Robert Rouder (US)

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Meaty Brand Messaging During a Crisis

Brand promotion may be seen as encompassing (at least) three distinct but overlapping modes: (i)  Advertising for the moment—the message is meant to drive immediate sales; (ii)  Advertising for post-sale burnishment—the message does more than sell products today, it builds the image or reputation of the brand; and (iii)  Advertising for posterity—a commercial communication that … Continue reading

Mitigating Advertising Risks During the COVID-19 Crisis

During this time of crisis, pharmaceutical and consumer product companies along with retailers are doing their best to provide the public with products to prevent and treat COVID-19. At the same time, the FTC and FDA have announced that they will be particularly vigilant in policing unscrupulous or overzealous marketers making unsubstantiated, misleading, or false … Continue reading

Package as “Advertising”

On October 17, 2016, a US federal trial court in the District of Columbia ruled that a competitor may pursue a Lanham Act claim for false advertising due to a container of black pepper. Watkins Inc. v. McCormick & Co., Inc., Case No. 1:15-cv-2188 (ESH) (D.D.C. Oct. 17, 2016) (2016 WL 6078250). In ruling on … Continue reading

Second Circuit may address apparent Apotex/Church & Dwight split

In our September 28, 2016 blog post, and subsequent Law360 Article, we reported that an internal Second-Circuit split had arisen regarding the deference owed to allegedly false and misleading pharmaceutical/medical device advertising where the FDA had considered and approved similar claims for labeling. The earlier decision involved in the split, Apotex, Inc. v. Acorda Therapeutics, Inc.  823 F.3d 51 (2d … Continue reading

Intra-Circuit split should give advertisers pause

While advertising off-label claims for medical devices and pharmaceuticals may be like sailing into stormy waters, companies might assume that advertising their products based on FDA-vetted labeling is, if not a safe harbor, at least a reasonably sheltered cove.  The recent Second Circuit decision in Church & Dwight Co. Inc., v. SPD Swiss Precision Diagnostics, … Continue reading

Amarin and FDA settle off-label suit

As we reported last August, US District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015,  article. Shortly afterward, Amarin and the government entered settlement talks. August 31, 2015 update. We are now able to report that on March 8, … Continue reading

Amarin wins injunction against FDA over off-label marketing

In June, we wrote about Amarin Pharma’s suit asking a federal court to hold that the FDA’s prohibitions on off-label promotion as applied to “speech Amarin proposes to make and [doctors] wish to receive” about its product Vascepa® “are unconstitutional.” June 11, 2015 article. On August 7, the court ruled that Amarin has a constitutional … Continue reading

FDA seeks to appease drug company in off-label marketing dispute

The FDA has long treated off-label marketing – the promotion of drugs for uses that have not received FDA approval – as evidence of intent to violate the “misbranding” provisions of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. According to the FDA, pharmaceutical manufacturers and their representatives may not … Continue reading

FTC grinds the Oz Effect out of coffee bean weight loss claims

On January 26, 2015, the Federal Trade Commission filed a complaint in federal court against Texas-based Genesis Today, Inc., a marketer of dietary supplements; its branding subsidiary, Pure Health LLC; and its founder and CEO, Dr. Lindsay Duncan. During the Fall of 2014, the defendants and the FTC agreed upon the terms of a settlement … Continue reading

Selling Applications Presents a Problem In Branding For Apple, Microsoft and Amazon

In July 2008, Apple began selling applications (colloquially, “Apps”) for its mobile devices through its APPSTORE. Contemporaneously, Apple applied to register the APP STORE mark with the U.S. Patent and Trademark Office. Two years later, in July 2010, Microsoft challenged the registration because, among other things, they claimed the proposed mark was a generic term. … Continue reading

Can a Lanham Act Case Generate a Lanham Act Claim?

That is the issue raised by a fight between two laboratories that perform sophisticated analyses of urine for the presence of drugs in order that physiacists (pain doctors) might manage patient compliance with opioid dosing. Millennium Laboratories Inc. sued Ameritox, Ltd. alleging false advertising under the Lanham Act and advancing a number of theories. See … Continue reading

The Brilliance of a Girl’s Best Friend is Challenged

On November 13, 2012, Sterling Jewelers filed a complaint charging its competitor, Zale Corporation, with false advertising under the Lanham Act and deceptive trade practices under Ohio law. Sterling operates 1,300 jewelry stores under the Kay Jewelers and Jared the Galleria of Jewelry brand names. Zale is a retailer operating 1,870 stores under the brand … Continue reading

K-V Pharmaceuticals Calls Upon the ITC To Defend Its Makena® Brand

In February, 2011, K-V Pharmaceuticals received FDA approval to market its branded pregnancy drug, Makena® as an orphan drug. Makena’s active ingredient, the hormone 17 HPC, aids at-risk expectant mothers in carrying their child to term. As we previously reported, K-V sued the FDA demanding that it prevent compounding pharmacies from continuing to supply a … Continue reading

FDA Says Wellbutrin Generic Really Isn’t Generic After All

The federal government both grants and restricts marketing advantages. For example, the patent protection and market exclusivity the government affords some pharmaceutical compounds lays the groundwork for a new drug to become a blockbuster brand. On the other hand, FDA approval of a generic can presage the demise of a brand drug. Pharmaceutical companies and … Continue reading

UPDATE: KV Cannot Require FDA to Protect the Market Exclusivity of Makena®

As we previously reported, K-V Pharmaceutical and its THER-Rx subsidiary (“KV”) sued the FDA in an effort to compel the agency to enforce KV’s market exclusivity for its drug, Makena®. At the center of the case, was the FDA’s decision to allow pharmacies to continue to offer a compounded version of the drug to patients. … Continue reading

Merck’s Claritin® Faces Challenge To Its Madagascar Co-Branding

Last month, The Public Health Advocacy Institute (PHAI) filed a complaint with the FTC alleging that Merck & Company’s marketing of its pediatric Claritin® products violate FTC precedent concerning promotional campaigns directed toward children. The promotion in question concerns OTC pediatric Claritin® and characters from the recent Dreamworks film, Madagascar 3. The marketing campaign involves … Continue reading

Can a Drug Company Require the FDA to Protect the Market Exclusivity of its Brand Drug?

This is the key question currently pending in the D.C. District Court. On July 5, 2012, K-V Pharmaceuticals and Ther-Rx (“KV”) sued the FDA alleging failure to enforce KV’s right to market exclusivity for its drug, Makena®. See the Complaint. Among other remedies, KV seeks a PI requiring the FDA to take “sufficient enforcement actions” to … Continue reading