On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more
This latest edition features an interview with retiring longtime Wilson Sonsini IP partner Vern Norviel and articles on MedTech and pharma trends for 2025, the eligibility of life sciences companies for qualified small...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more
The United States Patent and Trademark Office (USPTO) announced the finalized patent fee increases which will be taking effect on January 19, 2025. These fee changes include an average increase of 7.5 percent in fee...more
The Inflation Reduction Act (the Act) of 2022 was controversial at the time the Act was signed into law and remains so. To date, multiple legal challenges have been asserted against the Act, with more expected in the future....more
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
/ Acquisitions ,
Antitrust Provisions ,
Artificial Intelligence ,
Biopharmaceutical ,
Biotechnology ,
Business Strategies ,
Capital Markets ,
CEOs ,
Collaboration ,
Early Stage Companies ,
Entrepreneurs ,
Events ,
Exit Strategies ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Initial Public Offering (IPO) ,
Intellectual Property Protection ,
Investment Opportunities ,
Investors ,
Life Sciences ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Startups ,
Therapeutic Services ,
Venture Capital
On May 10, 2024, the United States Patent and Trademark Office (USPTO) issued a notice of proposed rulemaking to add a new requirement for terminal disclaimers filed to obviate nonstatutory double patenting rejections to the...more
On December 8, 2023, the National Institute of Standards and Technology (NIST) released the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (guidance) to the public for comment. The...more
Beginning November 1, 2023, notices from the European Patent Office (EPO) will have a response period that is computed from the date noted on the communication. This represents a change in EPO procedures. Currently, EPO...more
A major change to the European patent system is expected in 2023. Currently, patent owners: 1) validate European patents in individual States, 2) pay renewal fees, and 3) enforce the patent independently in each individual...more
The Inflation Reduction Act of 2022 (the Act) includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health...more
Government actions related to Russia's invasion of Ukraine have had a wide range of impacts on innovative U.S.-based companies. Over the past few days, several changes have arisen which directly relate to the holders of...more
On September 10, 2020, the Patent Trial and Appeal Board (PTAB) decided key motions in Interference No. 106,115, University of California v. Broad Institute. The interference involves 10 patent applications of the University...more
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
/ Appeals ,
FDA Approval ,
Life Sciences ,
Marketing Exclusivity Periods ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reaffirmation ,
Treatment Method Patents
On May 18, 2020, the Patent Trial and Appeal Board (PTAB) heard argument in Interference No. 106,115, University of California1 v. Broad Institute2. The interference involves 10 patent applications of University of California...more
The Federal Circuit, in Illumina, Inc., v. Ariosia, reversed the summary judgment decision of a lower trial court and upheld—as patent subject matter eligible—claims in two patents (U.S. 9,580,751; U.S. 9,738,931). The...more
On February 10, 2020, the European Patent Office Opposition Division announced the results of an opposition filed against patent EP2800811, owned by the Regents of University of California, University of Vienna, and Emanuelle...more
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 ,
Startups ,
United States-Mexico-Canada Agreement (USMCA)
In tandem with the Massachusetts Noncompetition Act, which reformed Massachusetts law governing non-compete agreements (described here in detail), Massachusetts has adopted its version of the Uniform Trade Secrets Act (the...more
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
Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...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
On November 2, 2016, the U.S. Patent and Trademark Office (USPTO) issued a memorandum ("November 2016 Memo") to its patent examiners, updating them on recent subject matter eligibility decisions from the U.S. Court of Appeals...more
On July 5, 2016, the Federal Circuit held that claims reciting methods for cryopreserving hepatocytes in U.S. Patent No. 7,604,929 ("the '929 patent") are eligible for patenting. The decision vacated a lower court's holding...more