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An Innovative Ecosystem for Medicines: Effective Patent Reform
An innovative pharmaceutical ecosystem makes possible the discovery of new life-saving medicines that benefit patients around the world. Policy makers are charged with creating balanced healthcare systems that ensure access to pioneering medicines and lowering the cost of medicines through the availability of generic drugs. The key to stimulating pharmaceutical innovation while facilitating access to lower cost pharmaceuticals is closely connected to the protection and enforcement of intellectual property rights.
The innovative industry is made possible by the protection of intellectual property- specifically patents. Patents are a key incentive for the pioneer industry to allocate scarce resources in costly and time-consuming research and development (R&D). Coupled with exclusive marketing rights, patent rights allow pioneers to recoup the costs which average about $1 billion to develop the drug and obtain the marketing approval to provide the medicine to patients. The mechanisms for implementing an effective patent enforcement system can vary; but the common characteristics of functioning systems include:
In the United States, a “patent linkage” system created by the Hatch-Waxman Act in 1984 provides a mechanism which encourages the early introduction of generic products without comprising the patent system. The pioneer retains the ability to enforce patents against an infringer and generics companies the ability to challenge patents to seek early access. The patent linkage system and the marketing exclusivities provided under the Hatch-Waxman Act have resulted in the United States having the largest and the strongest pharmaceutical industries in the world in terms of innovation and access to generic drugs.
At the same time, due to the balance achieved by the Hatch-Waxman Act,
This paper examines patent enforcement systems and mechanisms adopted by several countries, including the United States, Canada, and South Korea with a particular emphasis on the modern day U.S. patent linkage system and its impact on the innovative pharmaceutical ecosystem. Countries with effective patent enforcement systems and mechanisms have the foundations in place to support innovative and generic industries. The paper reviews U.S. history on patent linkage, clear rules of engagement; timely resolution of patent challenges through the court system, and the effectiveness of patent linkage through a review of the data from January 2010 to January 2016.