BioNJ is looking forward to Governor Murphy joining our community for our Annual Dinner Meeting and Innovation Celebration on February 8 to deliver opening remarks for the event. This will be the second time the Governor will join us following our Annual Meeting in 2019, and we are very much looking forward to hearing his perspectives on how the landscape in New Jersey has evolved since he last joined us and are excited to hear his goals moving forward.

Considered the kickoff event of the year for the life sciences industry in New Jersey, BioNJ's 31st Annual Dinner Meeting & Innovation Celebration will bring hundreds of biopharma professionals, academic leaders, Patients, advocates, service providers and government officials together to honor the groundbreaking medical innovation coming from the Garden State.

We hope to see you there!

Last week, the House Ways & Means Committee approved legislation that would restore and expand research and development (R&D) tax policies from the 2017 Tax Cuts and Jobs Act via a bipartisan vote. The bill would provide for 100% spending deductions through 2025, addressing a policy implemented in the 2017 tax bill that required all R&D expenses to be amortized over five years. As the ability to expense R&D costs in the years in which they are incurred enables life sciences entities to offset tax burdens, the availability of this option supports continued innovation that would otherwise be unviable.

Given the magnitude of investment and spending associated with R&D in the life sciences—which is among the most research intensive industries in the economy—this is a critical policy issue that can be devastating to many entities across the ecosystem.

The Biotechnology Innovation Organization (BIO) has launched an action campaign to encourage engagement with policymakers to convey how important the implementation of this policy is to sustained biomedical innovation. To join this campaign, click here.

As discussed in prior updates, the Biden administration in December announced a proposed framework for the use of March-In rights, as part of the White House’s broader efforts around the prices of prescription drugs. Recently the Bayh-Dole Coalition released a 2-minute explainer video capturing the basics of the Bayh-Dole Act, including its bipartisan creation, the numerous technological advancements it has facilitated and the intention behind its once-obscure march-in provision. 

According to the Bayh-Dole Coalition and other stakeholders, the proposal may deter public-private collaborations to advance new treatments and cures, and it will decimate confidence in the reliability of universities and federal laboratories as R&D partners, severely handicapping American innovation.

Please contact us if you have any questions. BioNJ will be submitting comments in response to the NIST RFI. We will continue to share information on the proposal as it develops. Thank you for your support.

To submit your comments on the Biden administration’s proposed use of march-in rights:

• WHO: National Institute of Standards and Technology (NIST)
• WHAT: Request for Information (RFI) seeking comments on the draft guidance framework, which reviews the factors that an agency may consider when deciding whether to exercise march-in rights.
• WHEN: Comments must be submitted before 5:00pm ET on February 6, 2024.
• WHERE: Electronic comments in response to the NIST RFI can be submitted by electronic submission via the Federal eRulemaking Portal with the docket number NIST–2023–0008 or HERE.

Additionally, the Bayh-Dole Coalition and Council for Innovation Promotion will be hosting a joint in-person briefing in Washington, D.C. in the Rayburn House Office Building, Room 2060 today at 12:00PM. Speakers will include:

• Joe Allen, Executive Director of the Bayh-Dole Coalition
• David Kappos, former Director of the U.S. Patent and Trademark Office (2009-2013) and current co-chair of the Council for Innovation Promotion (C4IP), who oversaw the U.S. patent system supported by the Bayh-Dole Act
• Andrei Iancu, former Director of the U.S. Patent and Trademark Office (2018-2021) and current co-chair of the Council for Innovation Promotion (C4IP), who oversaw the U.S. patent system supported by the Bayh-Dole Act 
• Kate Hudson, Associate Vice President and counsel for government relations and public policy for the Association of American Universities (AAU), who works directly with the universities impacted by President Biden's guidance

Finally, Almesha L. Campbell, Ph.D. and Assistant Vice President for Research and Economic Development at Jackson State University, penned an article in Fortune that explores President Biden’s record of support for the Bayh-Dole Act while in the Senate.

On January 17, the Bayh-Dole Coalition released a poll that was conducted at the end of December and solicited the perspectives of over 2,200 adults via online interviews. Highlights of the findings from this poll were that Americans support the protection of the nation’s intellectual property (IP) and that candidates who prioritize protecting the IP of Americans are popular across party lines.

