Justia Drugs & Biotech Opinion Summaries

West Virginia sued pharmaceutical distributors, seeking to hold them liable for contributing to the state’s epidemic of prescription drug abuse. The complaint alleged that certain pharmacies, “pill mills,” knowingly provided citizens with hydrocodone, oxycodone, codeine, and other prescription drugs, not for legitimate uses, but to fuel and profit from their addictions. The state contends that those pharmacies ordered drugs in quantities so large that the distributors should have known they would be used for illicit purposes. H.D. Smith, a distributor, had a general commercial liability insurance policy issued by Cincinnati Insurance. The policy covered damages that H.D. Smith became legally obligated to pay “because of bodily injury,” defined as “bodily injury, sickness or disease sustained by a person, including death.” “[D]amages because of bodily injury” include “damages claimed by any person or organization for care, loss of services or death resulting at any time from the bodily injury.” Cincinnati refused to defend the suit and obtained a declaratory judgment. The Seventh Circuit reversed summary judgment. The plain language of the policy requires Cincinnati to defend a suit brought by a plaintiff to recover money paid to care for someone who was injured by H.D. Smith. West Virginia’s suit fits that description. View "Cincinnati Ins. Co. v. H.D. Smith, LLC." on Justia Law

TMC owns patents relating to 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. In 2005, BV created batches of bivalirudin with levels of impurity above the FDA-approved maximum. TMC’s consultant discovered that certain methods of adding a pH-adjusting solution during compounding minimize the impurity. In 2008, TMC filed patent applications, describing this discovery. A year earlier, TMC had hired BV to prepare batches using the patented method. Each was released for commercial packaging. In 2010, TMC sued, 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 (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 initially reversed, but affirmed on reconsideration. To be “on sale” a product must be the subject of a commercial sale or offer for sale; a commercial sale bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code. No such invalidating commercial sale occurred in this case. View "Medicines Co. v. Hospira, Inc." on Justia Law

Hepatocytes, a type of liver cell, are useful for testing, diagnostic, and treatment purposes. Fresh hepatocytes can only be obtained from liver resections or non-transplantable livers of organ donors; their lifespan is short. Supply is erratic. Before the 929 patent, scientists developed “cryopreservation” techniques, but the process could damage the hepatocytes and was unsuitable for multi-donor hepatocyte pools. Prevailing wisdom was that hepatocytes could be frozen only once before being used or discarded. The 929 parent's inventors discovered that some hepatocytes can survive multiple freeze-thaw cycles and developed an improved process: subjecting thawed cells to density gradient fractionation to separate viable from non-viable cells; recovering the viable cells; and refreezing the viable cells. After refreezing only the viable cells, the preserved hepatocyte preparations can be thawed and used later without unacceptable loss of viability. Hepatocyte samples from single donors can be pooled into a composite preparation that can be refrozen for later use. In an infringement suit, the court found the patent invalid under 35 U.S.C. 101, as directed to a patent-ineligible law of nature—that hepatocytes can survive multiple freeze-thaw cycles—and that the patented process lacks the requisite inventive concept. The Federal Circuit vacated. That each of the individual steps (freezing, thawing, and separating) were known independently in the art does not make the claim unpatentable; patent-eligibility does not turn on ease of execution or obviousness of application. View "Rapid Litig. Mgmt. v. Cellzdirect, Inc." on Justia Law

Apotex applied to the FDA, under the Biologics Price Competition and Innovation Act of 2009, for permission to begin marketing a product allegedly “biosimilar” to Amgen’s FDA-approved Neulasta®. Apotex and Amgen proceeded under the Act’s process for exchanging information and channeling litigation about patents relevant to the application. In this suit, Amgen alleged that Apotex’s proposed marketing would infringe an Amgen patent. On Amgen’s motion, the district court preliminarily enjoined Apotex from entering the market unless it has given Amgen notice after receiving the requested FDA license and then waited 180 days, pursuant to 42 U.S.C. 262(l)(8)(A). The Federal Circuit affirmed. The Act’s commercial-marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice, and an injunction was proper to enforce the provision against even a biosimilar product​ applicant that did engage in the statutory process for exchanging patent information and channeling patent litigation. View "Amgen Inc. v. Apotex Inc." on Justia Law

Ranbaxy, a pharmaceutical company, seeks money damages and injunctive relief for alleged misrepresentations made by FDB, a company that publishes a drug information database for use by pharmacies across the United States. Ranbaxy alleges that FDB’s database, MedKnowledge, falsely represents that Ranbaxy’s acne drug Absorica is non-unique. The district court granted summary judgment to FDB. The court affirmed the order and judgment, concluding that Ranbaxy has not raised a genuine issue of material fact with regard to falsity. The court concluded that, because FDB provides ample explanation of the information and terms in its database, no reasonable reader would conclude that Absorica was therapeutically equivalent to or substitutable for other drugs. View "Ranbaxy Labs. Inc. v. First Databank, Inc." on Justia Law

Xolair, an injected drug approved by the FDA for treating allergies, is co-promoted in the United States by Genentech, Inc. and Roche Holdings, Inc. (Genentech) and Novartis Pharmaceuticals Corp. and Novartis Corp. (Novartis). Relators brought qui tam actions against Genentech and Novartis under the False Claims Act (FCA) and related state statutes, alleging that Defendants caused healthcare providers to submit false claims to the government for reimbursement for Xolair. The district court dismissed the federal claims with prejudice and then declined to exercise jurisdiction over the state-law claims and dismissed those claims with prejudice. The First Circuit affirmed in part and vacated in part, holding that the district court (1) did not abuse its discretion in denying Relators’ motion to amend; (2) did not err in dismissing the federal claims with prejudice; and (3) erred in dismissing the pendant state-law claims with prejudice. Remanded. View "Garcia v. Novartis Pharms. Corp." on Justia Law

