Justia Drugs & Biotech Opinion Summaries

Sandoz sought a declaratory judgment that two patents, exclusively licensed to Amgen, were invalid and unenforceable and would not be infringed if Sandoz uses, offers to sell or sells, or imports a drug product “biosimilar” to Amgen’s Enbrel®, which is a drug used for treatment of rheumatoid arthritis. Sandoz has not yet filed an application for approval of its contemplated product by the FDA and had only begun certain testing required for its contemplated FDA filing. The district court dismissed the case, determining that no Article III controversy (yet) existed between the parties and also that the suit was barred by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), 42 U.S.C. 262. The Federal Circuit affirmed, concluding that Sandoz did not allege an injury of sufficient immediacy and reality to create subject matter jurisdiction. The court did not address interpretation of the BPCIA. View "Sandoz, Inc. v. Amgen, Inc." on Justia Law

Tyco sued alleging that Ethicon’s ultrasonic cutting and coagulating surgical devices infringed certain claims in three of its patents. The district court held that certain claims of those patents would not have been obvious under 35 U.S.C. 103, but that the other asserted claims are anticipated under 35 U.S.C. 102(g). The Federal Circuit upheld the section102(g) findings, but held that the section 103 determination was improper, including the court’s decision to exclude the section 102(g) prior art from the obviousness analysis. View "Tyco Healthcare Grp., LP v. Ethicon Endo-Surgery, Inc." on Justia Law

Megestrol was used to treat wasting in cancer patients. In 1993, Squibb marketed an oral suspension of micronized megestrol, Megace OS, for treatment of anorexia and cachexia in AIDS patients. Other manufacturers submitted Abbreviated New Drug Applications to market generic versions of Megace OS. Par received approval, but continued to experiment and eventually formulated nanosized megestrol. Patients taking Megace OS with a meal showed a significantly higher rate and extent of absorption compared with patients in a fasting state. The nanosized formulation showed a greatly reduced food effect, especially vital for patients with reduced appetites. The Patent Office rejected Par’s claims covering methods for nanosized megestrol formulations as obvious in light of prior art. Par amended to address the lack of a food effect in the nanosized formulation. The FDA approved Par’s New Drug Application for its nanoparticle formulation, Megace ES, which has generated more than $600M in net sales since 2005. Par pled guilty to marketing Megace ES without FDA approval as an effective weight-gain method for geriatric patients and as having superior clinical efficacy over Megace OS despite lack of clinical studies. TWi filed an ANDA for a generic nanosized megestrol, asserting that the Par patent was invalid or would not be infringed. Par sued under 35 U.S.C. 271(e)(2)(A). The Federal Circuit vacated the district court finding of invalidity; that court incorrectly applied the law on inherency in the context of obviousness. View "Par Pharma., Inc. v TWi Pharma., Inc." on Justia Law

Antares’s 015 patent, entitled “needle assisted jet injector,” discloses a system in which a needle punctures the skin before forcefully expelling a medication. With typical injectors the medication itself ruptures the outer layers of skin. During prosecution, the applicants distinguished prior art by emphasizing the “jet injector” limitation. The originally issued claims all contained the “jet injection” limitation. Antares later sought reissue under 35 U.S.C. 251, stating that the patentee claimed “more or less than he had a right to claim.” The 846 reissue patent was granted. Specification and claims 1–22 were unaltered; claims 23–37 were added. The original claims recite embodiments of a jet injection device and specify, for example, the exact plunge depth of the needle assist. The reissue claims are not restricted to jet-injection devices, but concern safety features; they recite a different invention than originally claimed. Defendants submitted an FDA new drug application for pre-filled methotrexate syringes. Antares sought a preliminary injunction. Defendants counterclaimed for invalidity, arguing that the reissue claims were invalid for violating the recapture rule and failing the original patent requirement. The district court denied a preliminary injunction. The Federal Circuit affirmed; the reissue claims are invalid under section 251’s “original patent” requirement. View "Antares Pharma, Inc. v. Medac Pharma, Inc." on Justia Law

