Terminal Disclaimer Does Not Negate Patent Term Extension

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.”

 

Comments

[tom kelley]

So by the same rationale, because the statutory language in Section 154(b)(1)(A) says ".. the term of a patent shall be extended ...", patent term adjustment should also not be affected by a terminal disclaimer.

[Dennis Crouch]

Tom, Interesting point. However, Section 154(b)(2) includes a limitation that might exclude PTA:

154(b)(2)(B) DISCLAIMED TERM.- No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer.