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Published online by Cambridge University Press: 20 January 2017
In U.S. patent cases, a factor for demonstrating that an invention is non–obvious is the commercial success of the product embodying that invention. There must also be a nexus or connection between the patented characteristics of the claimed product and its commercial success. One may presume that a nexus exists if the characteristics of a product that is shown to have commercial success are covered by the patent claims at issue. In Europe, “commercial success alone is not to be regarded as indicative of inventive step. The following requirements must first be met: a long–felt need must have been fulfilled, and the commercial success must derive from the technical features of the invention and not fro mother influences (e.g. selling techniques or advertising).” Based on my understanding of U.S. and European patent law relevant to the issue of commercial success, this paper addresses some of the economic issues and associated data to consider in assessing whether a patented pharmaceutical product is a commercial success.
1 If the invention embodied in the patent at issue is obvious, then other sellers would have previously launched products embodying the associated technology. The product covered by the patent would not be successful. Alternatively, if the product covered by the patent is successful and the nexus exists, then the associated technology is presumed to be non-obvious. The patent is valid.
2 “Section 10.5 Commercial Success,” Case Law of the Boards of Appeals of the European Patent Office, available at http://www.epo.org/law-pracrice/legaltexts/html/caselaw/…/cir_i_d_10_5.htm.
3 Acquiring the information about the disease may involve interviews with physicians, review of the medical literature, and searching websites of government agencies (e.g., U.S. Centers for Disease Control and Prevention, National Institutes of Health, or World Health Organization) and disease groups (e.g., American Cancer Society).
4 Interviews with physicians and scientists working on treatments for the disease are usually helpful.
5 These alternative treatments may not exist for every disease. In the U.S., physicians may prescribe a pharmaceutical product for uses not approved by the FDA. This practice is referred to as offlabel usage. Among treatment options include pharmaceutical products used off-label for the disease.
6 IMS is a commercial data service that pharmaceutical companies routinely rely on when making business decisions. IMS reports data on dollar sales, total prescriptions, and new prescriptions. The 13 channels typically tracked by IMS are: chain stores, clinics, federal facilities, food stores, HMO, home health care, independent, long-term care, miscellaneous (other), prisons, universities, mail order, and non–federal hospitals. IMS collects data for the United States using a sampling methodology. IMS data reflect some of the discounts negotiated between manufacturers and third party payers. There are certain price discounts that are not measured by IMS; however, overstating prices and sales for specific products does not usually affect making relative comparisons for a product across time or comparisons among products.
7 “Section 10.5 Commercial Success,” Case Law of the Boards of Appeals of the European Patent Office, available at http://www.epo.org/law-pracrice/legaltexts/html/caselaw/…/cir_i_d_10_5.htm.
8 Part 202-Prescription Drug Advertising, § 202.1 Prescription-drug advertisements, 21 CFR Ch. 1 (4-1-06 Edition), p. 92.
9 The category ePromotions measures the number of invitations distributed to physicians for web tutorials provided by a pharmaceutical manufacturer related to a product.
10 Addressing European requirements in this area is beyond the scope of this paper.