U. settles suit over Retin-A

J & J to retain patent rights The University announced a compromise Wednesday with Johnson & Johnson in a two-year court battle over rights to sell the popular acne drug Retin-A as an anti-wrinkle cream. Under the terms of the settlement, Johnson & Johnson retains exclusive ownership of the patent rights to the drug, a position which the University and University Patents, Inc. challenged in two lawsuits against the drug company. And, according to The Wall Street Journal, the pharmaceutical giant will not have to pay the University $10 million in back royalties which the newspaper reported the University sought in damages. But Johnson & Johnson has agreed to pay the University and University Patents future royalties if the Food and Drug Administration approves a Retin-A compound as a treatment for sun-damaged skin. The contested compound, which Johnson & Johnson plans to market under the tradename Renova, is currently under review by the FDA. Renova contains the same active ingredient as Retin-A, but has a different formulation. As a result of the settlement, the University's 1990 lawsuit against Johnson & Johnson and emeritus professor and Retin-A discoverer Albert Kligman was dismissed by mutual consent in U.S. District Court on Tuesday. University Patents' 1989 suit was also dismissed Tuesday. In a statement released Wednesday, the University did not address the terms of the settlement, but emphasized instead "the opportunity to repair its relationship with Dr. Kligman." "It was not the University's purpose in the lawsuit to question Dr. Kligman's character, integrity and generosity," the statement reads. "We regret any inference that the lawsuit may have brought Dr. Kligman's character, integrity and generosity into question." The statement praised Kligman's donation of $15 million in royalties from the Retin-A acne invention to the University's dermatology department and his commitment to donate "substantial royalties" from potential sales of Renova. Kligman could not be reached yesterday, but his secretary said he had no comment on the settlement. Officials at both the University and Johnson & Johnson declined to comment on the details of the agreement, including how much money the University stands to gain. Ortho Pharmaceutical Corporation, the Johnson & Johnson subsidiary which makes the drug, has sold approximately $300 million worth of Retin-A since 1989, according to David Saks, a senior investment analyst at Wedbush Morgan Securities in New York. Sales of Retin-A skyrocketed in the late 1980s following widespread publicity of the drug's effectiveness at smoothing wrinkles and sun-damaged skin. Although the FDA has approved Retin-A only as an anti-acne treatment, the drug has been used by many people since then as an anti-aging treatment. Ortho spokesperson Rich Salem said earlier this semester that he is confident that Renova will gain FDA approval. "The fact that it is before FDA now is a strong indication of our belief in the effectiveness and promise of Renova as a product for photodamage," he said. "We are very hopeful that the FDA will move forward." Wednesday's settlement ends the long-running dispute which has its roots in 1981. At that time, Kligman, a researcher in the dermatology department, filed a patent in his own name for Retin-A's anti-wrinkle uses, claiming he discovered it on his own time. The University claimed that the patent and the right to license the patent belonged to the University because at least part of Kligman's research was performed at University facilities and involved University time. The University claimed in its suit that Kligman violated the University's patent policy when he filed independently for the patent, and then broke the University's conflict-of-interest guidelines when he sold Johnson & Johnson exclusive rights to the patent in 1984. Kligman denied the allegations throughout the dispute.

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