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The New 'Material Effect' Test

By Otis Littlefield
October 02, 2003

In Bayer AG v. Schein Pharm., Inc., 301 F.3d 1306 (Fed. Cir. 2002), the Federal Circuit articulated a new 'material effect' test for the best mode requirement. The court affirmed the validity of a patent covering the antibiotic drug ciprofloxacin on the grounds that it properly claimed priority to a parent application that satisfied the best mode requirement. With the priority date of the parent application, the patent was not invalidated under section 102(d) by an earlier filed foreign patent. The three-judge panel agreed that the parent application met the best mode requirement; however, the panel disagreed as to why the best mode requirement was satisfied. The majority reviewed the prior case law and found 'that the best mode of making and using the invention need be disclosed if it materially affects the properties of the claimed invention.' Id. at 1319-1320. Judge Radar concurred in the result, but strenuously objected to the creation of this additional criterion.

Majority Opinion

The majority began its analysis by examining the scope of the best mode requirement. The analysis began with a review of In re Brebner, 455 F.2d 1402 (C.C.P.A. 1972), wherein the Court of Customs and Patent Appeals held that the method of making two polymers was not within the scope of the best mode because the invention was the blend of the two polymers, not the starting materials. After reviewing the intervening case law, the Bayer majority noted that the scope of the best mode requirement is determined by the scope of the claims. However, the majority then reviewed those cases where the Federal Circuit held patents invalid for failing to disclose the best mode. Four of the seven cases issued during the late 1980s and early 1990s. During this period, the Federal Circuit had the broadest interpretation for the best mode requirement, extending beyond the scope of the claimed invention. In Northern Telecom, Inc. v. Datapoint Corp., 908 F.2d 931 (Fed. Cir. 1990), for example, the Court found that the patent at issue was invalid for failing to disclose the inventor's preferred audio cassette for use in the claimed invention, even though the claims covered only the device and not the audio cassette. In Bayer, however, the majority held that, in order to satisfy the best mode requirement, an inventor's preferred mode must be disclosed if it materially affects the properties of the claimed invention. This includes preferred modes outside the scope of the claims. Applying this standard, the Court ultimately found that the best mode was satisfied because the inventor's preferred mode did not affect the properties of the claimed invention.

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