Posts Tagged: "NIST"

I have been critical of certain National Institute of Standards and Technology (NIST) proposals to alter the regulations related to the Bayh-Dole Act, in 2021 (Notice of Proposed Rulemaking, NPR), and specifically, the NIST “Framework” published for comments in December, 2023.  My Comments submitted in February addressed numerous legal infirmities, ranging from construction analysis to demonstrated ambiguity problems of the Request for Information/Comments (RFI) itself. 

In what has to be the unkindest cut of all, those expected to benefit from the proposed misuse of march-in rights so the government can impose drug price controls say they don’t support it either. The proponents promoting this hot house theory have seen it denounced by those who created the Bayh-Dole Act as being unauthorized under their law and seen evidence they can’t refute that it would have little impact on drug prices but would devastate small business entrepreneurs in all fields of federally supported research and development. And now they’ve lost the generic drug industry.

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

February 6 is the final day of the 60-day public comment period set by the National Institute of Standards and Technology’s (NIST) request for information on its draft interagency framework for exercising march-in rights under the Bayh-Dole Act of 1980. While lauded by drug pricing advocates, almost every other sector of the American economy has come out in opposition to the draft framework. Senator Thom Tillis (R-NC), the U.S. Chamber of Commerce and the Bayh-Dole Coalition have all publicly opposed NIST’s efforts to exercise legal authority for relicensing patent rights based on product pricing considerations.

The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent Freedom of Information Act (FOIA) requests on January 9 to the Department of Commerce and the National Institutes for Standards and Technology (NIST) regarding the Biden Administration’s recent Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. The proposed framework was published in the Federal Register in December by NIST and the Department of Commerce and included suggestions on whether and when to exercise “march-in rights” under the Bayh-Dole Act that would arguably significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding.

The National Institute of Standards & Technology (NIST) and the Department of Commerce today published a draft version of a Federal Register Notice seeking comments on a proposed framework for deciding whether and when to exercise march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding. While Bayh-Dole contemplates march-in rights, the law strictly limits the situations in which they can be exercised and does not make any reference to pricing as a criterion for marching in. But under the proposed framework, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

In a recent surprise decision, the U.S. Department of Justice (DOJ), U.S. Patent and Trademark Office, and the National Institute of Standards and Technology officially withdrew their 2019 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments and declined to advance an alternative policy statement as a replacement. While the withdrawal of the 2019 policy statement was seen as a foregone conclusion (given the far more SEP-restrictive nature of a December 2021 draft policy statement (DPS) circulated by the agencies), moving forward without any guidance was not on anyone’s DOJ policy bingo card for 2022. The slim guidance that this withdrawal announcement does provide, however, paints a murky picture for the ability of SEP holders to obtain injunctive relief.

The U.S. Department of Justice (DOJ), the U.S. Patent and Trademark Office (USPTO) and the National Institute of Standards and Technology (NIST) have announced that they are officially withdrawing the 2019 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments. However, the withdrawal does not reinstate the 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments, which had been harshly criticized by many in the IP community. It also seems to scrap the Draft 2021 Statement, which also drew the ire of the IP world. The DOJ – Antitrust Division issued a request for public comment on a new iteration of the Policy Statement in December 2021. The announcement came in response to President Joe Biden’s July 2021 Executive Order on Promoting Competition in the American Economy, which asked the three agencies to review the 2019 statement.

In Part II of this series, we considered the language of a specific licensing commitment made to European Telecommunications Standards Institute (ETSI) and the prevailing law relating thereto. In this Part III, we consider the 2021 Draft Policy Statement with a particular view to highlighting its inconsistencies with the ETSI framework and the inapplicability of the hold-up narrative to the situation involving an individual United States patent. Despite its purported purpose of providing the agencies’ views on “remedies for the infringement of standards-essential patents (or SEPs) that are subject to a RAND and/or F/RAND licensing commitment”, the 2021 Draft Policy Statement does not take a clear position on this issue, instead merely stating the following (some might say “the obvious”):

Much like a biological ecosystem, the development, commercialization, and licensing of standardized technologies involves a delicate balance among many diverse and competing participants. The 2021 Draft Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments (hereinafter “the 2021 Draft Policy Statement”), however, appears to be primarily concerned with an issue faced exclusively by implementers when dealing with owners of larger patent portfolios, but without explicitly saying so. This observation is based on the 2021 Draft Policy Statement’s reference to the vague and ill-defined notion of patent “hold-up”.

On December 6, the Department of Justice – Antitrust Division (DOJ), U.S. Patent and Trademark Office (USPTO), and National Institutes of Standards and Technology (NIST) issued for public comment a “draft revised statement on remedies for the infringement of standards-essential patents (or SEPs) that are subject to a RAND or F/RAND licensing commitment, which also provides guidance on what demonstrates good-faith negotiation in this context.” The 2021 SEP Licensing Draft Statement responds to President Biden’s Executive Order on Competition, which called on the agencies to review the 2019 Trump Administration Statement dealing with SEP infringement remedies. The 2019 Statement in turn excised the anti-IP language from a 2013 Obama Administration Statement on this topic.

The Biotechnology Innovation Organization (BIO) recently submitted comments in support of a National Institute of Standards and Technology [NIST] rulemaking on “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions.” The proposed rule caps a nearly three-year effort by NIST, through engagement with stakeholders, to improve federal technology transfer and the commercialization of federally funded inventions. That effort resulted in a comprehensive Green Paper, “Unleashing American Innovation” in April 2019, which reviewed federal research efforts and made detailed recommendations to maximize the taxpayers’ return on investment.

Two organizations with which I work have filed comments with NIST on its Bayh-Dole regulatory proposals. The National Institute of Standards and Technology, or NIST, approaches completion of its two-and-a-half-year effort known as the Return on Investment Initiative, as the regulatory revision stage nears its close. NIST has conducted a commendable process and proposed mostly constructive or reasonable updating to rules associated with the Bayh-Dole Act. But one proposal puts at risk the continued success of the storied law for democratizing technology transfer and commercializing inventions coming from federally sponsored research. That is, this law facilitates bringing to practical use inventions that otherwise would sit on shelves.

The ipAwarenessAssessment (the Tool) is engineered for both business owners and inventors so that they can comprehensively value their intellectual property (IP) and manage their IP portfolios accordingly. Developed as a joint effort by the United States Patent and Trademark Office (USPTO) and the National Institute of Standards and Technology/Manufacturing Extending Partnership (NIST/MEP), the Tool allows a participant to asses their overall IP awareness, usage, and maintenance. The Tool itself is comprised of online multiple choice questionnaires where the pre-assessment contains five questions covering various types of IP; a customized assessment based on the answers provided during the pre-assessment that ranges from five to ten categories only relevant to the pre-assessment answers; and the full assessment which contains 10 categories and over 60 questions. These categories span a comprehensive spectrum of many aspects of IP and the individual questions are engineered to discover the user’s overall IP awareness.