Drug patents are meant to help pharmaceutical companies recoup high development costs by preventing competitors from using the intellectual property for a defined period of time, typically 20 years in the U.S.
But the global patent system — a patchwork of national laws loosely connected by international treaties — is vulnerable to manipulation. In the case of Keytruda, a blockbuster cancer drug, companies exploited the patent system to try to extend market exclusivity well beyond the expiration of the drug’s initial patents, keeping competitors at bay and prices artificially high for years. Prolonged patent monopolies can delay cheaper alternatives entering the marketplace, prioritizing profit over patient access, straining governments’ healthcare budgets and putting patients’ health — sometimes even their lives — at risk.
For its Cancer Calculus project, the International Consortium of Investigative Journalists tracked Keytruda-related patents to show how Merck & Co. and other pharmaceutical companies created a dense web of patent applications that can make it harder for more affordable versions of the drug, known as biosimilars, to enter markets around the world. Merck, known as MSD outside the U.S. and Canada, did this by applying for patents for changes to formulation and dosing regimens, altering the drug’s use in combination with other agents, or for switching patients to a similar, newer version of the same drug — known as a “product hop.” Each change can potentially reset the patent clock and add years of exclusivity.
Merck’s scramble to fortify its dominance has included filing for patents that are combinations of Keytruda and another medication that aren’t necessarily new or innovative, according to experts interviewed by ICIJ.
Even if a patent isn’t ultimately approved by a patent office, the application itself can increase the complexity of the competitive landscape, creating legal and commercial uncertainty that can delay or deter competitors, patent experts said.
Patents were only part of the data that explains Keytruda’s price dominance and patients’ struggles to cope with it. ICIJ also reviewed the prices of Keytruda (known generically as pembrolizumab) across dozens of countries. Those prices can vary wildly depending on location and medical context — the result of opaque negotiations between governments and Merck. We also reviewed lawsuits and other court documents filed in Latin America to track the rising number of patients fighting in court, regulatory bodies and elsewhere to gain access to Keytruda, a trend due, in part, to its high prices. Researchers in the region see the phenomenon as part of an increasing judicialization of healthcare .
The patent thicket
ICIJ anchored its analysis on patent applications in the U.S., which accounts for 60% of Keytruda sales globally. The Initiative for Medicines, Access, and Knowledge (I-MAK), a U.S.-based, not-for-profit organization that advocates for affordable access to medicines, provided our starting dataset of 184 U.S. patent applications related to Keytruda. After speaking with patent lawyers and pharmaceutical industry experts to refine our methodology, we reviewed each patent application to confirm key details, including legal status, patent owners, known as assignees, and relevant dates using Google Patents, a free public search platform that aggregates patent information from major patent offices worldwide.
We limited the final set to 180 U.S. patent applications (166 filed or co-filed by Merck & Co. and 14 by Ono Pharmaceutical Co., Ltd. a Japanese company we included because its PD-1 patents underpin Keytruda’s core mechanism. (The patents involve the use of what are known as PD-1-blocking antibodies that restore the immune system’s ability to recognize and attack tumor cells; Keytruda was developed using PD-1-blocking antibody technology.) After a legal dispute, Merck bought licenses to Ono patents as part of an interlocking patent structure. Our final set excluded four patent applications not assigned to either Merck or Ono Pharmaceutical.
For each U.S. application, ICIJ then tracked its so-called patent family — a group of patent applications from around the world that cover the same or closely related content, which can include patents filed or co-filed by Merck or MSD and other cancer research businesses. For companies like Merck, the interconnectedness of patents in such families allows them to extend protection around a single drug by filing new applications related to the original patent over time and across markets that can complicate competitors’ decisions about whether to enter a market.
To conduct our analysis, we scraped relevant records from two main websites: Espacenet, a patent search platform developed by the European Patent Office, and Google Patents. Espacenet constructs patent families using an automated system based on so-called shared priority claims, which links a later application to the filing date o…
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