Justia Drugs & Biotech Opinion Summaries

The patent at issue concerns methods for preventing bovine mastitis, the inflammation of udder tissue in cows, and is entitled “Antiinfective free intramammary veterinary composition.” The summary of the invention describes how the composition employs a physical barrier within the teat canal to block introduction of mastitis-causing organisms without requiring use of antiinfectives such as antibiotics. A patent examiner rejected certain claims introduced in the context of ex parte reexamination. The Patent Trial and Appeal Board and Federal Circuit affirmed, finding that substantial evidence supported the Board’s finding that one claim failed the written description requirement because the disclosure did not “describe[] a formulation excluding a specific species of the anti-infective genus, while permitting others to be present.” View "In re: Bimeda Research & Dev. Ltd." on Justia Law

Plaintiffs, a group of prisoners, filed suit against the FDA for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and misapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A). The court concluded that, because there were clear statutory guidelines for the agency to follow in exercising its enforcement powers, the FDA's compliance with section 381(a) was subject to judicial review under the standards of the APA. The court also concluded that the FDA's policy of admitting foreign manufactured thiopental destined for state correctional facilities were not in accordance with law because section 381(a) required the agency to sample and examine for violations of any drug offered for import that had been prepared in an unregistered facility. The court concluded, however, that the district court erred by failing to seek the joinder of the state governments whose possession and use of the thiopental at issue the court declared illegal. Accordingly, the order of the district court pertaining to the thiopental already in the possession of the states was vacated, but the underlying judgment of the district court was affirmed. View "Cook, et al. v. FDA, et al." on Justia Law

GSK holds patent and FDA rights to market and sell the pharmaceutical (paroxetine hydrochloride) controlled release tablets for treatment of depression, under the brand name Paxil. Under a 2007 settlement agreement, GSK granted Mylan certain rights to produce, market, and sell generic paroxetine. In 2010, GSK agreed, in an unrelated settlement, to begin supplying Apotex with GSK-produced generic paroxetine for marketing and sale. Mylan sued GSK and Apotex, claiming the 2010 agreement violated its licensing agreement, which did not permit GSK to provide its own form of generic paroxetine to another generic drug company to be marketed and sold in direct competition with Mylan. The district court found that the terms of the agreement were unambiguous and did not limit to whom GSK was permitted to market and sell its own version of generic paroxetine. The Third Circuit reversed the order of summary judgment on the breach-of-contract cause of action against GSK, but affirmed summary judgment on other claims. View "Mylan Inc. v. SmithKline Beecham Corp." on Justia Law

Plaintiffs are holders of Savient’s 4.75% convertible senior notes due in 2018, which are unsecured and subject to the terms of an indenture. Collectively, Plaintiffs own a face value of $48,709,000, approximately 40% of the outstanding Notes. Defendants are members of Savient’s board of directors USBNA serves as trustee for the Indenture governing the Notes. Following dismal sales of its new drug, KRYSTEXXA, Savient’s Board approved a financing transaction to exchange some existing unsecured Notes for new senior secured notes with a later maturity date. Through the Exchange, Savient exchanged around $108 million in Notes, raised around $44 million in new capital, and issued additional SSDNs with a face value of approximately $63 million. Like the Notes, the SSDNs are subject to an indenture for which USBNA serves as trustee. Plaintiffs sought a declaration that Savient was insolvent and brought derivative claims alleging waste and breach of fiduciary duty in connection with the Exchange Transaction; alleged breach of fiduciary duty and waste claims in connection with the Board’s approval of retention awards for certain Savient executives. The chancellor dismissed the receivership claim for lack of standing and granted a declaration that an Event of Default has not occurred.View "Tang Capital Partners LP, v. Norton" on Justia Law

This was an appeal from a forfeiture order entered by the district court against a total of $116,584 and certain items of personal property. The cash and personal property were seized from several individuals because of their alleged use in violation of the Wyoming Controlled Substances Act. Appellants Joseph Libretti and Frank Hohlios claimed $7,209 of the cash seized and appealed the forfeiture order, contending that the district court erred in holding an evidentiary hearing without ruling on their motions to dismiss or for a more definite statement, and in denying them the opportunity to file answers, conduct discovery, file summary judgment motions, or avail themselves of the right to a jury trial. The Supreme Court affirmed, holding that the district court acted in accordance with the Wyoming Rules of Civil Procedure in ruling on the State's forfeiture complaint and did not deny the rights of Appellants to file answers, conduct discovery, file summary judgment motions, or otherwise fully participate in the proceedings.View "Libretti v. State" on Justia Law

Plaintiff, a former corporate officer, sued defendant, his former employer, for advancement and indemnification in connection with several proceedings that arose out of regulatory and criminal investigations at the defendant corporation following defendant's distribution of oversized morphine sulfate tablets into the market. The dispute centered around whether plaintiff succeeded on the merits of any of the proceedings at issue, thus entitling him to indemnification as a matter of law, or whether additional discovery was required to determine whether plaintiff acted in good faith, in which case he would be entitled to indemnification under the Indemnification Agreement. The court found that plaintiff was not entitled to advancement for the Jail Records Matter; was not entitled to mandatory indemnification for the Criminal Matter or the HHS Exclusion Matter; was entitled to mandatory indemnification for the FDA Consent Decree Matter; and that the evidence relevant to plaintiff's claims for permissive identification was limited to plaintiff's conduct, and the facts related to that conduct, underlying the proceedings for which indemnification was sought.View "Hermelin v. K-V Pharmaceutical Co." on Justia Law