Schumann, as a qui tam relator under the False Claims Act (FCA), 31 U.S.C. 3729, and corresponding state laws, alleged that the drug company defendants improperly induced Medco Health, his employer, to offer certain of defendants’ drugs in its mail-order pharmacies and in health plans it managed; did not include those inducements when calculating the best price for their drugs, and thus submitted inaccurate best price reports to the government; overcharged the government based on those inaccurate best prices; and underpaid rebates owed based on those inaccurate best prices. The district court dismissed, holding that it lacked subject matter jurisdiction over Schumann’s claims because he did not have the requisite direct and independent knowledge to satisfy the original source exception to the FCA’s public disclosure bar. The Third Circuit affirmed. Schumann’s knowledge was not direct because it came from reviewing documents and discussing them with colleagues who participated in the underlying events. View "Schumann v. Astrazeneca Pharm., L.P." on Justia Law

In 2005, in connection with a magnetic resonance imaging procedure (MRI), Decker received a dose of Omniscan, a gadoliniumbased contrast agent manufactured by GEHC. After taking Omniscan, Decker developed Nephrogenic Systemic Fibrosis (NSF). In 2012, the Deckers sued GEHC, as part of a multidistrict litigation (MDL). Before the Deckers’ case, hundreds of similar cases in the MDL involving GEHC had been settled. The Decker case was the first case in the MDL to go to trial. The jury returned a verdict in favor of the Deckers on a failure-to-warn claim, awarding $5 million in damages. The Sixth Circuit affirmed, rejecting claims that the district court judge should have recused himself from the trial and a motion for a new trial; made several erroneous evidentiary rulings, which were applicable to all MDL cases; erroneously denied GEHC’s motion for a new trial because insufficient evidence supported the jury’s verdict regarding the causation element of the Deckers’ failure-to-warn claim; and erroneously failed to issue two proposed jury instructions. View "Decker v. GE Healthcare Inc." on Justia Law

AntiCancer, Inc. owns patents for technology related to the imaging of gene expression using a green fluorescent protein linked to a gene promoter. The fluorescent protein is derived from a species of green-glowing jellyfish, Aequorea victoria. The patented inventions are described as useful for drug discovery and evaluation in cancer control and treatment. The district court entered summary judgment of noninfringement, not on the substantive merits of any issue, but on a procedural aspect at the threshold of the litigation arising from application of the Patent Local Rules of the Southern District of California. The court imposed a fee-shifting sanction as a condition of permitting AntiCancer to supplement the Preliminary Infringement Contentions that found to be defective under Patent Local Rule 3.1. The Federal Circuit vacated the condition and remanded. Considering the language and purposes of the Local Rule, and the record of what Anti-Cancer disclosed in its Contentions and the limited, specific criticisms of the Contentions’ sufficiency, there was no reasonable basis for making the finding of bad faith that would be required to sustain the fees sanction. View "Anticancer Inc. v. Pfizer, Inc." on Justia Law

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

Laura Nunez's attorneys served Lunada with a notice under the Consumer Legal Remedies Act (CLRA), Civil Code section 1750 et seq., alleging that her dietary supplement, Amberen, was being marketed falsely and misleadingly as a natural remedy for Menopausal symptom relief. Lunada subsequently filed a declaratory relief action against Nunez and her attorneys. Nunez and her attorneys moved to strike the complaint under the anti-SLAPP statute, Code of Civil Procedure section 425.16. The trial court granted the motion and Lunada appealed. The court held that the declaratory relief action seeking a declaration that Lunada had not violated the CLRA is subject to the anti-SLAPP statute because it arose out of protected activity under the statute. Consequently, the trial court properly granted the special motions to strike because Lunada's declaratory relief action had no probability of success. The court, under the reasoning of Filarsky v. Superior Court, held that a potential defendant in a CLRA damages action after receiving the statutory notice may not maintain a declaratory relief action to establish that there was no violation of the CLRA. Accordingly, the court affirmed the order striking the complaint and the award of attorney fees to Nunez and her attorneys. View "Lunada Biomedical v. Nunez" on Justia Law

Appellant, by and through his attorney, John Irwin, filed a motion for rule on clerk and a motion to be relieved as counsel. Irwin, a full-time, state-salaried public defender, stated in his motion for rule on clerk that the clerk refused to file the untimely record because of Irwin’s failure to follow the Arkansas Rules of Appellate Procedure-Criminal. The Supreme Court granted the motion for rule on clerk, as Irwin candidly admitted fault for the failure to perfect the appeal, and granted the motion to be relieved as counsel, as Irwin was not eligible for compensation on appeal. View "Childers v. State" on Justia Law