By James DeGiulio --
PDL BioPharma Synagis Patent Invalidated
MedImmune gained major ground in its infringement and licensing dispute with PDL BioPharma after its last patent on antibodies used in the respiratory drug Synagis was found invalid. The relationship between the parties began in 1997, when PDL granted MedImmune a license to develop certain types of antibodies covered by five PDL patents. In 1998, MedImmune received approval from the FDA to market the antibody drug Synagis, which is used to prevent lower respiratory tract disease in infants and children. In December 2008, in a complaint filed in the U.S. District Court for the Northern District of California, MedImmune asked for a declaratory judgment that the five PDL patents covering the antibodies were invalid, and that it owed no payments to PDL under a patent license agreement reached by the companies. PDL argued that the patents were valid and that MedImmune's antibody treatments infringed those patents. Leading up to the latest ruling in the case, only a single claim of one patent (U.S. Patent No. 6,180,370) remained at issue, which MedImmune claimed was invalid and which PDL claimed covered Synagis. Recently, MedImmune moved for summary judgment of invalidity, and PDL moved for summary judgment with respect to MedImmune's restitution claim regarding the patent royalties paid.
On January 7, Judge Fogel granted MedImmune's motion for summary judgment, thus invalidating claim 28, the sole claim at issue in the case. Judge Fogel found that the claim was anticipated by U.S. Patent No. 6,548,640, which covered the composition claim for a class of humanized immunoglobulins. As a consequence, the Court held that MedImmune did not violate the licensing agreement. MedImmune also prevailed with respect to PDL’s fraud counterclaims. PDL did receive some good news, however, when the Court determined that it did not have to return $42 million in royalties MedImmune paid on a European patent that was invalidated in 2005. Judge Fogel saved the final licensing agreement issue for a jury. Judge Fogel’s order can be found here.
Novo's Prandin Patent Found Invalid
Despite the efforts Novo Nordisk has spent over the past five years defending and enforcing U.S. Patent No. 6,677,358, which covers Prandin, the '358 patent has been found invalid for obviousness and not enforceable due to inequitable conduct. Novo originally filed suit against Caraco in 2005 in the U.S. District Court for the Eastern District of Michigan, alleging infringement of the '358 patent based on Caraco's ANDA for a generic version of Prandin. Caraco counterclaimed that Novo's patent was invalid and would not be infringed by the sale of its generic version of the drug. In 2007, the FDA notified Caraco that it could not grant final approval of the ANDA because of the Novo lawsuit. Caraco then amended its ANDA with a Section VIII statement, but Caraco's claim was rendered moot when the FDA allowed Novo to modify the use code of the '358 patent to include a claimed method. Novo's request for a change of its use code was contested and appealed to the Federal Circuit, which ultimately ruled in April that the change was permissible (see "Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)"). In July, the Federal Circuit denied an en banc rehearing of the case. There was then a trial, extending over 11 days in June and August of 2010.
On January 19, in a detailed opinion, Judge Cohn found that the ‘358 patent is not invalid because of anticipation, but is invalid because of obviousness, and is not enforceable because of inequitable conduct. The Court looked closely at all the prior art, finding that the record clearly establishes that the prior art supplied the teaching, suggestion, and motivation to combine repaglinide with metformin as a combination therapy for Type II diabetes. Novo presented evidence of secondary considerations, particularly unexpected results and commercial success, but those were not found persuasive enough to overcome the prima facie case. Turning to inequitable conduct, Judge Cohn found that an incomplete declaration and withholding of information during patent prosecution was a violation of Novo's duty of disclosure, thus exceeding the necessary threshold levels of materiality and intent. As such, Judge Cohn concluded that the patent cannot be sustained. Judge Cohn’s opinion can be found here, and his judgment can be found here.
Aurobindo Pharma Settles with Wyeth in Effexor XR Litigation
Aurobindo Pharma and Wyeth have settled their patent dispute over Aurobindo's generic version of the antidepressant Effexor. In April, Wyeth brought suit in the U.S. District Court for the District of New Jersey, claiming that Aurobindo's plan to market its own generic version of Effexor XR infringed U.S. Patent Nos. 6,274,171; 6,403,120; and 6,419,958. The three patents, which were issued between August 2001 and July 2002 and subsequently assigned to Wyeth, cover an extended release formulation of the drug's active ingredient venlafaxine hydrochloride.
On January 6, Judge Freda L. Wolfson signed off on the parties' dismissal of the dispute without prejudice. The order preserved the right to reopen the action within 60 days if the proposed settlement is not consummated. Additional details of the dismissal were not disclosed. Judge Wolfson's order can be found here.
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