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Legal Insights and Perspectives for the Healthcare Industry

Proposed reforms to patent subject matter eligibility in the United States are once again making headlines. With advancements in medical device technologies and the increasing integration of software, patent eligibility considerations implicate a growing realm of medical devices. In a recent LawFlash, we address a draft bill in the US Congress that could broaden the range of patent eligible subject matter with implications for stronger commercialization of medical device technologies in the United States. We also discuss two recent letters to the US Senate that crystalize the growing debate over expanding patent eligibility with possible effects on medical device innovation, affordability, and availability.

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On a fourth go-around, the Trump administration has issued another set of proposed tariffs on an additional $300 billion of goods related to China, this time adding a range of commercial goods across industries. With respect to healthcare products, this round affects medical devices and their components, certain chemicals and precursors that can be used in pharmaceuticals and dietary supplements, and other FDA-regulated products. The administration continues to try to use tariffs as a means of balancing the trade deficit with China and to bring the Chinese government to the negotiating table on a longstanding set of issues related to intellectual property (IP), cyber, and technology transfer. There are two steps to the tariff process: