US Supreme Court Adopts International Exhaustion Of Patents (Part II): Addressing the New Competitive Landscape
Frederick M. Abbott writes: The US Supreme Court has created a new competitive landscape with its decision adopting international exhaustion of patents. For the pharmaceutical sector, we can expect an initial period of uncertainty as the US Food and Drug Administration (FDA) assesses the regulatory framework affected by the decision and as competing stakeholders advance their interests. In an earlier Inside Views contribution, I addressed the principal impact of the decision on the US pharmaceuticals market: downward pricing pressure.[1] This follow-on addresses some of the regulatory and access issues affected by the decision, observing that parallel trade in pharmaceutical products is a long-standing practice, that recently introduced US legislative proposals may shape the regulatory framework in the United States, and concluding with ways that access programs in favor of developing countries are protected.










