Reaffirming the two-way test for an interference-in-fact, the U.S. Court of Appeals for the Federal Circuit held that the standard for an interference between two patents, even in a district court § 291 proceedings, should mirror U.S. Patent and Trademark Office (USPTO) regulations. The Court vacated the district court’s priority determination to reconsider remanded proceedings and vacated the priority determination for failure to meet the jurisdictional limitation of interference-in-fact using the proper analysis. Medichem, S.A. v. Rolabo, S.L., Case Nos. 02-1461, 1480 (Fed. Cir. Dec. 23, 2003).
Medichem, S.A. (Medichem) and Rolabo, S.L. (Rolabo) are manufactures of Loratadine, the active antihistamine ingredient in Claritin®. Medichem appealed from a decision of no interference-in-fact under 35 U.S.C. § 291 between claimed inventions of Medichem’s U.S. Patent No. 6,084,100 (the `100 patent) and Rolabo’s 6,093,827 (the `827 patent). Both patents claim a process for the preparation of Loratadine. The claims in the `100 patent claimed the process in the presence of a tertiary amine. The claims in the `827 patent were silent as to this element, but were otherwise substantially the same. The lower court awarded priority to the `100 patent, but found the absence of a tertiary amine in the `827 patent claims to be not obvious over the `100 patent. Medichem appealed.
The Court held that the first step in any district court interference proceeding between two patents is the evaluation of whether an interference-in-fact exists. Establishing the existence of interference-in-fact between two patents is a jurisdictional limitation under § 291. Citing the recently decided case of Eli Lilly & Co. v. Bd of Regents of the Univ. of Wash., the Court reiterated that analyzing the existence of an interference-in-fact under the two-way test is a prerequisite for jurisdiction to make a priority determination. While the USPTO regulations do not bind a district court, the Court noted that a district court must nevertheless define the subject matter of an interference between two patents in the same manner as would the USPTO, which is to apply the two-way test. By USPTO regulation, the underlying analysis for the interference-in-fact inquiry is whether invention A is anticipated by (under § 102) or obviousness (under § 103) invention B, assuming invention B is prior art (step 1) and vice versa (step 2).
The Court held that, properly construed, the claims of the `827 patent could include additional steps, such as tertiary amines, because the claims use the transitional term "comprising." Based on this claim construction, the Federal Circuit reversed the district court, holding that the species claims of the `100 patent fell within the scope of, and, therefore, anticipated (under § 102), the genus claims of the `827 patent. However, because the lower court made no findings regarding the second leg of the test, i.e., whether invention B is anticipated by or obvious in view of invention A, the court remanded for further determination on whether the genus claims of the `827 patent anticipated or rendered obvious the species claims of the `100 patent.
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