The Problem of Patent Linkage in Mexico
In Mexico, a silent enemy is draining thousands of millions of pesos from the public treasury and condemning patients to inaccessible treatments: a bureaucratic concept known as patent linkage.
Typically, in Mexico, generic and biosimilar drugs arrive 3 to 4 years later than in other countries. These are “younger brother” versions of the innovative medicine, which come to market at a lower price because the patent protection period has ended. They are the solution for making cutting-edge treatments more accessible and saving more patients’ lives with high-cost diseases.
The issue lies in the fact that, due to this linkage—an administrative connection between Mexico’s Intellectual Property Institute (IMPI) and Cofepris—the former is obligated to ask the latter if any patent is being violated when registering a generic or biosimilar. This was established under the North American Free Trade Agreement (NAFTA), but it has become more rigid in Mexico than in the United States and Canada, where replicas are genuinely encouraged and reach the market faster.
Impact on Patients
For Mexican patients, this situation is devastating. A biosimilar that could save their lives does not reach Mexico because the registration request languishes for years in Cofepris. This creates direct barriers that prevent access to high-cost biotechnological treatments.
Financial Consequences
A recent analysis by pharmaceutical industry intellectual property experts, based on public tenders from 2023 to 2026, reveals that the delay in introducing biosimilars and generics for nine key molecules has cost Mexico’s healthcare system approximately 1,332 million pesos (over 76.1 million USD), affecting access to cancer, autoimmune disease, and rare disease treatments.
Key Offending Biosimilars
Among the leading cost-hidden biosimilars are:
- Bevacizumab (100 mg): A monoclonal antibody essential for colorectal and lung cancer treatment, tops the list with a 209.5 million peso (12 million USD) impact. Its arrival in Mexico was delayed by 82 months compared to the US, preventing price reductions.
- Omalizumab (202.5 mg): Used for severe asthma and chronic urticaria, it accumulates an overcharge for Mexico of 264.2 million pesos (over 15 million USD). In the US, it was approved in 2003, but its Mexican generic counterpart is still embroiled in endless litigation, leaving families without options or forcing them to bear catastrophic and impoverishing out-of-pocket expenses for the only available treatment, the patented one.
- Ranibizumab (2.3 mg): An injection for age-related macular degeneration seems modest at 16.3 million pesos (930,000 USD), but its delay—similar to other ophthalmological treatments—deprives thousands of elderly adults of affordable, low-cost vision preservation.
- Tocilizumab (80 mg and 200 mg): For inflammatory and autoimmune diseases, together they sum up 486 million pesos (27.8 million USD). Vital for rheumatoid arthritis and severe COVID-19, its biosimilar took decades to challenge the original innovator.
- Ustekinumab (45 mg): For psoriasis and Crohn’s disease. Apart from biosimilars, there are also small molecule generics stuck:
- Pazopanib (200 mg and 400 mg): A chemotherapy drug for renal cancer.
- Plerixafor (24 mg): For rare leukemia and transplants under rare conditions.
Comparison with North America
In North America, the linkage scheme is more balanced since it’s compensated by the Hatch-Waxman Act, which imposes a 30-month stay and rewards the first competitor of the original drug with 180 days of exclusivity. In Mexico, however, there is no such equilibrium: the linkage serves as a one-way shield for innovators, fostering the so-called evergreening of patents and protracted litigation, discouraging the production of replicas and perpetuating dependence on imports.
Call for Reform
It’s high time legislators, Cofepris, and IMPI prioritize patients over patents. A reform to the linkage is not a luxury; it’s an ethical and fiscal imperative. Otherwise, the true cost won’t just be millions of pesos but also countless delayed lives. How much longer will we wait?
Anafam’s Role in Promoting Biosimilares
Meanwhile, Mexico is being targeted as a case study to boost the biosimilar branch of the pharmaceutical industry, according to the International Generic and Biosimilar Medicines Association (IGBA). However, the road ahead is long. At the recent IGBA meeting in Geneva, where Ricardo del Olmo from Anafam participated, the potential of Mexico to advance in biosimilar research, development, and production was highlighted. The IGBA, linked to WIPO and ICH, underscored this opportunity but also exposed Mexico’s lag in this field. While 80% of the Mexican market comprises generics, biosimilars still face regulatory and investment barriers.
The IGBA’s initiative, supported by the WHO, aims to standardize global norms to facilitate access to these medications, potentially generating savings to strengthen the healthcare system. However, Mexico must accelerate its efforts to overcome its limitations and capitalize on this opportunity.
Amelaf’s Growth with New Members
Another association in this sector is Amelaf, the Mexican Association of Pharmaceutical Laboratories, which includes national capital-based companies producing generics and biosimilars. Recently, Amelaf has been very active and incorporated new members. Notable additions include:
- Ulsatech: Specialized in oncology and high-specialty biosimilars, which could boost cancer treatment access in Mexico, where there’s a significant lag.
- Sinbiotic: Founded in 1975 in the State of Mexico, joins as an API manufacturer, contributing to reducing the importation of 90% of these crucial components.
- Progel: With decades of experience in León, Guanajuato, produces gelatin capsules for the industry, supporting the formulation of affordable medications.
- Russek: A prestigious laboratory based in Tlalnepantla, contributes expertise in generics and injectables, essential for hospital supply.
- Novonafar: Established in Guadalajara, strengthens regional generic production, aligning with Amelaf’s goal of raising national content to 30% in raw materials.
These new allies represent a necessary advancement, but the industry still faces enormous tasks: working with Cofepris to harmonize regulations and investing in R&D to compete globally. What’s missing to consolidate a sovereign and efficient pharmaceutical industry is an industrial policy that includes, for example, respecting the 15% national preference in tenders.
