Animal health plays a critical role in protecting public health and ensuring the proper functioning of the agri-food system. Ensuring that animals are free from disease has a positive impact on animal welfare, but it also has a direct impact on the quality and safety of the food we consume. In this context, scientific and technological advances in the diagnosis, prevention, and treatment of diseases have been fundamental. And with them comes a key question for researchers, veterinary companies, and developers: what can and cannot be patented in animal health?
Understanding the legal limits of patentability in this field is essential to protect innovations that make a difference in animal disease control, improve available treatments, and reduce health risks to the population.
What can be patented in animal health according to the law?
For decades, the development of vaccines, antibiotics, diagnostic tests, and veterinary technologies has been a driving force for progress in animal health. These advances, in addition to enabling the prevention and eradication of costly and persistent infectious diseases, have helped livestock farmers maintain productivity, ensuring food security.
But before attempting to register, it is essential to know the criteria established by law regarding what can actually be patented in animal health. In Spain, Law 24/2015 of July 24 on Patents is the regulatory framework that governs the protection of innovations under this category. It establishes clear requirements that all inventions must meet in order to be patentable: novelty, inventive step, and industrial application.
In the specific case of animal health, inventions that meet these criteria and are related to technical products or processes are patentable, even when they involve the use of biological material.
Biological material: how to include it in a patentable innovation?
Precisely, one of the most notable aspects regulated by the Patent Law is the possibility of protecting inventions related to biological material. This point is especially relevant in animal health, where biotechnology is becoming increasingly important.
According to Article 4 of the Law, any invention that uses biological material can be patented in animal health. However, this is only possible if the material has been isolated from its natural environment or produced using a technical process. Thus, even if a microorganism exists naturally, if it is isolated, modified, or used technically to create a useful product—such as a strain used for a veterinary vaccine—it can be protected by a patent.
In addition, biological material is recognized as that which contains genetic information that is self-reproducing or reproducible in a biological system. The concept of microbiological process is also defined as one that intervenes in, modifies, or generates microbiological material. These definitions broaden the scope of innovation that can be protected, encouraging the development of increasingly effective solutions in the veterinary field.
What cannot be patented in animal health: necessary limits
As you can see, the Spanish legal framework allows for broad protection for innovation in the sector in question. However, it also clearly establishes what cannot be patented in animal health. Article 5 of the Patent Law details exclusions, many of which respond to ethical principles, animal welfare, or public interest.
Firstly, procedures that involve animal suffering without substantial medical or veterinary utility cannot be patented. In other words, practices that alter the genetic identity of an animal cannot be patented if they do not submit a clear benefit to the health of the animal itself or others.
Animal breeds and biological processes based exclusively on natural phenomena such as crossing or selection are also not patentable. However, if it is a technical or microbiological procedure—for example, a scientifically controlled and justified genetic modification—it could be admissible.
Another key point that limits patentability concerns therapeutic, surgical, or diagnostic methods applied directly to the animal’s body. In these cases, the legislation protects the welfare and dignity of living beings by preventing such interventions, in themselves, from being considered patentable commercial inventions. However, products, substances, or devices designed to carry out such methods can be patented. For example, a new type of veterinary healing gel or a portable ultrasound device for livestock is patentable.
So, what can be patented in animal health?
In the field of livestock and veterinary health, patents are a strategic tool for protecting technological and scientific developments. But what can be patented in animal health in practice? The answer is quite broad and ranges from pharmacological products to technological solutions that transform the way animal welfare is cared for.
Specifically, according to the Patent Law, products such as the following can be protected as patentable inventions:
- Veterinary medicines: vaccines, antibiotics, and antiparasitics, among others.
- Advances in animal genetics: genetic markers or techniques to increase disease resistance.
- Sensors that monitor vital signs in real time.
- Functional feed that, in addition to feeding the animal, prevents common ailments.
In all these cases, the key is compliance with the basic criteria: novelty, inventive step, and industrial application.
These innovations have a direct impact on the productivity and sustainability of the sector. They make it possible to reduce mortality rates, avoid mass slaughter due to communicable diseases, and improve efficiency in the use of resources. In other words, every patentable advance in animal health not only protects an invention but also submits concrete solutions to the daily challenges of the agricultural sector.
Diagnostic methods: the limits of patentability
Undoubtedly, one of the most sensitive aspects in the field of animal health is the protection of diagnostic methods. As a general rule, if the diagnostic procedure is applied directly to the animal’s body, it cannot be patented. This restriction seeks to protect free veterinary practice and avoid legal barriers that could hinder clinical care.
However, this limitation does not mean that all diagnostic tools are beyond the scope of patents. There are exceptions that allow certain related developments to be registered:
- Ex vivo methods. If the analysis or procedure is performed outside the animal’s body, for example on a blood or tissue sample processed in a laboratory, it could be considered patentable. The key is to clearly demonstrate that the method is not applied directly to the animal’s body.
- Products used in diagnosis. In fact, even if the method cannot be patented, the substances, compounds, devices, or instruments used in the process can be protected. This includes reagents, analysis kits, or clinical data interpretation software.
- Non-therapeutic methods. It is possible to patent some procedures that are intended to monitor, evaluate, or classify physiological conditions, without being directly linked to a therapy.
Of course, in the case of a genetic sequence or biomarker, it will be essential to justify its specific industrial application in order for it to be considered a protectable invention.
Why is it key to protect what can be patented in animal health?
Patents, apart from representing legal protection for an invention, also allow universities, research centers, and companies to recover and capitalize on their investments in R&D. As you know, in the context of animal health, product development can take years of search and testing. Therefore, having a patent guarantees a fair economic return and encourages continuous innovation.
Once granted, a patent confers exclusive exploitation rights for a limited period, usually 20 years. This means that no one else can manufacture, market, or use the invention without the consent of the owner. This exclusivity translates into a direct competitive advantage in the market and the possibility of capitalizing on innovation in several ways:
- License the patent. The owner allows another company to commercially exploit the invention in exchange for periodic payments or royalties.
- Sell the patent. In other words, ownership is transferred to a third party in exchange for a one-time payment.
- Exploit it directly. Develop, manufacture, and market the solution on your own, maximizing profit.
Furthermore, protection does not have to be limited to the national sphere. An invention can be registered in multiple countries through agreements such as the International Patent System. This is certainly an essential strategy for those who plan to export technology or establish an international presence in the veterinary sector.
And in any case of plagiarism, copying, or unauthorized use, having a solid patent allows you to take legal action and defend the authorship of the innovation.
Do you need to know what can be patented in animal health? At ISERN, we can help you.
Do you work in the development of animal health solutions and are unsure which advances can be protected by patent? At ISERN Patents and Trademarks, we offer you the support you need. Our team of specialists advises you on everything related to registrable inventions, both in the veterinary field and in other sectors related to intellectual property.
In this regard, we analyze the patentability of your developments and process the applications. If necessary, we also take legal action to protect your rights against misuse by third parties.
With over a century of experience and a multidisciplinary team of more than 150 professionals, ISERN is a leader in registering and defending patents, trademarks, and other intangible assets, both in Spain and internationally.
If you lead a laboratory, company, or research unit focused on veterinary products and want to ensure that your innovations are well protected, we are here to help you.e. Contáctanos para tener claro qué puede patentarse sobre la sanidad animal y acompañarte en todo el proceso.