Justia Drugs & Biotech Opinion Summaries

Articles Posted in International Trade
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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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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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Acetris obtains its pharmaceutical products from Aurolife, which makes them in a New Jersey facility, using an active pharmaceutical ingredient made in India. Acetris had contracts to supply the VA with several pharmaceutical products, including Entecavir (used to treat hepatitis B). The VA requested that Acetris recertify its compliance with the Trade Agreements Act of 1979 (TAA), which bars the VA from purchasing “products of” certain foreign countries, such as India. Ultimately, the VA requested that Acetris obtain a country-of-origin determination. Customs concluded that the Acetris products were products of India. Acetris agreed to cancel its Entecavir contract. The VA issued a new solicitation seeking proposals for Entecavir, indicating that it would continue to rely on the Customs determination. Acetris filed suit, challenging the VA’s interpretation of the TAA. The VA awarded the Entecavir contract to Golden, consistent with its policy to award contracts to the lowest-price technically acceptable bid. The government moved to dismiss the suit, arguing that Acetris lacked standing because Acetris would not have won the contract regardless of the interpretation of the TAA and that Acetris’ earlier-filed Court of International Trade suits divested the Claims Court of jurisdiction under 28 U.S.C. 1500.The Claims Court denied the government’s motions and rejected the government’s interpretation of the TAA. The Federal Circuit affirmed in part, holding that the suit is justiciable and agreeing with the Claims Court. The court remanded for the entry of a declaratory judgment and injunction. View "Acetris Health, LLC v. United States" on Justia Law

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Anjinomoto’s 655 patent claims E. coli bacteria that have been genetically engineered to increase their production of aromatic L-amino acids, such as L-tryptophan, during fermentation, as well as methods of producing aromatic L-amino acids using such bacteria. Ajinomoto filed a complaint against CJ with the International Trade Commission, alleging that CJ was importing certain products that infringed the patent. CJ used several strains of E. coli to produce L-tryptophan products, which it then imported into the United States. The Commission determined that CJ’s earlier strains did not infringe but that CJ’s two later strains did, and that the relevant claim of the 655 patent is not invalid for lack of an adequate written description. The Federal Circuit affirmed, upholding the Commission’s construction of “replacing the native promoter . . . with a more potent promoter.” The court rejected CJ’s claim of prosecution history estoppel and held that the 655 patent expressly provides four examples of “more potent promoters,” so that the Commission supportably found that a skilled artisan could make relatively predictable changes to the native promoter to arrive at a more potent promoter. View "Ajinomoto Co., Inc. v. International Trade Commission" on Justia Law

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Amarin markets Vascepa®, a prescription drug consisting of eicosapentaenoic acid in ethyl ester form, synthetically produced from fish oil, intended to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Vascepa® is the only FDA-approved purified ethyl ester E-EPA product sold in the U.S. Amarin filed a complaint with the International Trade Commission (ITC) under 19 U.S.C. 1337 (Tariff Act), alleging that certain companies were falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as “dietary supplements,” where the products are actually “new drugs” under the Food, Drug, and Cosmetic Act (FDCA) that have not been approved for use in the U.S. Amarin claimed that their importation and sale was an unfair act or unfair method of competition because it violates the Lanham Act, 15 U.S.C. 1125(a), and the Tariff Act “based upon" FDCA standards. The FDA urged the Commission not to institute an investigation and to dismiss Amarin’s complaint, arguing that the FDCA prohibits private enforcement actions and precludes any claim that would “require[] the Commission to directly apply, enforce, or interpret the FDCA.” The ITC and Federal Circuit agreed.Amarin’s allegations are based entirely on FDCA violations; such claims are precluded by the FDCA, where the FDA has not yet provided guidance as to whether violations have occurred. Although Amarin claimed violations of the Tariff Act, its claims constituted an attempt to enforce the FDCA. View "Amarin Pharma, Inc. v. International Trade Commission" on Justia Law

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A number of suits have challenged the accuracy of the warning label on Pradaxa, a prescription blood-thinning drug manufactured by Boehringer. The litigation is in the discovery stage. The district judge presiding over the litigation imposed sanctions on Boehringer for discovery abuse. Boehringer sought a writ of mandamus quashing the sanctions, which included fines, totaling almost $1 million and also ordered that plaintiffs’ depositions of 13 Boehringer employees, all of whom work in Germany be conducted at “a place convenient to the [plaintiffs] and [to] the defendants’ [Boehringer’s] United States counsel,” presumably in the United States. The parties had previously agreed to Amsterdam as the location. The Seventh Circuit rescinded the order with respect to the depositions but otherwise denied mandamus. View "Boehringer Ingelheim Pharm. v. Herndon" on Justia Law

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The companies are direct competitors in importing and distributing pharmaceutical ingredients manufactured in China. Plaintiff claimed that defendant intentionally interfered with one of its contracts and sought damages. In court-ordered settlement negotiations, plaintiff demanded $675,000. Defendant made a counter-offer, demanding that plaintiff pay it $444,444.44 in order to settle the case and avoid a motion for sanctions and a suit for malicious prosecution. The court noted that the peculiar amount was due to the fact that the number four is considered an unlucky number in Chinese culture because it is homophonous with the Chinese word for death, but concluded that it was not a death threat and declined to impose sanctions. The court later entered summary judgment for defendant. The First Circuit affirmed the court's refusal to impose sanctions under FRCP 11. Plaintiff's claims were not patently frivolous. View "CQ Int'l Co., Inc. v. Rochem Int'l, Inc., USA" on Justia Law