By Donald Zuhn --
On October 26th, the Federal Circuit affirmed a District Court's finding on summary judgment that certain claims of U.S. Patent Nos. 6,593,318 (the '318 patent) and 6,593,320 (the '320 patent) were invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement.
The '318 and '320 patents are directed to stable flocculated suspensions of megestrol acetate (see below) and methods for making such suspensions. Seeking to design around a patent owned by Bristol-Myers Squibb (BMS) and directed to stable suspensions of megestrol acetate, Plaintiffs-Appellants Pharmaceutical Resources, Inc. and Par Pharmaceuticals, Inc. (Par) discovered that flocculated suspensions of megestrol acetate could be formed using a wider array of ingredients (i.e., surfactants and wetting agents) and concentrations than disclosed in the BMS patent (the BMS patent discloses only one stable flocculated megestrol acetate suspension). Par received a number of patents for its flocculated megestrol acetate suspensions, including the '318 and '320 patents.
Par brought suit against Defendant-Appellee Roxane Laboratories, Inc. (Roxane) in 2003, asserting that Roxane infringes certain claims of the '318 and '320 patents. Following the District Court's Markman order, Roxane moved for summary judgment of invalidity, arguing that the '318 and '320 patent were invalid for lack of enablement. The District Court granted Roxane's motion for summary judgment of invalidity, finding that "as a matter of law Par is not entitled to the broad claims it asserts in this action."
On appeal, the Federal Circuit determined that "[t]he scintilla of evidence put forward by Par to suggest that the claims are enabled, most of which actually conflicts with the intrinsic evidence in this case, does not raise a genuine issue of material fact." In particular, the Federal Circuit noted that both the '318 and '320 patents disclosed that "[t]he surfactants in a stable flocculated suspension need to be selected carefully and be used within a critical concentration range because even minor changes can have an effect on the properties of such a stable formulation." However, the Federal Circuit found that while Par's patents describe the unpredictability of flocculated megestrol acetate suspensions, the patents disclose only three working examples, utilizing only one surfactant not described in the BMS patent.
The Federal Circuit also noted that the extrinsic evidence supported a conclusion that the preparation of flocculated megestrol acetate suspensions is unpredictable. For example, "Dr. Chao, a named inventor of the '318 and '320 patents, testified that predictions could not be made regarding whether or not particular combinations of ingredients including megestrol acetate would form a stable flocculated compound, but rather, this required actual experimentation."
In rejecting Par's argument that its own experiments with megestrol acetate are sufficient to create a genuine issue of material fact regarding enablement, the Federal Circuit concluded that given the teachings in the patent about the criticality of the choice of surfactant and concentration:
the extraordinarily broad scope of the claims, which encompasses hundreds of surfactants, the high degree of unpredictability of the art, and the minimal guidance provided by the three working examples in the specification, the mere fact that Par's inventors were able to create successfully a stable flocculated megestrol acetate suspension with seven surfactants does not create a genuine issue of material fact regarding enablement.
Thus, the Federal Circuit determined that the asserted claims of the '318 and '320 patents were invalid under 35 U.S.C. § 112, first paragraph, for lack of enablement.
Pharmaceutical Res., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2007)
Nonprecedential disposition
Panel: Chief Judge Michel, Circuit Judge Moore, and District Judge Cote
Opinion by Circuit Judge MooreAdditional information regarding this case can be found at the Orange Book Blog and Patently-O.
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