Therapeutic value is not the only consideration.
Holman et al. 18 , Christopher M. Holman is a Professor of Law at the University of Missouri-Kansas City School of Law and the Executive Editor of Biotechnology Law Report. Timo Minssen, LLD, LLM, MICL, is a Professor of Law and Director and Founder of the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), at the University of Copenhagen in Denmark. Eric Solovy, BA, JD, is a Partner in International Trade and Dispute Resolution at Sidley Austin LLP in Washington, DC. From 2001–2002, Mr. Solovy served as law clerk to the Honorable Pauline Newman, Circuit Judge, U.S. Court of Appeals for the Federal Circuit. (Christopher M., Timo Minssen, and Eric M. Solovy, 2018, “Patentability Standards for Follow-On Pharmaceutical Innovation,” Biotechnology Law Review, https://www.liebertpub.com/doi/pdf/10.1089/blr.2018.29073.cmh)
1.2. Improvement should not be viewed solely in terms of therapeutic properties Some of the critics of follow-on patents suggest that inventions that do not directly improve the therapeutic properties of a chemical compound are unworthy of patent protection. But to the contrary, improvements that do not directly improve therapeutic effect can nonetheless provide substantial benefits to patients. For example, with respect to patents on new salt forms of a chemical compound, the Guidelines paper itself acknowledges ‘‘[t]he choice of a salt for a particular drug is important in obtaining certain desirable characteristics related to stability, bioavailability, manufacturability and route of administration to the patient.’’37 Inexplicably, however, the Guidelines recommend against the patentability of a new salt form in spite of these advantages.38 It would be a mistake to disregard these nontherapeutic values in an assessment of obviousness or utility. As noted by the Federal Circuit’s Judge Lourie, it would not be sound policy to require an improvement in therapeutic properties over the prior art as a requirement of patentability, and to negate the importance of other physical properties of a claimed compound or salt.39 Oftentimes, the benefits of a particular salt form reside not in therapeutic effect but in other properties that nonetheless contribute substantial value to the product and, ultimately, patients.40