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Posts Tagged: "NIH"

Knowledge Ecology International’s New March-In Petition is Déjà vu All Over Again – With One Twist

Some say the definition of insanity is doing the same thing over and over while expecting a different outcome. That would appear to be the case with the recent refiling of a petition by Knowledge Ecology International (KEI) to the National Institutes of Health (NIH) asking it to march in under the Bayh-Dole Act to force licensing to additional parties of the prostate cancer drug Xtandi, because of its cost. The law allows academic institutions, companies and federal laboratories to own and license inventions made with government support. Similar petitions were rejected by NIH and the Department of Defense (which funded the research on the underlying invention) in the Obama/Biden Administration for a simple reason: the law is for the commercialization of federally funded inventions; it does not allow the government to set prices for successful products.

Inventing Chaos with the Moderna/NIH Dispute

Moderna and the National Institutes of Health (NIH) are poised for a legal battle over inventorship of a vaccine for COVID-19. While a court may resolve the dispute over inventorship for the patent application, court review of current inventorship rules could be a slippery slope to chaos. Moderna and NIH collaborated on developing a functional vaccine for COVID-19, which is not in dispute. As a result of the collaboration, a vaccine labeled “mRNA-1273” was created and a U.S. patent application was filed by Moderna, with no NIH scientists listed as inventors. Moderna has commented that, after an internal review, no NIH scientists designed the actual vaccine claimed in the U.S. patent application. NIH has commented that it believes three scientists should be included in the U.S. patent application as co-inventors with the Moderna scientists.

BIO Urges NIST to Continue Successful Public-Private Partnership in Recent Comments

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.

No, You Can’t March in On Remdesivir

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.

Links to China Prompt Purge at Moffitt Cancer Center

Underscoring the seriousness of the threat posed by the Chinese government’s campaign to obtain results of U.S. publicly funded research, the Board of Directors at the Moffitt Cancer Center in Tampa, Florida announced that its President and CEO, Dr. Alan List, along with center director, Timothy Sellers, suddenly resigned after an internal review found they had violated conflict of interest rules regarding their relationships with China. Four researchers also abruptly left.  The actions came after the Moffitt Center conducted an internal review of collaborations between its employees and Chinese institutions as a result of warnings from the National Institutes of Health (NIH) to its grant recipients about foreign attempts to influence or compromise their research. 

USPTO, DOJ & NIST Issue Joint Policy Statement on Injunctions for Standard Essential Patents

Earlier this afternoon, the United States Patent and Trademark Office (USPTO, National Institute of Standards and Technology (NIST) and the U.S. Department of Justice, Antitrust Division (DOJ), issued a Joint Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments (“2019 Joint Policy Statement”). This Joint Policy Statement explains that “[c]onsistent with the prevailing law… injunctive relief, reasonable…

Other Barks & Bites, Friday, November 8: SCOTUS Hears Allen v. Cooper Copyright Case, U.S. Government Sues Gilead, Amici Submit Briefs to CAFC in Chrimar

This week in Other Barks & Bites: the Trump Administration sues Gilead for infringement over HIVE PrEP treatment patents; Senators Inhofe and Wicker ask President Trump to show no leniency on Chinese IP theft; the Supreme Court hears the Allen v. Cooper copyright appeal; the Federal Circuit issues precedential opinions on PTAB evidence admissibility and limitation in patent claim preamble; the Copyright Office says that its digital recordation pilot project is on track for Spring 2020; the PTAB Precedential Opinion Panel (POP) will review the Board’s rejection of substitute patent claims in a motion to amend; “This Is Spinal Tap” creators settle copyright suit; and T-Mobile announces December launch for nationwide 5G network.

This Week in D.C.: Competition in Digital Tech Markets, NIH Medical Research Funding and Clean Industrial Innovation

This week in the U.S. capital, the Senate will hold committee hearings on antitrust issues in digital platforms and real-time payment systems, a sector of fintech that will also be explored by the House Task Force on Financial Technology. Elsewhere in the House of Representatives, there will be hearings on Veterans’ Affairs scheduling technology, clean industrial innovations and medical research funding at the NIH. The week kicks off at the Information Technology and Innovation Foundation with a look at small business innovation funding programs. The Brookings Institution will also host events on Army modernization efforts and issues in disaggregating health data for improved policy-making.

