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

Plaintiffs opposed the use of vaccines that contain thimerosal, a mercury-based preservative, and believed that vaccines containing mercury harm young children and pregnant women. Plaintiffs filed an action alleging that the FDA, by allowing thimerosal-preserved vaccines, violated its statutory duty to ensure the safety of vaccines. Plaintiffs asked for a court order requiring the FDA to prohibit the administration of vaccines containing more than a trace level of thimerosal to young children and pregnant women and sought to force the FDA to remove thimerosal-preserved vaccines from the market. The district court dismissed the suit for lack of standing. The court concluded that plaintiffs were not required to receive thimerosal-preserved vaccines; they could readily obtain thimerosal-free vaccines; they did not have standing to challenge the FDA's decision to allow other people to receive the vaccines; and plaintiffs could advocate that the Legislative and Executive Branches ban the vaccines. But because plaintiffs were suffering no cognizable injury as a result of the FDA's decision to allow the vaccine, their lawsuit was not a proper subject for the Judiciary. Accordingly, the court affirmed the judgment of the district court. View "Coalition for Mercury-Free Drugs, et al. v. Sebelius, et al." 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

Christopher M. Loften died from a rare disease called Toxic Epidermal Necrolysis (TEN) after taking Motrin. Lofton's wife and children brought suit against defendants asserting that Motrin caused the disease and defendants had failed to warn consumers about the risk of these severe autoimmune allergic reactions. At issue on appeal was whether the district court correctly found that federal law preempted Tex. Civ. Prac. & Rem. Code 82.007(b)(1), which required plaintiffs to assert, in failure to warn cases, that a drug manufacturer withheld or misrepresented material information to the FDA. The court held that section 82.007(b)(1) required a Texas plaintiff to prove fraud-on-the-FDA to recover for failure to warn and this requirement invoked federal law supremacy. Therefore, because the court concluded that section 82.007(b)(1) was a fraud-on-the-FDA provision analogous to the claim considered in Buckman Co. v. Plaintiffs' Legal Comm., the court held that it was preempted by the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., unless the FDA itself found fraud. Accordingly, the court affirmed the district court's grant of summary judgment in favor of defendants. View "Lofton, et al. v. McNeil Consumer & Specialty Pharmaceuticals, et al." 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

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