Brazil: The patent combination conundrum
Patents to new medicines usually protect the active ingredient (compound), provided that it is new and inventive. It is also a common practice for pharmaceutical companies to seek patent protection for drug combinations, which can be especially valuable for providing a competitive advantage over other companies that are developing single-component drugs.
According to the Brazilian Patent Office (BRPTO)’s understanding given by the current Examination Guidelines, combinations are the association of two or more compounds seeking a certain final product.
They can cover a variety of drug products, including fixed-dose combinations, where two or more active ingredients are combined in a single tablet or capsule, and co-packaged combinations, where two or more drugs are sold in separate packages but are intended for simultaneous applications.
Patent eligibility: The approach of the BRPTO
The patentability of pharmaceutical combinations is evaluated in accordance with the requirements set forth in the Brazilian Industrial Property Law No. 9.279/96 (IPL) and the Guidelines for the Examination of Patent Applications in the Field of Chemistry, Resolution No. 208/2017.
Obtaining combination patents in Brazil can be challenging due to some unique considerations on the legal requirements for patentability, including novelty and inventive step.
Novelty refers to the requirement that an invention must be new and not previously disclosed in the prior art. In the case of combination patents, the combination of compounds must not have been disclosed in the prior art.
Inventive step refers to the requirement that an invention must not be obvious to a person skilled in the art, in view of the existing prior art. In the case of combination patents, the combination must provide a non-obvious technical effect or result that is not predictable from the use of each compound individually, such as a synergistic or supra-additive effect.
To prove this technical advantage, the combination must show an effect that is greater than that obtained with each of the compounds used alone and not the mere sum of the effects produced by the use of the compounds separately, and this effect can be demonstrated through experimental data.
In addition to these requirements, the patent application must also meet the formal requirements, such as a clear and complete description of the invention. For instance, according to the current Examination Guidelines, in patent applications related to combinations in which the compounds are in separate forms, the specification must present evidence that such combinations are obtainable in the form of a product for simultaneous application, even if it is claimed by means of a kit.
Claims for combination therapy: How to protect
In case the above requirements are met, the combination per se may be protected independently of any medical use. A simple acceptable claim according to our local practice would be “A pharmaceutical combination, characterised by comprising compound A and compound B”.
Claims directed to the method of treatment itself, rather than the combination per se or a specific use thereof, are not considered to be patentable subject matter under Brazilian law, such as:
- “Use of a combination of drug X and drug Y, characterised by being for the treatment of disease Z”.
- “Use of drug X in combination with drug Y, characterised by being for the treatment of disease Z”.
- “A combination of drug X and drug Y, characterised by being for the treatment of disease Z”.
- “A method for the treatment of disease Z, characterised by comprising administering a combination of drug X and drug Y to a subject”.
Whenever patent applications include claims directed to combined therapies as a method of treatment, such claims will most likely be rejected by the BRPTO.
While claims directed to a combined therapy as a method of treatment are not patentable in Brazil, it is possible to obtain patent protection for the use of a combination to treat a particular disease or condition, provided that the claims define a specific use or indication of the therapy rather than the method of the treatment itself.
These types of claims are known as "second medical use" claims (the so-called “Swiss-type use claims) which are potentially patentable subject matter under Brazilian law. The acceptable standard format of a Swiss-type use claim is: “Use of a drug X and a drug Y, characterised by being for the manufacture of a medicament for treating/preventing disease Z”.
Attention should be drawn to claims drafted as: “Use of drug X, characterised by being for the manufacture of a medicament for treating/preventing disease Y in combination with a drug Z”. The BRPTO may understand this claim wording as a combination of compounds that may be administered sequentially, thus characterizing a therapeutic method.
It is also important to point out that second medical use claims must specify the disease to be treated. Excerpts contained in the claims related to the therapeutic regimen (such as dosage and administration mode/application) and/or group of patients do render the use of a combination novel. Whenever there is support in the specification, the dosage scheme of a pharmaceutical combination may be claimed by means of a kit.
Bearing these particularities of our local practice in mind, this subject matter requires a careful analysis of the technical considerations involved.
Benefits of patents for new combinations
Overall, under certain conditions, pharmaceutical combinations are worthy of patent protection in Brazil. Such patents play an important role in the pharmaceutical industry. They can stimulate innovation by providing incentives for companies to explore new drug combinations that could have enhanced therapeutic benefits compared to single-component drugs. This can lead to the development of new and effective treatments for a wide range of medical conditions. They can also improve patient adherence to treatments by reducing substantial costs to the healthcare systems.
Combination patents can potentially extend the life cycle of a product by providing additional protection for the underlying technology and preventing competitors from replicating the product by using a combination of different patent-protected technologies.
It is important to note that the effectiveness of combination patents in extending the life cycle of a product depends on a variety of factors, including the strength and breadth of these patents. Additionally, combination patents are subject to the same legal and regulatory limitations as other types of patents and their effectiveness can be challenged through legal proceedings and regulatory actions.
Patent applicants should then work closely with experienced patent attorneys to ensure that their applications meet the legal requirements and are as strong as possible.
Lívia Figueiredo is a senior patent specialist at Kasznar Leonardos. She can be contacted at: livia.figueiredo@kasznarleonardos.com
Priscila Kashiwabara is a partner at Kasznar Leonardos, heading the Life Sciences Patent Division. She can be contacted at: priscila.kashiwabara@kasznarleonardos.com
