TMEP 1301.01(b)(vi): Clinical Trials

This is the October 2015 Edition of the TMEP

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1301.01(b)(vi)    Clinical Trials

Because conducting clinical trials necessary for governmental approval of one’s own pharmaceuticals generally is a normally expected, routine, and legally required activity in connection with the sale of pharmaceuticals, it is not a separate registrable service done primarily for the benefit of others. Cf. In re Dr Pepper Co., 836 F.2d 508, 509, 5 USPQ2d 1207, 1208 (Fed. Cir. 1987) (“[I]t has become a settled principle that the rendering of a service which is normally ‘expected or routine’ in connection with the sale of one's own goods is not a registrable service whether denominated by the same or a different name from the trademark for its product.”); In re Landmark Commc’ns, Inc., 204 USPQ 692, 695 (TTAB 1979) (noting that “to be separately recognizable, as services, an applicant’s activity must be qualitatively different from anything necessarily done in connection with the sale of goods”).

Pharmaceutical companies are legally required to conduct clinical trials before pharmaceutical preparations can be approved for human use. See U.S. Food & Drug Admin., What is the Approval Process for a New Prescription Drug?, http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194949.htm (accessed Sept. 2, 2014); see also 21 C.F.R. §312.21 (explaining the three phases of clinical trials for a previously untested drug). An activity or process that is necessary or legally required for an applicant to be able to provide the main product or service is not separable from the main product or service. See In re Orion Research, Inc., 523 F.2d 1398, 1400, 187 USPQ 485, 486-87 (C.C.P.A. 1975) (holding a warranty to repair or replace one’s own merchandise to be a normally expected and legally required duty of a merchandiser and not a separate and registrable service); In re Television Digest, Inc., 169 USPQ 505, 508 (TTAB 1971) (noting that providing a schedule of advertising rates is necessary for publishing a directory or magazine and is not a separate service). Therefore, since conducting a clinical trial is a legally required prerequisite to pharmaceutical sales, when this service is conducted by a pharmaceutical company for its own goods, it is an expected and mandated activity not separately registrable from the principal activity of providing the pharmaceutical preparations themselves.

Accordingly, when registration is sought for a mark used in connection with the conducting of pharmaceutical clinical trials, the examining attorney must ascertain whether the services are provided for the pharmaceuticals of others. If the record is unclear, the examining attorney should request additional information, pursuant to 37 C.F.R. §2.61(b), to clarify whether the pharmaceutical clinical trials are registrable services as contemplated by the Trademark Act. See TMEP §814.