1. Protecting Pharmaceuticals at the Intersection of Patent and Regulatory Law

    Posted on 14.03.18 John Wizeman, on Articles, Biotech/Pharma, Recent News & Articles

    Over three decades ago, the United States Congress passed the Drug Price Competition and Patent Term Restoration Act[1]. This piece of legislation, known as the Hatch-Waxman Act, tackled the difficult task of protecting pharmaceutical innovator intellectual property while ultimately providing increased competition and decreased cost to consumers through accessible generic drugs. This legislative task was accomplished with two pieces of intersecting laws:  (i) the patent provisions under 35 USC which provide for up to five additional years of patent term extension and (ii) the drug exclusivity provisions under 21 USC 355 which provide certain regulatory and marketing exclusivity periods upon drug approval.  The intersection of these patent and regulatory/marketing exclusivity periods provide innovator drug developers with a net exclusivity period. Given the immense monetary and time investment for developing new drugs, maximizing this net exclusivity should be a major focus of patent practitioners in the pharmaceutical field. By maximizing this net exclusivity, innovator drug developers can recoup their investment, as well as provide a stable foundation and incentive for continued drug discovery. To understand how to maximize this window, those involved need to understand the important role this intersection of patent and regulatory law holds.

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  2. Diagnosing Patent Subject Matter Eligibility

    Posted on 14.12.17 John Wizeman, on Articles, Patent Related Court Rulings, Patent Trends & Activity

    Clarity on patent subject matter eligibility is still being sought five years after Mayo[1] and three years after Alice[2]. Further adding to the confusion is the fact that discoveries in diagnostics, despite their apparent importance to the biomedical sciences, have been repeatedly determined as ineligible subject matter under 35 USC § 101. The two step Alice/Mayo test has increased the percentage of invalid patents, and the decision by the Supreme Court to deny certiorari in the case of Ariosa vs. Sequenom[3] in 2016 means we are unlikely to see a reversal of this trend in the near future. Inventors are still finding it challenging to implement the current guidelines toward a successful diagnostics patent grant.  In this piece we provide perspective from a 2016 Federal Circuit decision that provides some over-looked hints for moving forward with inventions relating to diagnostics.

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