Carolina Mazzocato – Patent Specialist, Biologist
Rafael Garutti – Partner
Brazil has recently seen a visible expansion in the commercialization of compounded versions of medicines whose active ingredients remain under patent protection. For foreign pharmaceutical companies and biotech innovators, this trend raises important questions regarding both regulatory compliance and patent enforcement strategy.
Understanding how Brazilian law frames this issue is essential to assessing potential risks and defining appropriate responses.
Compounded medicines are not generics
A recurring misconception in the market is the assumption that compounded products are equivalent to generics. From a regulatory standpoint, they are not.
Generic medicines in Brazil must undergo strict evaluation by the National Healthcare Agency ANVISA (Agência Nacional de Vigilância Sanitária, in Portuguese), including bioequivalence, quality control, stability testing and manufacturing under certified industrial standards.
Compounded medicines, on the other hand, are prepared by pharmacies upon individual medical prescription, intended to address specific patient needs, such as dosage adjustments or formulation changes due to intolerance to certain excipients.
Brazilian regulation does not allow compounded medicines to be produced on an industrial scale or to systematically replace patented or commercially available products. Their legal basis is individualized care, not market substitution.
The patent exception under Brazilian law
Patent protection in Brazil is governed by the Law no. 9.279/1996 (Brazilian Industrial Property Law – “BIPL”).
As a general rule, patent owners have the exclusive right to prevent third parties from manufacturing, using, offering for sale or commercializing a patented product or process during the term of protection.
However, Article 43, item III of the BIPL establishes a specific exception:
Article 43. The provisions of the previous Article do not apply: […]
III. to the preparation of a medicine in accordance with a medical prescription for individual cases, carried out by a qualified professional, as well as to the medicine so prepared;
This exception is narrow and purpose driven. It allows individualized compounding but does not authorize repeated preparation for stock or distribution, marketing strategies targeting broad patient groups, nor commercial-scale reproduction of patented products.
When compounding activities exceed individualized prescriptions and begin to replicate market demand in a structured or recurrent manner, the activity may fall outside the scope of the legal exception and potentially infringe patent rights.
High-risk products and regulatory exposure
The issue becomes even more sensitive in the case of injectable products or substances classified as high sanitary risk.
These products require validated sterilized conditions, certified production protocols, lot traceability, and industrial-level quality assurance systems.
Such conditions are typically ensured only by ANVISA-certified manufacturers and importers. Any variation may not only create patent-related exposure, but also regulatory and public health liabilities.
For patent owners, intellectual property and sanitary/regulatory compliance open strategic avenues for action.
Strategic considerations for foreign patent holders
From an enforcement and compliance perspective, foreign companies should monitor:
- Whether compounded versions are being produced strictly upon individualized prescriptions,
- Whether pharmacies are engaging in recurrent preparation patterns that resemble industrial production,
- Whether marketing communications suggest systematic substitution of patented medicines,
- Whether high-risk products are being compounded beyond regulatory limits.
The Brazilian legal framework seeks to balance access to healthcare and protection of innovation. The compounding exception exists to preserve individualized medical care, not to dilute patent exclusivity.
Careful case-by-case assessment is critical. In certain circumstances, coordinated regulatory and judicial measures may be appropriate to safeguard both public health standards and patent rights.
For innovative companies operating in Brazil, proactive monitoring and early strategic positioning are often more effective than reactive litigation.