Justia Drugs & Biotech Opinion Summaries

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The Supreme Court dismissed this interlocutory appeal brought by the State challenging a sanctions order entered by the circuit court pursuant to Ark. R. Civ. P. 37, holding that this Court lacked appellate jurisdiction over the appeal.The Arkansas Attorney General brought this action in the name of the State against several pharmaceutical companies in connection with Defendants' role in the ongoing opioid epidemic. During the proceedings, the circuit court found that the Attorney General had not provided complete and specific discovery responses, in violation of the court's discovery orders, and then entered an order sanctioning the Attorney General. The Attorney General appealed. The Supreme Court dismissed the appeal, holding that the sanctions order was not a final or otherwise appealable order under Ark. R. App. P.-Civ. 2(a)(4). View "State ex rel. Rutledge v. Purdue Pharma L.P." on Justia Law

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Oakwood hired Dr. Thanoo in 1997. As Oakwood's Senior Scientist, he signed confidentiality agreements. Thanoo designed Oakwood’s microsphere process technology. Oakwood invested more than $130 million and two decades in its Microsphere Project and developed the “Leuprolide Products,” which are bioequivalent to Lupron Depot®. Aurobindo contacted Oakwood to discuss collaboration. Some of Oakwood’s trade secret information was shared under a confidentiality agreement. Negotiations failed. Aurobindo hired Thanoo six months later and began developing microsphere-based injectable products that Oakwood alleges are “substantially similar to and competitive with Oakwood’s Microsphere Project." Oakwood asserts that the product could not have been developed within the rapid timeframe without Thanoo’s assistance and the use of Oakwood’s trade secret information.The Third Circuit vacated the dismissal of Oakwood's suit, asserting trade secret misappropriation, breach of contract, and tortious interference with contractual relations. Under the Defend Trade Secrets Act, 18 U.S.C. 1836(b), Oakwood sufficiently identified its trade secrets and sufficiently alleged that the defendants misappropriated those trade secrets. The “use” of a trade secret encompasses all the ways one can take advantage of trade secret information to obtain an economic benefit, competitive advantage, or other commercial value, or for an exploitative purpose, such as research or development. A trade secret plaintiff need not allege that its information was the only source by which a defendant might develop its product. Aurobindo's avoidance of substantial research and development costs that Oakwood has invested is recognized as "harm" in the DTSA. View "Oakwood Laboratories LLC v. Thanoo" on Justia Law

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The FDA filed suit against the Clinic, alleging that the Clinic's stem cell procedure violates the Federal Food, Drug, and Cosmetics Act. The Clinic offers a procedure, which purportedly treats all kinds of chronic conditions, in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective.The Eleventh Circuit affirmed, concluding that the Clinic's stem cell procedure does not fall within the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. The procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. Furthermore, the procedure does not fall within the 361 HCT/P exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. View "United States v. US Stem Cell Clinic, LLC" on Justia Law

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The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 321(g) regulates homeopathic drugs. A 1988 FDA guidance document outlined the circumstances in which the FDA intended to exercise its discretion not to enforce the full force of the FDCA against homeopathic drugs. In 2019, the FDA withdrew the guidance document, explaining that the homeopathic drug industry had expanded significantly and it had received numerous reports of “[n]egative health effects from drug products labeled as homeopathic.” The FDA then implemented a “risk-based” enforcement approach and added six of MediNatura’s prescription injectable homeopathic products to an import alert, notifying FDA field staff that the products appeared to violate the FDCA.The D.C. Circuit affirmed the dismissal of MediNatura’s challenges. When a product is detained under an import alert, the importer is given notice and an opportunity to be heard, so the import alert was non-final agency action. The court declined to enjoin the withdrawal of the 1988 guidance, noting the public’s strong interest in the enforcement of the FDCA. Requiring the FDA to keep in place a guidance document that no longer reflects its current enforcement thinking, particularly in light of present public health concerns related to homeopathic drugs, is not in the public interest. View "MediNatura, Inc. v. Food and Drug Administration" on Justia Law

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Abbott Laboratories and Abbott Laboratories, Inc. (collectively, "Abbott"), petitioned the Alabama Supreme Court for a writ of mandamus to direct the Mobile Circuit Court to dismiss all claims asserted by the Mobile County Board of Health and the Family Oriented Primary Health Care Clinic (collectively, "Mobile Health") against Abbott on the basis that those claims are barred by the rule of repose or by the applicable statute of limitations. Mobile Health alleged that Abbott had participated in the marketing of a specific prescription drug, OxyContin. Mobile Health alleged that this marketing campaign "precipitated" an "opioid crisis" in the United States, and specifically in Alabama, because it caused an astronomical increase in the use of opioids by patients who quickly became dependent upon the drugs. Mobile Health asserted that it brought this action because of the burdens it had to bear as a result of the "opioid epidemic." The Alabama Supreme Court concluded the applicable statutes of limitations barred Mobile Health's claims against Abbott. Therefore, the Court granted Abbott's petition for a writ of mandamus, and directed the circuit court to enter an order dismissing Mobile Health's claims against Abbott. View "Ex parte Abbott Laboratories and Abbott Laboratories, Inc." on Justia Law

