In Apotex v. Pfizer (Sup. Ct. 05-1006), the Supreme Court said that it will not hear a case brought by generic pharmaceutical company Apotex that was trying to have Pfizer’s Zoloft patent invalidated. Zoloft (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) used to treat depression.

Earlier, Pfizer sent Apotex an unconditional covenant not to sue Apotex with respect to U.S. Pat. No. 5,248,699. It also announced that Teva Pharmaceutical had begun marketing its generic version of Zoloft®, starting the 180-day exclusivity period that Apotex sought to trigger with a court judgment. Therefore, any future court judgment regarding the ’699 patent would no longer have any effect on the exclusivity period.

In its supplemental brief, Pfizer argued that the case is now moot and requested that Apotex withdraw its petition for a writ of certiorari. Apotex, however, said that it did not consider the case moot and that it would not withdraw the petition. The Court had asked the Solicitor General to offer the views of the U.S. on the merits of the declaratory judgment jurisdiction question.

While Pfizer unconditionally promised that Pfizer will not sue or otherwise enforce the ‘699 patent against Apotex in connection with the manufacture, sale, offer for sale, use, or importation of Apotex’s proposed generic sertraline hydrochloride drug product, that is the subject of ANDA No. 76-882, it did not constitute any kind of license so Apotex would still need to wait out the 180-day exclusivity period.

A generic company that is first to break a branded drug’s patent is awarded a 180-day period of exclusivity over other generics. But an authorized generic can compete in this period. Generic companies are mad about the Teva deal because it means they don’t get a 180-day period of market exclusivity. Teva inherited the rights to generic Zoloft through its acquisition of Ivax Corp. earlier this year.

Ivax received FDA approval in December 2004 to sell a generic version of Zoloft after the patent expires and 180 days of marketing exclusivity upon launch. However, the exclusivity period does not apply to authorized generics. By launching their own generic products, branded companies hope to hang on to a bigger portion of sales from the drugs they developed and discourage generic companies from making patent challenges.

Now, Pfizer’s covenant not to sue can leave the status of the patent unresolved and create uncertainty for a generic drug company, since the brand-name company could later sue for patent infringement once the generic firm begins manufacturing and selling the drug. This threat can prevent generic companies from proceeding in the first place.

In Teva v. Pfizer, the CAFC had held that the court does not have declaratory judgment jurisdiction over a case between an ANDA filer and the patent holder unless the patent holder at least threatens suit stating that a listing in the Orange Book listing alone does not create a reasonable apprehension of suit.

In the present case, Apotex faces the same issue and Apotex argued that the unsure situation should give the generic a right to pursue declaratory relief. The FTC has argued that this is anticompetitive under antitrust laws.

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