Posts Tagged: "National Institute of Standards and Technology"

Senator Thom Tillis (R-NC) today sent a second letter to U.S. Attorney General Merrick Garland and Assistant Attorney General – Antitrust Division at the U.S. Department of Justice (DOJ) Jonathan Kanter expressing concern over the process for releasing, and the substance of, a revised version of the Joint DOJ-U.S. Patent and Trademark Office (USPTO)-National Institute of Standards and Technology (NIST) Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary FRAND Commitments. Tillis sent an initial letter on December 10, 2021, four days after the DOJ published the latest iteration of the Policy Statement for public comment.

The U.S. Department of Justice – Antitrust Division (DOJ) is requesting public comment on a new iteration of the Joint DOJ-USPTO-NIST Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary FRAND Commitments. The announcement comes 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.

On January 12, the National Institute of Standards and Technology (NIST) published a request for comments on proposed changes to regulations that support the University and Small Business Patent Procedures Act of 1980, which is more commonly known as the Bayh-Dole Act. At the time, NIST explained that this important update to Bayh-Dole represents a key element of the Return on Investment Initiative, which seeks to maximize American innovation arising from the federal government’s more than $150 billion annual investment in research and development. Monday, April 5, was the deadline to submit comments to NIST on the proposed rule revisions. Below are a handful of excerpts to comments submitted, together with links to the full text of the comments.

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 new Presidential Administration has hardly settled in before being confronted with a stark choice: will they continue policies that foster public/private sector R&D partnerships or be diverted down a path that’s been a dead-end? President Biden faces two herculean tasks: getting the COVID-19 pandemic under control while reviving the economy. The problems are intertwined and require continuous innovation to overcome, which means tapping the best minds in our public and private sectors. We’ve just witnessed a modern miracle, as such partnerships seamlessly came together to create effective COVID-19 vaccines and therapies in record time. But the policies these collaborations depend on are now being questioned.

It’s an honor to be sharing a virtual stage today with Senator Bob Dole and with Chris Bayh in celebrating the 40th anniversary of the passage of the Bayh-Dole Act.  I’d like to thank the Bayh-Dole 40 Coalition members for their tireless advocacy as champions for the enduring impacts of this seminal legislation. 40 years ago, Senators Birch Bayh and Bob Dole had a shared vision – that innovations arising from federally funded research could have monumental economic and societal impacts for American citizens.  They led the bipartisan charge in writing the Patent and Trademark Law Amendments Act of 1980, which today is widely known by their names – the Bayh-Dole Act.

Recently, Knowledge Ecology International sent to Congress a letter objecting to the draft “Green Paper on Unleashing American Innovation” disseminated by the National Institute of Standards and Technology (NIST) in December, 2018. The KEI letter was signed by 10 other organizations* (the Organizations). The letter, unfortunately, is full of misstatements, distortions, falsehoods and disingenuous arguments. It would be easier to focus on the letter’s one accurate statement:  that high drug prices are a serious concern for people everywhere. It is very unfortunate that KEI, in my opinion, utilizes tactics which continually sacrifice fair and constructive dialog in favor of apparently achieving goals “by any means necessary.” The most disturbing element of the letter is KEI’s advocacy of inappropriate and unjustified use of government march-in rights under the Bayh-Dole Act as a purported means of controlling drug prices. In doing so KEI and the Organizations are threatening medical advances and thereby undermining their own missions.

The National Institute of Standards and Technology recently indicated in its “Return on Investment Initiative draft green paper” that it would issue regulations effectively ending attempts to misuse march-in rights to assert government price controls over successfully commercialized federally-funded inventions. Such an announcement was bound to elicit a reaction. That it came in The Washington Post shouldn’t be a surprise. The paper’s April 18 article, “A rare deterrent to limitless drug price increases may die under Trump” gives coverage to both sides, but the takeaway is that something nefarious is underway: “As drug prices have soared, lawmakers and patient advocates have pushed the federal government to deploy for the first time a powerful deterrent: a legal provision that allows it to suspend a drugmaker’s patent and license someone else to produce the drug. Now, responding to industry alarm over those demands, the Trump administration is proposing to strictly limit the little-known power,” said the article. There’s a reason why this “little-known power” has never been used—it doesn’t exist.

After months of anticipation, the just released draft paper Return on Investment Initiative to Advance the President’s Management Agenda: Unleashing American Innovation signals that the Administration is serious about addressing a wide range of long neglected issues undermining effective technology commercialization.The paper, generated under the leadership of Commerce Under Secretary Walter Copan, who heads the National Institute of Standards and Technology (NIST), is “a discussion document”  based on feedback from a series of public meetings and written comments for improving the return on investment from $150 B spent annually on government-supported R&D… The suggested action is to “authorize scientists and engineers at Federal Laboratories to engage in entrepreneurial activities that support technology transfer and commercialization.”… The report effectively addresses a wide variety of problems in the system. Many have lingered for decades but the government lacked the leadership and the will to address them. It looks like that may be ending. That’s a good thing for American taxpayers.

It would be a tragic mistake to blame federal tech transfer underperformance on Bayh-Dole. Bayh-Dole needs no amending. Bayh-Dole demonstrates how secure patent rights are the lynchpin to society’s getting the greatest benefit from federal research dollars.

One difficulty holding back the further implementation of hyperloop infrastructure is the fact that the new mode of transportation doesn’t fit neatly into existing regulatory framework. In response to a question from Sen. Thune on that subject, Raycroft noted that hyperloop systems were currently under the jurisdiction of the Federal Railroad Administration (FRA). This is despite the fact that certain aspects of hyperloop technology don’t fit neatly into the FRA’s regulatory framework for railroads, including vehicle bodies which are more similar to commercial aircraft. Raycroft said that engagement between the FRA and other agencies within the Department of Transportation could help speed the regulatory process while ensuring that passenger safety remained a top priority. In response to a later question from Sen. Catherine Cortez Masto (D-NV), Raycroft said that, at the current pace, hyperloop technologies would be ready for widespread passenger use during the mid-2020s.

Three events boosted our economic turnaround in the 1980’s: the passage of Bayh-Dole, which injected the incentives of patent ownership into the federal R&D system; the enactment of the Court of Appeals for the Federal Circuit, which insured the courts would apply the patent law consistently; and the Supreme Court’s ruling in Diamond v Chakraberty that living organisms could be patented. That decision stated that patents could “include anything under the sun that is made by man.” Today that quote is only ironic.

The biggest complaint about federal labs is it’s too hard to complete deals. Many federal labs must run pending agreements through byzantine departmental procedures. Companies wonder what’s taking so long and are surprised when negotiated points come back altered… One reason why universities outperform the labs is that many academic licensing officers come from the private sector. They understand the pressures companies are under to complete agreements.

Secretary Ross gave an unequivocal endorsement of Bayh-Dole specifically, and more generally saying laws need to be updated to address business and technology realities of today, and to enable more companies to license federally funded technologies and take advantage of federally funded research in order to launch high-tech start-ups, create jobs, and grow the economy. “Our practices, policies, regulations, and laws all need to be updated to assure that technology transfer commercialization in the large-scale production and manufacture of innovative technologies occurs within the US,” Ross said. “We must address growing trade imbalances by producing in America the innovative products that the rest of the world needs to buy.”