Issue 173 | March 19, 2004
Medichem, S.A., v. Rolabo, S.L.

In Medichem, S.A., v. Rolabo, S.L., No. 02-1461-1480 (Fed. Cir. December 23, 2003), the federal circuit vacated a district court's priority determination (based on an erroneous application of the two-way test for determining an interference-in-fact), reversed the judgment that Rolabo's '827 patent was neither anticipated nor obvious in light of the Medichem's '100 patent, and remanded the case for further proceedings.

Both the '100 patent and the '827 patents relate to processes for the preparation of loratadine, which is the active ingredient of Claritin. Claim 1 of '100 patent recited a process consisting of reacting, in an organic solvent and in the presence of a tertiary amine, 8-chloro-5,6-dihydrobenzo[5,6]cyclohepta[1,2-b]pyridine-11-one of formula VII with a low-valent titanium species. Claim 1 of '827 patent recited a process comprising reacting a dibenzosuberone or an aza derivative thereof with an aliphatic ketone in the presence of low valent titanium wherein the low valent titanium is generated by zinc. In applying the first prong of the two-way test for interferences, the district court held that the '827 patent would not have been obvious in view of the '100 patent because the inclusion of a tertiary amine would have resulted in a materially different process. The district court also said that it would not have been obvious to remove the tertiary amine from the process of the '100 patent.

On appeal, Medichem argued the term “comprising” was open-ended and that, as a result, the absence of a tertiary amine in Rolabo's claims was irrelevant. That is, Rolabo's claims encompassed not only any improved processes for the manufacture of loratadine that did not include tertiary amines, but also, because of the open-ended transition term, processes like Medichem's that did include tertiary amines. The Federal Circuit agreed, and held that the district court erred in interpreting Claim 1 of the '827 patent to exclude tertiary amines and that the term "comprising" in a method claim was open-ended and allowed for additional steps. The federal circuit reasoned that the process described in the '827 patent included not only those steps listed in the claim, but also any additional steps that may be added. The addition of a tertiary amine to the process described in the '827 patent was described as a “undisputable possibility” demonstrated by both the '100 patent and Rolabo's concession at oral argument.

Reversing the district court finding that the first leg of the two-way test for interferences was not satisfied, the federal circuit held that, when construed properly, claims 1 and 2 of the '100 patent plainly anticipated claims 1 and 17 of the '827 patent when the '100 patent is the assumed to be prior art under the two-way test. The federal circuit remanded the second leg of the two-way test for further findings on anticipation and obviousness.

Finally, the federal circuit vacated the district court's finding of priority for lack of jurisdiction, because it was made before determining whether an interference-in-fact actually existed.

To view the full decision visit http://www.aplf.org/mailer/Issue173.doc

To discuss this topic further, please feel free to contact the author Michael R. Dzwonczyk, (mdzwonczyk@sughrue.com), at Sughrue Mion, PLLC in Washington DC., USA.

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