The United States Patent and Trademark Office’s (USPTO) recently proposed patent fee increases could have far-ranging consequences for applicants looking to build a patent family from a single patent application. In this first of a series of blogs, we will discuss the potential consequences of the USPTO’s proposed fee increases for continuing applications, including continuation, … Continue Reading
Most drugs are covered by multiple patents, with initial patents directed broadly to the compound and later patents directed to increasingly narrower uses of the compound. This provides opportunities for the compound to be approved as a generic drug before expiration of all of the patents, based on a “skinny” label – i.e., a label … Continue Reading
Back in July we wrote about the doctrine of equivalents (DOE) in bio/pharma cases in general, and the on-going saga of DOE in Lilly’s ALIMTA® litigation specifically. Last week, the Federal Circuit penned a new chapter, issuing a non-precedential decision in Eli Lilly and Company v. Apotex, Inc. Didn’t this all end last June? Not … Continue Reading
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
As potential COVID-19 treatments enter human trials, the question of pricing, access, and intellectual property has naturally entered the discussion. With numerous private entities working on a cure, the industry, governments, payers, healthcare groups, and other stakeholders are quickly pushing their respective (and, in most cases, expected) positions relating to the balance between IP rights … 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 January 2020, including: The Federal Circuit holds that post-priority evidence can be used to show inherency in the obviousness context The Federal Circuit explains that enablement of an allegedly anticipatory … Continue Reading
