“[T]he mere potential need for clinical work, without more, is not dispositive.” This opinion gives a great recap of the law surrounding undue experimentation and would be a good one to consult if the issue ever arises.
Background / Facts: The patents here relate to methods of administering a tablet (or other dosage form) that includes effervescent agents used as penetration enhancers, which influence drug absorption across the mucous membrane lining or mucosa in the oral cavity. The claims recite the use of at least one effervescent “agent” in an amount sufficient to increase absorption. The district court construed effervescent “agent” to mean “at least one compound” that evolves gas, but the specification only describes an effervescent “couple” (i.e., a pair of compounds) generating the claimed effervescent reaction, where the soluble acid source and the effervescent agent (carbonate source) are in the same tablet or other dosage form. This “single compound effervescent agent” construction requires the soluble acid source to be in a separate tablet or dosage form from the effervescent agent. In addition, in order to achieve the claimed effervescent reaction, this construction requires these separate dosage forms to be co-administered.
Issue(s): Whether the asserted patents are invalid for lacking enabling disclosures illustrating a dosage form having only the single compound effervescent agent.
Holding(s): No. “The district court’s emphasis on the mere fact that experimentation may be necessary is misplaced. … [T]he fact that a clinician’s involvement may be necessary to determine effective amounts of the single compound effervescent agent and its corresponding soluble acid source does not itself constitute undue experimentation. … In addition, extensive experimentation does not necessarily render the experiments unduly extensive where the experiments involve repetition of known or commonly used techniques.”