On October 21, 2024, the U.S. Department of Justice (DOJ) issued a Notice of Proposed Rulemaking (NPRM) to implement Executive Order 14117, which authorizes the Attorney General to prohibit or restrict transactions by U.S....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
The United States Patent and Trademark Office (USPTO) is requesting public comment on how they can accelerate and incentivize the commercialization of innovative technologies. Public comments can be submitted via this...more
On December 21, 2023, more than three years after the amendments to the Patent Law in 2020 (2020 Patent Law), the Implementation Regulations of the Patent Law (Rules) and the Guidelines for Patent Examination (Guidelines)...more
Invention assignment provisions are fundamental in employment agreements. On one hand, they are the mechanism by which an employer takes ownership of important types of intellectual property employees create that relates to...more
The U.S. patent system is based upon a quid pro quo balance that incentivizes innovation via a time-limited patent exclusivity, while encouraging the dissemination of new ideas for public benefit and use upon expiration of...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
Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall -
In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...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
In this Client Advisory, we answer some frequently asked questions (FAQs) about the Bayh-Dole Act or Patent and Trademark Law Amendments Act (Bayh-Dole)....more
On July 11, 2016, the United States Patent and Trademark Office (USPTO) published a notice detailing the initiation of the Post-Prosecution Pilot Program (P3). As implemented, the P3 provides an additional path forward for...more
In This Issue:
- The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities
- Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers
- Life...more
6/24/2015
/ Department of Justice (DOJ) ,
Diagnostic Tests ,
Emerging Growth Companies ,
Enforcement Actions ,
Equity Financing ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Human Genome Project ,
Initial Public Offering (IPO) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Myriad ,
Patent Infringement ,
Patents ,
Personalized Medicine ,
Venture Capital