Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more
Partner Andrew Wasson contributed a chapter to the Food & Drug Law Institute’s annual publication identifying the top food and drug cases of the year. Andrew’s chapter relates to the Supreme Court case, Amgen v. Sanofi, 598...more
On June 20, 2023, the Patent Trial and Appeal Board issued a decision in favor of Haug Partners client Sartorius BioAnalytical Instruments, Inc. (Gator Bio, Inc. v. Sartorius BioAnalytical Instruments, Inc., IPR2023-00215...more
Orphan drugs are the pharmaceutical industry’s way of helping those who suffer from rare conditions. Thanks to the Orphan Drug Act, such patients can get the medications they need, and pharmaceutical companies can be duly...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
9/18/2020
/ Bayh-Dole Act ,
Biomedical Advanced Research and Development Authority (BARDA) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Federal Acquisition Regulations (FAR) ,
Federal Funding ,
FOIA ,
Food and Drug Administration (FDA) ,
Freedom of Information ,
Intellectual Property Protection ,
Inventions ,
March-in-Rights ,
National Institute of Health (NIH) ,
Non-Exclusive License Agreements ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Public Health ,
State Attorneys General ,
Vaccinations
Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more
8/5/2020
/ Clinical Trials ,
Compliance ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Informed Consent ,
New Guidance ,
Public Health Emergency ,
Regulatory Requirements ,
Safety Precautions ,
Social Distancing ,
Vaccinations