The most interesting part of this decision by the Fed. Cir. (No. 24- 1061, Aug. 13, 2024) is that the court was faced with an argument by Sun that Allergan’s claims in U.S. Pat. No.11,311,516 et al. are invalid as failing to meet the WDR of § 112. Sun argued that the claims of certain of Allergan’s patent thicket were invalid because the specifications did not support a pharmaceutical composition containing the drug eluxadoline with a number of inert ingredients that did not include a “glidant.” In other words, Sun argued that there was no support for the absence of a glidant in any of the patent claims, a component Sun was apparently using in its compositions.Claim 1 of the ‘179 patent reads as follows:
[A pharmaceutical] tablet comprising:
– About 75 mg of [the active]
– About 60-80% by weight silicified microcrystalline cellulose;
– Crospovidone;
– About 5-15% by weight mannitol; and
– Optionally, a glidant and/or lubricant.
Sun had a tough row to hoe for a number of reasons. The fact that the claims-in-suite did not recite a broad genus containing millions of compounds and the presence or absence of “blaze marks” that would lead the POSA to the claimed species was irrelevant. In fact, the court called the claims “picture claims” and no patent attorney likes to hear their claims described that way since they are usually easy to avoid. The court noted that “the written description generally matches the scope of the claims….and each of the expressly recited ingredients and its recited amount, is adequately disclosed in the specification.
It seems like the inquiry could end here, especially since Claim 1 recites a glidant or a lubricant as optional ingredients, and Allegan used a SiO2 glidant in at least Claim 1 of the ‘179 patent. But Judge Lourie posits a question: “The issue is whether the inventors had possession of a formulation that lacked a component that is not claimed or only optional.” The court then examines the use of “optional” as describing “only two options, present or absent.” The court went on to find that the specification describes two embodiments in which a glidant is not required. One is where the specification recites a composition comprising the active and an inert ingredient selected from a list of nine adjuvants including silicon dioxide – a glidant. The other situation is a disclosure that the composition consists of the active and an inert ingredient selected from five adjuvants including SiO2. The court found that these compositions must contain the active and at least one of the listed adjuvants and that one could be other than SiO2, the glidant; stated otherwise, the compositions contemplate a formulation in which a glidant is optional.
One takeaway from this decision is that little words like “a,” “an,” or “and” at least mean “one or more.” Also, a “consisting of” claim can still give you room to move—if handled with care.
