Posted: 30 Aug 2017 06:59 PM PDT
By Kurt R. Karst –
Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or successfully challenging FDA’s denial of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our previous post here), that then led to yet another first, the dismissal of related ANDA patent litigation (see our previous post here), Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (collectively “Amarin”) have broken significant new ground in food and drug law over the past several years with victory after victory in court against FDA and others. Now, Amarin aligns itself closely to the FDC Act and years of related FDA interpretations as the company seeks to break even more new ground by turning its sights on a new target: synthetic omega-3 oil manufacturers and dietary supplement distributors; and in a new forum: the United States International Trade Commission (“ITC”). Without saying as much, Amarin characterizes these players as “cheaters,” and the company is seeking to shut them out of the omega-3 game with respect to products that resemble VASCEPA. Although derived from fish, VASCEPA is not fish oil. It is 1 gram of the ethyl ester form of the omega-3 Eicosapentaenoic Acid (“EPA”) that is manufactured synthetically through chemical alteration.
In a 110-page Complaint filed with the ITC on August 30, 2017 (along with a Brief on Jurisdiction and a Public Interest Statement), Amarin requests that the ITC “commence an investigation into the unlawful importation or sale in the United States of synthetically produced omega-3 products that are predominantly comprised of EPA in either ethyl ester (‘EE’) or re-esterified (‘rTG’) form and are falsely labeled, and/or promoted for use as, or in ‘dietary supplements’. . .” According to Amarin, “[t]hese products are cloaked as ‘dietary supplements’ but are actually unapproved ‘new drugs’ under the Federal Food, Drug and Cosmetic Act (‘FDCA’).” Furthermore, says Amarin, “[t]he false labeling or promotion of these products constitutes an unfair act and/or unfair method of competition under Section 337 [of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337] because, among other things, these acts violate Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and the standards established by the FDCA.” (For those folks not familiar with the Tariff Act, Section 337 prohibits unfair acts and unfair methods of competition involving imports, and provides that the importation or sale of infringing goods in the United States is unlawful.)
Essentially, Amarin seeks to prevent import into the United States and the further sale of synthetic concentrated omega-3 products that contain predominantly EPA. But, to be clear, this is not a case against common fish oil, which comprises the large majority of the omega-3 dietary supplement market. Instead, it is a case against only those products – which Amarin refers to as “Synthetically Produced Omega-3 Products” in the company’s ITC filings – that have synthetically modified oil in EE or rTG form that contain more EPA than Docosahexaenoic Acid (“DHA”) (another omega-3) or any other component. “An exclusion order in this case will not raise any public health, safety, or welfare concerns. Rather, removal of the purported ‘dietary supplements’ will further the public interest because those products are actually drugs that evade FDA regulation,” says Amarin in the company’s Public Interest Statement. “Absent such an exclusion order, Proposed Respondents will continue to operate outside of the FDCA’s drug regime, which was established by Congress to protect and promote the public health. 21 U.S.C. § 393(b). These activities will undermine incentives to invest in drug development, . . . and they may more immediately affect the public health.”
With respect to the Lanham Act, Amarin alleges that the importation and sale of the Synthetically Produced Omega-3 Products identified in the Complaint, as well as their “false or misleading representations about those products,” constitute unfair acts or unfair methods of competition in violation of the Lanham Act and the federal common law of unfair competition. For starters, Amarin alleges that distributors of the identified Synthetically Produced Omega-3 Products are making literally false statements about their products insofar as their labeling asserts that the products are “dietary supplements”:
Of particular note is Amarin’s attempt to leverage and seek to extend the U.S. Supreme Court’s 2014 ruling in POM Wonderful LLC v. Coca-Cola. As we previously posted, the Supreme Court held in POM Wonderful that the FDC Act does not preclude a private party from bringing a Lanham Act claim in U.S. District Court challenging a misleading food label that is regulated under the FDC Act.
Amarin applies the POM Wonderful decision for the first time at the ITC, and seeks to extend the POM Wonderful notion of “regulatory synergies” achieved from competition-focused lawsuits that have a basis in a regulatory violation. “POM Wonderfulis directly on point,” says Amarin in the company’s Brief on Jurisdiction.
Whether in the context of asserting First Amendment protection for a pharmaceutical manufacturer’s off-label promotion of an otherwise approved drug (see our previous post here), or successfully challenging FDA’s denial of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our previous post here), that then led to yet another first, the dismissal of related ANDA patent litigation (see our previous post here), Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (collectively “Amarin”) have broken significant new ground in food and drug law over the past several years with victory after victory in court against FDA and others. Now, Amarin aligns itself closely to the FDC Act and years of related FDA interpretations as the company seeks to break even more new ground by turning its sights on a new target: synthetic omega-3 oil manufacturers and dietary supplement distributors; and in a new forum: the United States International Trade Commission (“ITC”). Without saying as much, Amarin characterizes these players as “cheaters,” and the company is seeking to shut them out of the omega-3 game with respect to products that resemble VASCEPA. Although derived from fish, VASCEPA is not fish oil. It is 1 gram of the ethyl ester form of the omega-3 Eicosapentaenoic Acid (“EPA”) that is manufactured synthetically through chemical alteration.
