On January 7, 2020, in Amgen Inc. v. Amneal Pharmaceuticals, the CAFC decided that the open ended term “comprising” controlled, even when the narrower “consisting of” Markush phrase is used subsequently. In other words, so long as the narrower phrase is met independently, when a claim recites “comprising” after the preamble, it is possible for more than one other component of the same subtype to be present as well.
In the case at hand, the claim was directed to:
A pharmaceutical composition comprising:
. . .
(c) from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and
(d) from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovid[o]ne, sodium starch glycolate, croscarmellose sodium, and mixtures thereof,
The issue was raised whether the fact that an accused product contained binders and/or disintegrants that were not specified in c) or d), took the composition outside the claim scope. The court’s answer was NO.
In other words, if an accused composition had a specified binder and disintegrant within the specified weight range, the claim still permitted the presence of other binders and disintegrants. “Without more,” the court concluded,
“such language is satisfied when an accused product contains a component that is from the Markush group and that meets the limitation’s requirements for the component. It does not forbid infringement of the claim if an additional component is present and functionally similar to the component identified in the Markush group limitation, unless there is a further basis in the claim language or other intrinsic evidence for precluding the presence of such additional components.”