No, Kevin, you just have to wait.

The beleaguered biotech suffered another blow today as the US Supreme Court declined to consider a patent dispute over the anemia meds that account for almost half its sales.

The justices, without comment, today turned away Amgen’s appeal in a decade-old legal fight with Shire and Sanofi-Aventis over patents that cover Epogen. A successful appeal would have helped Amgen in a separate bid to keep a Roche drug, known as Cera, off the US market.

A federal district court largely agreed with Amgen’s claims, but the Court of Appeals for the Federal Circuit issued a mixed decision last year, ruling that two of Amgen’s patents were valid while reversing the lower court’s findings on two others.

Amgen urged the Supreme Court to rule on the Federal Circuit’s practice of considering the factual record behind its patent claims, even though that record was also subject to thorough review at the district court level. Typically, appeals courts such as the Federal Circuit consider issues of law, rather than fact.

The Federal Circuit’s willingness to reconsider the factual aspects of the case “produces incorrect results and causes litigants and district courts to waste tremendous resources,” Amgen said in its court filing.

Amgen is trying to prevent competition to Epogen and Aranesp, which accounted for $6.6 billion, or 47 percent, of 2006 sales. Amgen is struggling to retain sales of its anemia drugs after studies found they can cause lethal side effects in high doses.

Further reading…
Bloomberg News;
Associated Press.
[tags]Amgen, Aranesp, Epogen, Patents[/tags]