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Court Suspends Alnylam Patent-Adjustment Suit Pending Outcome of Separate Litigation

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By Doug Macron

A US District Court late last month agreed to a request by Alnylam Pharmaceuticals to stay a suit it filed against US Patent and Trademark Office over the terms of a patent submitted by the company’s one-time German subsidiary.

The request, which was submitted jointly with the USPTO, sought to stay the suit until a ruling is made on an appeal in an unrelated but similar patent-term suit that drug makers Wyeth and Elan Pharma filed against the patent office.

Alnylam’s suit “presents a legal issue identical to the one” in the Wyeth case, the company and USPTO wrote the court. “The parties believe that staying this action until final disposition of the appeal in [the Wyeth case] will promote judicial economy and assist in the orderly development of precedent.”

The court granted Alnylam and the USPTO’s request on Aug. 31. It was not immediately clear when the appeal on the Wyeth suit will be heard.

In early July, Alnylam filed suit in the US District Court for the District of Columbia against John Doll, the USPTO’s acting director and deputy under secretary of commerce for intellectual property, for allegedly cutting short the adjusted term of one of its US patents by about a year and a half (see RNAi News, 7/23/2009).

The patent, No. 7,473,525, is entitled "Compositions and Methods for Inhibiting Expression of Anti-Apoptotic Genes.” Filed in 2003 and granted earlier this year, the IP claims, among other things, a dsRNA less than 25 nucleotides long that can inhibit the expression of an anti-apoptotic gene such as a Bcl-2.

As part of its standard operating procedures, the patent office provides patent term adjustments, or day-by-day extensions to the standard term of a patent, in order to compensate for delays, such as ones resulting from the failure of the agency to prosecute the patent in a timely manner.

In its suit, Alnylam charged that Doll determined that the '525 patent should be adjusted by 768 days, but said that the IP should have actually been given an added 1,334 days of exclusivity. The company is seeking a court order for the longer adjustment.

However, late last month, Alnylam and the USPTO asked the court to stay the case pending the outcome of the Wyeth suit.

In 2007, Wyeth and Elan sued the patent office in order to obtain “a review of the denial of the correct patent term adjustments” for two of Wyeth’s US patents related to the use of humanized antibodies against beta amyloid peptide. Specifically, the plaintiffs argued that the patents’ adjusted terms had been wrongly set by the then-Director of the USPTO John Dudas at 462 and 492 days, rather than 756 and 722 days, respectively.

About a year ago, the court granted the plaintiffs’ request for summary judgment. Shortly thereafter, the USPTO appealed the case, which now stands before the US Court of Appeals for the Federal Circuit.

Given the similarities between the Wyeth suit and Alnylam’s, Alnylam and the USPTO jointly asked the court hearing their case to stay the litigation “until final disposition of Wyeth by the Federal Circuit.”

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