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PacBio’s patents describe methods for sequencing a nucleic acid, such as DNA, using nanopore technology. PacBio sued Oxford for infringement. Before trial, the district court granted PacBio’s motion “to prevent [Oxford] from using ‘pejorative’ terms (such as ‘non-practicing entity,’ ‘NPE,’ and ‘paper patents’), stating “it would be inappropriate to put before the jury evidence or argument about the potential impact of a verdict in favor of PacBio— such as higher prices or slower medical research.”A jury found all asserted claims infringed but also determined that they are invalid under 35 U.S.C. 112 for lack of enablement. The district court upheld the verdict on enablement and denied PacBio’s request for a new trial because of Oxford’s improper opening remarks that included references to the potential applications of its accused products to the then-emerging global COVID-19 crisis. The Federal Circuit affirmed. The record supports the legal conclusion that the disclosures of the patents, even combined with the knowledge of relevant artisans, required undue experimentation to enable the full scope of the relevant claims. The court reasonably denied a new trial, given PacBio’s own conduct and references to COVID-19, and its successful request for no more than curative instructions. View "Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc." on Justia Law

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Janssen challenged Customs and Border Protection’s classification of Janssen’s product darunavir ethanolate, the active ingredient in Prezista®, is a medication for the treatment of the human immunodeficiency virus (HIV) under the Harmonized Tariff Schedule of the United States (HTSUS) and the Pharmaceutical Appendix to the Tariff Schedule. Customs had applied subheading 2935.00.95, “Sulfonamides: Other: Drugs: Other,” for a duty rate of 6.5 percent ad valorem, Janssen alleged that it has paid approximately $100 million in duties for entries of darunavir ethanolate that should have received duty-free treatment. The Trade Court concluded that the subject merchandise was properly classified under HTSUS subheading 2935.00.60 and subject to duty-free treatment under the Pharmaceutical Appendix. The Federal Circuit affirmed. The court held that darunavir ethanolate was properly classified under HTSUS subheading 2935.00.60 because it belongs to the sulfonamides class or kind of organic compounds. View "Janssen Ortho, LLC v. United States" on Justia Law

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Plaintiffs, three women who suffered persistent hair loss after chemotherapy treatments, sued as a part of a multidistrict litigation (MDL) against distributors of the drug Taxotere (docetaxel) for permanent chemotherapy-induced hair loss, asserting a failure-to-warn claim.Louisiana law provides a one-year liberative prescription period for products-liability cases. Furthermore, under Louisiana law, there is a firmly rooted equitable-tolling doctrine known as contra non valentem agere non currit praescriptio, which means "[n]o prescription runs against a person unable to bring an action."The Fifth Circuit affirmed the district court's judgment in favor of Sanofi, agreeing with the district court that plaintiffs' claims are facially prescribed. The court interpreted Louisiana law to require that once hair loss persisted after six months, contra non valentem tolled the prescription period until the point when a prospective plaintiff through the exercise of reasonable diligence should have "considered [Taxotere] as a potential root cause of" her injury. In this case, the court concluded that plaintiffs did not act reasonably in light of their injuries and their causes of action were reasonably knowable in excess of one year prior to their filing suit. Therefore, Louisiana's equitable tolling doctrine of contra non valentem did not save plaintiffs' claims. View "Thibodeaux v. Sanofi U.S. Services, Inc." on Justia Law

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The Fifth Circuit affirmed the district court's grant of summary judgment on plaintiff's failure-to-warn claim asserted against the manufacturers of Taxotere, a chemotherapy medication. Plaintiff argues that Taxotere's manufacturers failed to provide an adequate warning of potentially permanent hair loss, which caused her injuries.The court concluded that, under Louisiana law, plaintiff cannot establish causation where, on this record, it is beyond any genuine dispute that a warning of the risk of permanent hair loss—as opposed to temporary hair loss—would not have affected the prescribing physician's decision to prescribe Taxotere. Therefore, plaintiff's claim fails as a matter of law. View "Phillips v. Sanofi U.S. Services, Inc." on Justia Law

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The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law