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To date, Purdue has maintained a monopoly on the manufacture of the extended release formula of oxycodone hydrochloride. Purdue is the owner of several patents issued by the U.S. Patent and Trademark Office (PTO) based on claims that nearly all patients received relief using low doses of the drug.
In 2000, Endo Pharmaceuticals Holdings (Endo) first applied to the FDA for approval for a generic version of oxycodone hydrochloride c-r; amendments followed requesting approval for additional doses of the product. Purdue responded to these applications by filing suit against Endo with claims of patent infringement, leading to an automatic delay in FDA approval. However the FDA gave Endo tentative approval on July 31, 2002 for a generic version of OxyContin, contingent on the resolution of the patent disputes.
On January 5, 2004, in the case brought by Purdue against Endo, a federal judge ruled that Purdue's OxyContin patents were invalid, because Purdue purposely misrepresented information to the PTO about the efficacy of the drug at low dosages. In fact, it seems that the clinical claims to OxyContin's unique low dosing properties were only "in the head" of the drug developer and were never clinically proven.
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In early July 2004, the case was consolidated with other OxyContin cases in U.S. District Court for the Southern District of New York, where the underlying patent litigation was heard.
Defendant's appealed the District Court's summary judgment decision on the invalidity of their patents to the Federal Circuit Court of Appeals, a specialized appellate court dealing with patent law. The court held, first on June 6, 2005 that the patents at issue were unenforceable because Purdue failed to disclose material information to the patent office and its conduct reflected "a clear pattern of misdirection throughout the prosecution" of its patents. Unfortunately, Purdue requested a rehearing by this court, which, on February 1, 2006, reversed its June 6 decision, to find that the patents were indeed enforceable. The case was remanded (or ‘sent back') to the lower court for additional rulings.
Update September 2008:
The generic manufacturers Endo, Teva, Impax, and BIPI/Boehringer who were parties to the original underlying patent litigation all settled with Purdue by August, 2007.
However, during that time period, Defendant Purdue brought similar patent infringement litigation against three other generic manufacturers (KV Pharmaceuticals, Actavis, and Mallinckrodt) based on applications to the FDA to begin marketing their own generic versions of OxyContin.
On September 2, 2008, Purdue again settled with one of the generic manufacturers, Malinckrodt. This deal included Malincrodt gaining a limited license to produce the drug until 2009. The Court continues to evaluate the patent disputes between Purdue and the two remaining generic manufacturers, KV Pharmaceuticals and Actavis. This continues to stay the anti-trust claims.
Court: U.S. District Court, Southern District of New York (Judge Stein)
Federal Circuit Court of Appeals