Ritter Advogados

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 compounding of medications by compounding pharmacies, based on medical prescriptions, for individualized use.

This exception serves a legitimate and essential purpose: ensuring access to treatment when there are no industrialized alternatives suitable to the patient’s clinical needs. Without this possibility, many individuals would effectively be denied access to the medication—such as in cases where the patient is unable to swallow a pill available only in solid form or has allergies to excipients present in the industrial formulation, even though they do not react to the active ingredient.

In such cases, compounded adaptation—whether to alter the pharmaceutical form or to adjust non-essential components—is the only way to make the therapy viable. Thus, item III reaffirms the importance of individualized treatment, ensuring that legitimate medical needs are met without this constituting a violation of the rights granted by the patent.

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

The mechanism originally intended for individual cases is being used on a mass, commercial, standardized, and often indiscriminate scale—especially when it comes to the well-known weight-loss pens, such as Ozempic, Victoza, Mounjaro, among others. This abuse of the legal exception may pose risks to both industrial property rights and public health.

Within the scope of industrial property, Article 43, as it establishes exceptions to the patent holder’s rights, must be interpreted restrictively. Any broad interpretation compromises the fundamental balance between access to medicine and protection of innovation.

This restrictive interpretation of the law imposes clear limits on the compounding of medications: (i) there must be a medical prescription; (ii) this prescription must be individualized; and (iii) the compounding must be performed by a qualified professional. Only when these specific conditions are met is the use of the legal exception permitted¹.

In this sense, when compounding pharmacies begin producing patented medications in a standardized manner, with the same dosage and presentation, aiming at large-scale sales, this can no longer be considered an exception—it constitutes a patent infringement.

From a legal standpoint, when a patented drug is improperly compounded, the patent holder can—and should—take measures to stop the infringement. In practice, the first step is usually the individual extrajudicial notification of the involved pharmacies, informing them of the violation and demanding the immediate cessation of the irregular compounding.

Even though in some cases the multiplicity of infringers and the fragmented market may make extrajudicial notification seem ineffective, it remains the best immediate mechanism available before resorting to more complex and costly legal actions.

For this reason, it is essential that the patent holder is well advised, both strategically and preventively. Qualified legal counsel helps identify improper uses of the exception provided in Article 43, item III, and ensures broad and effective protection of patent rights—without disregarding the necessary balance between exclusivity and access to individualized treatment.

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

This risk has already prompted a recent intervention by ANVISA. Faced with the uncontrolled market surrounding the so-called weight-loss pens, the Agency published TECHNICAL NOTE No. 200/2025/SEI/GIMED/GGFIS/DIRE4/ANVISA², harmonizing interpretations on the importation, compounding, and sanitary control of GLP-1 receptor agonist Active Pharmaceutical Ingredients (APIs). With this, it sought to curb unsafe practices and to standardize mandatory inspection criteria—going as far as significantly restricting the compounding of these APIs due to the lack of proof regarding their safety and efficacy.

The case of the weight-loss pens is a clear warning: without a restrictive interpretation and strong action by regulatory bodies, the exception intended for individual use risks becoming the norm.

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

¹Reference to doctrinal understanding of Article 43, III of the LPI. INSTITUTO DANNEMANN SIEMSEN DE ESTUDOS JURÍDICOS E TÉCNICOS. Comentários à Lei de Propriedade Industrial. 3rd Edition.

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