Bayh-Dole Act

News & Analysis as of

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

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

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 ability...more

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

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

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


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

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

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

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

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

Important Update re: Bayh-Dole Law and Policy: Another “March-In” Petition

Another “march-in petition” has been filed recently as part of the on-going implementation of the Bayh-Dole system. The attached web page provides access to the petition, cover letter, and broader context. Now, several groups...more

IP Provisions and ROI for State-Funded Stem Cell-Based Products and Technologies in California

The California Institute of Regenerative Medicine (CIRM) reaches the end of its initial charter in 2017 and recently published its Transition Plan. The plan is a roadmap to sustained development of stem cell-based...more

Supreme Court Decision: Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc.

In its decision announced yesterday in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., 563 U.S. ___ (2011), the Supreme Court clarified the ownership of inventions resulting from...more

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