ORTHO SUIT ALLEGING HARM TO FUTURE RENOVA SALES FROM ANTI-AGE COSMETIC

ORTHO SUIT ALLEGING HARM TO FUTURE RENOVA SALES FROM ANTI-AGE COSMETIC product sold by Cosprophar is dismissed by the Manhattan federal court Judge Charles Tenney on Aug. 10. In its complaint, Johnson & Johnson subsidiary Ortho had alleged that future sales of Renova (.05% tretinoin cream) would be negatively affected by Cosprophar's advertising, which, among other claims, says the Anti-Age products are effective in diminishing wrinkles or other effects of photoaging.

Although the Anti-Age ads mention the "alleged benefits and dangers of transretinoic acid," they do not name Retin-A, Judge Tenney's opinion states. "This might be sufficient to create a 'link' between drug and cosmetic skin-care markets" but "the parties here do not compete in any market because Ortho is barred by federal law from promoting Retin-A for anti-wrinkle use," the court concluded. Thus, Ortho was not found to have standing to pursue its claims.

Furthermore, the opinion notes that all of the ads mentioning transretinoic acid state that it is a prescription drug. "There was no evidence that people seeking the medicinal benefits of transretinoic acid would eschew a prescription in favor of cosmetics, some of which would exceed the price of a prescription," the court said. The Anti-Age products range in price from $ 23 to $ 440. Moreover, no "testimony was introduced suggesting that consumers who might be dissatisfied with Cosprophar's products would subsequently reject pursuing a prescribed anti-wrinkle treatment with Retin-A," the document adds. "Ortho showed no damages whatsoever," the court stated.

The current NDA for Renova has been pending at FDA since October 1991 following the March 1991 withdrawal of the original submission, which was made in July 1989. An FDA advisory committee recommended Renova for approval in April 1992 as a prescription drug effective for the cosmetic treatment of photoaging. Ortho's Retin-A prescription anti-acne tretinoin cream has been widely used off-label as a wrinkle treatment.

Ortho had requested a permanent injunction blocking Cosprophar from claiming that its products contain retinol, that they are effective in diminishing wrinkles or other effects of photoaging and that they have been proven effective by scientific evidence. The firm also had requested that Cosprophar be directed to run corrective advertising and recall the products. The company is planning to appeal the ruling.

Ortho filed the suit in 1991 alleging false description and representation of goods by the Italian firm Cosprophar (parent of New York City-based Korff USA) for its Anti-Age skin care lines. Cosprophar sells its products, which contain retinyl acetate and a form of retinyl palmitate, in independent pharmacies, primarily in the Northeast and California. The company promotes its products via "advertorials" in newspapers and magazines and pamphlets distributed in-store. The ads claim that the products contain "Super retinol" and that the primary difference between the Anti- Age products and those with tretinoin is that the former have no side effects.