Non-infringement upheld on ANDA claim where patentee relied only on evidence related to a different formulation; invalidity on enablement and written description reversed where District Court failed to address determinative question; no JMOL of invalidity on patents not raised at trial not an abuse of discretion.

The two patents at issue pertain to methods for enhancing the chemical stability of certain pharmaceutical compositions through the addition of polyethoxylated castor oil (“PECO”). The district court found that the accused infringer did not infringe two of the patents because the patentee put forth no evidence that the accused product was manufactured by a method that included adding an amount of PECO that chemically (as opposed to physically) stabilized the composition. The district court also held that the asserted claims of the same two patents were invalid for lack of enablement and written description under 35 U.S.C. § 112 in part because the claims were too broad, the disclosure was too limited, and the art of chemical stabilization was too unpredictable. Finally, the district court refused to grant the accused infringer’s motion for JMOL of non-infringement on another two patents related to the pharmaceutical composition on the basis that neither party had presented any evidence on those patents at trial. The patentee appealed the finding of non-infringement and invalidity, and the accused infringer cross-appealed on the denial of JMOL of non-infringement.

The Federal Circuit upheld the district court’s finding of non-infringement, observing that the only evidence presented by the patentee that the addition of PECO during the process of manufacturing the accused product improved chemical stability was a table that pertained to a composition tested during development of the patentee’s product. The court explained that the infringement analysis should focus on a comparison of the asserted patent against the product that is likely to be sold. Because the district court found that 1) the accused product differed significantly from the tested composition; and 2) such differences can have an impact on the stability, data pertaining to the test composition had no bearing on whether the accused product infringed.

The Federal Circuit reversed the district court’s ruling that the asserted claims were invalid for non-enablement and lack of written description. On enablement, the Federal Circuit held that the district court had failed to address the determinative question of whether a person of ordinary skill in the art would not be able to practice the claimed invention without undue experimentation. Rather, the district court’s ruling relied on simply applying the Wands factors to determine if the full scope of the claims was enabled. Similarly, on written description, the Federal Circuit held that the invention was amply demonstrated in the patent disclosures, which provided exemplary compositions within the scope of the claims, details as to how those example compositions were prepared from commercially available ingredients, and step-by-step procedures for adding PECO to a prostaglandin composition in a way that embodies the claimed invention.

Finally, the Federal Circuit upheld the district court’s denial of the accused infringer’s motion for JMOL of non-infringement on the two patents not presented at trial. The court held that Third Circuit law governed the procedural question of whether this denial was proper given that the patentee never put forward evidence of infringement nor obtained a formal dismissal of the claims. Applying the Third Circuit’s abuse of discretion standard, the court held that the district court had not abused its discretion. The court further relied on its own precedent, stating that a court is not required to render judgment on claims not raised in the pretrial statement nor litigated at trial, and that neither formal stipulation nor motion is required to remove claims from a case. In addition, the court noted that the district court’s analysis may have been different had the accused infringer filed a counterclaim or declaratory judgment of non-infringement as to those two patents.

A copy of the opinion can be found here.