Jamie Love Responds to Criticism of Knowledge Ecology International Letter

On May 12, Frederick Reinhart published an article titled “Knowledge Ecology International Letter Misleads on March-In Rights.” Reinhart is a past president of the Association of University Technology Managers (AUTM), and his views echo those expressed by many in the university technology transfer field, including a frustration that not everyone acknowledges and appreciates the considerable investments and risks undertaken by the for-profit companies that license patents to inventions funded by the federal government. Knowledge Ecology International (KEI) recognizes the importance of the private sector in bringing therapies to the market, even when federal funding of R&D has played a role, and also that robust returns on those investments have a positive impact on innovation.

Patents in the Crosshairs During House Drug Pricing Debate

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House Committee on Oversight and Reform—how to lower the price of prescription drugs. And it didn’t take long to make it clear that patents are right in the middle of the scrum. The role of patents was a prominent part of the House hearing. While cursory nods were made to the importance of encouraging innovation, the witnesses discussed how patent exclusivity, thickets, and evergreening drove up prices while promoting the greater use of Patent Trial and Appeal Board (PTAB) reviews against drug patents. The Committee was assured that curtailing patents wouldn’t harm innovation because the National Institutes of Health (NIH) is such an important funder of life science R&D.

Price Controls and Compulsory Licensing Reduce Patient’s Healthcare Options

Once we go down a path of government price controls and compulsory licensing we will have foregone opportunities for other, more rational policy choices and will soon find ourselves in a race to the bottom. Of course, making prescription drugs more affordable must be an important, shared goal. But the solutions we pursue cannot risk choking off America’s innovative ecosystem that leads the world in discovering new cures and treatments. As Nobel laureate and NIH Director Harold Varmus said in 1995, one must first have a new drug to price before one can worry about how to price it.  Letting our federal government import foreign price controls and expropriate patents is not the way to go about it.

Compulsory Licensing for Medicare Drugs– Another Bad Idea from Capitol Hill

Rep. Lloyd Doggett (D-TX) recently introduced the Medicare Negotiation and Competitive Licensing Act of 2018. Lest the title confuse you, by “competitive licensing” Rep. Doggett means compulsory licensing anytime a company declines to sell their drug for whatever price the Secretary of Health and Human Services  cares to offer during “Medicare negotiations” where the government holds all the cards. Past attempts to impose artificial “reasonable pricing” requirements on developers of government supported inventions did not result in cheaper drugs. A study titled Compulsory Licensing Often Did Not Produce Lower Prices For Antiretrovirals Compared to International Procurement found that resulting drug prices were often higher than they would have been under a more cooperative approach.

Unleashing American Innovation, Oil States and Eroom’s Law

NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private sector partner willing and able to assume the burden of commercial development, which dwarfs the amount of money the government spent on the underlying research. This investment can only be justified if the technology has strong patent protection… There’s a reason it’s called intellectual property. Ownership of inventions in the United States of America isn’t a gift from the king but the right of a free people to securely own what they create. That’s the driver of American entrepreneurs, who with proper support will astound centralized governments run by dictators for life with what they can do when turned loose. Restoring our patent system removes the leash holding them back. After that, watch out if you’re in their way.

When Big Brother Comes Marching In: Patent Challenges on Entrepreneurial Campuses

Bayh-Dole has recently come under attack, as some are trying to highjack certain provisions to be used as a cost control measure for novel therapeutics as the cost of drugs skyrocket. Should the federal government actually march in on an exclusive license covering a federally funded technology, there will be rippling effects throughout many industries. Academic institutions would reassess the value in investing resources and energy in the commercialization process if they struggle to secure a licensee for their federally funded technologies. The biggest effect, however, will most likely be felt by the general public, as they will no longer benefit from the research their tax dollars have funded for decades, but will instead be on the hook for funding the development of once promising, but now languishing, inventions.

Why NIH/Industry Partnerships Matter: Ask an HIV patient

Those who believe that patents aren’t important or that companies would undertake the rigors of commercial development with only non-exclusive licenses don’t understand the realities facing innovators like Inovio… Unfortunately, there’s good reason for anxiety. If they are successful their patents could be subjected to years of post-grant reviews by competitors and those who believe life science patents harm the public interest. Even if their IP holds up, they may face howls from critics and politicians demanding that the government step in to issue compulsory licenses so others here and abroad can copy the vaccine. For the 35 million living with HIV, the scientific barriers aren’t the only ones standing in the way of effective treatments.