Justia Drugs & Biotech Opinion Summaries

In 2012 Schmidt, a former shareholder in Genaera, a biotechnology company that dissolved in 2009 and liquidated its assets, brought suit on behalf of himself and other former shareholders against the liquidating trustee (Argyce); the Genaera Liquidating Trust; Argyce’s CEO and Genaera’s former CFO; former major Genaera shareholders Xmark and BVF; former Genara directors and officers (D&O defendants); and the purchasers of certain Genaera assets. The complaint alleged that the liquidating trustee and the D&O defendants breached their fiduciary duties by disposing of promising drug technologies in tainted insider deals for far less than their true value and that Xmark and BVF aided and abetted this behavior so that companies they controlled could acquire Genaera’s assets at fire sale prices. Schmidt did not dispute the applicability of the two-year statute of limitations and that he filed suit more than two years after the assets were sold, but argued that the limitations period should be tolled under Pennsylvania’s discovery rule because he could not have been aware of the insider nature of the sales or that the assets were sold for below actual value until he learned the details of the sales, and subsequent market events suggested to him that the assets were quite valuable. The district court dismissed. The Third Circuit reversed in part, stating that it was premature to determine whether Schmidt exercised reasonable diligence. View "Schmidt v. Skolas" on Justia Law

A.S., who suffers from a congenital birth defect, and his mother, Miller, who ingested Paxil while pregnant, sued GSK in the Philadelphia County Court, alleging that all parties were citizens of Pennsylvania. GSK removed the case based upon diversity. On plaintiffs’ motion, the case was consolidated with other Paxil cases before a district court judge who had previously held that GSK was a citizen of Pennsylvania and who remanded A.S.’s case and the other consolidated cases to state court. The case returned to state court on January 4, 2012. On June 7, 2013, the Third Circuit issued its opinion in Johnson, which held that GSK was a citizen of Delaware. Less than 30 days after the Johnson decision, GSK filed a second notice of removal in A.S.’s case and in eight other cases with the same procedural posture. The district court denied the motion and certified its order for interlocutory review. The Third Circuit directed remand to state court, holding that the second removal request was untimely under 28 U.S.C. 1446(b) because there had been a final order. View "A.S. v. SmithKline Beecham Corp" on Justia Law

Bristol-Myers Squibb (BMS) was sued in a coordinated proceeding before the San Francisco Superior Court for alleged defects in Plavix, a drug BMS manufactures and sells throughout the country. BMS moved below to quash service of the summons regarding the complaints concerning plaintiffs who are not California residents, for lack of personal jurisdiction. The trial court denied BMS’s motion, finding that California had general jurisdiction over BMS, and did not address the issue of specific jurisdiction. Following the U.S. Supreme Court’s ruling in Daimler AG v. Bauman (2014) which limited the application of general jurisdiction under the Fourteenth Amendment, the California Supreme Court remanded to the court of appeals, which affirmed denial of the motion to quash. California does not have general jurisdiction over BMS in this case, but, applying the International Shoe Co. v. Washington test of “fair play and substantial justice,” the court reasoned that BMS has engaged in substantial, continuous economic activity in California, including the sale of more than a billion dollars of Plavix to Californians. That activity is substantially connected to claims by non-residents, which are based on the same alleged wrongs as those alleged by California-resident plaintiffs. BMS has not established that it would be unreasonable to assert jurisdiction over it. View "Bristol-Myers Squibb Co. v. Superior Court" on Justia Law

Endo sells Opana® ER extended-release tablets containing a painkiller, oxymorphone. In earlier litigation, Endo sued Roxane and Actavis for patent infringement, 35 U.S.C. 271(e)(2)(A), based on their Abbreviated New Drug Applications to market generic versions of Opana® ER. The lawsuits settled; Endo granted defendants a license and a covenant not to sue. After making the agreements the 122 and 216 patents issued to Endo. They are continuations of the same parent application and directed to extended-release oxymorphone compositions and methods of treating pain using those compositions. Endo also acquired the unrelated 482 patent, concerning purified oxymorphone compositions and methods of making those compositions. The asserted patents are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Opana® ER. Endo again sued for infringement and sought a preliminary injunction to prevent marketing or sales of generic oxymorphone formulations. The district court held that Endo was estopped from claiming that the activity of defendants, “which has gone on for a substantial period of time, is now suddenly barred because of these new patents.” The Federal Circuit vacated, finding that the defendants did not have an express or implied license to practice the patents at issue.View "Endo Pharm. Inc. v. Actavis, Inc." on Justia Law

Senju’s patent covers an ophthalmic solution for eye drops containing Gatifloxacin, an antimicrobial agent, to kill bacteria. Tear dilution and the outer layer of the eye can prevent Gatifloxacin from passing into and treating the aqueous humor. The patent discloses a solution combining Gatifloxacin with disodium edetate, to expand the intercellular spaces of the cornea, accelerating passage of Gatifloxacin solution into the eye. In 2007, Apotex filed an Abbreviated New Drug Application with the FDA (Hatch-Waxman Act, 98 Stat. 1585), requesting approval to manufacture and sell a generic version of the solution. Senju filed an infringement action. The district court held that, though the ANDA product infringed claims 1–3, 6, 7, and 9, claim 7 was invalid as obvious. The Federal Circuit affirmed. In the gap between the court’s 2010 issuance of findings and its December 2011 entry of final judgment, Senju requested reexamination of claims 1–3, 6, 8, and 9; amended claim 6 to include additional limitations; and added new independent claim. In October 2011, the PTO issued a reexamination certificate cancelling claims 1–3 and 8–11, and certifying amended claim 6, new independent claim 12, and new dependent claims as patentable. Before entry of final judgment in the first action, Senju sought a declaratory judgment that Apotex’s manufacture, use, or sale of Gatifloxacin ophthalmic solution infringed claims set forth in the reexamination certificate. The district court dismissed. The Federal Circuit affirmed, finding the suit barred by claim preclusion. View "Senju Pharm. Co., Ltd. v. Apotex, Inc." on Justia Law