IP Law Daily, TRADEMARK—D.N.J.: Novartis entitled to partial preliminary injunction in trade dress case against generic drug maker, (Mar 18, 2025)

By George Basharis, J.D.

Novartis won a preliminary injunction to block MSN Laboratories from launching a generic heart failure medication with a strikingly similar appearance to Novartis’s ENTRESTO pills, though claims of trademark infringement were rejected.

A New Jersey federal court has ruled in favor of pharmaceutical giant Novartis in part of its legal battle against MSN Laboratories, granting a preliminary injunction that prevents MSN from introducing a generic version of Novartis's heart failure medication ENTRESTO due to trade dress infringement concerns. The U.S. district court in New Jersey found that MSN’s planned generic drug tablets too closely resembled Novartis’s distinctive pill designs, creating a likelihood of confusion in the marketplace. However, the court rejected Novartis’s claims that MSN’s use of the NOVADOZ brand name infringed on Novartis’s trademark rights (Novartis AG v. Novadoz Pharmaceuticals LLC, No. 2:25-cv-00849-EP-JRA (D.N.J. Mar. 17, 2025)).

Novartis’s ENTRESTO, launched in 2015, has become “the number one heart failure brand prescribed by physicians” and has “helped reduce the risk of death and hospitalization for over 2.5 million patients,” according to Novartis. The medication is available in three distinctive doses, each with a unique combination of size, shape, and color: a violet white oval tablet (24/26 mg), a pale yellow oval tablet (49/51 mg), and a light pink oval tablet (97/103 mg). Each pill is marked with “NVR” on its face.

MSN submitted an Abbreviated New Drug Application (ANDA) for its generic equivalent to ENTRESTO in July 2019. As required by FDA regulations, the generic drug contains the same active ingredients as the branded drug and comes in the same dosage forms. MSN’s proposed tablets appeared strikingly similar to Novartis’s products in shape and color, though they were marked with “M” instead of “NVR.”

Novartis alleged that MSN was planning to “imminently bring to market a generic version of ENTRESTO, under the NOVADOZ name, intending to confuse healthcare providers and consumers into believing NOVADOZ is affiliated with Novartis.” The lawsuit claimed this would pose health risks to patients and cause reputational damage to Novartis.

In analyzing Novartis’s trade dress infringement claim, the court applied a three-element test: whether the allegedly infringing design is nonfunctional, whether the design has acquired secondary meaning, and whether consumers are likely to confuse the source of the products.

On the functionality question, MSN argued that communication of functional information to patients through colors and sizes is essential. The company claimed that consistent color-coding systems can reduce therapeutic errors and that the similarity in appearance helps patients who switch from branded to generic drugs.

The court rejected this argument, writing that “the functionality doctrine cannot stand for the broader proposition that any distinctive look and feel of a pill means generic brands are free to wholesale copy them under the guise of ensuring patients, whose medication is prescribed by doctors, know what they are taking.” The court observed that “MSN could have just picked different colors. Or different shapes. Or different sizes.” The court also distinguished this case from a similar case involving Adderall, noting that unlike with Adderall dosing, which may involve multiple daily dosages of different strength, ENTRESTO patients typically take one type of pill and do not need to distinguish between daily doses.

On the question of secondary meaning, the court found that ENTRESTO has achieved recognition in the marketplace as the only drug of its kind available for the past nine years, generating more than $10.5 billion in cumulative net sales in the United States since 2015.

Finally, in assessing the likelihood of confusion, the court applied the Third Circuit’s ten-factor test and concluded that there was a substantial risk of patients and healthcare providers confusing the products due to their near-identical appearance.

Trademark infringement claims rejected. While the court sided with Novartis on trade dress protection, it rejected claims that MSN’s NOVADOZ brand name infringed on the NOVARTIS trademark. The court found the marks were not confusingly similar in appearance, sound and meaning despite both having three syllables and beginning with similar sounds.

The court was persuaded by MSN’s explanation that the name NOVADOZ is a combination of “Nova,” meaning bright new star, and “doz,” which invokes the word “dose.” It also noted evidence of numerous other pharmaceutical trademarks that begin with “Nov” or “Nova,” which diminished the strength of Novartis’s claim to exclusive use of that prefix.

Irreparable harm and public interest considerations. In granting the preliminary injunction on trade dress grounds, the court had to determine whether Novartis would suffer irreparable harm without court intervention. Novartis argued it would face reputational damage if MSN’s drug was defective and consumers associated it with Novartis due to similar appearance.

MSN countered that Novartis’s multi-year delay in bringing the action undermined claims of irreparable harm, noting that Novartis had access to information about the appearance of MSN’s pills since at least 2020 through related patent litigation.

The court sided with Novartis, citing its “recognized theory of irreparable harm of ‘lack of control which potentially might result in a damaged reputation.’” The court acknowledged that MSN would suffer significant hardship if enjoined, including loss of first mover advantage and financial setbacks, and recognized the societal benefits of affordable alternatives to brand-name drugs. However, the court concluded that MSN had “brought that injury upon itself” by choosing to closely mimic Novartis’s distinctive pill designs.

The Case is No. 2:25-cv-00849-EP-JRA.

Judge: Padin, E.

Attorneys: Cynthia Stencel Betz (McCarter & English, LLP) for Novartis AG. Rebekah R. Conroy (Stone Conroy LLC) for Novadoz Pharmaceuticals LLC

Companies: Novartis AG; Novadoz Pharmaceuticals LLC

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