W.M. Wrigley Jr. Co., v Cadbury Adams USA LLC (Fed. Cir. 2012).

http://caselaw.findlaw.com/us-federalcircuit/ 1604143.html

When is a disclosed genus sufficiently small to anticipate a claimed species? The test established by In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962) is that a genus (or a preferred subgenus) anticipates a species if one of ordinary skill in the art is able to “envisage” the claimed species within the disclosed genus (or subgenus). That test becomes trickier, however, when the claimed invention is a combination of species selected from two or more genus lists disclosed in a single reference. That was the challenge faced by the court in Wrigley.

Wrigley and Cadbury Adams each owned a patent claiming a chewing gum containing a combination of menthol and a coolant (WS-3 in the Cadbury patent, and WS-23 in the Wrigley patent). After Wrigley introduced its menthol/WS-23 gum prompted by Wrigley’s commercial success, Cadbury reformulated its gum to contain menthol and WS-23, leading to the present patentinfringement dispute. The district court granted Wrigley’s motion for summary judgment of noninfringement of Cadbury’s patent, and granted Cadbury’s summary judgment motion that the Wrigley patent was invalid on grounds of anticipation and obviousness.

The anticipating reference applied against the Wrigley patent was a patent to Shahidi (US 5,688,181) which discloses a variety of oral compositions, including chewing gum, whose novel components are a combination of xylitol and bisglycinate, but which could additionally contain ingredients selected from lists of cooling agents (of which WS-3 and WS-23 and one other were identified as particularly preferred); water-soluble fluoride agents, humectants, abrasive polishing materials, surfactants, antimicrobial agents, and flavoring agents (of which menthol was identified as among 23 other “most suitable” flavorants).

Wrigley argued that Shahidi was not anticipating for two reasons. First, although Shahidi discloses all of the ingredients in the claimed chewing-gum composition, it does not disclose them in the combination recited in the claim. Second, and related to the first, Shahidi would not have enabled a person of ordinary skill in the art to derive the claimed combination of ingredients, because undue experimentation would be required to select the claimed combination from among the thousands of ingredients in the several lists in Shahidi.

By a 2-1 panel majority, the Federal Circuit upheld the district court’s summary judgment ruling that the Wrigley patent is invalid as anticipated by Shahidi. This despite the fact that the combination of chewing gum, menthol and WS-23 was not contemplated in the Shahidi reference, and there was no preference or guidance in Shahidi for selecting these three components out of the thousands of possible combinations of ingredients from the several lists.

In her dissent, Judge Newman reminded the majority that, “in order to anticipate, the prior art must be such that a person of ordinary skill would ‘at once envisage’ the specific claimed composition”, and concluded “the purported anticipatory reference does not show this combination and does not present so short and selective a list of these ingredients as to warrant an inference that their combination was already known.”

The majority decision in Wrigley appears to back away from the holding in Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. 545 F. 3d 1312 (Fed Cir. 2008), where the court concluded that undue experimentation would be required to select a compound from one list of thousands of possibly therapeutic compounds and to select a given therapeutic indication from another list, in the absence of any guidance that would lead one in the art to associate the claimed compound with the claimed therapeutic indication.

It is tempting to think that the Wrigley case would have had a more satisfying outcome if the Shahidi reference had been considered for obviousness rather than for anticipation. The issue posed by Shahidi as a §102 reference is whether it enables the claimed combination, i.e., chewing gum, menthol, and WS-23. Wrigley’s arguments on this point amounted to little more than hand-waving, as seen above. Had Shahidi been applied as a §103 reference, Wrigley would have had the full arsenal of arguments for overcoming an obviousness rejection based on a combination of teachings (in this case, the combined teachings from three separate lists in a single reference). Those arguments could include: the reference fails to provide motivation to select the combination of chewing gum with a flavorant and cooling agent; it fails to provide motivation for selecting the combination of menthol and WS-23 as species of flavorants and cooling agents; there was no reasonable expectation that the combination of selected ingredients would produce a satisfactory chewing gum; the combination achieved an unexpected cooling effect; and the combination met with commercial success.