Issue 65 | April 8, 2003
Pharmaceutical or Biotechnology:
Recent case of interest
 If you work in the area of pharmaceuticals or biotech, you may be interested in the recent case, Allergan v. Alcorn et al., decided March 28, 2003. The case deals with a lawsuit filed by a patentee whose patents cover two distinct methods of using a compound, against a generic company who filed an ANDA seeking approval for one of the methods, but not the other method. The twist in the case was that the generic company sought delayed FDA approval, i.e., approval that would become effective AFTER expiration of the patent on the method of use that was the subject of the ANDA. However, such approval would then occur BEFORE expiration of the other method of use patent.

The patentee filed an action for patent infringement under 35 U.S.C. Sec. 271(e)(2), charging that the generic company would be inducing off-label use of the second patent if/when it received FDA approval. The issue on appeal was whether Sec. 271(e)(2) could be used to support an action for inducing infringement of a method patent that was not same method as that for which ANDA approval was being sought.

The panel reluctantly held in the negative, i.e., for the defendants, confirming that Sec. 271(e)(2) could not be used in this manner. However, the panel was very clear in stating that this outcome was dictated by a prior recent decision, Warner-Lambert v. Apotex, 316 F.3d 1348 (Fed. Cir. 2003).

Interestingly, Judge Schall filed a concurring statement, joined by Judge Clevenger (i.e., a majority of the panel), wherein he (they) flatly and strongly disagreed with the Warner-Lambert holding. The concurring statement makes very clear that the present decision was issued solely because of the Federal Circuit practice of giving precedential effect to decisions of a previous panel. It would seem likely, in view of these comments, that the patentee will be seeking a rehearing in banc, probably with the support of Judges Schall and Clevenger.

To discuss this topic further, please contact the author, Daniel A. Boehnen, at McDonnell Boehnen Hulbert & Berghoff.

The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.