Justia Drugs & Biotech Opinion Summaries

Masters filed suit challenging the DEA's 2014 decision to revoke the company's certificate of registration, without which it cannot sell controlled substances. The DC Circuit denied the petition for review, holding that the Administrator's conclusions -- that whenever an order for controlled substances was held by the SOMS Computer Program, that order was presumptively "suspicious" under 21 C.F.R. 1301.74(b), and Masters' employees rarely undertook the investigation required to dispel the suspicion surrounding held orders -- were well founded. The court held that Masters failed to identify any prejudicial errors in the Administrator's decision. View "Masters Pharmaceutical, Inc. v. DEA" on Justia Law

The State of New Hampshire moved to enforce administrative subpoenas served on defendants Actavis Pharma, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Purdue Pharma L.P., and Teva Pharmaceuticals USA, Inc. The State was investigating defendants’ role in allegedly causing health care providers to prescribe opioids to treat chronic pain. Defendants resisted, arguing the Office of the Attorney General’s (OAG) engagement of outside counsel was unlawful. In addition, defendants moved for a protective order, seeking to “bar the Attorney General from engaging contingent fee counsel to: (a) participate in or assume responsibility for any aspect of the State’s investigation of alleged violations of the Consumer Protection Act . . . ; or (b) participate in or assume responsibility for any subsequent enforcement action pertaining to alleged CPA violations.” Defendants argued that the OAG’s fee agreements with the firm Cohen Milstein: (1) violated RSA 21-G:22 and :23 (2012) (amended 2016); (2) violated New Hampshire common law; (3) were ultra vires because the OAG did not comply with RSA 7:12 (2013) (amended 2016) or :6-f (Supp. 2016); (4) violated the doctrine of separation of powers; (5) violated the New Hampshire Rules of Professional Conduct; and (6) violated due process under the New Hampshire and United States Constitutions. The State replied that an objection to the Attorney General’s use of outside counsel was not appropriate justification for refusing to comply with lawful subpoenas, and that defendants lacked standing to raise that complaint. The trial court denied the State’s motion to enforce the subpoenas and granted the defendants’ motion for a protective order “to the extent that the OAG and Cohen Milstein’s contingency fee agreement is invalid.” The trial court determined that the defendants had demonstrated standing to bring their claims, that the fee agreement was void, and therefore denied the State’s motion to enforce the subpoenas on that basis. The New Hampshire Supreme Court concluded defendants lacked standing to challenge the outside counsel agreement. It reversed and remanded the matter for further proceedings. View "New Hampshire v. Actavis Pharma, Inc." on Justia Law

The Fourth Corner Credit Union applied for a master account from the Federal Reserve Bank of Kansas City. The Reserve Bank denied the application, effectively crippling the Credit Union’s business operations. The Credit Union sought an injunction requiring the Reserve Bank to issue it a master account. The district court dismissed the action, ruling that the Credit Union’s stated purpose, providing banking services to marijuana-related businesses, violated the Controlled Substances Act. The Tenth Circuit vacated the district court’s order and remanded with instructions to dismiss the amended complaint without prejudice. By remanding with instructions to dismiss the amended complaint without prejudice, the Court’s disposition effectuated the judgment of two of three panel members who would allow the Fourth Corner Credit Union to proceed with its claims. The Court denied the Federal Reserve Bank of Kansas City’s motion to strike the Fourth Corner Credit Union’s reply-brief addenda. View "Fourth Corner Credit Union v. Federal Reserve Bank of Kansas" on Justia Law

The claims at issue involve testing methods for fetal aneuploidies, conditions in which a fetus either has an abnormally high number of chromosomes (e.g., Down’s syndrome) or an abnormally low number (e.g., Turner’s syndrome). Previously, physicians diagnosed fetal aneuploidies using invasive amniocentesis or chorionic villus sampling or less invasive methods, such as ultrasonography and biochemical marker detection that had suboptimal accuracy. In three interference proceedings between Stanford and Chinese University, the Patent Trial and Appeal Board found that Stanford’s claims were unpatentable for lack of written description. The Federal Circuit vacated, finding that the Board relied on improper evidence and did not cite other substantial evidence to support its key findings. Whether a patent claim satisfies the written description requirement, 35 U.S.C. 112, depends on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed. On remand, the Board should examine whether a person of ordinary skill would have understood that the patent’s specification disclosed random MPS sequencing and would have known, as of the priority date, that the specification’s reference to Illumina products meant random MPS sequencing as recited in the claims, by examining the record evidence as to pre-filing date art-related facts on Illumina products. View "Stanford University v. Chinese University of Hong Kong" on Justia Law

When an artery is damaged or inflamed, the body releases the enzyme myeloperoxidase (MPO). Prior art taught that MPO could be detected in an atherosclerotic plaque or lesion that required a surgically invasive method; could be indirectly detected in blood; or could be detected in blood with results that were not predictive of cardiovascular disease. Cleveland Clinic purportedly discovered how to “see” MPO in blood and correlate that to the risk of cardiovascular disease. True Health, a diagnostic laboratory, purchased the assets of Diagnostics, which had contracted with Cleveland Clinic to perform MPO testing. Rather than continue that relationship, True Health performed its own MPO testing. Cleveland Clinic sued, asserting infringement of the patents. The district court found all the claims patent-ineligible under 35 U.S.C. 101; dismissed the contributory and induced infringement claims of the 260 patent; denied leave to amend; and held that it was proper to consider section 101 at the motion to dismiss stage.. The court found that the claims were directed to a law of nature, with no saving inventive concept. The Federal Circuit affirmed. Cleveland Clinic provided no proposed construction of any terms or proposed expert testimony that would change the analysis. The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. View "Cleveland Clinic Foundation v. True Health Diagnostics. LLC" on Justia Law

The Biologics Price Competition and Innovation Act, concerning FDA approval of a drug that is biosimilar to an already-licensed biological “reference product,” 42 U.S.C. 262(k), treats submission of a biosimilar application as an “artificial” patent infringement. An applicant must provide its biosimilar application and manufacturing information to the reference product’s sponsor. The parties collaborate to identify patents for immediate litigation. Second phase litigation is triggered when the applicant gives the sponsor notice at least 180 days before commercially marketing the biosimilar. Amgen claims patents on methods of manufacturing and using filgrastim. Sandoz sought FDA approval to market a biosimilar, Zarxio, and notified Amgen that it had submitted an application, that it intended to market Zarxio immediately upon receiving FDA approval, and that it did not intend to provide application and manufacturing information. Amgen sued for patent infringement and asserted that Sandoz engaged in “unlawful” conduct under California law by failure to provide its application and manufacturing information and by notification of commercial marketing before obtaining FDA licensure. The FDA licensed Zarxio. Sandoz provided Amgen another notice of commercial marketing. The Supreme Court unanimously held that section 262(l)(2)(A) is not enforceable by injunction under federal law, but the Federal Circuit should determine whether a state-law injunction is available. Submitting an application constitutes artificial infringement; failing to disclose the application and manufacturing information does not. Section 262(l)(9)(C) provides a remedy for failure to turn over the application and manufacturing information, authorizing the sponsor, but not the applicant, to bring an immediate declaratory-judgment action, thus vesting in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation. An applicant may provide notice under section 262(l)(8)(A) before obtaining FDA licensure. View "Sandoz Inc. v. Amgen Inc." on Justia Law

After plaintiff's son died of Hepatosplenic T-cell lymphoma (HSTCL), an exceedingly rare and aggressive form of cancer, they filed suit alleging negligence and strict liability concerning the manufacture and distribution of drugs used to treat inflammatory bowel disease (IBD). The Ninth Circuit reversed the grant of summary judgment to Teva, holding that the district court erred by excluding plaintiffs' causation experts' testimony. In this case, the district court looked too narrowly at each individual consideration under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993), without taking into account the broader picture of the experts' overall methodology. The district court improperly ignored the experts' experience, reliance on a variety of literature and studies, and review of the son's medical records and history, as well as the fundamental importance of differential diagnosis by experienced doctors treating troubled outpatients. Furthermore, the district court overemphasized the fact that the experts did not develop their opinions based on independent research and the experts did not cite epidemiological studies. The panel reversed the district court's grant of summary judgment to Teva in regard to the duty to warn claim because there was a genuine dispute of material fact as to whether the prescribing physician's conduct would have changed with warnings from Teva and GSK. The panel declined to affirm the district court on four alternative grounds and reversed the district court's denial of plaintiffs' motion for reconsideration. View "Wendell v. GlaxoSmithKline" on Justia Law

In multi-district litigation involving 315 product liability claims, plaintiffs alleged that Pfizer’s drug, Zoloft, a selective serotonin reuptake inhibitor (SSRI), caused cardiac birth defects. The Plaintiffs’ Steering Committee introduced several experts to establish causation. The testimony of each of these experts was excluded in whole or in part. In particular, Nicholas Jewell, Ph.D., a statistician, used the “Bradford Hill” criteria to analyze existing literature on the causal connection between Zoloft and birth defects. The district court conducted a Daubert hearing, excluded Jewell's testimony, and granted summary judgment to defendants, stating that Jewell: “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.” The Third Circuit affirmed, holding that the district court did not require replication of significant results to establish reliability, but merely made a factual finding that teratologists generally require replication of significant results, and this factual finding did not prevent it from considering other evidence of reliability. View "In Re: Zoloft t (Sertraline Hydrochloride) Products Liability Litigation" on Justia Law

Appellee was charged with a single count of possession with intent to distribute, or possession, of a “designer drug,” a substance similar to a scheduled controlled substance, not the same. The trial court here determined experts have been unable to reach an agreement on a method for analyzing and determining the similarities between the chemical structures the controlled substance and its designer analogue, leading it to conclude this disagreement rendered the Pennsylvania designer drug statute unconstitutionally vague. The Pennsylvania Supreme Court reversed, finding the common pleas court did not account for the difference between the concepts of analogue and substantial similarity, the latter of which is more readily apprehensible to the lay citizen in the context of comparing chemical structures; nor did it recognize that, unlike the controlled-substance provision, the designer drug provision included a narrowing scienter specification. Moreover, the Court found in this case that there were “considerable similarities” as between the two molecules based on their two-dimensional diagrams. View "Pennsylvania v. Herman" on Justia Law

Apicore owns, and Mylan Is the exclusive licensee of, the 992, 616, and 050 patents, which relate to isosulfan blue (ISB), a triarylmethane dye used to map lymph nodes. The 992 and 616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting isoleuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. In response to Aurobindo’s FDA application to market a generic version of Myland’s drug, Lymphazurin®, Apricore and Myland obtained a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused ISB product that allegedly infringes the patents. The Federal Circuit affirmed. While the district court’s “equivalents analysis” was deficient and there remains a substantial question concerning infringement, so that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion, the injunction stands under the 050 patent. View "Mylan Institutional LLC v. Aurobindo Pharma Ltd." on Justia Law