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Makers of generic drugs may find it easier to enter the market in this part of the country, thanks to a ruling by the 3rd U.S. Circuit Court of Appeals. The court upheld a trial judge’s refusal to enjoin Barr Laboratories Inc. from distributing its look-alike version of Adderall, a brand-name drug for attention deficit hyperactivity disorder. Adderall’s manufacturer, Shire US Inc., claimed the generic product violated its trade dress. But Judges Morton Greenberg, Julio Fuentes and Samuel Alito ruled on May 23 that the appearance of a pill is not protected as trade dress if the similar look of a generic equivalent enhances the generic drug’s acceptance, safety and effective use. Shire US Inc. v. Barr Laboratories, No. 02-3647. Shire alleged trade dress infringement under the Lanham Act, 15 U.S.C. 1125(a) and unfair competition. It was unlikely to succeed on the merits because it failed to prove that the appearance of its pills was nonfunctional, the judges found. A product feature is considered functional and outside trademark protection “if it is essential to the use or purpose of the article or if it affects the cost or quality of the article,” the court said. Shire failed to rebut testimony by Barr’s experts that the similar size, shape and color of its pills helped people identify the drug and provided reassurance to patients switching from the brand name to the generic. As a result, the court concluded that U.S. District Judge Joel Pisano of the District of New Jersey did not err in finding that the similar appearance “enhances patient safety by promoting psychological acceptance.” The appeals court recognized that its decision was somewhat of a departure from other circuit trade dress decisions rejecting similar functionality arguments. Most of those cases predated the 1984 Hatch-Waxman Act, 21 U.S.C. 355, enacted to expedite approval of generic drugs by the Food and Drug Administration, Greenberg said. A 1999 amendment to the Lanham Act places the burden on a party claiming infringement of an unregistered trade dress to prove nonfunctionality. The U.S. Patent and Trademark office recently refused to register Adderall’s color and shape as a trademark. The court also distinguished the other cases on their facts. For example, none of them concerned a controlled substance, in contrast to Adderall, which is an amphetamine. In addition, unlike Shire, all involved efforts to pass off a different product, often an inferior version, as a more costly brand-name medication. Barr’s generic pill, though not identical, is rated by the FDA as bioequivalent to Adderall, meaning it can be freely substituted for the original. The court chiefly relied on a 1981 decision from the Eastern District of New York, Ives Laboratories, Inc. v. Darby Drug Co., 488 F.Supp. 393 (1980). There, the court refused to enjoin the generic-drug maker from copying the coloring of the plaintiff’s vasodilator tablets because the colors were functional and lacked secondary meaning. Ives was ultimately affirmed, 697 F.2d 291 (2d Cir. 1982). The Shire court also relied on “the Supreme Court’s most recent trade dress decisions, which caution against the over-extension of trade dress protection.” Shire attorneys Barbara Solomon and Marie Driscoll of New York’s Fross Zelnick Lehrman & Zissu did not return calls seeking comment. Barr Laboratories’ lawyer, Virginia Richard, thinks that Newport, Ky.-based Shire chose to sue her Pomona, N.Y.-based client in New Jersey because the 3rd Circuit “was thought to be a friendly forum” for its claim. Shire is a “departure from the 3rd Circuit’s prior decisions,” says Richard, a partner with Winston & Strawn in New York. She also notes that a factor in the case was that the chief users of the drugs at issue — many of them children — rely on visual cues like color and shape. Barr’s oval pills are blue (5 mg and 10 mg doses) or orange/peach (20 and 30 mg). Adderall comes in seven dosages ranging from 5 to 30 mg, which are variously round or oval and blue or orange/peach.

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