Justia Drugs & Biotech Opinion Summaries

Conventional tests for prenatal abnormalities caused by genetic abnormalities have relied on invasive and potentially risky techniques like amniocentesis to obtain fetal cells. As an alternative, scientists developed methods of analyzing DNA extracted from fetal cells floating in maternal blood to determine fetal abnormalities and other fetal traits. These methods require separating fluids from the cells and then discarding the fluids, either plasma or serum, and then separating fetal cells from the much more common maternal cells. The 540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical waste: maternal plasma or serum. The new tests presented fewer risks and a better rate of abnormality detection. Ariosa sought a declaratory judgment that it could use its Harmony test without infringing the 540 patent. The district court denied the patent holder’s motion for summary judgment. The Federal Circuit vacated and remanded, finding that the district court incorrectly interpreted the asserted claim terms “amplifying” and “paternally inherited nucleic acid” and improperly balanced factors regarding issuance of a preliminary injunction. View "Aria Diagnostics, Inc. v. Sequenom, Inc." on Justia Law

Rembrandt’s patent relates to contact lenses that have a highly wettable surface and are permeable to oxygen. The patent discloses a soft gas permeable lens with an acrylic layer on the surface of the lens body that increases the wettability and comfort of the contact lens. The district court held that Johnson & Johnson did not infringe the patent. The Federal Circuit affirmed. View "Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care, Inc." on Justia Law

Generic manufacturers submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Copaxone®, a drug used in treating multiple sclerosis. Teva, which markets Copaxone®, sued the generic manufacturers for patent infringement under 35 U.S.C. 271(e)(2)(A). The patents at issue share a common specification and are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®. The patents include claims reciting a product called copolymer-1 and recite two methods of making copolymer-1: one using statistical average measures and the other describing how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range. The district court found that various claims of the nine patents by Teva are infringed, based on holdings regarding indefiniteness, nonenablement, and obviousness. The Federal Circuit affirmed in part and reversed in part, holding that Group I claims are invalid for indefiniteness, but that Group II claims were not proven indefinite. The district court did not err in finding that the claims are infringed, and that the generic manufacturers failed to prove that the claims would have been obvious and are not enabled. View "Teva Pharm. USA, Inc. v. Sandoz, Inc." on Justia Law

The patent at issue concerns methods for preventing bovine mastitis, the inflammation of udder tissue in cows, and is entitled “Antiinfective free intramammary veterinary composition.” The summary of the invention describes how the composition employs a physical barrier within the teat canal to block introduction of mastitis-causing organisms without requiring use of antiinfectives such as antibiotics. A patent examiner rejected certain claims introduced in the context of ex parte reexamination. The Patent Trial and Appeal Board and Federal Circuit affirmed, finding that substantial evidence supported the Board’s finding that one claim failed the written description requirement because the disclosure did not “describe[] a formulation excluding a specific species of the anti-infective genus, while permitting others to be present.” View "In re: Bimeda Research & Dev. Ltd." on Justia Law

Plaintiffs, a group of prisoners, filed suit against the FDA for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and misapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A). The court concluded that, because there were clear statutory guidelines for the agency to follow in exercising its enforcement powers, the FDA's compliance with section 381(a) was subject to judicial review under the standards of the APA. The court also concluded that the FDA's policy of admitting foreign manufactured thiopental destined for state correctional facilities were not in accordance with law because section 381(a) required the agency to sample and examine for violations of any drug offered for import that had been prepared in an unregistered facility. The court concluded, however, that the district court erred by failing to seek the joinder of the state governments whose possession and use of the thiopental at issue the court declared illegal. Accordingly, the order of the district court pertaining to the thiopental already in the possession of the states was vacated, but the underlying judgment of the district court was affirmed. View "Cook, et al. v. FDA, et al." on Justia Law

GSK holds patent and FDA rights to market and sell the pharmaceutical (paroxetine hydrochloride) controlled release tablets for treatment of depression, under the brand name Paxil. Under a 2007 settlement agreement, GSK granted Mylan certain rights to produce, market, and sell generic paroxetine. In 2010, GSK agreed, in an unrelated settlement, to begin supplying Apotex with GSK-produced generic paroxetine for marketing and sale. Mylan sued GSK and Apotex, claiming the 2010 agreement violated its licensing agreement, which did not permit GSK to provide its own form of generic paroxetine to another generic drug company to be marketed and sold in direct competition with Mylan. The district court found that the terms of the agreement were unambiguous and did not limit to whom GSK was permitted to market and sell its own version of generic paroxetine. The Third Circuit reversed the order of summary judgment on the breach-of-contract cause of action against GSK, but affirmed summary judgment on other claims. View "Mylan Inc. v. SmithKline Beecham Corp." on Justia Law

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