Justia Drugs & Biotech Opinion Summaries

Plaintiffs are the owner of the patents, which cover a modified-release dosage form of skeletal muscle relaxants (793) and a method of relieving muscle spasms with the formulation disclosed in the 793 patent, and the exclusive licensee of the patents. The district court found the patents invalid as obvious, but enjoined defendants from launching their generic product, pending appeal. The Federal Circuit reversed. The district court failed to consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation and, therefore, erred when it assessed the importance of the teachings of the prior art to the obviousness analysis. The court rejected defendants' alternate argument that the patents were invalid for failure to disclose the best mode (35 U.S.C. 112), stating that the evidence supported a finding that the patents enable one of ordinary skill in the art to practice the inventor's preferred dew points.View "In re Cyclobenzaprine Hydrochloride Extended Release Casule Patent Litigation" on Justia Law

Plaintiff's 561 and 512 pharmaceutical patents for "Taxotere" are related to administration of the chemotherapy cancer drug docetaxel (a successor to the cancer drug paclitaxel, covered by a now-expired patent). To stabilize the perfusion and delay precipitation, the cancer drugs are mixed with additives like surfactants and ethanol. Prior art used the surfactant Cremophor, but it was known to trigger serious allergic reactions. The 561 and 512 patents relate to using surfactants other than Cremophor and decreasing the amount of ethanol to reduce alcohol intoxication and anaphylactic effects in patients. After defendants applied for FDA approval to market generic versions of Taxotere, plaintiff claimed infringement, 35 U.S.C. 271(e). The district court found certain claims invalid for obviousness and that the patents were unenforceable for inequitable conduct. The Federal Circuit affirmed, concluding that withheld references to prior art were material View "Aventis Pharma S.A. v. Hospira, Inc." on Justia Law

In 1996, RG, exclusive licensee of a German patent and corresponding patents in the U.S., Europe, and Japan relating to genetic identification, entered into a license agreement with Promega, granting Promega certain licenses. The agreement included a clause, providing that “all controversies or disputes arising out of or relating to this Agreement, or relating to the breach thereof, shall be resolved by arbitration” and prohibited assignment without consent. Assignments were approved in 2001 and 2003; a subsequent assignment from IP to LT was not approved. In 2008 LT believed that Promega was paying less than required royalties. Negotiations failed and LT demanded arbitration. Promega sought a declaratory judgment of non-arbitrability, alleging infringement of five patents and contenting that rights under the 1996 agreement had never been assigned to LT. IP then moved to compel arbitration. The district court ordered arbitration, finding that IP was the assignee, remained in existence, and that it was irrelevant that Promega alleged that IP was merely a puppet of LT. The Federal Circuit affirmed.View "Promega Corp. v. Life Tech. Corp." on Justia Law

The patent describes an infusion system used to meter and deliver fluids from multiple sources into a patient's body. Different fluids may be discharged at different rates using a central control device. Ergo sued CareFusion for infringement of several of the patent's claims; the parties stipulated that several terms were means-plus-function terms, including the terms "programmable control means" and "control means." The parties agreed that the analysis for both terms is the same and that the function for the terms is "controlling the adjusting means." The district court held that the "control means" terms are indefinite for failure to disclose corresponding structure. The Federal Circuit affirmed. View "Ergo Licensing, LLC v. CareFusion 303, Inc." on Justia Law

The patent claims at issue covered processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level was too low or too high. The claims purported to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage would be ineffective or induce harmful side-effects. At issue was whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. The Court concluded that they have not done so and that therefore the processes were not patentable. The steps in the claimed processes involved well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. Therefore, the Court reversed the judgment of the Federal Circuit. View "Mayo Collaborative Services v. Prometheus Laboratories, Inc." on Justia Law

Plaintiff owns the 245 Patent, originally issued in 2005, and claims p-GlcNAc, a polymer extracted from another polymer called chitin, that accelerates hemostasis (a process that causes bleeding to stop) and is useful in trauma units for treating serious wounds. The district court found infringement. While the case was pending, the patent was re-examined; the scope of the claims changed. In 2011, the Federal Circuit vacated an injunction and award of damages and remanded. The court subsequently granted reconsideration en banc and affirmed the district court. Although the district court did not have the reexamination before it, the Federal Circuit considered arguments with respect to reexamination and concluded, as an alternative ground for affirmance, that intervening rights do not apply to claims that have not been amended and are not new. View "Marine Polymer Tech., Inc. .Hemcon, Inc." on Justia Law

The technology involves prosthetic vascular grafts, fabricated from highly-expanded polytetrafluoroethylene, and used to bypass or replace blood vessels to assure adequate and balanced blood flow to particular parts of the body. The 135 patent application was filed in 1974, but the patent did not issue until 2002. The district court found that the patent had been willfully infringed and was not invalid for improper inventorship, anticipation, obviousness, or lack of written description, and awarded enhanced damages, attorneys' fees and costs, and an ongoing royalty. The Federal Circuit affirmed, finding substantial evidence to support the jury verdict. View "Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc." on Justia Law

Plaintiff markets, under the name CRESTOR, a cholesterol-lowering drug, rosuvastatin calcium, a member of a class of drugs known as statins, and holds related patents, 314, 618, and 152. After filing its 2003 New Drug Application and obtaining FDA approval, the company complied with the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), notifying the FDA that those patents were among those it believed could be infringed by the unlicensed manufacture, use, or sale of rosuvastatin calcium to be published in the FDA's "Orange Book," 21 U.S.C. 355(b)(1). Defendants are generic pharmaceutical manufacturers that filed Abbreviated New Drug Applications with the FDA seeking to market generic rosuvastatin calcium. The district court ruled in favor of plaintiff in a case claiming infringement of the 314 patent. Plaintiff brought a second action, claiming that defendants' ANDA filings infringed the other patents. The district court dismissed. The Federal Circuit affirmed. Plaintiff failed to state a 35 U.S.C. 271(e)(2) claim based on defendants' existing ANDA filings, and claims premised on presumed future labeling amendments were not ripe for adjudication. View "AstraZeneca Pharmaceuticals, L.P. v Apotex Corp." on Justia Law

In 2005, plaintiff filed the 261 application and requested an interference based on defendant's 213 patent. The Board of Patent Appeals and Interferences held that the single count of the interference, drawn to humanized antibodies, was barred under 35 U.S.C. 135(b)(1). The Federal Circuit affirmed. View "Adair v. Carter" on Justia Law

Hematology controls are used to monitor and test the accuracy and consistency of hematology analyzers, which clinical laboratories use to analyze patient blood samples by measuring components of whole blood. Plaintiff and defendant manufacture and sell hematology control products. In 1999, plaintiff filed a patent application directed to an integrated reticulocyte control; about two months later, defendant filed its application. In 2003, after some of plaintiff's patents issued, defendant copied claims from those patents into its pending application and asked the PTO to declare an interference to determine priority of invention. While the request was pending, defendant began manufacturing and selling integrated hematology controls. Plaintiff filed an infringement suit. The district court dismissed invalidity counterclaims with respect to claims plaintiff did not include in its infringement allegations; ruled in favor of plaintiff on enablement; and issued an injunction in favor of plaintiff. The Federal Circuit affirmed. The district court properly refused to address the validity of unasserted claims and correctly denied written description and enablement defenses as a matter of law. View "Streck, Inc. v. Research & Diagnostic Sys., Inc." on Justia Law