Background on the Case
On January 22, 2026, a Mexican collegiate court made an unusual decision to revive the expired patent of Amgen’s drug Prolia, which protects the active ingredient Denosumab. This molecule is crucial for treating osteoporosis and certain bone cancers. The patent, which expired in 2022, was set to allow generic and biosimilar competition, expanding access at lower prices. However, with the patent extension until 2027, monopoly protection has been resurrected, leaving potential competitors in limbo who had already invested in development and regulatory approvals.
Who is Amgen?
Amgen is a multinational biopharmaceutical company based in the United States. The company focuses on research, development, manufacturing, and marketing of human therapeutics based on biotechnology. Prolia is one of Amgen’s commercialized drugs, used to treat osteoporosis and certain bone cancers.
Experts’ Reactions and Implications
Heidi Lindner, a founding partner of Arochi & Lindner, a firm specializing in Intellectual Property and Health Regulation, expressed her indignation over the court’s decision. She pointed out that extending patents is not uncommon, but this case with Prolia is particularly problematic. In Mexico, patent extensions occur years after expiration through legal loopholes, whereas other countries have clear rules and strict deadlines for extensions.
Impact on Patients, Public Budget, and Generic Competition
Denosumab is not a luxury; it’s essential for thousands of patients. In the private market, a single injection costs between 8,000 to 10,000 Mexican pesos, making it unaffordable for most. In the public sector, the burden is even greater; over 1.9 billion pesos were allocated in 2025-2026 for purchasing this medication. Reviving the patent creates a barrier to competition, prolonging high prices and straining public budgets while excluding patients from affordable treatments.
Comparison with Rituximab Case
Lindner compared this situation to the historical case of Rituximab, where Swiss company Roche removed Probiomed’s biosimilar from the Mexican market using legal maneuvers, despite its safety and public benefit. She emphasized that large pharmaceutical companies find ways to extend monopolies, leaving generic competitors unaware until late in the process.
Legal Battles and Institutional Responsibility
The Mexican Institute of Industrial Property (IMPI) has denied these patent extensions, but companies continue to litigate and win in district or collegiate courts. In this case, the 2-1 vote highlights the controversy surrounding patent extensions. Lindner stressed that legal maneuvers to resurrect expired patents are detrimental to the country and its citizens.
Mexico’s History of Obstacles for Generics
This case is not isolated; Mexico has a history of obstacles for generic drugs. Many medications have available generics or biosimilars in the United States and Canada, but Mexico still enforces patents, limiting access. These obstacles range from the “linkage” between patents and registrations to international pressures, including the USMCA, which strengthen innovator protections at the expense of limiting access to more patients.
Uncertain Future for Pharmaceutical Industry
Currently, there are over 55 pending pharmaceutical patents compensating for delays. The spirit of generic drugs promises accessible treatments for the majority, but obstructing this goal hinders access. While patents encourage innovation, prolonged monopolies beyond reason become abusive.
Call for Action from Economy and Health
The Secretariat of Economy, led by Marcelo Ebrard, must act to align regulations, enforce strict deadlines for extension requests, and ensure stakeholder participation in litigation. The balance and sustainability of a strategic pharmaceutical industry, as outlined in Mexico’s National Development Plan, are at stake. Authorities like Health Secretary David Kershenobich and Cofepris head Víctor Hugo Borja must also take action against legal maneuvers that hinder access to therapies and threaten public health, especially for vulnerable patients.
Bayer’s Collaboration with UNFPA
In an interesting development, the German conglomerate Bayer signed a collaboration agreement with the United Nations Population Fund (UNFPA) to work on shared interests in various regions worldwide, including Mexico. The partnership aims to share information, capabilities, and evaluate joint projects in priority social and public health areas like sexual and reproductive health, focusing on contraception, adolescent pregnancy prevention, and women’s health throughout their lives.
First Study on Menopause and Women’s Economic Participation in Mexico
“Sin Reglas,” an initiative founded by Gabriela Rojas and Mamen Díaz, conducted a study in collaboration with UNFPA and sponsored by Essity and Bayer. The research highlights the significant impact of menopause on women’s well-being, productivity, and economic autonomy in Mexico. With around 12 million Mexican women experiencing menopause, the study concludes that institutional recognition, flexible work conditions, and increased awareness can mitigate the effects of menopause on women’s lives.
