Re: BLT - Benitec Limited
Benitec Update:
Reexamination
Nucleonics initiated a third party Reexamination at the U.S. Patent and Trademark Office (“USPTO”) on October 4, 2004, providing the USPTO with art it asserted invalidated U.S. Patent No. 6,573,099 (“099 Patent”). The USPTO rejected the claims based on the provided art. Benitec successfully overcame the references, and the USPTO withdrew all rejections but instituted new rejections on additional art it had uncovered. Benitec then filed a response, which it believed overcame the rejections of Record.
Nucleonics then requested a second Reexamination, adding art it asserted invalidated the ‘099 Patent. The USPTO merged the two Reexaminations and recently sent out an Office Action. The USPTO withdrew most of the earlier rejections it made, modified other rejections, and added rejections based on the art Nucleonics provided in its second Reexamination request.
Benitec has reviewed this new art and believes it does not raise any issues that would preclude patentability of the invention disclosed in the ‘099 Patent. Benitec also believes it has strong arguments for overcoming the art of record. Benitec plans to respond to the rejections found in the merged Reexaminations on or before the Response due date of March 24, 2007.
Litigation
On September 29, 2005 the Delaware District Court granted Benitec’s motion to dismiss the Benitec v. Nucleonics litigation based on the Supreme Court’s Merk v. Integra decision. Nucleonics appealed the District Court decision to the Court of Appeals for the Federal Circuit. The appeal will decide whether the District Court has jurisdiction to permit the Benitec v. Nucleonics litigation to continue to be prosecuted in view of the Merk v. Integra decision holding that the safe harbor provision of 35 U.S.C. §271(e) broadly protects research and development work activities used to support activities submitted to the FDA. After briefing, on December 6, 2006 the Federal Circuit heard oral argument on the appeal.
On January 7, 2007, the Supreme Court issued a decision in MedImmune v. Genentech, which addressed the question of whether a license holder could file suit against a licensor without breaching the license first. The Federal Circuit has requested Nucleonics and Benitec to provide supplemental briefing on what effect, if any, the Supreme Court’s decision in the MedImmune case has on Nucleonics’ Appeal. Benitec is presently awaiting the Nucleonics’ briefing on the matter. At present, Benitec believes the recent Supreme Court case does not affect the District Court’s determination that the case should be dismissed and Benitec intends to respond accordingly.