Pompe’s disease is a genetic condition associated with a deficiency or absence of the lysosomal enzyme acid α-glucosidase (GAA), which breaks down glycogen, a larger molecule, into glucose. In a person with Pompe’s disease, glycogen accumulates in the heart and muscles, causing progressive muscle weakness and respiratory symptoms, and, in early-onset cases, cardiac symptoms. Early efforts at enzyme replacement therapy failed because the injected enzyme was predominantly taken up by the patient’s liver. By 1997, research had progressed and the FDA approved Duke University’s application for Orphan Drug Designation for a new therapy, involving injection of a recombinant form of GAA. In 2013, Biomarin sought inter partes review of Genzyme’s patents, directed to treating Pompe’s disease with injections of GAA, asserting that claims were obvious, given the Duke press release and prior references. Genzyme argued that because all references described in vitro experiments, a person of ordinary skill would not find those experiments predictive of results in a human patient. The Federal Circuit affirmed the Patent Board’s conclusion that “a person of ordinary skill in the art would have had a reasonable expectation of success at the time the invention was made,” and “no more than routine processes were needed” to achieve the results recited in the disputed claims. View "Genzyme Therapeutic Prods., Ltd. P'ship v. Biomarin Pharma., Inc." on Justia Law

Levoleucovorin is better known by the brand-name Fusilev, which Spectrum has sold since 2008 for the purpose of counteracting liver damage during a type of chemotherapy known as methotrexate therapy. Under the Orphan Drug Act amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa-ee, intended to increase incentives for companies to develop new orphan drugs, Spectrum received exclusive marketing rights to the Methotrexate Indications for seven years. Spectrum then received approval from FDA to market Fusilev for an altogether new use: helping patients with advanced colorectal cancer to manage their pain. Two days after Spectrum’s exclusivity period expired for the Methotrexate Indications, Sandoz received FDA approval to market a generic version of levoleucovorin for the Methotrexate Indications. Spectrum argued that Sandoz’s sole intended use of the generic was to treat patients with colorectal cancer, even though the label provided for use only in patients undergoing methotrexate therapy. The district court granted summary judgment against Spectrum. FDA concluded that it need look no further than the use indicated in Sandoz’s abbreviated new drug application (ANDA) to make certain the generic drug will not trench on the prior grant of exclusivity to Spectrum. The court agreed and found FDA's interpretation of the Orphan Drug Act reasonable. The statute does not unambiguously foreclose FDA's interpretation that “for such disease or condition” refers only to the uses included on a drug’s label. The court noted that, to the extent FDA has discretion in choosing how best to implement the Orphan Drug Act, it is up to the agency to strike the balance between the congressional policy goals of drug affordability and innovation. The court rejected Spectrum's remaining arguments and affirmed the judgment. View "Spectrum Pharm., Inc. v. Burwell" on Justia Law

Fabry Disease, a rare genetic disorder, leaves afflicted persons unable to synthesize a key enzyme that helps the body break down fats. Untreated, Fabry patients suffer progressively more severe symptoms, including pain in their extremities, gastrointestinal issues, vision and hearing losses, stroke, and heart and kidney failure, eventually leading to premature death. Researchers at the Mt. Sinai School of Medicine developed a method for producing a replacement enzyme, which effectively treats (but does not cure) Fabry. After patenting this method, Mt. Sinai granted an exclusive license to Genzyme, which became the sole producer of the replacement enzyme, "Fabrazyme," the only FDA-approved enzyme replacement therapy for the treatment of Fabry. Genzyme provided the drug to Fabry patients until 2009. After a virus was discovered in improperly cleaned equipment at the company's manufacturing facility, Genzyme reduced production, leading to a Fabrazyme shortage. The company began rationing. Despite setbacks in reestablishing production levels, in 2011 Genzyme diverted some Fabrazyme to the European market, allegedly because of competition Genzyme faced from an alternative enzyme replacement therapy approved only in Europe. Two class action complaints were consolidated and dismissed. The First Circuit affirmed in part, for lack of standing, noting “the utter failure of any plaintiff (other than Mooney) to plausibly allege that he or she suffered an injury in fact as a result of accelerated disease progression or receipt of a contaminated drug.” View "Hochendoner v. Genzyme Corp." on Justia Law

Plaintiff appealed the dismissal of his suit brought under the False Claims Act (FCA), 31 U.S.C. 3729(a)-(b), and state analog. Plaintiff alleged that Pfizer, his former employer, improperly marketed Lipitor as appropriate for patients whose risk factors and cholesterol levels fall outside the National Cholesterol Education Program Guidelines; the Guidelines are incorporated into and made mandatory by the drug’s label; and Pfizer thus induced doctors to prescribe the drug, pharmacists to fill the prescriptions, and federal and state health care programs to pay for “off‐label” prescriptions. Judge Cogan dismissed the claims because he determined that the FDA’s approval of Lipitor was not dependent upon compliance with the Guidelines. The court expressly endorsed and adopted Judge Cogan’s carefully considered and thorough analysis, and affirmed on that basis. View "United States ex rel. Polansky v. Pfizer" on Justia Law