Patents, Convenience, and the Future of Cancer Care
A recently published article in The Lancet Oncology, Subcutaneous immunotherapy—a wolf in sheep’s clothing?, brought renewed attention to the transition of major immunotherapies from intravenous (IV) to subcutaneous (SC) administration. And with the recent FDA and EMA (European Medicines Agency) approval of SC pembrolizumab, we need to open the debate.
While framed as a step toward convenience and patient-centered care, the Lancet Oncology paper raised concerns that this transition primarily serves to extend patent life and delay biosimilar competition.
The Logic of Patent Protection — and Its Evolution
Drug development is expensive, slow, and uncertain. Patents exist to reward innovation and make investment feasible. Without exclusivity, few companies would undertake the clinical and financial risk required to bring novel therapies to market. Companies are loath to let patents fade away when they expire. As the end of exclusivity approaches, manufacturers often deploy secondary strategies to preserve market protection.
One of the most efficient strategies is to alter the route of administration. By converting an intravenous drug into a subcutaneous, oral, or depot formulation, the drug itself remains unchanged, but the delivery method can be patented anew.
What may present clinically as an incremental improvement can, in reality, function as a sophisticated form of product hopping, preserving high pricing and extending commercial dominance far beyond the original patent’s lifespan.
Let’s have a look at the #1 blockbuster in oncology: Pembrolizumab.
Pembrolizumab: A Decade of Expansion
Pembrolizumab (Keytruda) is a monoclonal antibody to programmed cell death-1 (PD-1). It received its first FDA approval on September 4, 2014. The initial approval was for unresectable or metastatic melanoma progressing after ipilimumab. Since then, its uses have expanded rapidly. According to Merck’s healthcare-provider information, pembrolizumab is now approved for 42 indications across 18 cancer types, spanning melanoma, lung, urothelial, renal, head and neck, gastrointestinal, gynaecological, and more.
This expansion has translated into mind-boggling revenue. Merck’s full-year 2024 financial results reported US$29.5 billion in Keytruda sales — an 18% increase from 2023. This represents 46% of Merck’s total pharmaceutical revenue.
Against this backdrop, it is not surprising that Merck feels the need to act before patent protection expires.
Enter the Subcutaneous Formulation
The subcutaneous formulation — pembrolizumab plus berahyaluronidase alfa (Keytruda Qlex) — was designed to enable rapid SC delivery. In March 2025, the FDA accepted its biologics license application based on the phase III study MK-3475A-D77, which demonstrated noninferior pharmacokinetics and comparable efficacy to IV pembrolizumab when combined with chemotherapy in metastatic NSCLC.
On 19 September 2025, the FDA approved Keytruda Qlex for SC use across most of the indications already held by IV pembrolizumab. The EMA followed soon after, recommending its approval for all adult indications.
The convenience is undeniable — but so is the timing. As the patents for IV pembrolizumab approach expiry, a new formulation appears — one that can secure new patent protection, potentially extending exclusivity for years. Crucially, Merck itself has signalled that it expects the SC formulation to account for 30–40% of all pembrolizumab use within a few years.
Ethical considerations
The ethical questions hardly need to be articulated.
If the active molecule is unchanged, is it reasonable that altering the route of administration yields a fresh stretch of effective monopoly?
Is this truly innovation, or is it primarily patent extension?
And if we call it patent extension, and we reward companies with the possibility of continuing profits, should manufacturers also be required to demonstrate non-inferiority in every clinical setting where the intravenous formulation is already approved? Or is it acceptable that regulatory agencies extrapolate efficacy and safety across all indications based on a limited number of bridging trials and pharmacokinetic studies?
If patents are extended, should there be guarantees of price cuts?
Is it ethical to withhold a therapy, which is more convenient for patients, until it is most advantageous for the maker?
Choosing Our Priorities
Every penny spent sustaining ultra-high-priced branded therapy is a penny not spent elsewhere in the health system—on earlier diagnosis, surgery, radiotherapy capacity, nursing staff, or access to basic medicines in other disease areas. Pharmaceutical companies cannot be faulted for testing the boundaries of the regulatory framework in pursuit of financial return. That is the nature of industry, and we rely on it to continue innovation. But we, as a healthcare community and as a society, must decide whether we want to go along with this trajectory, and whether the convenience of “product hopping” being sold to us truly justifies the cost.
With increasing pressure on healthcare systems and escalating treatment-related expenditures, my position is that the answer is largely no. Where safe and effective biosimilar IV formulations become available, we should be prepared to accept slightly reduced convenience in exchange for profound savings and broader access to treatment.
The arrival of subcutaneous pembrolizumab is not merely a pharmacological shift — it is a test case in the future economics of oncology. Whether it represents smart innovation or strategic preservation of profit will depend less on scientific data and more on the choices we collectively make in the years ahead. In the end, the future of oncology will be shaped not only by molecules, but by the values we choose to fund.
Dries Develtere, MD, is a Urologist at the General Hospital of Ypres, Belgium. He is the founder of Surgical Vision, a video platform that provides high-quality surgical training videos. Dries also started the Beyond The Abstract: Urology Substack, which provides clear, independent, and unbiased analysis of new research in urology and uro-oncology.
Photo Credit: Dima Solomin
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It’s true that the subcutaneous version of pembrolizumab will make visits easier for a lot of people. I’m glad to have it. But the timing is exactly what you’d expect in a system where extending a patent is more profitable than bringing the next major advance to the clinic. And think about how many patients could have benefited if they brought it earlier.
This isn’t a new story. Companies respond to the incentives we put in front of them, and we shouldn’t be surprised when their strategy matches the rules of the game.
We can do better if we center this on the patient. If a new formulation shows up right as exclusivity is running out, then the value needs to be clear in ways that matter to real people. Fair pricing. Better access. Solid data across the cancers where the original drug is already standard.
This needs to happen on the regulatory side—FDA and EMA can set clearer expectations about what qualifies for extended protection. If a change is mostly convenience, that’s fine, but the benefits and the costs should be aligned.
We depend on pharma for the breakthroughs that have changed survival across so many cancers. But we also need a system where the rewards match meaningful progress, and where patients aren’t the ones absorbing the downside of strategic timing.
Just my two cents.
The issues here are important and not new. I would be interested in hearing from someone who could speak to these ethical problems from an alternative viewpoint. As a pharmacologist-physician with a 'compationate conservative' viewpoint, I find these marketplace ethical questions difficult to resolve...