Justia Drugs & Biotech Opinion Summaries

This appeal stemmed from a group of fourteen diversity cases that were consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the Northern District of Oklahoma. The plaintiffs in all fourteen cases were cancer treatment providers who purchased multi-dose vials of Herceptin, a breast cancer drug, from defendant Genentech, Inc. (Genentech). Plaintiffs alleged that Genentech violated state law by failing to ensure that each vial of Herceptin contained the labeled amount of the active ingredient, and by misstating the drug concentration and volume on the product labeling. After the cases were consolidated, Genentech moved for summary judgment, arguing that plaintiffs’ claims were pre-empted by federal law. The district court agreed with Genentech and granted its motion for summary judgment. Plaintiffs appealed. The Tenth Circuit disagreed with the district court's conclusion that plaintiffs' claims were preempted, and consequently, reversed summary judgment and remanded for further proceedings. View "In re: MDL 2700 Genentech" on Justia Law

Cochlear’s patent describes a hearing aid with several parts. A vibration-producing component is implanted and mechanically anchored into a patient’s skull on the patient’s deaf side. An external component, which includes a microphone, picks up sound on the patient’s deaf side, processes the sound, and generates vibrations in the implanted part, which are transmitted through th skull to the patient’s non-deaf ear, which then perceives sound originating from the deaf-ear side. The Patent and Trademark Office instituted two inter partes reviews, 35 U.S.C. 311–319, and concluded that claims 4–6 and 11–12 had been proven unpatentable; claims 7–10 were not unpatentable. Cochlear disclaimed claims 1–3 and 13.The Federal Circuit affirmed except with respect to claim 10, as to which it vacated. The Board correctly held that the preamble phrase “for rehabilitation of unilateral hearing loss” is not a limitation on the scope of the apparatus claims. The court upheld obviousness determinations concerning claims 4-6 and found claims 11-12 anticipated by prior art. On remand with respect to claim 10, the Board should consider whether the directivity-dependent-microphone alternative is outside the scope of 35 U.S.C. 112, because it recites a structure (the directivity dependent microphone) that sufficiently corresponds to the claimed directivity means. View "Cochlear Bone Anchored Solutions AB v. Oticon Medical AB" on Justia Law

The Food Drug and Cosmetic Act's (FDCA) broad preemption clause, 21 U.S.C. 379s, bars plaintiffs from seeking to impose additional or different labeling requirements through their state-law claims, especially when Congress and the FDA already have provided for specific labeling requirements. Plaintiffs filed suit against L’Oréal, alleging common law claims for unjust enrichment and breach of the implied warranty of merchantability, as well as claims under eight state consumer protection statutes. Plaintiffs believed they were being deceived into buying more product, because a portion of each of the liquid cosmetics they purchased could not be extracted.The Second Circuit affirmed the district court's dismissal of the complaint, holding that plaintiffs' state law claims at issue are preempted by the FDCA. In this case, plaintiffs alleged that their injuries resulted from the fact that the labels of the various L’Oréal products omitted certain critical information—specifically, that the creams could not be fully dispensed from their respective containers. Plaintiffs also admit that the packages comply with federal labeling requirements. The court explained that, if plaintiffs were permitted to move forward with their claims, they would be using state law to impose labeling requirements on top of those already mandated in the FDCA and the regulations promulgated thereunder. View "Critcher v. L'Oreal USA, Inc." on Justia Law

Eage filed suit, alleging infringement of four patents under the doctrine of equivalents, stemming from Slayback’s new drug application for a generic version of Eagle’s branded bendamustine product, BELRAPZO®. Bendamustine is used to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. The district court entered a judgment of non-infringement on the pleadings.The Federal Circuit affirmed, rejecting Eagle’s arguments that the district court erred when it concluded that the asserted patents disclose, but do not claim, ethanol—and therefore dedicated ethanol to the public and that the district court improperly applied the dedication disclosure doctrine at the pleadings stage, in the presence of factual disputes and without drawing all inferences in Eagle’s favor. The disclosure-dedication doctrine bars application of the doctrine of equivalents: “when a patent drafter discloses but declines to claim subject matter, . . . this action dedicates the unclaimed subject matter to the public.” The application of the doctrine is a question of law. The asserted patents disclose ethanol as an alternative to propylene glycol in the “pharmaceutically acceptable fluid” claim limitation. The only reasonable inference that can be made from the disclosures is that a skilled artisan would understand the patents to disclose ethanol as an alternative to the claimed propylene glycol. View "Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC" on Justia Law

Under California law, the donor's intent controls the disposition of his or her gametic material upon death. Plaintiff appealed the trial court's judgment sustaining demurrers to her causes of action alleged against defendants. After plaintiff's husband entered into an irreversible coma, she arranged to extract his sperm in hopes of one day conceiving a child with it. Plaintiff stored the sperm in a tissue bank that ultimately came under the control of defendants, and, ten years later, when she requested the sperm, defendants disclosed that they could not locate it. Plaintiff filed suit, alleging contract and tort claims based on the loss of her ability to have a child biologically related to her deceased husband.The Court of Appeal affirmed the trial court's judgment, holding that the complaint failed to adequately plead facts supporting tort damages. In this case, plaintiff's tort causes of action are all premised on the loss of her ability to conceive with her deceased husband's sperm. However, the court held that the complaint failed to allege facts establishing that plaintiff was legally entitled to use her husband's sperm to conceive a child after he died. In this case, plaintiff's status as his spouse did not entitle her to conceive with his sperm; absent an affirmative showing that the husband intended to allow plaintiff to conceive with his sperm, plaintiff was not entitled to do so; and thus the complaint failed to allege that it was the husband's intent that his sperm be used for posthumous conception. Finally, the court held that plaintiff cannot recover emotional distress damages on her breach of contract cause of action. View "Robertson v. Saadat" on Justia Law

