuit reversed and remanded. Rejecting a claim that DEA did not justify withholding the five documents under FOIA Exemption 4, the court concluded that DEA showed that substantial competitive harm was likely. DEA did not make “barren assertions” that the documents were exempt, but linked each document to identifiable competitive harms. The court remanded for consideration of FOIA’s segregability requirement. DEA did not show “with reasonable specificity why documents withheld pursuant to a valid exemption cannot be further segregated.” Its Declaration does not address how disclosure of the data from, for example, 2007, leads to the proffered substantial competitive harms of a competitor “target[ing] specific markets” or “forecast[ing] potential business of new locations.” View "Madel v. Dep't of Justice" on Justia Law

When Samantha Reckis was seven years old, she developed toxic epidermal necrolysis, a life-threatening skin disorder, after receiving multiple doses of Children’s Motrin, an over-the-counter medication with ibuprofen as its active ingredient. Plaintiffs, Samantha and her parents, sued the manufacturer and marketer of Children’s Motrin and its parent company, alleging that Samantha developed TEN as a result of being exposed to ibuprofen in the Children’s Motrin and that the warning label on the medication’s bottle rendered the product defective because it failed to warn consumers about the serious risk of developing a life-threatening disease from it. A jury found in favor of Plaintiffs and awarded Samantha a total of $50 million in compensatory damages and each of Samantha’s parents $6.5 million for loss of consortium. The Supreme Judicial Court affirmed, holding (1) Plaintiffs’ claim of failure to warn was not preempted by the Federal Food, Drug, and Cosmetic Act; (2) a pharmacologist who offered the causation evidence essential to Plaintiffs’ case was qualified to testify as to specific medical causation, and the testimony was reliable and admissible; and (3) the damages awarded to each of the plaintiffs were not grossly excessive or unsupported by the record. View "Reckis v. Johnson & Johnson" on Justia Law

From 1998 to 2012 Abbott marketed the anticonvulsant medication Depakote for applications that had not been FDA-approved (off-label uses). Physicians may prescribe drugs for off-label uses, but pharmaceutical companies are generally prohibited from marketing drugs for those same applications. Qui tam actions were filed under the False Claims Act. In 2009, Abbott disclosed in an SEC filing that the Department of Justice was investigating its marketing. Abbott pleaded guilty to illegally promoting Depakote from 2001 through 2006 and agreed to pay $1.6 billion to settle the criminal and qui tam actions. Employee benefits funds filed suit 15 months later, alleging that Abbott misrepresented Depakote’s safety and efficacy for off-label uses, paid kickbacks to physicians, established and funded intermediary entities to promote the drug for off-label uses, and concealed its role in these activities, in violation of the Racketeer Influenced and Corrupt Organizations Act. The district court dismissed, finding that the statute of limitations for the RICO claim began to run in 1998, when the funds initially reimbursed a prescription for off-label use. The court refused to toll the limitations period until the guilty plea, finding that Abbott’s concealment efforts were not designed to hinder potential lawsuits. The Seventh Circuit reversed, finding that dismissal was premature without an opportunity for discovery into when a reasonable fund should have known about its injuries from off-label marketing. View "Sidney Hillman Health Ctr. of Rochester v. Abbott Labs., Inc." on Justia Law

Pfizer’s patent discloses methods of treating eye infections by topical administration of azithromycin to the eye and states that before the invention, azithromycin was commonly administered orally for the treatment of antibacterial infections, but was not known to be effective when topically administered to the eye. Insite owns three patents. Inspire is the licensee of all four patents and markets the FDA-approved topical azithromycin solution, “Azasite®.” The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations lists the four patents. Sandoz filed an Abbreviated New Drug Application for its generic version of Azasite® with a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) that the patents were invalid or not infringed. The patent holders sued under 35 U.S.C. 271(e). After claim construction, Sandoz stipulated to infringement. The district court ruled that Sandoz failed to show that the asserted claims would have been obvious to a person of ordinary skill in the art and upheld the validity of the patents under 35 U.S.C. 103(a). The Federal Circuit affirmed, rejecting an argument that the court “misframed” the inquiry relating to development of “improved topical treatments for ocular infections,” rather than the narrower problem of topically administering azithromycin to treat conjunctivitis. View "Insite Vision, Inc. v. Sandoz, Inc." on Justia Law