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Newark, N.J.’s federal courthouse has become the main arena of a battle between Warner-Lambert and competitors who have been trying to market generic versions of its anti-seizure drug Neurontin since patents expired two years ago. At least seven patent infringement actions are pending before U.S. District Judge John Lifland, some transferred to Newark last year by the Judicial Conference on Multi-District Litigation. On top of that, Warner-Lambert and Pfizer Inc. — which acquired the drug maker in 2000 — have been hit with at least 12 antitrust, class action suits on behalf of consumers who bought Neurontin since Jan. 16, 2000. Four were filed in New Jersey between March 26 and April 2, and eight were filed in New York beginning on March 5. The plaintiffs allege they paid much higher prices because they were “deprived of the benefits of free and open competition in their purchases.” They accuse Warner-Lambert and Pfizer of anti-competitive acts — false filings with the Food and Drug Administration and “baseless” patent infringement suits filed against would-be generic competitors. The New Jersey plaintiffs include individual users; Smithfield Foods, which alleges it had to pay more for employee health care; consumer-advocacy group New Jersey Citizen Action; and senior citizen groups from California, Indiana, Massachusetts, and Virginia. The plaintiffs, accusing Warner-Lambert and Pfizer of blocking cheaper generic substitutes to keep Neurontin’s price artificially high, seek disgorgement of the amounts by which they say the drug makers were unjustly enriched. Neurontin, the brand name for a form of the drug gabapentin, was approved by the FDA in 1993 for treatment of epileptic seizures. Pfizer’s 2001 annual report boasts Neurontin sales of $1.8 billion, up from $1.3 billion in 2000. The company projects revenues will top $2 billion this year. Warner-Lambert holds two expired patents that pertain to Neurontin. One covers the form of gabapentin used in Neurontin and another the use of Neurontin to treat epilepsy. The class action plaintiffs contend that Warner-Lambert and Pfizer — with the intent of preventing or delaying approval of generic substitutes — listed with the FDA three unexpired patents on non-Neurontin forms of gabapentin, claiming they cover Neurontin. The effect was to block generic substitutes from entering the market. Warner-Lambert and Pfizer allegedly accomplished this by misusing the 1984 Hatch-Waxman Act, 21 U.S.C. � 355, enacted to expedite FDA approval of generic drugs. Also known as the Drug Price Competition and Patent Term Restoration Act, the law allows a potential generic drug maker to piggyback on safety and effectiveness findings for the original, brand-name drug by filing an Abbreviated New Drug Application, or ANDA. The act also entitles brand-name patent holders to notice of ANDA filings and an automatic 30-month delay of an ANDA filer’s market entry if they file a patent infringement suit within 45 days. By suing the generic companies that filed ANDAs for Neurontin substitutes, Warner-Lambert and Pfizer wrongfully retained their monopoly past the patent term, the class action complaints say. Esther Berezofsky, who represents the plaintiffs in one of the class actions, brought by New Jersey Citizen Action, says Pfizer, Warner-Lambert and other brand-name drug manufacturers are standing Hatch-Waxman on its head. “Pharmaceutical costs are out of control in this country and are sapping precious health-care dollars largely because major drug manufacturers are not permitting competition,” says Berezofsky, a partner with Williams, Cuker & Berezofsky in Cherry Hill, N.J. The Pfizer and Warner-Lambert patent infringement suits are against Purepac Pharmaceutical Co., Zenith Laboratories, Teva Pharmaceuticals, Eon Labs Manufacturing and Apotex. In most of the cases, the sued generic companies asserted antitrust counterclaims. Another would-be generic competitor, Geneva Pharmaceuticals, has a declaratory judgment action against Pfizer and Warner-Lambert over rights in Neurontin, which is pending before Lifland. The class action complaints “seem to confirm what we already knew: … the major drug companies are finding ways to use the Hatch-Waxman Act as a means of extending the shelf life of expired patents,” says Eon Labs’ lawyer Stanley Lieberstein, of St. Onge Steward Johnston & Reens in Stamford, Conn. John Francis, a partner with Drinker Biddle & Shanley in Florham Park, N.J., who is representing Pfizer and Warner-Lambert in the patent cases, says, “Warner-Lambert and Pfizer believe their patents are valid.” Pfizer declines comment on the litigations. Last year, federal Judge Paul Plunkett in Illinois granted summary judgment to one of the generics, Apotex, finding that its plan to make Neurontin would not infringe two of the three allegedly non-Neurontin patents relied on by Warner-Lambert and Pfizer. Warner-Lambert v. Apotex Corp., 2001 U.S. Dist. LEXIS 14592 (N.D. Ill.). A patent suit against Apotex transferred to New Jersey by the MDL Panel involves the third patent. Joseph Fleischman, a partner with Somerville’s Norris, McLaughlin & Marcus, Apotex’s local counsel in that case, says he is awaiting a ruling on his motion for summary judgment. The attorney for Purepac, Arnold Calmann, a partner with Newark’s Saiber Schlesinger Satz & Goldstein, also has a motion for summary judgment pending. The four New Jersey antitrust cases are Owens v. Pfizer, 02-CV-1390, Trujillo v. Pfizer, 02-CV-1391, Smithfield Foods Inc. v. Pfizer, 02-CV-1397, and Salowe-Kaye v. Pfizer, 02-CV-1527. The Smithfield Foods complaint was filed by Craig Hilliard, a partner with Princeton’s Stark & Stark, and Merril Hirsh, of Washington, D.C.’s Ross, Dixon & Bell. The Owens and Trujillo plaintiffs are represented by Evan Smith and Jason Brodsky of Cherry Hill’s Brodsky & Smith, along with Marc Topaz of Schiffrin & Barroway in Bala Cynwyd, Pa. Pfizer is not the only drug company accused of abusing Hatch-Waxman. Similar claims are pending against Bristol-Myers Squibb in the Southern District of New York in two consolidated litigations, In re Buspirone Patent Litigation, MDL Docket No. 1410, and In re Buspirone Antitrust Litigation, MDL Docket No. 1413. The MDL conference’s move in consolidating both types of litigation involving buspirone in New York suggests that the same might be done with Neurontin in New Jersey. In January, the Federal Trade Commission filed an amicus curiae brief in the litigation over buspirone, an anti-anxiety drug. The agency argued against dismissing the antitrust claims against Bristol-Myers Squibb, based on the company’s asserted “patent immunity” from the antitrust laws. A Jan. 9 FTC statement says it filed the brief “based on its continuing interest in ensuring that competition between the manufacturers of generic and branded pharmaceuticals is not impeded by potentially anti-competitive acts or practices.”

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