The Ukrainian patient-led organization 100 Percent Life, a member of the Make Medicines Affordable campaign, has filed oppositions against patent applications on the HPV vaccine, which reduces the incidence rate of cervical cancer by up to 86%, and pembrolizumab, an immunotherapy which blocks the PD-1 protein, is used to treat several types of cancer, including cervical cancer. Pembrolizumab improves survival among cancer patients, with one study from the U.S. National Cancer Institute reporting a 40% reduced risk of death.
For cervical cancer prevention, the focus is on a patent application on a single-dose HPV vaccine. While a single-dose regimen is essential for Ukraine’s National Immunoprophylaxis Program, the opposition argues that Merck Sharp & Dohme’s (MSD’s) use of a lipid nanoparticle -based adjuvant to enable a single -dose vaccine was already documented years before this application was filed (known as prior art, or use of existing knowledge) which fails to meet the inventive step requirement for obtaining a patent. Through this patent challenge, 100 Percent Life aims to prevent unjustified patent barriers that could block other manufacturers from providing more affordable single-dose vaccines.
“Preventing unjustified patent monopolies on the HPV vaccines is critical for our national health system. We must ensure that patent legislation is not used to block affordable cervical cancer prevention programs in Ukraine,” says Kochubei.
Pembrolizumab is priced at US $150,000 per year in the US or Canada, although production costs account for only 0.8% to 2.4% of this price. Despite its exorbitant pricing — which keeps it out of reach for most of the world — the World Health Organization recently included pembrolizumab for cervical cancer into its Model Essential Medicines List. Pembrolizumab was the world’s top selling drug in 2024, generating nearly $29.5 billion in sales for Merck Sharp & Dohme.
The oppositions 100 Percent Life filed on pembrolizumab patents seek to improve affordability of and access to pembrolizumab. They challenge the patent application on MSD’s less frequent dosing regimen (involving the administration of approximately 400 mg of pembrolizumab every six weeks (instead of 200 mg every 3 weeks) and a combination therapy using pembrolizumab with chimeric Newcastle disease viruses (NDV). According to 100 Percent Life, the change in dosing frequency is not a new invention; it is a routine optimization that cancer specialists could easily find in existing, publicly available data. Similarly, the second application sought to patent a method of treating cancer, by administering chimeric NDV and PD-1 protein blockers, such as pembrolizumab. 100 Percent Life states that knowledge about using these therapies together already exists, and therefore, it fails to meet the inventive step requirement necessary for obtaining a patent.
Veronika Kochubei, who is 100 Percent Life’s intellectual property counsel, explains that the attempts to patent the dosing regimen and combination therapy constitute evergreening, a practice where pharmaceutical companies seek to extend their market monopolies by patenting minor modifications (such as new dosing regimen or combinations of known therapeutic agents) rather than genuine innovations.
“Granting patents for a dosing regimen or for combinations of known therapeutic agents does not reward genuine innovation; it creates artificial barriers by keeping prices high, and preventing patients from accessing the life-saving treatments they need,” said Kochubei. “Our goal is to ensure that the Ukrainian patent system serves the public interest. By rejecting applications that lack inventive steps, we protect the public budget and, more importantly, the lives of thousands of patients.”
100 Percent Life argues that if the current patent applications on pembrolizumab are granted, they will “…block competition in the Ukraine’s pharmaceutical market for a long time” and “…will further limit the access of Ukrainian patients to this important drug.”
100 Percent Life’s opposition highlighted the case of the breast cancer drug trastuzumab. When competition with a biosimilar, non-patented version of trastuzmab was allowed in Ukraine, the price dropped significantly, making the treatment much more affordable, and accessible to patients who need it. The biosimilar version is over ten times cheaper than the original, resulting in savings exceeding 892 million UAH annually (approximately $22 million USD) for the state.
“We have seen with drugs like trastuzumab that competition can lower prices by more than 90%. We are filing these oppositions to ensure that the same thing happens for cancer patients who need pembrolizumab today,” says Kochubei.
ABIA’s Legal Battle Against Unjustified Patent Extensions
ABIA (the Brazilian Interdisciplinary AIDS Association), a civil society advocacy organization in Rio de Janeiro, through the Working Group on Intellectual Property of REBRIP (GTPI) is challenging MSD’s patent on pembrolizumab formulations.
The opposition against MSD’s patent application for pembrolizumab (BR 11 2019 022972 8) targets what ABIA states is a lack of “inventive step.” ABIA argues that the patent seeks to monopolize specific liquid formulations of the antibody (using standard components like histidine buffers and polysorbate 80), which are routine in the pharmaceutical industry. By claiming these common formulations as inventions, Merck effectively blocks the entry of more affordable biosimilar versions. According to ABIA, such “secondary patents” do not represent true innovation but are strategic barriers designed to extend the monopolies that keep prices too high at the expense of people who need them.
“Based on our patent landscaping for pembrolizumab, we identified more than 32 related patent filings. With the earliest patent expected to expire in about two years, Brazil must be able to secure timely entry of biosimilars. Our oppositions are a direct response to the industry’s patent evergreening playbook. Stopping these abusive extensions is essential to protect the public health system’s budget and ensure that people who need pembrolizumab can access it,” says Susana van der Ploeg, the coordinator of the GTPI at ABIA.
The primary objective of these filings is to protect Brazil’s Unified Health System (SUS). By challenging unjustified patents, ABIA seeks to lower prices through biosimilar competition, ensuring that the government can afford to provide these life-saving treatments to all patients in need.
Holding Big Pharma Accountable
Despite MSD’s claims to “increase the availability, accessibility and affordability of our medicines for underserved patient populations in low- and middle-income countries,” the pharmaceutical company has been blasted several times for its patenting practices by grassroots health activists and medical humanitarian groups such as Médecins Sans Frontières (MSF), which has stated that the company’s profits on life-saving medications and treatments exceed “sustainable generic prices.”
Advocates can clear the way for biosimilar and generic medications by ensuring that only true innovations receive patent protection – thereby increasing affordability and access to life-saving medications.