In a precedential decision issued on August 13, 2024, the U.S. Court of Appeals for the Federal Circuit held that a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued,...more
Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more
8/14/2024
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Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more
8/25/2020
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FDA Approval ,
Life Sciences ,
Marketing Exclusivity Periods ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
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Prescription Drugs ,
Reaffirmation ,
Treatment Method Patents
After more than a year of negotiations, the U.S., Mexico, and Canada recently concluded the United States-Mexico-Canada Agreement (USMCA). The USMCA, when it takes effect, will replace the North American Free Trade Agreement...more
10/17/2018
/ Biologics ,
Canada ,
Delays ,
Intellectual Property Protection ,
Mexico ,
NAFTA ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Reform ,
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United States-Mexico-Canada Agreement (USMCA)
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
Factoring in Human Factors -
According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more
Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
Chinese patent prosecution recently made worldwide headlines when the press announced that the Chinese Patent Office (SIPO) rejected a Gilead Sovaldi prodrug patent. Sovaldi (sofosbuvir) is a breakthrough drug used to treat...more