Genus Lifesciences Inc. v. Lannett Co.

Facts

1. 7 Commercial advertising or promotion not pleaded

   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.

2. 7 Commercial advertising or promotion not pleaded

   Although the procedural posture in RPost is different, Genus has failed to allege (rather than prove as in RPost ) that the SEC statements and investor calls were made for the purpose of influencing consumers to buy its goods or services, or that they were disseminated sufficiently to pharmacists, doctors, and hospital groups.

3. 7 Commercial advertising or promotion not pleaded

   But in order to be actionable, the statements must be accompanied by specific allegations that they were made for the purpose of influencing the customers of cocaine hydrochloride solutions to buy C-Topical, or were disseminated sufficiently to the relevant purchasing public (pharmacists, hospitals, and doctors) to constitute "advertising" or "promotion" within the pharmaceutical industry.

4. 7 Commercial advertising or promotion not pleaded

   I find that the allegations contained in the SEC filings and investor calls stating that C-Topical is "grandfathered" or under a "preliminary new drug application" cannot, without more, state a claim for Lanham Act false advertising because they do not rest on any statements made in advertising or promotion.

5. 8 False or misleading factual representation satisfied pleaded

   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."

6. 8 False or misleading factual representation satisfied pleaded

   Lannett's label states that C-Topical is "indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities."

7. 8 False or misleading factual representation satisfied pleaded

   Taking Genus's allegations as true for the purposes of this motion, the inside of the nose, mouth, and larynx are not "particular spots on the outer surface of the body" and C-Topical's route of administration cannot accurately be described as "topical" under the FDA's definitions.

8. 8 False or misleading factual representation satisfied pleaded

   Genus has sufficiently alleged that C-Topical's label route of administration is false.

9. 8 False or misleading factual representation satisfied pleaded

   It is relevant that consumers would have to click on yet another link to be informed that C-Topical has not completed the ANDA approval process required for generic drugs.

10. 8 False or misleading factual representation satisfied pleaded

    Lannett's statement in its website's meta description states a claim for false advertising under the Lanham Act.

11. 9 Judicial actual-deception or tendency-to-deceive requirement satisfied pleaded

    Genus's complaint contains essentially the same allegations as described in Par. It asserts that Lannett lists C-Topical on price lists and appears to cite to the same studies as in Par.

12. 9 Judicial actual-deception or tendency-to-deceive requirement satisfied pleaded

    For example, a nationwide survey of 500 pharmacists found that 91% thought all products pharmacists dispense are FDA approved.

13. 9 Judicial actual-deception or tendency-to-deceive requirement satisfied pleaded

    Additionally, allegations about the survey data meet the standard articulated in JHP Pharm., 52 F. Supp. 3d at 1002-03.

14. 9 Judicial actual-deception or tendency-to-deceive requirement not pleaded

    According to the complaint, Lannett's website states that its "leadership is committed to quality, adherence to FDA standards, and compliance with regulatory requirements to ensure patient safety."

15. 9 Judicial actual-deception or tendency-to-deceive requirement not pleaded

    Genus must plausibly allege that the statements actually conveyed the implied message that C-Topical was grandfathered or sold with FDA approval, and deceived a significant portion of recipients. JHP Pharm. , 52 F. Supp. 3d at 1002-03. It has not done so yet.