Justia Drugs & Biotech Opinion Summaries

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

Stryker’s 243 patent concerns a socket assembly used in prosthetic hip implants. The patent addresses three major components involved: a shell member and a bearing member, which together replace the socket (technically the acetabulum) part of the pelvis bone, and the femoral component, the ball-shaped end of the thigh bone that marries with the socket. The district court granted summary judgment of noninfringement following claim construction. The Federal Circuit upheld the construction of “relative location” claim language to require that “the recess is essentially midway along the taper such that the effectiveness of each is not compromised” and to require that “the internal taper of the shell mates with the external taper of a metallic securing member (i.e. sleeve) secured to and separate from the bearing member,” essentially requiring the presence of a sleeve in between the shell and the bearing, for the taper type of securement. The district court did not abuse its discretion in applying its local rules to preclude Stryker from arguing infringement under the doctrine of equivalents. View "Howmedica Osteonics Corp. v. Zimmer, Inc." on Justia Law

Sanofi has sold Lovenox, an anticoagulant drug, in the U.S. since 1993. Fragmin, a competing injectable, sold only abroad until 2005, when Eisai obtained a U.S. license. Some Fragmin indications overlap Lovenox’s indications. The relevant product market also includes two other injectable anticoagulant drugs. In 2005-2010, Lovenox had the most indications of the four drugs, the largest sales force, and a market share of 81.5% to 92.3%. Fragmin had the second largest market share at 4.3-8.2%. In 2005-2010, Sanofi offered the “Lovenox Acute Contract Value Program.” Eisai alleged anticompetitive conduct by: market share and volume discounts, a restrictive formulary access clause, and aggressive sales tactics in marketing the Program. The Third Circuit affirmed summary judgment in favor of Sanofi. What Eisai called “payoffs” were only discounts Sanofi offered its customers; what Eisai called “agreements with hospitals to block access” were actually provisions proscribing customers from favoring competing drugs over Lovenox. What Eisai called “a campaign of ‘fear, uncertainty, and doubt’” was simply Sanofi’s marketing. Under the rule of reason, there was no evidence that Sanofi’s actions caused broad harm to the competitive nature of the anticoagulant market. If Sanofi’s conduct caused damage to its competitors, that is not a harm for which Congress has prescribed a remedy. View "Eisai Inc v. Sanofi Aventis U.S. LLC" on Justia Law

VRC filed suit against HHS and the Secretary, seeking the recoupment of payments VRC returned to Medicare after it was issued notice of an overpayment. At issue is the reimbursement rate of the intravitreal injection of Lucentis. VRC did not follow the Lucentis label’s instructions limiting dosage to one per vial. Instead, VRC treated up to three patients from a single vial. Because VRC was extracting up to three doses from a single vial, it was reimbursed for three times the average cost of the vial and three times the amount it would have received had it administered the drug according to the label. The court affirmed the denial of recoupment, concluding that VRC's charge to Medicare did not reflect its expense and was not medically reasonable; the Secretary's decision was supported by substantial evidence; and VRC is liable for the overpayment. View "Vitreo Retinal Consultants v. U.S. Dep't of Health & Human Servs." on Justia Law