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Neurontin - Antitrust Case (Suppression of Generic Versions)
About Neurontin
Neurontin® is the brand name for the drug gabapentin and is a widely prescribed anti-convulsant approved by the Food and Drug Administration (FDA) for the treatment of epilepsy. Warner-Lambert Company (Warner) has manufactured and sold the brand name prescription drug Neurontin since its approval by the FDA on December 30, 1993 . Warner marketed Neurontin through its Parke-Davis division. Warner was acquired by Pfizer in June of 2000 and is presently a wholly owned subsidiary of Pfizer.
Background
Warner was the owner of two patents related to Neurontin which have since expired. These included a patent for the anhydrous compound gabapentin, which expired in 1998, and a patent covering the use of gabapentin to treat epilepsy which expired on January 16, 2000 . Neurontin has been an extremely profitable pharmaceutical for Warner and subsequently for Pfizer. Neurontin generated in excess of $1.3 billion in worldwide revenues in 2000, a substantial portion of which was derived from sales within the United States. Pfizer reported Neurontin sales of $432 million for the last quarter of 2000 and sales of $812 million for the first two quarters of 2001.
In order to prevent other companies from selling a generic version of Neurontin and thereby creating a loss in revenue for Pfizer and Warner and a loss of market share for the drug, Warner caused to be listed in the FDA's Orange Book three other patents which, although related to gabapentin, do not cover the form of gabapentin marketed by defendants as Neurontin or the use of gabapentin for the treatment of epilepsy. Despite the fact that these patents were not related to Warner's formula or use of Neurontin, it caused these three patents, the first of which will not expire until May, 2008, to be listed in the Orange Book under Neurontin. This action delayed the FDA from approving generic versions of Neurontin.
In addition, no fewer than six generic drug manufacturers subsequently filed applications with the FDA to market generic versions of Neurontin. In support of their applications, the generic manufacturers attached certifications that the Neurontin patents claimed by Warner to cover Neurontin were invalid and unenforceable because they are unrelated to Warner's formula or use of gabapentin. In response, Warner and Pfizer sued the generic manufacturers to prevent them from manufacturing generic versions of Neurontin.
The generic manufacturers claim that none of the three patents listed by Warner as related to Neurontin would be violated by their formula or use of gabepentin.
PAL Member Litigation
In April 2002, PAL filed a federal class action lawsuit in New Jersey against Pfizer and Warner alleging that U.S. consumers have been harmed as a result of their anti-competitive conduct in:
- listing patents unrelated to the formula for Neurontin in the Orange Book; and
- filing baseless patent infringement suits against potential competitors in order to prolong its monopoly over the sale of Neurontin in the United States .
Consumers have never had the opportunity to buy lower-cost generic versions of Neurontin. As a result of Warner's anti-competitive conduct, consumers have been paying for Neurontin at an artificially high price.
In June 2002, PAL's lawsuit was consolidated with other cases around the country in the U.S. District Court in New Jersey.
In March 2003, all patent-related Neurontin cases were consolidated, but further proceedings have been suspended until the underlying patent litigation between Pfizer and generic manufacturers is resolved. Since early 2006, the case has been stayed pending resolution of the underlying patent litigation, including appeal of some issues.
Update:
In late 2007, the Judge hearing the case, Judge Lifland, retired and the case was reassigned to Judge Faith S. Hochberg. Judge Hochberg lifted the stay, and adopted an aggressive schedule for the litigation going forward. In the wake of several rulings in the underlying patent litigation, the plaintiffs voluntarily dismissed the case on April 2, 2008.
Court: U.S. District Court, District of New Jersey
Neurontin Plaintiff Class
The proposed Neurontin litigation class members included individuals who paid out-of-pocket costs for the drug from January 16, 2000 to the present.
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