Laundry List of Formulations Fails to Satisfy § 112 for Broad Functional Claims

Judge Bryson, sitting in the District of Delaware invalidated four patents owned by Lipocine, Inc., finding that the patents did not meet the written description and enablement requirements of 35 U.S.C. § 112. Lipocine Inc. v. Clarus Therapeutics, Inc., No. 19-622 2021 (D. Del. 2021). Lipocine’s patents were directed to methods for treating men deficient in naturally produced testosterone and consisted of orally administering testosterone undecanoate (“TU”), measuring their resulting serum testosterone levels, and then adjusting the dosage level accordingly to achieve certain pharmacokinetic (“PK”) results.

The patents shared a lengthy common specification, which included a long list of excipients and examples of TU formulations. The court held that providing a list of excipients and formulations was insufficient to show that Lipocine completed the invention or had possession of the broad formulation claims.

Specifically, while the specification disclosed 49 exemplary formulations, it did not sufficiently disclose which formulations would produce the claimed PK results. The few examples for which data was provided supported the PK limitations for only a small subset of formulations covered by the broad claims. As Judge Bryson stated, “[s]imply presenting a ‘laundry list’ of compositions that might or might not satisfy the claims is not sufficient.”

The list of excipients was similarly insufficient, as many of the claims did not require the compositions to contain any particular excipients at all, and those that attempted to limit the excipients recited broad categories. The specification also failed to specify the nature or quantity of excipient needed, or if the excipient could be used with other unclaimed excipients to achieve a formulation that would satisfy the PK limitations. Ultimately, the invalidated patents could have covered any oral method using almost any formulation containing the broad dosage ranges if it produces the desired PK results.

This case is instructive for ANDA filers facing broad claims with functional limitations. Despite the lengthy specification disclosing numerous examples of excipients and formulations, failure to provide data showing which formulations would have produced the claimed PK values was fatal.  ANDA holders in such cases should carefully scrutinize the specification to determine whether a representative number of examples are supported by data demonstrating that the full scope of the claim is enabled.