Healthy Skepticism Library item: 7302

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Rugaber C.
Supreme Court Denies Zoloft Patent Case
Law.com 2006 Oct 11
http://www.law.com/jsp/article.jsp?id=1160471119354

Abstract:

The Supreme Court said Tuesday that it will not hear a case brought by a generic pharmaceutical company that sought to invalidate a patent held by Pfizer Inc. for its blockbuster anti-depression drug Zoloft.

The case, brought by Winnipeg, Canada-based Apotex Inc., involved a controversial issue in the pharmaceutical industry: whether generic drug makers are sometimes blocked from issuing new products by brand-name companies that refuse to sue them for patent infringement during the FDA approval process.

This refusal to sue can leave the status of patents 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, in turn, can prevent generic companies from proceeding in the first place.

Apotex argued in its filing with the Supreme Court that it “faced potentially crippling patent liability” because of the uncertainty that remained around a patent Pfizer listed in connection with Zoloft. The patent, one of two related to Zoloft, does not expire until 2010. The other expired June 30, 2006.

Pfizer, meanwhile, responded that it did not intend to sue Apotex for patent infringement and therefore there was no dispute for the courts to adjudicate. Federal courts have previously decided that a company must have a “reasonable apprehension” that it will be sued for patent infringement before there is a clear “case or controversy” for the courts to decide.

The “reasonable apprehension” standard is intended to ensure that the courts avoid becoming entangled in hypothetical or advisory opinions.

A federal district court agreed with New York-based Pfizer and dismissed the case in January 2005, and a federal circuit court affirmed the decision in December 2005.

Shares of Pfizer fell 31 cents to $27.34 Tuesday on the New York Stock Exchange.