Mike Hennessy Jr. is the President and CEO of 

Mike Hennessy Jr.

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The bio/pharma industry is not unfamiliar with “patent cliffs”; however, the current one being faced is notably steep and, in combination with other factors, is set to negatively impact revenues significantly in the near future. A similarly steep patent cliff was experienced by the bio/pharma industry during the 2000s, but at that time industry had the benefit of pricing tailwinds in the United States, helping industry to overcome the related revenue slump (1).

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players and potentially leading the industry to lose up to $400 billion (2). For example, Merck’s humanized antibody therapy, pembrolizumab (Keytruda), is scheduled to lose its patent in 2028; Regeneron/Bayer’s anti-vascular endothelial growth factor therapy, aflibercept (Eylea), is expected to lose its patent either in 2025 or 2026; and Eli Lilly’s glucagon-like peptide-1 receptor agonist, dulaglutide (Trulicity), is set to lose patent protection in 2027 (3).

Furthermore, while this hefty patent cliff is ongoing, industry is also facing a raft of other issues that are straining profit margins. Issues such as newer and more complex therapeutic modalities are trending, which are more expensive for companies to develop and are targeted at smaller patient populations; various geopolitical tensions are causing supply chain concerns; new legislation is shortening the exclusivity period for drugs; and investment being heavily placed on trending disease areas and specific technologies (1).

However, while the patent cliff will need companies to strategically pivot to negate revenue losses, potential opportunities may open up for other companies seeking to develop a generic or biosimilar form of the blockbuster drugs. According to research, many of the biologic therapies that are set to lose their patent exclusivity in the coming years have no biosimilars in development (4). Such a gap in the market could be a lucrative opportunity indeed.

Möller, C.; Kristic, S.; Walker, G.-C.; Aguilar, J.; Chandran, P. Biopharma’s Patent Cliff Puts Costs Front and Center. BCG, Article, Feb. 18, 2025.

DeAngelis, A.; Feuerstein, A. With a Major Patent Cliff Coming, Will JPM Play Host to Some Serious Deal-Making? STAT, Jan. 8, 2025.

Burke, H. Top 10 Drugs with Patents Due to Expire in the Next Five Years. Proclinical, Feb. 16, 2024.

Jeremias, S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. AJMC, Feb. 5, 2025.

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Facing the Latest Patent Cliff. 

Articles

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

Facing the Latest Patent Cliff

Technological advances are continuing to push boundaries for global industries. Artificial intelligence (AI) is one such advancement and is being increasingly employed in research and scientific work across multiple disciplines as a result of its ability to improve efficiencies.

A recent example of how AI is improving efficiency at the research stage has been demonstrated by co-scientist, Google’s new AI research tool, which solved a complex problem about superbugs—that had taken microbiologists a decade to work out—in a mere 48 hours (1). Google’s AI tool, built on Gemini 2.0, has been created to help scientists generate novel hypotheses and research proposals, which it does through a combination of specialized agents based on scientific methodology (2).

“The AI co-scientist represents a promising advance toward AI-assisted technologies for scientists to help accelerate discovery,” said Juraj Gottweis, Google Fellow, and Vivek Natarajan, Research Lead, in a blog post (3). “This project illustrates how collaborative and human-centered AI systems might be able to augment human ingenuity and accelerate scientific discovery.”

On the theme of collaboration, earlier this year, in January 2025, accelerated computing company, NVIDIA, announced new partnerships with IQVIA, Illumina, Mayo Clinic, and Arc Institute, to transform the healthcare and life sciences industry with AI (4). Using AI agents, NVIDIA’s partners are seeking to accelerate clinical trials, advance drug discovery, and support industry growth.

Looking a little further along the development lifecycle, towards the larger-scale commercial manufacturing end, the benefits of smarter technology and AI implementation are also being seen. However, as highlighted in this issue’s Focus piece, which can be found on pages 10–13, while technological advances are accelerating progress, there are still hurdles to overcome. “Plenty of challenges stand in the way, including cost of implementation, regulatory compliance, and more. We have heard from experts who anticipate that fully automated, ‘lights-out’ biomanufacturing facilities could become a reality within the next five to 10 years,” explains Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products (5).

Gerken, T. AI Cracks Superbug Problem in Two Days that Took Scientists Years. 

Haigney, S. Google Launches AI Co-Scientist System. 

Gottweis, J.; Natarajan, V. Accelerating Scientific Breakthroughs with AI Co-Scientist. Blog Post. Google Research. Research.google. Feb. 19, 2025.

NVIDIA. NVIDIA Partners with Industry Leaders to Advance Genomics, Drug Discovery, and Healthcare. Press Release, Jan. 13, 2024.

Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

Mike Hennessy Jr is President and CEO of MJH Life Sciences®

When referring to this article, please cite it as Hennessy, M. Pushing Tech Boundaries. 

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

Pushing Tech Boundaries

In January each year, global healthcare and life sciences industry leaders, investors, and government officials come together in San Francisco, Calif., at the J.P. Morgan Healthcare Conference to discuss market trends that are expected to shape the industry in the near future. For 2025, this annual barometer of the healthcare sector has left industry with a reasonably positive outlook on the potential for M&A activity.