On October 4th, SIGA moved for reargument to the remedy ordered in a September 22 Opinion. SIGA contended that the court misapplied the law and misunderstood material facts in awarding PharmAthene an equitable lien on a share of future profits derived from a biodefense pharmaceutical known as ST-246. The court held that it did not misapprehend the law of remedies by imposing an equitable remedy reasonably designed to compensate PharmAthene for its lost expectancy; SIGA had not shown that the September 22 Opinion was the product of either a misapplication of law or a misunderstanding of material fact; and the legal and equitable basis for the structure of the equitable payment stream was the court's authority to provide relief "as justice and good conscience may require" and to remedy in equity what otherwise would amount to unjust enrichment. Accordingly, the court denied SIGA's motion for reargument.View "PharmAthene, Inc. v. SIGA Technologies, Inc." on Justia Law

This action arose out of a dispute between two companies involved in the development of pharmaceuticals. Plaintiff was a biodefense company engaged in the development and commercialization of medical countermeasures against biological and chemical weapons and defendant was also a biodefense company that concentrated on the discovery and development of oral antiviral and antibacterial drugs to treat, prevent, and complement vaccines for high-threat biowarfare agents. The court rejected plaintiff's claim that defendant breached a binding license agreement, but found that defendant did breach its obligations to negotiate in good faith and that defendant was liable to plaintiff under the doctrine of promissory estoppel. The court rejected defendant's claim that plaintiff breached its obligation to negotiate in good faith. The court denied plaintiff's claims for specific performance of a license agreement with the terms set forth in the time sheet or, alternatively, for a lump sum award of its expectation damages. The court concluded, however, that plaintiff was entitled to share in any profits relied on from the sale of the drug in question, after an adjustment for the upfront payments it likely would have had to make had the parties negotiated in good faith a license agreement in accordance with the terms of the term sheet. In addition, plaintiff was entitled to recover from defendant a portion of the attorneys' fees and expenses plaintiff incurred in pursuing the action.View "PharmAthene, Inc. v. SIGA Technologies, Inc." on Justia Law

The Food, Drug, and Cosmetic Act requires Food and Drug Administration (FDA) approval before marketing any brand-name or generic drug in interstate commerce, 21 U.S.C. 355(a). The manufacturer of an approved drug is prohibited from making any major change to the "qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application." Generic manufacturers are also prohibited from making any unilateral change to a drug’s label. In 2004, a patient was prescribed Clinoril, a brand-name nonsteroidal anti-inflammatory drug (NSAID) sulindac, for shoulder pain. Her pharmacist dispensed a generic form of sulindac manufactured by Mutual. The patient developed an acute case of toxic epidermal necrolysis and is severely disfigured, has physical disabilities, and is nearly blind. At the time of the prescription, sulindac’s label did not specifically refer to toxic epidermal necrolysis. By 2005, the FDA had recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning. A jury found Mutual liable on a design-defect claim and awarded the patient more than $21 million. The First Circuit affirmed. The Supreme Court reversed. State-law design-defect claims based on the adequacy of a drug’s warnings are preempted by federal law under a 2011 Supreme Court decision, PLIVA, Inc. v. Mensing. It is impossible for Mutual to comply with both its federal-law duty not to alter sulindac’s label or composition and its state-law duty to either strengthen the warnings on the label or change sulindac’s design. Redesign was not possible because the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as its brand-name drug equivalent and, due to sulindac’s simple composition, the drug is chemically incapable of being redesigned. Mutual could only ameliorate sulindac’s "risk-utility" profile, therefore, by strengthening its warnings, an action forbidden by federal law. View "Mut. Pharma. Co. v. Bartlett" on Justia Law

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), 21 U.S.C. 355(j)(2)(A)(vii)(IV) established procedures for identifying and resolving patent disputes between brand-name and generic drug manufacturers. One procedure requires a prospective generic manufacturer to certify to the FDA that any listed, relevant patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug (paragraph IV). Generic manufacturers filed paragraph IV applications for generic drugs modeled after Solvay’s FDA-approved, patented drug AndroGel. Solvay claimed patent infringement, 35 U.S.C. 271(e)(2)(A). The FDA approved the generic product, but the generic companies entered into “reverse payment” settlements, agreeing not to bring the generic to market for a number of years and to promote AndroGel to doctors in exchange for millions of dollars. The FTC sued, alleging violation of section 5 of the Federal Trade Commission Act by agreeing to abandon patent challenges, to refrain from launching low-cost generic drugs, and to share in Solvay’s monopoly profits. The district court dismissed. The Eleventh Circuit affirmed. The Supreme Court reversed and remanded, calling for application of a “rule of reason” approach rather than a “quick look.” Although the anti-competitive effects of the reverse settlement might fall within the exclusionary potential of Solvay’s patent, the agreement is not immune from antitrust attack. It would be incongruous to determine antitrust legality by looking only at patent law policy, and not at antitrust policies. The Court noted the Hatch-Waxman Act’s general pro-competitive thrust, facilitating challenges to a patent’s validity and requiring parties to a paragraph IV dispute to report settlement terms to antitrust regulators. Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses. That a large, unjustified reverse payment risks antitrust liability does not prevent parties from settling their lawsuits; they may settle in other ways, e.g., by allowing the generic to enter the market before the patent expires without payment to stay out prior to that point. View "Fed. Trade Comm'n v. Actavis, Inc." on Justia Law