The Distortion of the Legal Exception: Legal and health risks of mass compounding patented medications

Article 43 of Law No. 9,279/1996, the Industrial Property Law (LPI), establishes exceptions to the patent holder's exclusive rights and, in item III, authorizes the preparation of medications by compounding pharmacies pursuant to a medical prescription for individualized use.

This exception fulfills a legitimate and essential purpose: ensuring access to treatment when there are no manufactured alternatives suited to the patient's clinical needs. Without this mechanism, many individuals would be effectively deprived of using the medication, such as cases where a patient cannot swallow a tablet available only in solid form or suffers from allergies to excipients present in the commercial formulation, even though they do not react negatively to the active ingredient.

In these scenarios, magistral adaptation—whether to alter the dosage form or to adjust non-essential components—constitutes the sole means of enabling therapy. Thus, item III reaffirms the importance of individualized treatment, ensuring that legitimate medical needs are met without infringing upon the rights conferred by the patent.

However, a genuine distortion of this exception is currently being observed.

The mechanism designed to serve individual cases is being deployed on a mass scale—commercially, in a standardized manner, and often indiscriminately—particularly concerning popular weight-loss pens such as Ozempic, Victoza, Mounjaro, among others. This abuse of the legal exception poses significant risks to industrial property rights and public health.

Within the scope of industrial property, because Article 43 sets forth exceptions to the patent holder's rights, it must be interpreted restrictively. Consequently, any broad reading compromises the fundamental balance between access to medicine and the protection of innovation.

This restrictive interpretation of the Law imposes clear limits on drug compounding: (i) there must be a medical prescription; (ii) this prescription must be individualized; and (iii) compounding must be carried out by a qualified professional. Only by meeting these specific conditions is reliance on the legal exception permissible¹.

In this regard, when compounding pharmacies begin producing patented medications in a standardized manner—with the same dosage and presentation for mass sale—it is no longer a matter of legal exception, but rather patent infringement.

From a legal standpoint, when unauthorized compounding of a patented medication occurs, the patent owner can—and should—take measures to halt the infringement. In practice, the initial step usually involves sending individual extrajudicial notices (cease-and-desist notices) to the involved pharmacies, notifying them of the violation and demanding the immediate cessation of irregular compounding.

Even if, in certain cases, the multiplicity of infringers and market fragmentation make extrajudicial notices appear minimally effective, they remain the best immediate mechanism available before escalating to more complex and costly legal proceedings.

For this reason, it is essential for the patent holder to have sound legal counsel, both strategically and preventively. Qualified legal assistance helps identify potential misuses of the exception set forth in Article 43, item III, ensuring comprehensive and effective protection of patent rights while maintaining the necessary balance between exclusivity and access to individualized treatment.

This abuse of the legal exception can also pose health risks that extend far beyond the private legal sphere. Mass compounding without proper oversight, validated standardization, and often utilizing raw materials of unverified origin exposes consumers to real dangers.

This risk has already prompted recent intervention by ANVISA (the Brazilian Health Regulatory Agency). Facing an uncontrolled market surrounding so-called weight-loss pens, the Agency published TECHNICAL NOTE No. 200/2025/SEI/GIMED/GGFIS/DIRE4/ANVISA², harmonizing guidelines on the importation, compounding, and sanitary control of GLP-1 receptor agonist Active Pharmaceutical Ingredients (APIs). Through this measure, ANVISA sought to curb unsafe practices and standardize mandatory inspection criteria, ultimately significantly restricting the compounding of these ingredients due to a lack of proven safety and efficacy.

The case of weight-loss pens serves as a clear warning: without a restrictive interpretation and firm action from regulatory bodies, an exception intended for individualized use risks becoming the rule.

Therefore, the exception in Article 43 of the LPI remains an essential tool for guaranteeing access to individualized treatments. However, the improper reliance on this exception to justify the large-scale compounding of patented drugs creates a distortion that compromises consumer health and safety, the integrity of the industrial property system, and trust in the pharmaceutical market.

¹ Reference to legal scholarship on Art. 43, III of the LPI. DANNEMANN SIEMSEN INSTITUTE FOR LEGAL AND TECHNICAL STUDIES. Comments on the Industrial Property Law (Comentários à Lei de Propriedade Industrial). 3rd Edition.

² NATIONAL HEALTH SURVEILLANCE AGENCY (ANVISA). TECHNICAL NOTE No. 200/2025/SEI/GIMED/GGFIS/DIRE4/ANVISA.