Justia Drugs & Biotech Opinion Summaries

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

At his Reedsville, Wisconsin home, Dessart manufactured and sold products containing the active chemical ingredients in numerous prescription drugs, offering them for sale online with the disclaimer “for research only” to evade FDA oversight. After receiving an anonymous tip, investigating Dessart’s website, and intercepting three packages connected to Dessart’s operation, agents obtained a warrant, conducted a controlled delivery, and search Dessart’s house. He was convicted of violating the Food, Drug, and Cosmetic Act, 21 U.S.C. 331, with the intent to defraud or mislead the agency, which converted his violations from strict-liability misdemeanors into specific-intent felonies. The Seventh Circuit affirmed, rejecting arguments that the FDA’s investigator lied in procuring a search warrant and the warrant otherwise lacked probable cause; the government’s evidence was insufficient to prove that he acted with deceptive intent; and the district court erred in instructing the jury on the definition of “prescription drug.” The evidence of Dessart’s intent to mislead the FDA was ample and easily sufficient to support the jury’s verdict. View "United States v. Dessart" on Justia Law

Apotex filed suit alleging that Acorda filed a sham citizen petition with the FDA to hinder approval of Apotex's competing formulation of a drug for treating spasticity, in violation of Section 2 of the Sherman Act, 15 U.S.C. 2, and that Acorda violated the Lanham Act's, 15 U.S.C. 1125(a)(1), proscription on false advertising. The district court ruled that the simultaneous approval by the FDA of Apotex’s drug application and its denial of Acorda’s citizen petition was by itself insufficient to support a Sherman Act claim. The district court then granted summary judgment and dismissed all of Apotex’s false advertising claims on the grounds that (with the exception of one graph) no representation was literally false or likely to mislead consumers. In regard to the graph, Apotex failed to show that the false depiction would meaningfully impact consumers’ purchasing decisions. The court concluded that, although precedent supports an inference that a citizen petition is an anticompetitive weapon if it attacks a rival drug application and is denied the same day that the application is approved, that inference has been undercut by recent FDA guidance.  As to false advertising, the court agreed with the district court that no reasonable jury could have found that Acorda made literally false or misleading representations in its advertisements, with the exception of a single representation that Apotex has failed to show affected decisions to purchase. Accordingly, the court affirmed the judgment. View "Apotex Inc. v. Acorda Therapeutics, Inc." on Justia Law

Finacea® Gel contains azelaic acid as the therapeutically active ingredient in a concentration of 15% by weight and is indicated for the topical treatment of rosacea. Finacea® is manufactured as a “hydrogel,” which the court construed to mean “a semisolid dosage form that contains water and a gelling agent to form a gel, which may contain dispersed particles and/or insoluble liquids.” The FDA Orange Book lists the 070 patent as covering Finacea® Gel. The 070 patent, entitled “Composition with Azelaic Acid,” issued in 2003 and claims priority to a 1998 provisional application. Glenmark submitted an Abbreviated New Drug Application to the FDA seeking to market a generic version of Finacea®, including a paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)) that the patent was invalid and not infringed. Unlike Finacea®, the proposed generic product substituted isopropyl myristate for the claimed triglyceride and lecithin. The court held that certain claims were infringed under the doctrine of equivalents and not invalid. The court concluded that the isopropyl myristate in Glenmark’s generic product met the claim elements triglyceride and lecithin under the doctrine of equivalents, relying on the function-way-result test. The court rejected arguments that infringement under the doctrine of equivalents would encompass the prior art and was barred by prosecution history estoppel. The Federal Circuit affirmed, agreeing that the asserted claims would not have been obvious. View "Intendis GMBH v. Glenmark Pharma., Inc." on Justia Law

In 1997, Merck and Weider considered jointly introducing, into the U.S., dietary supplements with Merck ingredients, including crystalline calcium salt of a tetrahydrofolic acid (MTHF), agreeing that, until a definitive agreement was signed, neither party was under any legal obligation. Weider later notified Merck that it was no longer interested in a joint venture, but would like to purchase two kilograms of MTHF. Merck quoted a price of $25,000 per kg. After extensive correspondence, in October 1998, Merck sent confirmation of the “first order.” Merck then met with a Weider competitor. Merck contacted Weider in January 1999, asking whether its purchase order was still “active.” Weider sent confirmation that the parties had mutually cancelled Weider’s “existing order for [MTHF].” Merck filed its 168 patent application, including claim 4 (MTHF), in 2000; the patent issued in 2002. In a 2013 infringement suit concerning Abbreviated New Drug Applications, the court held that claim 4 was not anticipated, obvious, or invalid for lack of adequate written description and was not invalid under the on-sale bar. Although the court determined that MTHF was ready for patenting by September 1998, it concluded that there had been no invalidating commercial offer for sale or sale, because Merck’s fax did not include “important safety and liability terms.” The Federal Circuit reversed. Merck’s September 1998, offer to sell MTHF was a premature commercial exploitation of its invention. View "Merck & Cie v. Watson Labs., Inc." on Justia Law