On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in...more
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more
12/13/2023
/ Bayh-Dole Act ,
Biotechnology ,
Inventions ,
Life Sciences ,
March-in-Rights ,
NIST ,
Patent Applications ,
Patent Ownership ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Comment
President Biden recently signed Executive Order 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which places greater emphasis on manufacturing products in the United...more
In a letter dated March 21, 2023, the National Institutes of Health (“NIH”) again refused the request of petitioners to exercise march-in rights under the Bayh-Dole Act to control the price of a drug. Here, as before, the NIH...more
Director Katherine Vidal of the U.S. Patent and Trademark Office (“USPTO”) issued a precedential review decision with respect to the interpretation of multiple dependent claims, in a case of first impression before the...more
On February 1, 2023, the United States Patent & Trademark Office (USPTO) will begin accepting petitions to accelerate examination under the Cancer Moonshot Expedited Examination Pilot Program (the “Moonshot Program”). The...more
The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”)...more
After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry during examination of a patent application and a Request for Comments (RFC) on the...more
The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties of disclosure and reasonable inquiry during examination of a patent application,...more
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more
8/1/2022
/ Abbreviated New Drug Application (ANDA) ,
Biden Administration ,
Biologics ,
Biosimilars ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
USPTO
Since its enactment in 1980, the Bayh-Dole Act has been credited with promoting the development of over 10,000 startup companies and at least 200 pharmaceutical drugs and vaccines, while contributing more than $500 billion...more
3/17/2021
/ Bayh-Dole Act ,
Comment Period ,
Federal Contractors ,
Federal Funding ,
Inventions ,
IP License ,
March-in-Rights ,
NIST ,
Notice of Proposed Rulemaking (NOPR) ,
Patent Applications ,
Patent Ownership ,
Patents ,
Public Comment
Any business entity or nonprofit organization that receives federal government funding, and has inventions and patent applications made with such funding – even in part – is required to timely disclose and elect title (i.e.,...more
Businesses and nonprofit organizations that receive federal government funding, such as NIH, DoD or SBIR grants, are required diligently to report and elect title to inventions and patent applications that have been made with...more