Genus Lifesciences Inc. v. Lannett Co.

378 F. Supp. 3d 823
CourtDistrict Court, N.D. California
DecidedMay 3, 2019
DocketCase No. 18-cv-07603-WHO
StatusPublished
Cited by5 cases

This text of 378 F. Supp. 3d 823 (Genus Lifesciences Inc. v. Lannett Co.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Genus Lifesciences Inc. v. Lannett Co., 378 F. Supp. 3d 823 (N.D. Cal. 2019).

Opinion

William H. Orrick, United States District Judge

Genus Lifesciences Inc. ("Genus") is a competitor of Lannett Company Inc. and Cody Laboratories, Inc., Lannett's wholly owned subsidiary, in the market for cocaine hydrochloride nasal spray. It is suing Lannett and Cody for false advertising and maintaining a monopoly related to Lannett's production of C-Topical® ("C-Topical"), a cocaine hydrochloride solution that competes with Genus' own cocaine hydrochloride solution, GOPRELTO® ("Goprelto").1 It also sues First Databank, Inc. a pricing list company that compares drug products and their prices so that wholesalers and customers can see all the alternatives available for a particular medication, for false advertising and contributory false advertising. Some of Genus's claims against Lannett and Cody are plausibly stated, but none against First Databank is because First Databank's challenged statement in the pricing list was not "commercial speech" and First Databank did not influence Lannett's conduct about which Genus complains. Accordingly, First Databank's motion to dismiss is granted and Lannett and Cody's motion to dismiss is granted in part and denied in part.

BACKGROUND2

Genus claims that Lannett and Cody falsely advertise, market, and promote C-Topical as approved when it has not been approved by the U.S. Food and Drug Administration ("FDA"). Complaint at ¶¶ 1-5 [Dkt. No. 1]. It also asserts claims against Lannett and Cody for engaging in anticompetitive conduct aimed at maintaining a monopoly and preventing Genus from occupying a place in the market. Id. at ¶ 1.

Otolaryngologists (commonly known as ear, nose and throat specialists, or ENTs) use Lannett's product, Goprelto, while performing intranasal medical procedures. Id. at ¶ 3. On December 14, 2017, the FDA granted approval of Goprelto's New Drug Application 209963. Id. at ¶ 2. To gain *828approval, Genus performed five clinical trials and ten non-clinical trials involving over 700 human subjects. Id. at ¶ 29. The FDA approved Goprelto "for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults." Id. at ¶ 30. The FDA determined that Goprelto's route of administration is "nasal." Id. The drug's packaging, label, and package insert are regulated and approved by the FDA. Id. at ¶ 34. As the first FDA approved cocaine product, Goprelto was awarded new chemical exclusivity, which bars any third-party applicant from seeking FDA approval until December 14, 2022. Id. at ¶ 135.

C-Topical and Goprelto have the same active ingredient, the same strength, and the same dosage form, making them commercially equivalent. Id. at ¶ 127. Both drugs are interchangeable for certain medical uses, including Goprelto's approved indicated use. Id.

Unapproved Marketed Drugs and FDA Procedures

Today, most prescription drugs marketed in the United States must have FDA approval. Id. at ¶ 36. To legally market a drug, a company has several options. It may obtain approval of a new drug application ("NDA") or approval of an abbreviated new drug application ("ANDA") for generic drugs. Id. at ¶ 67. A drug may also be exempt from the NDA requirement. Id. Exempt drugs include "grandfathered" drugs, drugs subject to an ongoing drug efficacy study implementation proceeding, drugs that are generally recognized as safe and effective, and drugs marketed in accordance with a final or tentative over-the-counter drug monograph. Id. at ¶ 68.

In 1984, after about 40 infants died after taking unapproved vitamin intravenous injections, the FDA created a program called the "Prescription Drug Wrap-Up" to identify the universe of unapproved drugs in the United States. Id. at ¶ 40. The FDA identified approximately 5,150 unapproved, marketed products. Id. According to the FDA, each of these drugs is illegally marketed unless the manufacturer establishes that the drug is "grandfathered." Id. A drug is grandfathered if, among other requirements, its composition and labelling have not changed since the October 10, 1962 enactment date of an amendment to the Food, Drug, and Cosmetic Act. Id. at ¶ 39.

In 2006 and 2011, the FDA published "guidances"-nonbinding recommendations-to encourage makers of unapproved drugs to seek formal NDA approval for their products. Id. at ¶ 41. The stated goals of the 2006 guidance were to "(1) clarify to FDA personnel and the regulated industry how we intend to exercise our enforcement discretion regarding unapproved drugs and (2) emphasize that illegally marketed drugs must obtain FDA approval." Id.

The FDA's 2006 guidance also stated that in cases where one drug was approved but had unapproved competitors, there would generally be a grace period of one year before the FDA initiated enforcement action against the unapproved drug. Guidance for FDA Staff and Industry: Marketed Unapproved Drugs-Compliance Policy Guide (2006) at 6, attached as Exhibit 6 to Compliant [Dkt. No. 1-1]. Although C-Topical's grace period would have ended in December 2018, the FDA does not appear to have taken any action against Lannett or Cody.

The FDA has Not Approved C-Topical

Lannett commercially launched C-Topical at least as early as 2008. Id. at ¶ 47. Lannett was the sole supplier of cocaine hydrochloride solution products to ENTs from 2012 until Genus's launch of Goprelto *829in 2017. Id. at ¶ 48. C-Topical had a monopoly on the market after Lannett's only competitor at the time withdrew from the marketplace. Id. Genus claims that Lannett falsely advertises C-Topical as "grandfathered," as a "preliminary new drug application" product, as FDA approved, as a generic of Goprelto, or as a branded drug pursuant to a NDA. Id.

On November 12, 2015, the FDA rejected Lannett's request that C-Topical be grandfathered. Id. at ¶¶ 58-60; Exhibit 15 ("FDA Rejection Decision") attached to Compl [Dkt. No. 1-1]. The FDA found that the evidence provided by Lannett was inadequate to support a conclusion that either cocaine hydrochloride products in general, or Lannett's drug in particular, met the requirements of the grandfather clause. Compl. at ¶ 59; FDA Rejection Decision at 16. Nevertheless, Lannett claimed that C-Topical was grandfathered in a number of Securities and Exchange Commission ("SEC") filings and investor calls in between December 2017 and September 2018. Compl. at ¶¶ 51-54; Exhibits 10-14 attached to Compl. [Dkt. No. 1-1].

Genus also claims that Lannett has advertised C-Topical as being legally marketed under a "preliminary new drug application" in a number of SEC filings. Compl. at ¶¶ 63-66; Exhibits 2, 13, 14 attached to Compl. [Dkt. No. 1-1]. It argues that the FDA does not permit production or marketing of prescription drug products under a "preliminary new drug application" and that the phrase is a fictitious regulatory category fabricated by Lannett. Compl. at ¶ 70.

Genus points out that Lannett's meta description for its C-Topical webpage is misleading: it states, "Learn more about the facts and characteristics of the generic pharmaceutical C-Topical® Solution CII." Id. at ¶ 74.

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378 F. Supp. 3d 823, Counsel Stack Legal Research, https://law.counselstack.com/opinion/genus-lifesciences-inc-v-lannett-co-cand-2019.