Judge Sweet Holds “Transmucosal” Delivery Does Not Require Mucosal Membrane Absorption
On January 22, 2019, Judge Robert W. Sweet (S.D.N.Y.) issued a claim construction opinion in Ferring B.V. v. Serenity Pharm., LLC following a Markman hearing. Plaintiffs Ferring (“Ferring”) moved for claim construction of disputed preamble claim terms in U.S. Patent Nos. 7,405,203 (the “’203 Patent”) and 7,579,321 (the “’321 Patent”), two patents owned by Defendants Serenity (“Serenity”).
The parties dispute the meaning of the shared claim preamble from claims 1 and 19 of the ‘321 Patent. Among the disputed terms are the term “transmucosal” and the phrase “a dose of desmopressin sufficient to achieve a maximum desmopressin plasma/ serum concentration no greater than [various concentrations]”, or slight variations thereof, in the ‘203 and ‘321 Patents.
The shared preamble lists two aims of the invention claimed in the ‘321 Patent, while the bodies of claims 1 and 19 disclose the dosages of desmopressin. Serenity contends that the preamble should be given its plain and ordinary meaning, but Ferring proposes a limitation on the dose of the desmopressin into the preamble. The Court sided with Serenity, holding that the shared preamble is a “statement of purpose” to “limit and more narrowly teach” the dosage language in claims 1 and 19.
On the term “transmucosal” in several of the claims in the ‘203 and ‘321 Patents, the Court also adopted Serenity’s proposed construction of “delivering desmopressin by way of a mucosal tissue, such as the sublingual mucosa.” Ferring proposes to add the limitation of “absor[ption] across the mucosal membrane.” In construing the term without Ferring’s absorption limitation, the Court observed that the shared specification of both patents mentioned “sublingual mucosa” as only an example of “transmucosal.” Therefore, absorption is not necessary and unsupported by the shared specification.
As with the shared preamble, Serenity proposes that the phrase “a dose of desmopressin sufficient to achieve a maximum desmopressin plasma/ serum concentration no greater than [various concentrations]”, or slight variations thereof, be given its plain and ordinary meaning. Ferring proposes adding a dose range. The Court, in siding with Serenity, noted that the dose range is not mentioned in the language of the claims themselves, and observed that the references to dose or dose range in the specification do not create a claim limitation, as “the Federal Circuit has ‘repeatedly warned against confining claims to these embodiments.’” In addition, Ferring’s proposed construction is unsupported by the prosecution history of the patents, where the inventor broadened the claims by removing dose-specific language during claim amendment and the patent examiner’s Notice of Allowance also distinguished the ‘203 Patent over prior art on the basis of the recited blood/plasma concentration (Cmax) and noted the linear relationship between desmopressin dosage and Cmax.
The case is Ferring B.V. v. Serenity Pharm., LLC, No. 1:17-cv-00992-RWS (S.D.N.Y. Jan. 22, 2019).