Back in June, the United States Food and Drug Administration (FDA), “as part of an Agency-wide effort to modernize the Orange Book,” published a request for comments relating to patent listing. Apparently prompting this request was FDA’s recognition that New Drug Application Sponsors have “submitted patents for listing in the Orange Book, including certain types … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from June 2020.… Continue Reading
On June 15, 2020, the Supreme Court denied a petition for certiorari from the Federal Circuit’s 2019 Eli Lilly & Co. v. Hospira, Inc. opinion affirming infringement under the doctrine of equivalents (DOE). In doing so, the Supreme Court put to rest a more than decade-long dispute over attempts to market a generic version of … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from May 2020.… Continue Reading
Normally, a branded bio/pharm company is pleased to escape an inter partes review (IPR) unscathed. Doubly so when the challenger moves voluntarily to dismiss its appeal. So what happened in Amneal Pharms. LLC v. Almirall, LLC, No. 20-1106, to cause Almirall to insist on receiving its attorney fees for a mere month of work before … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from April 2020, including: The Federal Circuit potentially extends the potential reach chemical compound structural similarity obviousness law The Federal Circuit holds that a section 156 patent term extension … Continue Reading
On May 8, 2020, the United States Patent and Trademark Office (USPTO) began a Pilot Program to provide prioritized examination of patent applications of a product or process related to COVID-19 diagnosis or treatment. Examples of such patents include: an Investigational New Drug (IND) application, an Investigational Device Exemption (IDE), a New Drug Application (NDA), … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from March 2020, including: The Federal Circuit reverses two district court decisions holding method of treatment and method of preparing claims patent ineligible The Federal Circuit finds that clearly … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from December 2019, including: The Solicitor General, on behalf of the US, asserts that the Supreme Court’s Section 101 precedent creates “substantial uncertainty” requiring clarification The Federal Circuit holds that there … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from November 2019, including: Federal Circuit affirms the Patent Trial and Appeal Board’s (“PTAB”)’s application of the “blocking patent” doctrine as applied to objective indicia of non-obviousness District court … Continue Reading
The November issue of Squire Patton Boggs Bio/Pharma Beat is now available. Our monthly newsletter reports on important patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from October 2019, including: The Federal Circuit holds the “hope” that a potentially promising drug will treat a … Continue Reading