In a 110-page Complaint filed with the ITC on August 30, 2017 (along with a Brief on Jurisdiction and a Public Interest Statement), Amarin requests that the ITC “commence an investigation into the unlawful importation or sale in the United States of synthetically produced omega-3 products that are predominantly comprised of EPA in either ethyl ester (‘EE’) or re-esterified (‘rTG’) form and are falsely labeled, and/or promoted for use as, or in ‘dietary supplements’. . .” According to Amarin, “[t]hese products are cloaked as ‘dietary supplements’ but are actually unapproved ‘new drugs’ under the Federal Food, Drug and Cosmetic Act (‘FDCA’).” Furthermore, says Amarin, “[t]he false labeling or promotion of these products constitutes an unfair act and/or unfair method of competition under Section 337 [of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337] because, among other things, these acts violate Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and the standards established by the FDCA.” (For those folks not familiar with the Tariff Act, Section 337 prohibits unfair acts and unfair methods of competition involving imports, and provides that the importation or sale of infringing goods in the United States is unlawful.)
Essentially, Amarin seeks to prevent import into the United States and the further sale of synthetic concentrated omega-3 products that contain predominantly EPA. But, to be clear, this is not a case against common fish oil, which comprises the large majority of the omega-3 dietary supplement market. Instead, it is a case against only those products – which Amarin refers to as “Synthetically Produced Omega-3 Products” in the company’s ITC filings – that have synthetically modified oil in EE or rTG form that contain more EPA than Docosahexaenoic Acid (“DHA”) (another omega-3) or any other component. “An exclusion order in this case will not raise any public health, safety, or welfare concerns. Rather, removal of the purported ‘dietary supplements’ will further the public interest because those products are actually drugs that evade FDA regulation,” says Amarin in the company’s Public Interest Statement. “Absent such an exclusion order, Proposed Respondents will continue to operate outside of the FDCA’s drug regime, which was established by Congress to protect and promote the public health. 21 U.S.C. § 393(b). These activities will undermine incentives to invest in drug development, . . . and they may more immediately affect the public health.”
With respect to the Lanham Act, Amarin alleges that the importation and sale of the Synthetically Produced Omega-3 Products identified in the Complaint, as well as their “false or misleading representations about those products,” constitute unfair acts or unfair methods of competition in violation of the Lanham Act and the federal common law of unfair competition. For starters, Amarin alleges that distributors of the identified Synthetically Produced Omega-3 Products are making literally false statements about their products insofar as their labeling asserts that the products are “dietary supplements”:
The definition of “dietary supplement” in the FDCA applies only to products that, among other things, bear or contain one or more of the following “dietary ingredients”: “(A) a vitamin, (B) a mineral, (C) an herb or other botanical, (D) an amino acid, (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).” 21 U.S.C. § 321(ff)(1). Products marketed with ingredients that do not fall within the categories of “dietary ingredients” listed in Section 201(ff)(1) of the FDCA, 21 U.S.C. § 321(ff)(1), cannot be marketed as, or for use in, “dietary supplements.” See id.Instead, Amarin says that all of the Synthetically Produced Omega-3 Products meet the definition of “drug” in the FDC Act . . . and that they’re also unapproved “new drugs,” “because they are not generally recognized by qualified experts as safe and effective for their intended uses.” As such, the importation and sale of the identified Synthetically Produced Omega-3 Products “constitute unfair acts or unfair methods of competition under Section 337 based upon the standards set forth in the FDCA.”
The Synthetically Produced Omega-3 Products are not “dietary supplements” because E-EPA, rTG-EPA, E-OM3, and rTG-OM3 do not fall into any of the categories of “dietary ingredients” under the Section 201(ff)(1) of the FDCA.
Of particular note is Amarin’s attempt to leverage and seek to extend the U.S. Supreme Court’s 2014 ruling in POM Wonderful LLC v. Coca-Cola. As we previously posted, the Supreme Court held in POM Wonderful that the FDC Act does not preclude a private party from bringing a Lanham Act claim in U.S. District Court challenging a misleading food label that is regulated under the FDC Act.
Amarin applies the POM Wonderful decision for the first time at the ITC, and seeks to extend the POM Wonderful notion of “regulatory synergies” achieved from competition-focused lawsuits that have a basis in a regulatory violation. “POM Wonderfulis directly on point,” says Amarin in the company’s Brief on Jurisdiction.
The Synthetically Produced Omega-3 Products are labeled as “dietary supplements,” or are intended for use in “dietary supplements,” such that FDA and potential customers are tricked into believing that these products in fact meet the definition of “dietary supplement” in the FDCA, 21 U.S.C. § 321(ff), even though that is not the case. Like the beverage at issue in POM Wonderful, the purported “dietary supplements” at issue here are sold without FDA premarket review.Amarin’s Complaint may very well be the start of a Battle Royale between the pharmaceutical and dietary supplement industries. It could be the food and drug law version of Floyd Mayweather versus Conor McGregor. Right now we’re at the weigh-in. We’ll be closely watching this case as it progresses through the rounds. Will Amarin score another knock-out?
“Dietary supplements,” like beverages, are in fact a type of “food” under the FDCA. See id. § 321(f), (ff). As with beverages, to police purported “dietary supplements,” FDA has to rely on enforcement actions, warning letters, and other measures. Because of limited resources, however, the agency cannot detect every violation nor, as the Supreme Court observed in POM Wonderful, can it pursue every violation it detects. . . .
Thus, as in POM Wonderful, the regulatory synergies between the Lanham Act and the FDCA are important here – if a federal district court were to preclude the Lanham Act claims over dietary supplements, commercial interests and, indirectly, the “public at large” would be unprotected.
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