Since the bumper year of 2019, the bio/pharma industry has experienced a slower pace in M&A activity. While there have been some high value deals, such as Pfizer’s acquisition of Seagen in 2023—valued at approximately $43 billion (1)—the overall value and volume of deals have been lower than expected.

According to the EY 2025 Firepower analysis—which found that there was a decrease in deal value of 41% in 2024 compared with 2023—2024 may be considered a “reset year” when bio/pharma companies were turning away from larger deals and looking at smaller strategic ones (2). In 2025, the EY analysts expect a continued focus on smaller and smarter deals (2), with the emerging field of artificial intelligence (AI) proving a popular opportunity, as was demonstrated by NVIDIA’s announcement in San Francisco (3) and discussed in depth in this issue’s cover story on pages 10–13 (4).

Customarily, industry sees a flurry of deals announced during the J.P. Morgan Healthcare Conference, and 2025 proved no different. The biggest deal, announced on day one of the conference, was Johnson & Johnson’s proposed acquisition of Intra-Cellular Therapies for $14.6 billion (5), marking the largest seen at the conference in years.

While unlikely to hit the heights of years gone by, there is an abundance of ‘dry powder’ private equity funding potentially available (6). So, if the conditions prove optimal, the right opportunities are focused on, and policymaking shakes out in a beneficial way, 2025 could well be a prosperous year for deals for bio/pharma.

Pfizer. Pfizer Completes Acquisition of Seagen. Press Release, Dec. 14, 2023.

EY. EY Firepower Report: Life Sciences Dealmaking—Trends in 2025. Featured Thinking, EY.com, Jan. 13, 2025.

Hollan, M. NVIDIA Announces Pharma Partnerships to Expand AI. 

Thomas, F. Expanding Pharma’s Horizons Through AI and Acquisitions. 

J&J. Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc. Press Release, Jan. 13, 2025.

Whaley, E.; Ward Woffenden, T.; Mahoney Jr., P.M. At JP Morgan Conference, Health Care Investors Gear Up for Transformative Legal Developments

®
Vol. 49, No. 1
January/February 2025
Page: 8

When referring to this article, please cite it as Hennessy, M. Dealmaking on the Rise? 

If the conditions prove optimal, 2025 could be a prosperous year for bio/pharma business deals.

Dealmaking on the Rise?

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The 340B Drug Pricing Program was created by Congress back in 1992 as a way to help vulnerable patients have access to hospital services and more affordable medicines; however, the savings that hospitals are gaining are not always finding their way to the patient via the intended pathway (1). This discrepancy is leading some drug manufacturers to change their drug-discount models.

French drug manufacturer, Sanofi, is the latest to announce their changing plans for drug discounts to certain US hospitals, which will require the institutions seeking the discounted drugs to provide specific information up front (2). “The changes we are making are consistent with the 340B program’s mission ... helping to eliminate prohibited duplicated discounts and diversion of 340B drugs away from eligible patients,” said Sanofi in the news release (2).

Earlier in November, lawsuits were raised by Eli Lilly (3) and Johnson & Johnson (4) against the Health Resources and Services Administration (HRSA) as a result of the government agency’s actions to block their reduced drug price models, which both companies assert will provide greater transparency for drug access. The actions being taken by drug manufacturers to innovate the discounted drug payment structure should not only improve transparency but also help to reduce any potential abuse of the funding received, and these actions, as reported in 

, should be considered by legislators (5).

In a study assessing the cost of the 340B program, IQVIA used a model to quantify the potential financial impact of the drug discount program. Through their analysis, IQVIA found that there are increased costs for self-insured employers and their workers of around 4.2% versus if the program did not exist (6).

Given the outcomes of IQVIA’s analysis and recent litigation cases, the 340B program is under greater scrutiny and reforms are generally expected as a priority. In an interview with the 

, Lindsay Baelor Greenleaf from ADVI Health stated that a Republican-led Congress and Republican White House are more likely to lead to some significant 340B reforms enacted into legislation (7).

1. PhRMA. The 340B Drug Pricing Program. 

 (accessed Nov. 25, 2024).
2. Reuters. Sanofi Plans to Change Hospital Drug-Discount Program. News Release, Nov. 22, 2024.
3. Eli Lilly. Lilly Statement on New 340B Litigation. Press Release, Nov. 14, 2024.
4. Johnson & Johnson. Why Transparency is Critical for Patients. Press Release, Nov. 12, 2024.
5. Numerof, R. Rethinking 340B: Johnson & Johnson’s Bold Challenge to HRSA and What it Means for Healthcare Transparency. 

, Nov. 22, 2024.
6. Sun, C.; Zeng, S.; Martin, R. The Cost of the 340B Program Part 1: Self-Insured Employers. IQVIA White Paper, March 12, 2024.
7. Caffrey, M. The Trump Sequel: What to Expect on PBMs, 340B, Drug Pricing, and RFK Jr. 

