Patent holders Wyeth and Elan Pharma successfully challenged the USPTO's method for calculating patent term adjustments (PTAs) this month, adding about 8-9 months each to the terms of 2 patents covering treatments for Alzheimer's disease. Wyeth and Elan Pharma International Limited v. Kappos, No. 2009-1120 (Fed. Cir. 2010).
The Federal Circuit held that USPTO rules applied 35 U.S.C. §154(b) "overlap" provisions too broadly. Under 35 U.S.C. §154(b)(1) and (2), a patent term may be extended by the number of days lost due to (i) USPTO delays during prosecution, or (ii) prosecution occurring more than 3 years after filing. However, where only one day was lost, a patentee cannot recoup two days, even if the lost day falls under ("overlaps") both criteria. The decade-old USPTO rules started the "overlap" clock 3 years too early, said the Federal Circuit, resulting in calculations according fewer PTA days than allowed under 35 U.S.C. §154(b).
We expect that the term of many issued patents will be extended as a result of this ruling. The USPTO has advised that it is changing its method for calculating PTAs and that it will issue guidance for expediting recalculation requests in the near future.
Vol. 53, June 2010