Proposals to Weaken IP Rights Will Devastate U.S. Life Sciences Industry

From concept to commercialization, the United States is a global leader across all stages of biopharmaceutical product development. Partnerships between research universities, non-profit institutions and the federal government play a significant role in bringing an innovative product from the research stage to a treatment that can transform lives. 


However, in an ill-conceived attempt to lower prescription drug costs, the White House is proposing to weaken critical intellectual property protections on certain biopharmaceutical innovations. This decision will weaken our national ability to develop medications, respond to public health threats and advance biomedical innovation.


The U.S. life sciences and biotechnology industry is a significant driver of our national economy. Our biopharmaceutical industry supports nearly 5 million jobs, as companies and employers nationwide work to research, develop and bring to market treatments that address and treat chronic and debilitating health conditions.


Bringing a new treatment from a lab to a patient’s medicine cabinet requires significant time, resources and funding. Strong IP rights, such as patents and copyrights, allow companies to retain market exclusivity and recoup investments made in developing a drug.


Collaboration between our public and private sectors plays a significant role in bringing a product to consumer’s hands. Many companies partner with universities or non-profits to help commercialize their research.


Congress has long recognized the value of this collaboration. In 1980, federal lawmakers passed the Bayh-Dole Act, a law that incentivizes continued partnership between public and private institutions in the name of bringing cutting-edge innovations to Americans. Bayh-Dole enables research universities, non-profit institutions, and small businesses to own, patent and commercialize inventions developed under federally funded research programs.


These entities are at the forefront of research, but often lack the resources needed to successfully bring a product to market. Bayh-Dole encourages these institutions to find commercial partners to help bring inventions to consumers. The legislation contributed to the launch of 300 drugs between 1996 and 201. Federally funded research brings three products to market daily. 


However, through a provision in the Bayh-Dole Act that allows the federal government to “march in” and seize patents on drugs created with federal funding, the White House is advancing a proposal to seize patents on drugs deemed to be too expensive. This misguided interpretation of the Bayh-Dole Act directly contradicts the original intent of the legislation and will jeopardize the nation’s life sciences innovation ecosystem. 


The law grants the federal government so-called march-in rights only under specific circumstances, all centered on whether the patent holder has made a timely effort to commercialize the product. The National Institutes of Health has previously denied all march-in requests because no request has ever fit the specific circumstances outlined in the law.


Abusing march-in rights will have devastating consequences across the process of bringing medication to patients in need. Should the federal government seize patents on drugs made with federal funding, universities and small biotech companies will have to spend more time navigating bureaucracy and less time researching and developing innovations. Ultimately, vulnerable patient populations will bear the brunt of weakened IP protections, with fewer revolutionary medications and clinical trials available.


Sen. Bill Cassidy, R-La., ranking member of the Senate Health, Education, Labor, and Pensions Committee, recently sent a letter to the Department of Health and Human Services highlighting that the proposals to exercise march-in rights as a means to lower health care costs is just one example of egregious executive agency overreach. He notes that efforts to exercise march-in rights may not stand in the light of the Supreme Court’s decision to reform the ability of federal agencies to interpret ambiguities in laws.


The United States excels in life sciences and biotechnology innovation, partly due to federal policies that facilitate bringing products to consumers, such as the Bayh-Dole Act. It is critical that the White House not move forward with efforts to weaken IP protections through abuse of march-in rights. Without a strong IP framework, universities and small businesses, our local economy, and, most important, patients across the country will suffer the consequences that come with misguided bureaucratic efforts to lower prescription drug costs.


Source: https://dcjournal.com/proposals-to-weaken-ip-rights-will-devastate-u-s-life-sciences-industry/

