Justia Drugs & Biotech Opinion Summaries

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

Based on his role in operating an online pharmacy that did not require prescriptions, defendant was convicted of conspiracy to import controlled substances, 21 U.S.C. 963 and 18 U.S.C. 2, conspiracy to possess controlled substances with the intent to distribute 21 U.S.C. 846 and 18 U.S.C. 2, and conspiracy to launder money, 18 U.S.C. 2; 1956-1957 with intent to promote the importation of controlled substances. The Seventh Circuit affirmed, upholding admission of expert testimony by a pharmacologist who testified about the classification of various drugs, their side effects, and the medical supervision needed to prescribe them. Although the testimony had only minimal relevance, the threshold for relevance under Rule 401 is quite low. Parts of the testimony related to side effects and birth defects should have been excluded under Rule 403 because the probative value was negligible, but the error was harmless given the weight of the evidence. View "United States v. Boro" 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

Flying from Cairo to New York, a flight attendant thought plaintiff looked ill and recruited a second-year medical resident to perform an examination. The resident thought that plaintiff was suffering an ischemic stroke or transient ischemic attack. The pilot made an emergency landing and, less than two hours later, plaintiff was treated at a hospital. The hospital did not administer an intravenous shot of tissue plasminogen activator (t-PA), a form of thrombolytic therapy that dissolves clots, but is not appropriate for all patients. His condition deteriorated, then stabilized, and he was transferred for care in New York. The district court held a "Daubert" hearing in plaintiff's malpractice claim and two experts gave vastly different opinions about whether failure to administer t-PA caused plaintiff's injuries. The court held that the standard for causation was "more likely than not" and that Maine had not adopted the "lost chance" doctrine, excluded plaintiff's expert, and granted summary judgment for defendants. The First Circuit affirmed, holding that plaintiff failed to show causation.View "Samaan v. St. Joseph Hosp." on Justia Law

The patent claims methods for preparing multi-cryopreserved hepatocytes (a type of liver cell), used for evaluating drug candidates. The owner claimed infringement and obtained a preliminary injunction. The Federal Circuit affirmed. The district court acted within its discretion in finding likelihood of success on the merits, considering defenses of non-infringement, obviousness, written description, and inequitable conduct. The court considered and properly addressed the public's interest in obtaining an adequate supply of pooled multi-cryopreserved hepatocyte products. View "Celsis In Vitro, Inc. v. Cellzdirect, Inc." on Justia Law

The 2006 patent, entitled "Surgical Devices Having a Polymeric Material with a Therapeutic Agent and Methods for Making Same" and the 2007 patent, entitled "Surgical Devices Containing a Heat Bondable Material with a Therapeutic Agent" have identical specifications and are directed to a surgical implant in which a polymeric material is bonded by heat to an expandable implant, where the polymer includes a therapeutic agent such as an antibiotic. The owner of the patents sued. The district court made a finding of noninfringement. The Federal Circuit affirmed the finding and construction of the term "bonded." The district court then declared the case exceptional under 35 U.S.C. 285 and awarded defendant attorney and expert witness fees totaling $4,683,653.03. The Federal Circuit affirmed. The district court opinion indicates its finding that plaintiff acted in bad faith in filing a baseless infringement action and continuing to pursue it despite no evidence of infringement and engaged in vexatious and unjustified litigation conduct that unnecessarily prolonged the proceedings and forced defendant to incur substantial expenses. View "MarcTec, LLC v. Johnson & Johnson" on Justia Law

Defendants, who operated what purported to be online pharmacies, were convicted on a 42-count indictment alleging crimes arising from a multi-national, internet-based, controlled-substance-distribution scheme. They have appealed multiple decisions of the trial court and appealed their conviction. The Third Circuit affirmed. Among other challenges, the court rejected arguments: that the money-laundering convictions impermissibly merge with underlying predicate felonies; that the district court should have suppressed evidence from untimely-sealed surveillance records; that the indictment, evidence, and jury instructions were insufficient to sustain a Continuing Criminal Enterprise conviction; and that the court erred in calculating sentences; the the alleged conduct, distribution of controlled substances via the internet, was not illegal at the time charged; that the money laundered was obtained by lawful means; and that certain convictions were misdemeanors, not felonies. View "United States v. Mullinix" on Justia Law

Plaintiff's 502 patent for a statin drug is a reissue of a patent that claims the benefit of a provisional application filed on April 10, 2000. The earliest date by which plaintiff asserts that it conceived and reduced to practice its claimed invention is December 1, 1999. In 2008 plaintiff sued for infringement by the drug Crestor. The district court found the 502 claims invalid, based on defendant's showing that it had conceived and reduced its drug to practice prior to plaintiff's first conception of the claimed subject matter (35 U.S.C. § 102(g)(2)). The Federal Circuit affirmed. View "Teva Pharm. Indus., Ltd. v. Astrazeneca Pharm., LP" on Justia Law