Even skeptics agree pharma patents are necessary due to high R&D costs and the ease of replicability.

It is generally recognized that most pharmaceutical innovation depends uniquely and critically upon the availability of effective patent protection.1 Even economists such as Bessen and Meurer, who are otherwise skeptical that benefits outweigh the costs of the patent system, explicitly acknowledge that pharmaceutical innovation is a special case where the benefits of patent protection likely outweigh the costs.2 The underlying basis for the particular importance of patents to pharmaceuticals is, in addition to the expense and riskiness that comes with developing new drugs in the laboratory, the extremely high cost and length of time involved in subsequently bringing that nascent drug out of the laboratory and transforming it into a safe, effective, and well-characterized human therapeutic. Even then, the innovator must conduct the extensive human clinical trials required to achieve marketing approval from a regulatory authority (e.g., the U.S. Food and Drug Administration [FDA] and its European counterpart, the European Medicines Agency [EMA]). Patents on pharmaceuticals are also particularly important due to the relative ease with which, in the absence of patent protection or some other form of exclusivity, a generic competitor can bring a bioequivalent product to market once the innovator has secured regulatory approval and established a demand for the product.