Justia Drugs & Biotech Opinion Summaries

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

Myriad obtained patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. The discovery enabled Myriad to develop medical tests for detecting mutations for assessing cancer risk. Myriad’s patents would give it the exclusive rights to isolate an individual’s BRCA1 and BRCA2 genes and to synthetically create BRCA composite DNA. The district court entered summary judgment, finding the patents invalid under 35 U.S.C. 101 because they covered products of nature. On remand following the Supreme Court’s decision, Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Federal Circuit found both isolated DNA and composite DNA patent-eligible. The Supreme Court affirmed in part and reversed in part, noting that the case did not involve “method claims” for new applications of knowledge about the genes or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. A naturally-occurring DNA segment is not patent-eligible merely because it has been isolated, but composite DNA is patent-eligible because it is not naturally-occurring. Myriad did not create or alter the genetic information encoded in the genes or the genetic structure of the DNA. Even brilliant discovery does not alone satisfy the section 101 inquiry. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Composite DNA, however, is not a “product of nature;” a lab technician unquestionably creates something new when introns are removed from a DNA sequence to make composite DNA. View "Assoc. for Molecular Pathology v. Myriad Genetics, Inc." on Justia Law

The National Childhood Vaccine Injury Act of 1986 established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties. Under the Act, a proceeding for compensation is “initiated” by service upon the Secretary of Health and Human Services and “the filing of a petition containing” specified documentation with the clerk of the Court of Federal Claims, who forwards the petition for assignment to a special master. 42 U. S. C. 300aa–11(a)(1). An attorney may not charge a fee for services in connection with such a petition, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith. In 1997, shortly after receiving her third Hepatitis-B vaccine, Cloer began to experience symptoms that led to a multiple sclerosis (MS) diagnosis in 2003. In 2004, she learned of a link between MS and the Hepatitis-B vaccine, and in 2005, she filed a NCVIA claim. The special master concluded that Cloer’s claim was untimely because the Act’s 36-month limitations period began to run when she had her first MS symptoms in 1997.The Federal Circuit agreed. Cloer then sought attorney’s fees and costs. The Federal Circuit ruled in Cloer’s favor. The Supreme Court affirmed. Nothing in the attorney’s fees provision suggests that the reason for the subsequent dismissal of a petition, such as untimeliness, nullifies the initial filing. An NCVIA petition delivered to the court clerk, forwarded for processing, and adjudicated before a special master is a “petition filed under section 300aa–11.” The government’s contrary position is inconsistent with the fees provision’s purpose, which was to avoid limiting petitioners’ ability to obtain qualified assistance by making awards available for “non-prevailing, good-faith claims.” View "Sebelius v. Cloer" on Justia Law

Once the FDA has approved a brand manufacturer's drug, another company could seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585. The relevant statute at issue in this case provided that a generic company "may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted... under [two statutory subsections] on the ground that the patent does not claim... an approved method of using the drug." 117 Stat. 2452, 21 U.S.C. 355(j)(5)(C)(ii)(I). At issue in this case was whether Congress had authorized a generic company to challenge a use code's accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit. The Court held that a generic manufacturer could employ this provision to force correction of a use code that inaccurately described the brand's patent as covering a particular method of using the drug in question. Therefore, the Court reversed the judgment of the Federal Circuit. View "Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S" on Justia Law