Posts Tagged: "march-in rights"

On April 9, Knowledge Ecology International (KEI), the Union for Affordable Cancer Treatment (UACT) and Universities Allied for Essential Medicines (UAEM) sent a letter to Chiquita Brooks-LaSure, Administrator for the Centers for Medicare and Medicaid Services, requesting that CMS use alleged statutory authority to allow companies to make and sell generic versions of the blockbuster prostate cancer drug, Xtandi®. The letter comes two months after the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the drug under 35 USC §203.

It’s rare that a federal policy inspires fierce opposition from both sides of the aisle. But the Biden administration’s recent proposal to gut the Bayh-Dole Act is doing exactly that. Bayh-Dole is a pivotal and successful bipartisan law, but Biden’s proposal would effectively allow federal agencies to tear up patent licensing agreements signed between federally funded universities and private businesses. The economic consequences would be dire. Individuals from across the political spectrum, including former Obama administration officials, have warned the proposal would threaten America’s small businesses and inventors.

The U.S. Chamber of Commerce today announced it is partnering with entrepreneurs and other business advocates to counter threats to innovation due to “excessive government overreach,” including the Biden Administration’s proposed framework to expand the use of so-called patent march-in rights.

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.

It was little more than a month ago when the Biden Administration unleashed its draft guidelines for applying the march-in provisions of the Bayh-Dole Act. For more than 43 years, the law was implemented as written. Every Administration—including the Biden Administration—rejected repeated attempts to misuse the law so the government could license copiers when critics felt that a product based on a federally-funded invention was too expensive. This was mainly sought under the guise of lowering drug prices. Even though the Administration issued a stinging denial of the most recent attempt last March, in December it reversed course.

Today, a letter signed by a coalition of top academics opposing the Biden Administration’s efforts to exercise march-in rights under the Bayh-Dole Act of 1980 was sent to the White House. Signed by academics in fields including law, economic policy and sciences, the letter warns the Biden Administration that its efforts to drive down drug pricing by seizing patent rights will “undermine fundamental principles that have made the American IP system the golden standard for supporting domestic innovation.” A growing topic during recent Congressional debates, march-in rights under Bayh-Dole took on a new focus in early December when the National Institutes of Standards and Technology (NIST) and the U.S. Department of Commerce released a draft framework of factors that federal agencies should consider for the exercise of authority codified at 35 U.S.C. § 203 that would compel patent owners holding rights to federally-funded inventions to license those rights to “responsible applicants.”

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.

Senator Thom Tillis sent a letter today to President Joe Biden asking him to answer three broad questions related to his proposal earlier this month that would allow government agencies considerable discretion in deciding whether and when to “march in” on patents. As we previously reported, the National Institute of Standards & Technology (NIST) and the Department of Commerce published a Federal Register Notice on December 8 seeking comments on a proposed framework for exercising march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding, particularly with respect to drug pricing.

One might think that we had enough crises already without creating a new one, but apparently that’s not the case. To much fanfare, the Biden Administration unveiled its long awaited “guidelines” for agency use of the march in rights provision of the Bayh-Dole Act. Ironically, it started this exercise just as it had joined every other administration in dismissing attempts to misuse the statute as a pretext for the government to micro-manage the price of a successfully commercialized government funded invention.

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”.

On March 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter addressed to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), respectively the Chair and Ranking Member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, regarding a Health Committee hearing held that same day on the pricing of Moderna’s COVID-19 vaccine. The GIPC’s letter sought to push back on false narratives regarding the role of public funding in private pharmaceutical research & development (R&D,) and also doubled down on the Center’s criticisms of drug pricing controls in the recently enacted Inflation Reduction Act.

Perhaps after their favorite theory was blown apart again, as it has been every time it’s been trotted out over the past 20 years, the critics of the Bayh-Dole Act learned a painful lesson. Their carefully constructed thesis that the law contains a hidden provision allowing the government to set prices on successfully commercialized products has been summarily rejected by every Democratic or Republican Administration which has considered it. They say the definition of insanity is doing the same thing repeatedly while expecting a different result. But that didn’t keep the proponents from refiling the same petition which was rejected three times in the Obama-Biden Administration. So once again, the National Institutes of Health (NIH) denied the request that it should “march-in” under the law against the prostate cancer drug, Xtandi, because critics felt it is not “reasonably priced.” Apparently, the petitioners thought that the fourth time would be the charm. Now they know better. And this time, NIH included a subtle, but fatal blow to attempts to go down this path again.