Janssen Pharms., Inc. v. Tolmar, Inc.

Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 834762 (D. Del. Feb. 26, 2024) (Bryson, J.) 

Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone extended-release suspension); U.S. Patent No. 9,439,906 (“the ’906 patent”)

Nature of the Case and Issue(s) Presented: Janssen developed its injectable schizophrenia treatment drug product in response to problems associated with oral administration of antipsychotic drugs. The court’s opinion detailed Janssen’s development efforts, including clinical trial failures leading to the ’906 patent’s inventor developing a complex population pharmacokinetics model to analyze individual patient data. Those studies revealed two important factors that appeared to contribute to the clinical trial failures: (i) body weight affected efficacy, and (ii) injection site (gluteal versus deltoid) affected efficacy. These studies influenced Janssen’s dosing regimen; the ’906 patent claims that dosing regimen.

Tolmar filed an ANDA, which included a paragraph IV certification to the ’906 patent, referencing Janssen’s Invega Sustenna. Janssen filed a complaint alleging infringement of the ’906 patent under 35 U.S.C. § 271(e)(2)(A). Going into the bench trial, the parties stipulated to infringement issues (some infringement, some non-infringement). The parties tried validity to the court. Tolmar argued that the ’906 patent was invalid for three reasons: Section 103 obviousness; Section 112 lack of written description; and Section 112 non-enablement. The court found that Tolmar failed to prove each of its validity challenges.

Why Janssen Prevailed: Obviousness: The court determined that Tolmar’s main prior art reference was, in fact, not prior art. First, Tolmar did not prove that the ’906 patent was not entitled to claim priority to its provisional application (Tolmar bore this burden because the Patent Office had already determined that the provisional application supported the claims). Second, Tolmar did not prove that the main reference—a poster—was actually published. Evidence suggested that a conference intended to display the poster. But no direct evidence confirmed that the conference did in fact display it. The court then determined that Tolmar’s remaining references did not invalidate the ’906 claims, and, importantly, secondary considerations reinforced non-obviousness (i.e. unexpected results and commercial success).

Lack of Written Description. Tolmar took issue with the claimed “a month + 7 days” dosage interval, arguing that the written description did not provide for plus-or-minus 7 days or otherwise describe the claimed dosing interval. The court noted that “[t]he claims Tolmar seeks to invalidate for lack of written description are exactly the types of claims that justify not requiring disclosure of every embodiment.” Thus, Tolmar’s written description arguments failed.

Non-enablement. Finally, Tolmar argued that the dosing interval claim limitations were not enabled. The court determined that a skilled artisan would know how to administer intramuscular injections. And to do so within a certain date range would also be within a skilled artisan’s knowledge. The court also determined that Tolmar’s arguments were flawed because they “incorrectly assume that enablement requires disclosure of how to achieve a desirable result using the invention. Enablement requires only that the specification impart to a person of skill in the art the ability to practice ‘the invention as defined by its claims.’” Tolmar’s third and final validity challenge failed.