News & Analysis as of

Bayh-Dole Act

March-in Rights and Compulsory License in the United States

March-in rights in the US were created in 1980, as part of the Bayh-Dole Act. Simply stated, when the US government funds research that results in patents, it obtains rights to those patents. These rights are retained even...more

Global Patent Prosecution Newsletter - October 2017

March-in Rights and Compulsory Licensing of Biopharmaceutical Inventions - Very few topics in international intellectual property have been as controversial as compulsory licensing. In the US, consumer groups have...more

Sovereign immunity shields university from inventorship dispute

by Hogan Lovells on

In a case involving medical methods invented by two Nobel laureates, the U.S. Court of Appeals for the Federal Circuit has ruled that sovereign immunity prevents a third researcher from pursuing his claim of co-inventorship...more

An Omitted Inventor Can’t Correct Inventorship of a Patent Owned by a Government Agency

In a non-precedential opinion in Ali v. Carnegie Institution of Washington, [2016-2320] (April 12, 2017), the Federal Circuit affirmed the dismissal, on grounds of sovereign immunity, of Ali’s lawsuit to be added as a...more

Changes to Bayh-Dole Act Regulations Impacting Ownership of Patent Rights

by Goodwin on

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

The Bayh-Dole Act

The Bayh-Dole Act allocates rights for intellectual property developed with federal funds between contractors or grant recipients and the government. This infographic provides an overview of the Bayh-Dole Act, the steps that...more

What is Technical Data and How Do You Protect It

by PilieroMazza PLLC on

Technical data, as defined by the FAR, is “recorded information (regardless of the form or method of the recording) of a scientific or technical nature (including computer databases and computer software documentation).” See...more

What you need to know about retained rights in federally funded patented drugs

by Dentons on

The issue of drug pricing is top of mind - More than 50 members of Congress, led by Rep. Lloyd Doggett (D-TX), sent a letter to Secretary of Health and Human Services Sylvia Matthews Burwell and to National Institutes of...more

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

“March-in” Rights – The (Paper) Damoclean Sword of Federal Procurement Patent Law

by PilieroMazza PLLC on

Given the recent PilieroMazza webinar on Data Rights in federal contracting, we have had a number of clients raise concerns or questions about the government’s “march-in” rights under the Bayh-Dole Act, which controls certain...more

Patenting: A Guidebook For Patenting in a Post-America Invents Act World

by Foley Hoag LLP on

Patenting - Patenting generally offers a superior means for legally protecting most inventions, particularly since: • copyright, when available, does not provide a broad scope of protection; and • the...more

Applying for a Waiver From U.S. Manufacturing Requirements For Federally Funded Intellectual Property

by Mintz Levin on

Countless ideas and inventions are developed at U.S. universities every year, often with federal funding. Many of these important ideas could not be commercialized for the public’s benefit without the Bayh-Dole Act, which...more

Product Liability Update - July 2015

by Foley Hoag LLP on

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Data Rights for Government Contractors

by PilieroMazza PLLC on

In this presentation: - FAR AND DFAR - TYPES OF DATA - TECHNICAL DATA - COMPUTER SOFTWARE - COMMERCIAL COMPUTER SOFTWARE - TYPES OF RIGHTS - LICENSE RIGHTS - BAYH-DOLE...more

Stanford University v. Roche Molecular Systems, Inc.’s Impact on Government Contracts

by Burns & Levinson LLP on

A decision by the Supreme Court of the United States on June 6, 2011 has a great impact on the interpretation of the Bayh Dole Act as well as assignment of contracts relating not just to the Bayh Dole Act but to assignments...more

Patenting Necessary for Continued Innovation in Biotech/Pharma Industries, Academics Conclude

Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the purported soiling of the...more

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

Brookings Paper Calls for Technology Transfer Model Based on University Start-ups

A paper released by the Center for Technology Innovation at the Brookings Institution asserts that by relying on a technology transfer model based on patent licensing, only a few universities have been able to generate...more

NIH Declines to Exercise March-in Rights over Abbott Laboratories' Norvir®

Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more

A Reply to the New England Journal of Medicine

In its August 29, 2013 edition, the New England Journal of Medicine saw fit to print two "perspective" pieces attacking the Bayh-Dole Act. The primary article is by Dr. Howard Markel entitled "Patents, Profits, and the...more

NEJM Perspective Calls for Recalibration of Bayh-Dole Act

In a perspective published in the August 29 issue of the New England Journal of Medicine, Dr. Howard Markel outlines the events leading up to the enactment of the Bayh-Dole Act and states that "a review of [the Act's] origins...more

Patents, Genetic Testing, and Federal Funding

by Foley & Lardner LLP on

In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more

Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test

On Friday, Sen. Patrick Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the National Institutes of Health (NIH), "to urge [the Director] to consider using march-in rights under the Bayh-Dole Act to ensure...more

2012 Remarkable Year for U.S. Nanotechnology Patenting – Over 4,000 Nanotechnology Applications Published

by Foley & Lardner LLP on

The nanotechnology patent filing boom continues. In 2012, the USPTO published 4,098 nanotechnology class 977 applications, which represents a 19.2% increase over last year....more

Ownership of Inventions Funded with Federal Research Grants

by Smith Anderson on

The FY-2012 National Defense Authorization Act reauthorized the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs through 2017. Administered by the U.S. Small Business...more

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