Justia Drugs & Biotech Opinion Summaries

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

Olivia, born in 2000, apparently healthy, became ill after her first vaccinations. Her condition required extensive hospitalization; she still requires a ventilator and a wheelchair. Her parents filed a petition with the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-1 to34. Olivia's injuries are not covered by a table of injuries presumed to be caused by vaccines, so the parents were required to show that one of the administered vaccines caused or significantly aggravated her condition. They submitted two reports by experts. The special master identified unanswered questions, but the parents took the position that it was unreasonable to require such detail at the pre-hearing stage. Based on failure to submit a supplemental report and failure to identify a clear theory of causation, the special master dismissed. The claims court affirmed. The Federal Circuit reversed. The special master did not appropriately review the evidence of causation under the summary judgment standard. View "Simanski v. Sec'y of Health & Human Servs." 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

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

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

In the first appeal in a case regarding clopidogrel bisulfate tablets, sold by plaintiff under the brand name Plavix®, the Federal Circuit affirmed the district court's grant of a preliminary injunction concerning defendants' generic product. In the second appeal, the court affirmed a judgment that the patent-in-suit is not invalid, was infringed, and not unenforceable. The district court then awarded prejudgment interest and denied defendants' motion for leave to file a supplemental answer, affirmative defenses, and counterclaims pleading patent misuse and breach of contract. The Federal Circuit reversed in part. The district court erred by awarding prejudgment interest in addition to actual damages specified in a settlement agreement. The court affirmed the district court’s holding that defendant is jointly and severally liable for all damages and denial of defendant's motion. View "Sanofi-Aventis v. Apotex" on Justia Law