King Pharma v. Teva, 78 USPQ2d 1237 (D.N.J. 2006).
In a pharmaceutical patent dispute, Teva argued that Wyeth’s patent on zaleplon drug products (Sonata) had expired because of a terminal disclaimer. Wyeth (and its exclusive licensee King) argued that patent’s term was ongoing because of a Patent Term Extension due to FDA regulatory review delay.
Under 35 U.S.C. 156(a), the term of a patent “shall be extended” after a series of provisions are satisfied. The district court found the language of the statute unambiguous and gives the court “no discretion.”
Thus, if the enumerated conditions are satisfied, the patentee is entitled to a term extension calculated pursuant to Section 156.
Teva’s motion to dismiss was consequently denied because “a terminally disclaimed patent is eligible for extension under [Section] 156.”