The fact that the claims encompass many variables and parameters does not by itself require undue experimentation. Adjusting variables may be relevant to optimizing a given implementation, but optimization may not be required in order to practice the claimed invention unless specifically recited.
Background / Facts: The patents being asserted here in response to a generic drug ANDA submission are directed to methods for enhancing the stability of prostaglandin compositions, including the patentee’s glaucoma and ocular hypertension drug Travatan Z®. The claimed methods comprise only a single step, “adding a chemically-stabilizing amount of a polyethoxylated castor oil [(‘PECO’)]” to a prostaglandin composition. The patents disclose exemplary compositions of this type, detail how these example compositions are prepared from commercially-available ingredients, and provide step-by-step procedures for adding PECO to a prostaglandin composition in a way that embodies the claimed invention.
Issue(s): Whether the claims nevertheless lack enablement because they encompass many variables and parameters that may affect the chemical stability of prostaglandins in ophthalmic formulations.
Holding(s): No. “The claims as a whole merely require that the addition of PECO to the composition provide some increase in chemical stability, but do not require a particular level of stability or a particular magnitude of increase.” No evidence was presented “that changing any of the ‘variables’ or ‘[v]arious parameters’ identified by the district court would render [the] claimed invention inoperable, nor was there any evidence that experimenting with those variables was required for an ordinarily skilled artisan to be capable of increasing the chemical stability of a prostaglandin by adding PECO. Adjusting variables may be relevant to optimizing the stability of a given prostaglandin composition, but … no evidence [was proffered] that any experimentation, let alone undue experimentation, with those variables would be necessary in order to practice the claimed invention.” Furthermore, the court emphasized that “a patent does not need to guarantee that the invention works for a claim to be enabled. It is well settled that an invention may be patented before it is actually reduced to practice. … Similarly, a patentee is not required to provide actual working examples; we have rejected enablement challenges based on the theory that there can be no guarantee that prophetic examples actually work.”