Teva v astrazeneca invalidating a patent with secret prior art

The district court construed the term “alkaline salt” and “pharmaceutically acceptable salt” to be limited to the disclosed salts. Based upon a certification from the Defendant that it would not manufacture below 0.3%, the District Court granted summary judgment of non-infringement.

After this ruling, the parties consented to a final judgment that Hanmi’s proposed product does not infringe the claims of either of the asserted patents. What Reddy has asked the FDA to approve as a regulatory matter is the subject matter that determines whether infringement will occur, and the fact that Reddy either tells the court that its manufacturing guidelines will keep it outside the scope of the claims or has even filed a declaration in the court stating that it will stay outside the scope of the claims does not overcome the basic fact that it has asked the FDA to approve, and hopes to receive from the FDA, approval to market a product within the scope of the issued claims.

The Federal Circuit affirmed as to one claim of the asserted patents, concluding that the defendants had failed to prove by clear and convincing evidence that the claim was obvious.

The Court reversed as to the other claims, concluding they would have been obvious to one of skill in the art. The case turned on whether one of skill would have been motivated to combine the teachings of the prior art to derive the claimed subject matter.

At trial, Cadence and Pharmatop successfully proved by a preponderance of the evidence that Exela's generic version of OFIRMEV® literally infringed all ten asserted claims of the '222 patent.

Despite Exela's arguments to the contrary, the plaintiffs successfully proved that in Exela's generic product, sodium ascorbate acted as a "buffering agent" and mannitol acted as a "free radical scavenger" (i.e., an antioxidant).

This meant that Exela's generic product met each of the asserted claim limitations.

This second-class status is the result of a perception, if not outright truth, that it is more difficult to sustain the validity of formulation patents, whether on appeal or otherwise. The relevant dispute in this case is thus not over whether the prior art discloses all of the claim elements or over the motivation to combine the prior art references.Judge Leonard Stark held that all fourteen asserted claims from the two patents in suit were not invalid and would be infringed by Exela's generic product. (collectively, "Exela") for patent infringement after Exela notified the plaintiffs that it had filed ANDA No.Judge Stark's reasoning was revealed in his November 14 which was unsealed on November 22. 203092 seeking regulatory approval for a generic version of OFIRMEV®. 6,028,222 ("the '222 patent") and 6,992,218 ("the '218 patent"), which are directed to, respectively, a formulation of, and a method for preparing, a liquid acetaminophen (or paracetamol) composition.Cadence and Pharmatop had also sued Perrigo Company, and its subsidiaries Paddock Laboratories, Inc. Each of these three parties were dismissed from the suit by a joint stipulation of the parties after the parties settled and entered into a license agreement.

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