Revitalizing the Patent System to Incentivize Pharmaceutical Innovation: The Potential of Claims with Means-Plus-Function Clauses
Tang, Wanli, Duke Law Journal
The pharmaceutical industry relies on innovation. However, many innovative firms are cutting their research and development investments and seeing their new product pipelines dry up, due in part to a lack of sufficient patent protection. This Note identifies two major factors that have caused this inadequacy in patent protection. First, pharmaceutical patents are challenged early and often by generic manufacturers, as encouraged by the 1984 Hatch-Waxman Act. Second, the scope of pharmaceutical-patents is sometimes unduly restrained due to limited application of the doctrine of equivalents. Consequently, pharmaceutical patents, especially drug-product patents, are easily designed around and cannot offer the protection necessary for innovative firms to recoup their developmental costs.
This Note argues for a wider application of means-plus-function clauses in pharmaceutical patents as a potential cure for this problem. Means-plus-function claims, although authorized by Congress in the 1952 Patent Act, have not been explored much in the pharmaceutical context. This Note argues that this claiming strategy is not only appropriate but also particularly effective for pharmaceutical patents. Means-plus-function claims would give drug-product patents adequate scope even with the limited use of the doctrine of equivalents and thus would provide the protection necessary for innovative firms to withstand frequent attacks by generic manufacturers. Finally, this Note examines issues anticipated with applying means-plus-function claims to pharmaceutical patents and proposes possible solutions.
The United States Constitution endows Congress with the authority to grant inventors time-limited, exclusive rights "[t]o promote the Progress of Science and useful Arts." (1) Pursuant to this authority, Congress established the patent system to give inventors temporary rights to exclude others from making, using, or selling their inventions or importing them into the United States. (2) These exclusive rights allow inventors to profit from their ideas, thus providing strong financial incentives for innovation. (3)
Traditionally, the patent system has been considered successful in promoting innovation in the pharmaceutical industry. (4) Currently, however, a number of branded pharmaceutical companies face the daunting reality of losing patent coverage on their most lucrative drugs, creating what is known as the "patent cliff" phenomenon. (5) To be sure, the expiration of such drug patents and the subsequent market entry of generic versions of branded drugs means significant savings for consumers. (6) This phenomenon, however, also raises concern for the future of new drug development. In the past few years, loss of patent protection has caused sales revenue for innovative firms to plummet, compelling them to restructure to survive financially. (7) As a part of this restructuring, many firms have heavily cut their investments in research and development (R&D) for new products. (8)
Widespread reduction in R&D investment is particularly alarming because the pharmaceutical industry is very research intensive and heavily depends on product innovation. (9) Over the years, developing a new drug has become increasingly expensive, time-consuming, and risky. (10) On average, developing a new medicine and securing Food and Drug Administration (FDA) approval requires screening between five and ten thousand compounds. (11) This process takes on average ten to fifteen years and costs $1.3 billion. (12) Indeed, with shrinking R&D investment and increasingly costly drug development, a number of branded pharmaceutical firms have experienced a drying up of their new-product pipelines in the past decade, (13) indicating an industry-wide decrease in innovative activities. Because the development of new health-improving or even life-saving drugs relies on pharmaceutical innovation, the potential social loss is difficult to estimate. …