By Maria Thacker Goethe August 1, 2025
As Washington heads into August recess, Georgia Life Sciences is counting down the days to the 2025 Georgia Life Sciences Summit , taking place August 26–27 in Sandy Springs . With just one month to go, this pivotal gathering will bring together innovators, investors, policymakers, and ecosystem leaders at a time when the national policy landscape is shifting rapidly—and not always in our favor. In just the past week, we’ve seen: A short-lived but deeply disruptive pause in NIH funding : The White House Office of Management and Budget (OMB) temporarily halted the issuance of NIH research grants, contracts, and training awards—impacting institutions nationwide, including here in Georgia. After significant backlash from Congress, research leaders, and advocacy groups, the administration quickly reversed course and released the funds. However, this episode underscores the growing unpredictability of federal research funding—one of the lifelines for our academic and startup ecosystem. The return of pharmaceutical tariffs : The administration announced a 15% tariff on European pharmaceutical imports , though it will not take effect until a national security review is completed. While far lower than the previously floated 200% rate, this move still poses a concern for supply chains and U.S. companies relying on EU-based manufacturing. Escalating pressure on drug pricing : President Trump has now issued direct letters to CEOs of 17 major pharmaceutical companies demanding implementation of Most Favored Nation (MFN) pricing within 60 days. The directive includes MFN pricing for all existing Medicaid drugs, future Medicare and commercial launches, and even repatriation of foreign revenues. While regulatory specifics remain vague, the message is clear: the administration is increasing its pressure on pricing reform—and that could have broad implications for biotech innovation, particularly among smaller companies. At the same time, a new BIO report shows that early-stage biotech funding continues to contract. Series A investment remains flat, IPOs are sluggish, and Q2 startup funding dropped to just $900 million—down from $2.6 billion in Q1. Layoffs across the sector have surged. This paints a sobering picture for many companies in Georgia and beyond. In this environment, Georgia Life Sciences remains committed to elevating our state’s voice, regionally and nationally . We continue to advocate for stable federal funding, smart policies, and the resources innovators need to survive and thrive. The Georgia Life Sciences Summit will be a platform to do just that, demonstrating the resilience of our ecosystem, celebrating homegrown successes, and shaping the future of health innovation in Georgia. I hope to see you there.
By Maria Thacker Goethe July 28, 2025
By: Clary Estes “Small companies are the lifeblood of the industry and a lot of what they do, and what they’re experiencing, greatly affects the industry as a whole,” said Chad Wessel, Director of Industry Analysis at the Biotechnology Innovation Organization (BIO). He spoke with Bio.News in an interview about BIO’s 2025 report, “ The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends ,” focused on the biotech industry from the early-stage perspective. As researchers found, the current landscape is challenging, but there are still opportunities. “In the last couple years, we’ve had a little bit of a contraction of the industry. During COVID, we kind of had this sugar rush for the industry,” said Wessel. “A lot of companies were being created. A lot of money was being thrown out there. A lot more companies were being funded. And in the last couple of years, there has been a little bit more of a correction, and we’re seeing funding levels going down to what we’ve seen prior to COVID.” “But when you add on other challenges, like the political landscape and everything, it is leaning towards a very challenging environment for a lot of companies,” he continued. Bearish venture capital “In venture capital, yes, you have a lot of money, but it’s going to fewer companies at higher average amounts,” explained Wessel. “It’s creating this competitive haves and have-nots type marketplace or environment. So it just makes it a lot more competitive and more challenging to raise funds.” Instead of finding new opportunities, venture capitalists are investing more in companies they are already working with. As the BIO report found, the amount of new series A-1 investment rounds into biopharma remained flat between 2023 and 2024, while the number of U.S. companies receiving their first series A-1 tranche went from 102 to 100. This is in comparison to 181 in 2021, reflecting the COVID influx to emerging biotechs. Comparatively, as the BIO report found, the average amount for A-1 transactions in the U.S. saw a remarkable increase of 700% in the last 15 years, with the average amount raised sitting at $60 million in 2024. The rest of the world stayed relatively steady in comparison to the U.S.’s persistent growth. And with the more bearish tendencies of investors, Wessel and team observed an interesting trend. “2024 was the first year that clinical programs actually raised more venture dollars than pre-clinical, which hasn’t happened in a while,” said Wessel. “I think the last time that happened was in 2018. This ties into some of the information that we’ve heard anecdotally, which is that a lot of VC firms are focusing on the companies that they currently have in their portfolio, rather than adding new companies.” Licensing and deals dip It is not too surprising, then, that as investors shore up what they already have in the pipelines, the R&D pipeline and licensing have slowed somewhat. As the BIO report observed, long-term growth in the R&D pipeline continues with an overall growth of 145% since 2010. Yet, the 2024 expansion rate (4.6%) subsided slightly, trailing the 5-year average of 6.7%. “The growth has slowed on new programs, and more of those programs are being licensed with larger companies,” explained Wessel. “There are fewer options for big companies to backfill their pipeline with products because a lot of them are already out.” The data also shows a notable slowing of the R&D typically done by large biopharma companies. “The areas that are not licensed out as much are the ones with some of the higher patient populations and subsequently the ones that are not being run by small companies,” said Wessel. “These are areas like endocrine and cardiovascular diseases, which are areas where there are a lot of things like type 2 diabetes, psoriasis , high blood pressure, etc. Those all have a lot of burden on the healthcare sector or the patient population, and those aren’t really being worked on that much by smaller companies.” Comparatively – and also not surprisingly – oncology has stayed at the top of the clinical pipeline, along with neurology and infectious disease. “Same thing with licensing,” said Wessel. “While there are deals that are still happening, the upfront amount is lower currently than it has been in years past, and most of the value is tied up into milestone payments, which may or may not happen.” This is also being felt when it comes to new companies going public, which has been an oft-discussed challenge in the biotech industry for the last few years. “The IPO market has still been challenging,” Wessel says. “We went from having 40 companies a year going public, down to 15 in 2023, and now we’re back up in 2025, but it’s still down from the pre-COVID era timeframe.” Biopharma layoffs Another notable characteristic of this year’s biopharma landscape has been uptick in layoffs. “Sometimes it’s just the nature of the economy. But the amount that we’ve seen in the last few years is quite a bit higher,” said Wessel. “To counter that, we don’t really have a way of measuring job creation, but we do know it’s happening. We just are unable to put a value on that.” The BIO report found that layoff announcements ticked up to 65 during Q1 of 2025. While two points lower than Q1 of the previous year, this still marks a jump from 2024’s Q2, Q3, and Q4, which saw the number of layoff announcements at 41, 54, and 46, respectively. All in all, Wessel noted, the biotech industry is still in a bit of a holding period when it comes to trying to navigate the coming months. “It’s too early to be able to say much about the coming years for the industry based on these numbers,” he said. “It takes a little time for reality to kind of catch up for multiple reasons. But what I can say is that we do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge of raising funds and continue doing their best to try to maintain operations as long as they can until they can get funds.” “We know the challenge is out there, but we’re going to have to kind of wait and see a little bit on the data side of things to understand how everything is going to catch up going forward.” Source: https://bio.news/bioeconomy/bio-2025-state-of-emerging-biotechs-report-market-trends/?mkt_tok=NDkwLUVIWi05OTkAAAGb7m5php-rTOf0a_GTaj5pj7Zl-HlpVM25WtyVvCYudM82a9GKjoazUg9sqU66hlAbhqbEuYvcX3C4EqfBG7Q
By Maria Thacker Goethe July 26, 2025
Pioneer Institute has released updated #340B state fact sheets for 2025
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