1. Hold the Mayo: Guide to a Healthy Patent Application

    Posted on 24.08.18 John Wizeman, on Patent Related Court Rulings, Patent Trends & Activity, Recent News & Articles

    Back in April, the Court of Appeals for the Federal Circuit (CAFC) handed down a split decision that breathes life into an otherwise suffocating Mayo/Alice world.  This case, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd. has been contrasted and compared to the Supreme Court’s original Mayo finding, since both Mayo and Vanda related to drug dosing and involved a law of nature. However, the comparison ends there, as the underlying patent in Vanda was deemed subject matter eligible, whereas the patent in Mayo was not. The Mayo decision, in conjunction with the Alice decision of course, led to the creation of the current two-step patent eligibility test that has proven difficult to consistently apply. Three key differences likely led to the divergence between the Vanda and Mayo decisions:  (i) the focus of the innovation, (ii) the actual method steps recited, and (iii) the clarity in presenting the result of the application of the method. Furthermore, the USPTO recently issued a guidance memorandum analyzing the decision.

    Read Full
  2. 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.

    Read Full
  3. 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.

    Read Full