In particular, this poll speaks to the deliberations at the World Trade Organization regarding the potential expansion of IP waivers enacted during the COVID-19 pandemic, or “TRIPS waiver”, to further include diagnostics and therapeutics. Given the severe ramifications that this policy would have, which would be implemented at a time that both the World Health Organization and United States have both concluded the associated public health emergency, BioNJ is hopeful that policymakers will consider these perspectives as the U.S. determines its position on this potential TRIPS waiver expansion.

For a press release from the Bayh-Dole Coalition on the results of the poll, click here.

At the end of last week, the U.S. House voted 314 to 108 to approve a government spending bill that will fund agencies until early March which follows the “laddered” framework of the prior spending bill. Funding for some agencies will now conclude on March 1st and others will expire on March 8. 

Things have been relatively quiet in the State’s Legislature following the inception of the 221st legislative session as all of the new members settle into their new offices. Nearly 6,000 bills have been introduced at the beginning of the session, and BioNJ is reviewing them to identify provisions that may have relevance to the life sciences in New Jersey. Tomorrow, several Senate Committees will meet with fairly light agendas. While there will be more opportunities for both Senate and Assembly committees to meet before the end of the month, we can likely expect to see a bit more activity in February in the run-up to budget season.

Additionally, there is going to be a roundtable with the New Jersey Legislative Manufacturing Caucus focused on the semiconductor industry on January 31, from 1:30PM-3:30PM in Committee Room 4. The group is interested in hearing from entities in the industry to speak about their core capabilities, number of employees, the importance of the semiconductor sector to their firms and ways by which the State can support New Jersey’s efforts to pursue support through the CHIPS and Science Act.

Please contact Ian McLaughlin, Vice President of Government Affairs, with any interest in speaking: IMcLaughlin@BioNJ.org

On January 17, Senator Bill Cassidy (R-LA), the ranking member of the Senate Health, Education, Labor & Pensions (HELP) Committee announced that he will be seeking information from some of the major contract pharmacies into how they use and generate revenue from the 340B program. This is one of several inquiries that the Senator has opened into the 340B program more broadly.

Given how this program, initially devised to improve access to medications among Patients with limited resources, has been exploited over the years, we look forward to the outcomes of the Senator’s investigation and hope to see policies that ensure it successfully redounds to the benefit of the Patients for whom it was initially devised.

In addition, a letter to the Majority and Minority leaders of both legislative chambers was sent on January 16 that articulates the importance of reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA). BioNJ joined over 115 partner organizations in signing this letter that emphasizes the crucial role that this policy plays in ensuring that the U.S. is in a position to effectively confront any future biomedical threat or other disaster that jeopardizes the safety of the residents of the U.S.

To read a statement from Senate HELP Committee Ranking Member Cassidy, click here.

On January 16, the U.S. Department of Justice (DOJ) moved to withdraw its appeal against a decision that prohibited a rule from the U.S. Department of Health and Human Services that enabled insurers to avoid counting copay assistance from manufacturers towards the deductibles and out-of-pocket maximums of beneficiaries. While the ways that this development will play out remain to be seen, this victory by the HIV & Hepatitis Policy Institute, representing the interests of Patients, is a welcome development and BioNJ hopes to see further policy developments that ensure that the assistance provided to Patients truly benefits the Patients themselves.

Yesterday, the Senate Judiciary Subcommittee on Intellectual Property held a hearing entitled “The Patent Eligibility Restoration Act – Restoring Clarity, Certainty, and Predictability to the U.S. Patent System.”

The study, conducted by Vital Transformation with support from We Work for Health, focuses on the impact that H.R. 4895, or the “Lowering Drug Costs for American Families Act”, would have on the life sciences ecosystem. The study’s findings include:

• A loss of 136,000 – 216,000 direct jobs and 678,000 – 1,076,000 indirect jobs nationally.
• 134 fewer new FDA approvals that treat primarily Medicare-eligible individuals, particularly in rare disease, oncology, neurology and infectious disease.
• 76 of the 198 therapies that have been developed and are potential targets for IRA-related pricing provisions would never have reached patients if H.R. 4895 had been implemented prior to their development.

For a summary of the study in BioSpace, click here.

BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are now available for 2024. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.  

Click here for more information.

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