InnovationRx: A Patent Fight Over The World's Top-Selling Drug

Forbes

30-04-2025

In this week's edition of InnovationRx, we look at a patent fight over the world's top-selling drug, breakthroughs from the American Association for Cancer Research, Verily's Parkinson's dataset, the relationship between microplastics and heart disease, and more. To get it in your inbox, subscribe here.
Robert Davis, chief executive officer of Merck & Co.
Merck's Keytruda is the world's top-selling drug, bringing in nearly $30 billion in sales last year. The drug, which is used to treat lung cancer, melanoma and certain other cancers, has historically been given by intravenous infusion, but Merck is gearing up to launch an injectable version that would be easier on patients. That formulation is currently pending FDA approval (the agency has a target of September 23 to decide) and, if approved, Merck has said it plans to launch on October 1.
San Diego-based Halozyme is fighting that plan–and last week filed suit in U.S. District Court in New Jersey, alleging that the injectable version of Keytruda infringes on its patents. Halozyme, which is publicly traded with a market cap of $7.5 billion, partners with pharmaceutical companies to make injectable versions of important medicines, and said that it had expected Merck to sign a licensing deal in order to use its hyaluronidase technology. It's now seeking an injunction to block Merck's planned commercialization of the drug. Merck has said that the suit is 'meritless.'
The court battle comes at a critical time for Keytruda, which is facing the approaching expiration of some key patents starting in 2028 that could potentially open the way for less costly versions known as biosimilars. Merck's efforts to change the blockbuster drug's delivery system could potentially both increase its sales and extend its patent runway. On Tuesday, Merck said that it would spend $1 billion on a new factory in Delaware that would include biologic drugs, the new injectable version of Keytruda among them.
More than 21,000 people gathered over the past few days at the annual meeting of the American Association of Cancer Research in Chicago. Companies presented innovative research, suggesting hope for patients against some of the world's deadliest diseases.
Here are a few highlights from the meeting: Diagnostic Help From AI: Artificial intelligence is proving to be helpful in better diagnosing cancer. In one new academic paper, an AI model was able to predict whether a cancer patient is at risk of developing wasting disease better than conventional methods. Other research found that an AI model was able to classify sarcomas (cancers that attack soft tissues) from images alone, a task that normally requires complex chemical analysis. And in a third study, AI was used to help diagnose nonmelanoma skin cancers.
Promise For Boehringer Ingleheim's Lung Cancer Drug: Just under 5% of patients with non-small cell lung cancer have a mutation in a gene called HER2 that results in much more aggressive tumors that are harder to treat, because the mutations closely resemble other proteins in the body, which can cause toxic side effects. Pharmaceutical company Boehringer Ingelheim presented data from a clinical trial of its drug zongertinib, which binds tightly to HER2 proteins. The study found a durable response to the drug in patients with lower rates of adverse side effects than comparable treatments.
Promising Immunotherapies: An off-the-shelf cell therapy developed by Sentio Biosciences caused complete remission in blood cancer patients with fewer side effects than a typical CAR-T treatment in a small phase 1 clinical trial. Plus, a study from the Dana-Farber Cancer Institute found that the use of immunotherapy both before and after surgery improved outcomes for patients with head and neck cancer.
One Shot For HPV: A large-scale clinical study conducted by the National Cancer Institute suggests that Gardisil, a vaccine that protects against HPV, is just as effective at preventing cervical cancer after only one dose as the current schedule of two doses currently prescribed in the United States.
Sudip Parikh, CEO of the American Association for the Advancement of Science, which publishes the Science family of journals, testified to the Senate Appropriations Committee about the state of biomedical research in the United States on Wednesday. In his testimony, Parikh criticized the execution of cuts to jobs and grants to scientific agencies by the Trump administration. 'Too many game-changing decisions are being made by individuals with little to no understanding of the complex ecosystem,' he testified. He also criticized proposed budget cuts to NIH, stating that they would lead to fewer treatments for cancer, dementia and other maladies and cost America its leadership in the field.
'Unfortunately, the implementation and execution of these efforts have caused both collateral and targeted damage to the biomedical research enterprise,' he stated in his prepared comments. 'And — if rumored proposed budgets for 2026 are realized – will hand leadership of biomedical research to China and, even more devastatingly, dismantle the engine of hope and prosperity for millions of Americans.'
A new study by a team of economists at American University's Institute for Macroeconomic and Policy Analysis found that a 25% reduction in research funding would lower government revenues 4.3% in the long term, while a 75% cut would lower it 11.3%–more than since the Great Depression.
Plus: The FDA approved Abeone Therapeutics' gene therapy Zevaskyn, which is used to treat a rare genetic condition that causes extremely fragile skin, leading to blistering and other wounds over the body.
Verily, Alphabet's health and AI company, received a $14.7 million grant from the Michael J. Fox Foundation to build a large molecular dataset of Parkinson's patients. The dataset is designed to help researchers better understand the relationship between genetics, immunology and metabolism, which could accelerate new treatments for the debilitating neurological disease. As many as 1 million people in the U.S. have Parkinson's disease with nearly 90,000 new cases diagnosed annually.
Diagnostics company Predicta Biosciences announced the commercial launch of its first test, GenoPredicta. The test uses whole genome sequencing of blood or bone marrow from patients to detect genetic variations that can diagnose and guide treatment for multiple myeloma (a blood cancer). The test is intended as a next generation of diagnostics, enabling more accurate diagnosis than the current standard, fluorescence in situ hybridization, without requiring the painful intrusion of a bone marrow biopsy. The company's test can also identify genetic mutations that indicate a patient won't respond to a particular medicine.
'There's really a lot of benefits both from the blood-based side and from the whole genome sequencing side, which gives us just a much more complete view of the alterations in that patient's cancer than the current standard does,' cofounder Irene Ghobrial, who's also a professor at the Dana Farber Cancer Institute, told Forbes.
A new study published this week suggests that exposure to phthalates, a class of chemicals used to make plastic used in household items, may be linked to hundreds of thousands of deaths from heart disease each year. The study focused on a specific phthalate called DEHP, which can prompt inflammation in the heart's arteries, leading to disease. The study estimates exposure to DEHP caused more than 350,000 deaths from heart disease–about 13% of all heart disease deaths–in 2018 alone.
Novo Nordisk will sell low-cost versions of its popular weight-loss drug Wegovy through telehealth companies Hims, Ro and LifeMd. The three companies had been selling compounded versions of the drug, which the FDA permitted when there was a shortage, but that shortage was declared ended last month. Compounding pharmacies have filed suit to keep being able to produce those versions. (Disclosure: Forbes Media owns a small stake in Ro.)
Plus: IVF automation company Overture Life raised $21 million from Overwater Ventures, GV and Khosla Ventures bringing its total investment to $57 million at an undisclosed valuation. The Palo Alto, Calif.-based company uses software and robotics to bring down the costs of fertility procedures.
As Trump pushes coal, a federal program to screen coal miners for deadly black lung disease has been shuttered.
The shingles vaccine appears to lower dementia risk, according to several recent studies.
Measles continues to spread in the United States, with over 900 cases nationwide, putting the country at a tipping point for the return of endemic measles for the first time since it was declared eradicated 25 years ago, new research warns.
Damage from a gut bacteria may help explain why colon cancers have been rising in people under age 55.
Chinese biotech Akeso won approval in China for its drug challenging Merck's Keytruda. Summit Therapeutics has a deal with Akeso for the drug's development in the U.S.
Trump's cuts to science funding mean that mice, rats and even monkeys used in research face being euthanized.
Health system operating margins dropped below 1% in March, according to a report from Strata.