PMRS petitioned for review of the FDA's denial of PMRS's application to market a prescription opioid drug. The DC Circuit rejected PMRS's challenges under the Administrative Procedure Act (APA), and held that the FDA's decision to deny the application was reasonable and consistent with law. The court held that the FDA examined the material factors, considered the record as a whole, and provided a reasonable explanation for its decision to deny PMRS's application. In this case, the court had no basis to question the agency's conclusion that the operative version of PMRS's proposed label created the false and misleading impression that the drug possessed abuse deterrent physical and chemical properties. The court also held that the FDA's decision to deny PMRS's request for a hearing was not an abuse of discretion. View "Pharmaceutical Manufacturing Research Services, Inc. v. FDA" on Justia Law

In this case, one of thousands filed by state and local governments against opioid manufacturers across the country, the Supreme Court affirmed the judgment of the second district court granting a manufacturer defendant's motion to transfer the Davis County action to the third district court for discovery and pretrial proceedings, holding that the district court did not abuse its discretion.Plaintiffs in these cases asserted that manufacturers and distributors of opioid drugs misled the public about the safety of these drugs, leading to the opioid epidemic. Fifteen opioid cases were filed in Utah courts. When certain manufacturer defendants moved to consolidate all of the state's pending cases in third district, the court invited judges in other district courts to consider transferring their opioid cases to the third district. Janssen Pharmaceuticals, Inc. filed a motion in the second district asking that the court transfer the Davis County action to the third district for discovery and pretrial proceedings. The second district granted the transfer petition. The Supreme Court affirmed, holding (1) the district court has inherent authority to grant a motion to transfer for pretrial proceedings; and (2) the district court did not exceed the bounds of its discretion in transferring this case to the third district. View "Davis County v. Purdue Pharma, LP" on Justia Law

GSK’s patent to an anti-epilepsy drug, Lamictal, was to expire in 2009. Teva sought to market a generic version of Lamictal, lamotrigine, before GSK’s patent expired. Teva submitted an Abbreviated New Drug Application. GSK sued for infringement. After Teva received a favorable ruling with respect to one claim in 2005, the parties settled. Teva would begin selling lamotrigine six months before it could have had GSK won but later than if it had succeeded in litigation. GSK promised not to launch an authorized generic (AG) version of Lamictal. Had the parties not settled and had Teva succeeded in litigation, it would have been entitled to a 180-day exclusivity period as the generic first filer but GSK could have launched an AG.Companies that directly purchased Lamictal or lamotrigine (Direct Purchasers) sued, claiming the settlement violated the antitrust laws because GSK “paid” Teva to stay out of the market by promising not to launch an AG, resulting in Direct Purchasers paying more than they would have otherwise.The district court certified a class of all companies that purchased Lamictal from GSK or lamotrigine from Teva. The Third Circuit vacated. The district court certified the class without undertaking the required “rigorous” analysis, failing to resolve key factual disputes, assess competing evidence, and weigh conflicting expert testimony, all of which bear heavily on the predominance requirement, and confused injury with damages. View "In re: Lamictal Direct Purchaser Antitrust Litigation" on Justia Law

Biogen holds the New Drug Application for the active ingredient dimethyl fumarate (DMF), which was FDA-approved in 2013 as Tecfidera®, a twice-daily pill for the treatment of relapsing forms of multiple sclerosis at a daily dose of 480 mg. The 001 patent, “Utilization of Dialkylfumarates,” discloses that dialkyl fumarates may have therapeutic uses “in transplantation medicine and for the therapy of autoimmune diseases,” including multiple sclerosis. After the five-year data exclusivity for Tecfidera® expired, Banner submitted an application under 21 U.S.C. 355(b)(2) to market a twice-daily monomethyl fumarate (MMF) pill at a daily dose of 380 mg. Biogen alleged infringement of the 001 patent. Banner argued that section 156(b)(2) limits the scope of the patent’s extension to methods of using the approved product as defined in 156(f)—DMF, its salts, or its esters—and that MMF is none of those things. Biogen responded that section 156(b)(2) limits extension only to uses of any product within the original scope of the claims. The patent will expire in June 2020.The Federal Circuit affirmed the district court’s finding of non-infringement. The monomethyl ester, covered by claim 1, is not covered by the extension. The scope of a patent term extension under 35 U.S.C. 156 only includes the active ingredient of an approved product, or an ester or salt of that active ingredient; the product at issue does not fall within those categories. View "Biogen International GmbH v. Banner Life Sciences, LLC" on Justia Law

CardioNet’s 207 patent, titled “Cardiac Monitoring,” claims priority to an application filed in 2004 and describes cardiac monitoring systems and techniques for detecting and distinguishing atrial fibrillation and atrial flutter from other various forms of cardiac arrythmia. The district court dismissed CardioNet’s patent infringement complaint against InfoBionic, finding that the asserted claims of the patent are ineligible under 35 U.S.C. 101.The Federal Circuit reversed, applying the Supreme Court’s two-step “Alice” framework and finding that the asserted claims of the 207 patent are directed to a patent-eligible improvement to cardiac monitoring technology and are not directed to an abstract idea. Nothing in the record suggests that the claims merely computerize pre-existing techniques for diagnosing atrial fibrillation and atrial flutter. View "CardioNet, LLC v. InfoBionic, Inc." on Justia Law