A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more
2/7/2019
/ Amended Legislation ,
Amended Regulation ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Farm Bill ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Hemp ,
Marijuana ,
Marijuana Related Businesses ,
Patents ,
Utility Patents
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
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)
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. ยง 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
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
Digital health is the convergence between healthcare, genomics, and digital technologies. It is a fast-growing sector with important implications for individuals and institutions alike. Whether it is hospitals and health...more
11/9/2017
/ 21st Century Cures Act ,
Acquisitions ,
Digital Health ,
Emerging Growth Companies ,
Emerging Technology Companies ,
Health Care Providers ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Software ,
Trade Secrets ,
Warranties ,
Wearable Technology
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
When a new drug is first approved by the U.S. Food and Drug Administration (FDA), the drug is entitled to a period of market exclusivity. For a subset of these new drugs, the FDA will determine that the product has the...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
In this issue:
- A New Accelerator Takes Digital Health Start-Ups to the Next Level
- The Return of the MedTech IPO Market
- Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters
-...more
In this issue:
- How to Expedite Examination of a Patent Application
- The FDA Releases Final Guidance for Mobile Medical Applications
- Creating Value in the Medtech Industry Using a Gender Lens
-...more
10/4/2013
/ Biotechnology ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Mobile Apps ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Telemedicine ,
USPTO ,
Venture Capital
In this issue:
- Best Patent Practices Under the America Invents Act
- CMS Issues Final Rule for Implementing Sunshine Act
- New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more