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Alnylam, Patent Office Ask Court to Lift Stay on Patent Term-Adjustment Lawsuit

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By Doug Macron

Alnylam Pharmaceuticals scored a victory in its lawsuit against the director of the US Patent and Trademark Office over the term of a patent originally submitted by its one-time German subsidiary, with both parties in the case requesting that the court permit the patent office to conduct a review of the intellectual property.

Previously, the case had been stayed pending the outcome of a similar suit between the USPTO and drug maker Wyeth. Now, with that case decided, Alnylam and the USPTO have asked the court to lift the stay and to allow the patent office to review the IP's term in light of the Wyeth case.

Last July Alnylam sued John Doll, the USPTO’s acting director and deputy undersecretary of commerce for intellectual property, for allegedly cutting short by about a year and a half the adjusted term of one of its US patents (RNAi News 7/23/2009).

The lawsuit, filed in the District Court for the District of Columbia, now names as the defendant USPTO Director David Kappos, who was confirmed as head of the patent office last August.

The patent, No. 7,473,525, is entitled "Compositions and Methods for Inhibiting Expression of Anti-Apoptotic Genes.” Filed in 2003 and granted in early 2009, 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.

The USPTO routinely 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.

In September, however, Alnylam and the USPTO asked the court to put the case on hold until a ruling was made on an appeal in an unrelated but similar patent-term suit that Wyeth and Elan Pharma filed against the patent office.

At the time, Alnylam said that the Wyeth case “presents a legal issue identical to" its own, and that it and the patent office felt that "staying this action until final disposition of the appeal … will promote judicial economy and assist in the orderly development of precedent.”

The court granted the request.

Last week, however, Alnylam and the USPTO jointly asked that the stay be lifted since the court hearing the Wyeth appeal upheld the original decision in the case, which found that terms on patents held by Wyeth and Elan had been improperly set by the patent office due to delays in prosecuting the companies' patent applications.

"Both the USPTO and the Department of Justice have decided not to seek further review" of the decision on the Wyeth appeal, Alnylam and the patent office said in last week's request to the court.

"This case involves a request by Alnylam for review of a patent-term adjustment granted by the USPTO … a legal question identical to the patent-term adjustment issue in Wyeth," they added. Due to the decision on that case, "the USPTO believes that adjustment of the patent term pursuant to Alnylam's claims … is warranted."

Alnylam and the patent office therefore asked the court to "lift the stay applied to [their] case, vacate the patent-term calculation determined by the USPTO, and remand the case to the USPTO for recalculation and adjustment of [the company's] patent term."

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