Mike Hennessy Jr is president and CEO of MJH Life Sciences®

When referring to this article, please cite it as Hennessy, M. Rethinking Drug Pricing. 

The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.

Rethinking Drug Pricing

The 2024 fall season has already seen perilous weather conditions impacting many areas of the world, none more so than the southeastern coastal states of the United States. Towards the end of September, the US was hit by Hurricane Helene, which underwent rapid intensification as it traveled over warm ocean waters, and was then swiftly followed by five further hurricanes, including Hurricane Milton (1).

These recent storms have caused significant damage, with major efforts already underway to provide assistance to affected areas. However, for the healthcare industry, there are wider-reaching issues arising from the devastation of the storms.

In North Cove, Marion, NC, Baxter’s largest manufacturing facility was flooded, and bridges accessing the site were damaged, resulting in the facility being forcibly closed. This facility is, in fact, the largest manufacturing site for intravenous and peritoneal dialysis solutions in the US, and its closure has led to nationwide shortages of certain medicines (2).

“Our goal is to begin restarting North Cove production as soon as possible and in phases by the end of this year. We do not yet have a timeline for when we expect production to be fully restored to pre-hurricane levels,” Baxter stated in a progress update press release (3).

Responding to the shortages, FDA has added three new parenteral products to its drug shortages list and released guidance for the temporary compounding of certain parenteral products to help fill any supply gaps. Additionally, FDA is assessing potential imported products to help meet patient needs within the US (4).

However, the disruption being caused by this weather-related emergency should further intensify governmental assessments of the fragility and opacity of the US pharma supply chain—facets that have been under scrutiny for some time (5).

1. Poynting, M.; Dale, B.; Rivault, E.; Rogers, L. How Unusual Has this Hurricane Season Been? 

, Oct. 11, 2024.
2. Baxter. Baxter Provides Update on North Cove, N.C., Facility and Hurricane Helene Relief Plans for Community. Press Release, Sep. 29, 2024.
3. Baxter. Hurricane Helene Updates. Press Release, Oct. 21, 2024.
4. FDA. 

Hurricane Helene: Baxter’s Manufacturing Recovery in North Carolina

Short Supply: The Health and National Security Risks of Drug Shortages

When referring to this article, please cite it as Hennessy, M. Weathering the Storms. 

Recent hurricanes in the US close Baxter plant, shining a spotlight on supply chain fragility again.

Weathering the Storms

It’s an election year in the United States, and it’s not just the cost of groceries that Americans are concerned with. The cost of medications has been a long-standing debate in the US government. How the Republican and Democrat presidential candidates might appeal to voters on this topic is starting to be seen. But will pharmaceutical companies take a hit?

In the past, according to Allison Gatlin of 

, the previous administration under Donald Trump proposed an approach whereby the Medicare prices for drugs given in doctor’s offices are linked to an international pricing index. There was also a plan to pass rebates to Medicare enrollees that would go to insurers and pharmacy benefit managers (1). If Trump is elected for a second term, it is possible that he could seek to implement the use of international price referencing for prescription drug costs, which had failed to get approval during his first term in office (2).

The current Administration, which includes Democrat presidential nominee, Vice President Kamala Harris, is jumping into the ring by announcing lower prices for the first 10 drugs selected for Medicare price negotiation (3). Medicare can negotiate prescription drug prices as part of the power given to it by the Inflation Reduction Act, which was signed into law by President Biden in August 2022.

Harris has also backed a draft guidance to allow federal agencies to exercise “march-in rights” (4). This guidance, if approved, would mean that federal contractors could retain the rights to patents for innovations developed with federal financial backing. Essentially, this is aimed at enabling greater competition within a specified market, such as healthcare.

However, this is not the first time that market competition has been assessed in the US. In fact, this year sees the 40th anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984, which was created to increase market competition between generic-drug companies and pharmaceutical companies. This Act, according to Darby Kozak, PhD, deputy director for the Center for Drug Evaluation and Research, Office of Generic Drugs, in FDA, resulted in a growth in the generic-drug market, with generic drugs increasing from 19% of the market in 1984 to 90% in 2024 (5).

Whichever way the pendulum swings in November 2024, the bio/pharma industry should probably brace itself for an impact.

1. Gatlin, A. 2024 Election: Drug Prices Remain a ‘Hot Topic’. Can Pharma Stocks Withstand the Pressure? 

2. Cohen, J.P. Trump Plans to Rescind Funds for IRA Law’s Climate Provisions, but May Keep Drug Price Measures. 

FACT SHEET: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation to Lower Costs for Millions of Americans. 

March-In Rights Under the Bayh-Dole Act: Draft Guidance. 

5. FDA. 40th Anniversary of the Generic Drug Approval Pathway. CDER Conversations. 

, Sept. 23, 2024 (accessed Sept. 25, 2024). 

When referring to this article, please cite it as Hennessy, M. Drug Prices on Debate. 

How the Republican and Democrat presidential candidates might appeal to voters on this topic is starting to be seen. 