Every innovative pharma company faces the same challenge, how to delay the patent cliff. The existence of the “skinny viii” (21 U.S.C. § 355(j)(2)(A)(viii)) makes developing additional FDA approved indications unattractive from an LCM viewpoint. Such additional indications may allow for market expansion during the life of the patents protecting the original indication but offer no protection once those patents have expired. With a skinny viii the generic seeks approval only for indication with the earliest patent expiration. Formulation patents often provide scant protection because of the possibility of design arounds and being more easily challenged for invalidity since often the original patents are available as prior art.
However, a fertile area for additional patent protection are developments made during the clinical trial period and later where new inventions may be made which the generics cannot avoid identifying on their label. Examples of such inventions include special dosing for patient sub-populations (Vanda Pharm., Inc. v. W-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018)), patient selection inventions (Sanofi-Aventis U.S., LLC v. Watson Labs. Inc. 875 F.3d 636 (Fed. Cir. 2017); drug Multaq), the discovery of reduced adverse events as compared with the prior art treatments (it is necessary to craft claims which avoid the inherency invalidity defense). In some cases, the developments may occur even post-approval. (Cumberland Pharm. Inc. v. Mylan Institutional LLC, 846 F.3d 1213, (Fed. Cir., 2017)).
An area often overlooked for LCM opportunities are the results of clinical trials where a large number of drug effects are measured, such as metabolic profile, incidents of sexual dysfunction, seizures, drug interactions, and the like. A drug which exhibits a lack of or reduced adverse metabolic effects, such not adversely impacting lipid levels may offer opportunities for LCM. If the such results are not expected for the drug, such as where existing drugs cause the adverse event to a greater degree than in people not taking the drug, one may be able to draft claims to take advantage of the reduced adverse event. For such patent claims to be effective it is necessary that the advantage be set forth in the label. This requires that the regulatory and IP groups work together with the clinical trial group. Vanda teaches in 35 U.S.C. 271(e)(2) litigation the label alone may be sufficient to prove inducement by the generic company whose label must be identical to the brand label (21 U.S.C. § 355(j)(2)(A)(v) and 21 C.F.R. § 314.94(a)(8)(iv)).
By looking to developments during the clinical testing phase and later it may be possible to obtain patents expiring a decade or more after the basic patent. In the case of Multaq, the NCE expired in 2014, the formulation patent in 2019, but the patient selection patent (U.S.P. 8,410,167) does not expire until 2029, the first date the FDA may approve a generic equivalent.
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