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
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
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
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
The United States Patent and Trademark Office (USPTO) is implementing a COVID-19 Prioritized Examination Pilot Program for small and micro entities. The program is intended to help independent inventors and small businesses...more
This is the third part of our three-part series on the impact of the COVID-19 on patent offices around the world (Part 1 was on the USPTO and Part 2 was on the Chinese Patent Office). We focus today on the European Patent...more
As a follow-up to our Wilson Sonsini Alert on March 23, 2020, which discussed the United States Patent and Trademark Office's (USPTO's) response to the COVID-19 update, today we are providing a summary of the response from...more
While the COVID-19 pandemic poses challenges for most businesses, currently United States Patent and Trademark Office (USPTO) operations are proceeding without interruption. This has allowed Wilson Sonsini to continue to do...more
As an Applicant for a patent, your information becomes public when the application publishes and once again when the patent itself issues. Unfortunately, there are several companies that mine this information for their own...more
Beware of “Most Favored Nations” Clauses in Commercial Contracts -
Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more
11/20/2019
/ Antitrust Violations ,
Competition ,
Contract Negotiations ,
Cybersecurity ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medical Devices ,
Most-Favored Nations ,
Patient Privacy Rights ,
PHI ,
Preferred Hospital Networks Arrangement
Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products -
The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more
6/24/2019
/ Digital Health ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
HIPAA Privacy Rule ,
Life Sciences ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Popular ,
Pre-Market Notification ,
Regulatory Oversight ,
Regulatory Standards
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 2) -
In Part 1 of this article from our last Digital Health Report, we looked at the opportunities and some of the potential limitations of...more
10/31/2018
/ Business Model ,
Digital Health ,
Early Stage Companies ,
Entrepreneurs ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Partnerships ,
Patent-Eligible Subject Matter ,
Patents ,
Startups ,
Strategic Planning ,
Technology Sector
Evaluating Prospective Partners When Scaling Your Digital Health Company (Part 1) -
Picture this: You have built a digital health company that could revolutionize healthcare delivery; upend diagnostic processes; accelerate...more
6/1/2018
/ Colleges ,
Digital Health ,
Due Diligence ,
Health Care Providers ,
Intellectual Property Protection ,
IP License ,
Joint Venture ,
Medical Devices ,
Partnerships ,
Software Developers ,
Technology Sector ,
Universities ,
Venture Capital
Machine Learning and Digital Health Applications -
The use of artificial intelligence (AI) algorithms to solve complex problems has risen dramatically in the last several years. In 2017, Gartner identified more than 1,000...more
3/9/2018
/ Digital Health ,
Health Care Providers ,
Innovative Technology ,
Life Sciences ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Data ,
PHI ,
Section 101
Voters in the United Kingdom have voted to leave the European Union (EU). The exit of the UK from the EU (the "Brexit") could result in a delay in the implementation of the Unitary Patent (UP) and the Unified Patent Court...more
Ten Considerations for Companies Evaluating a Pre-Negotiated Acquisition -
In recent years, there has been a shift in the research and development strategy of large pharmaceutical and medical device companies from...more