The pharmaceutical industry stands on a complex foundation: constant research, million-dollar investments, and a high level of risk. Every time a laboratory begins developing a new drug, it knows the road will be long and costly. Therefore, pharmaceutical patents become an indispensable element, as they grant researchers and companies an exclusive right over their invention for a limited time. This exclusivity, in addition to rewarding the effort invested, incentivizes the creation of new treatments that otherwise would hardly reach patients.
But which products can benefit from this right and which cannot, and what are the requirements set by Spanish legislation for their granting? This is what we will attempt to answer in the following lines.
What are pharmaceutical patents and why are they so important?
Pharmaceutical patents are part of industrial property rights, a field within intellectual property. In practice, they are a set of privileges granted by a State to the inventor of a compound, procedure, or technology with medical application. These rights grant exclusivity over the manufacturing, commercialization, and use of the invention, preventing third parties from exploiting it without the owner’s consent.
The principle is simple: in exchange for that exclusivity, the inventor must make the technical information of the patented compound or process public. In this way, knowledge is shared, but the exploitation right remains protected.
The standard term of a patent is 20 years. However, in the pharmaceutical field, that period is effectively reduced. The reason is that between the patent application and the final commercialization authorization for a drug, an average of ten years passes. This time includes the research phases, clinical trials, and regulatory evaluation. Consequently, the actual exclusivity time to recover the investment and generate profits is usually much shorter than theoretically planned.
This detail is critical! In certain cases, developing a drug can cost several billion euros. Out of every 10,000 compounds investigated, barely one becomes an approved drug. Without the security provided by pharmaceutical patents, most companies would hardly assume a risk of such magnitude.
Types of pharmaceutical patents and their impact on the Spanish market
In reality, not all innovations related to medicines are protected in the same way. There are different types of pharmaceutical patents, each with a different scope and function:
- Product patents: they protect the chemical compound itself. They are the most robust, as they prevent another laboratory from manufacturing, using, or marketing that active ingredient without permission.
- Process patents: they focus on the manufacturing method of the medicine, that is, on how it is produced.
- Use patents: they grant exclusivity over new therapeutic applications of an already known compound. For example, when a molecule initially developed to treat hypertension proves effective against another disorder.
- Formulation patents: they protect innovations in the presentation of the medicine, such as new forms of controlled release or more effective administration routes.
Incidentally, the weight of these patents in Spain is notable. According to data from the European Patent Office (EPO), in 2024 the pharmaceutical sector led the number of applications from our country, with 221 registrations, representing an 11.6% increase compared to the previous year. Biotechnology and medical technology also stood out, ranking second. Together, bioscience (which integrates the three sectors) represented nearly a quarter of the total patents applied for in Europe with Spanish origin.
This growth reflects not only the dynamism of the sector but also the strategic importance of protecting innovation in medicines.
What products can become pharmaceutical patents?
Spanish legislation, contained in Patent Law 24/2015, does not literally define what a patent is. Instead, it specifies which inventions can be registered and which cannot be patented.
For a development to become a pharmaceutical patent, certain patentability requirements must be met:
- Novelty: the invention must not have been previously disclosed anywhere in the world. Indeed, this criterion is absolute; it is enough for a prior publication, presentation, or registration to exist for the possibility of patenting to be lost.
- Inventive step: the proposed solution cannot be obvious to a specialist in the field. That is, it must provide a creative leap regarding existing knowledge. This examination is done considering the invention as a whole, not piece by piece.
- Industrial application: the innovation must be susceptible to production and use in practice. In the case of medicines, this implies they can be manufactured repeatably and used for a clear therapeutic purpose.
In addition to meeting these conditions, laboratories need to have prior authorization from the Spanish Agency for Medicines and Health Products (AEMPS). Likewise, they must have qualified personnel and guarantee the correct production, distribution, and transport of the drug.
Pharmaceutical patents and ethical limits in innovation
To tell the truth, the pharmaceutical patent system is not absolute. Although it protects a large part of the innovations developed in laboratories and research centers, it also establishes a series of clear prohibitions. These limitations seek to prevent the commercial exploitation of certain discoveries or procedures from conflicting with ethical principles, public health, or respect for life.
In Spain, the Patent Law (24/2015) and European regulations are forceful in pointing out which inventions cannot be registered. And it is precisely in the field of medicines and biotechnology where these restrictions make the most sense, as scientific advances can open very complex ethical dilemmas. Among these, we find: human cloning, the use of embryos, or the genetic manipulation of animals.
Cloning and human genetic manipulation
One of the most sensitive fields is human biology. Therefore, regulations expressly prohibit patents related to cloning people. Cloning, understood as the creation of identical individuals from somatic cells, is a forbidden practice in both Spanish legislation and international agreements, such as the 2005 United Nations Declaration on Human Cloning.
Along the same lines, it is forbidden to patent any procedure that permanently alters the germline genetic identity of the human being. In other words, those modifications that are transmitted from generation to generation. On the other hand, techniques such as somatic gene therapy, tissue engineering, or cell therapy are outside this restriction, as they do not modify the hereditary germline and have specific therapeutic applications.
Inventions that use human embryos for industrial or commercial purposes are also excluded from the pharmaceutical patent system. Even so, it is feasible to patent discoveries in which embryos are used for medical purposes, such as treatments or diagnostics, provided there is no commercial exploitation.
Pharmaceutical patents and genetically modified animals
The use of animals in research opens another field of debate. The law prohibits patenting procedures that modify the genetic identity of animals when this causes them suffering without a relevant medical or veterinary benefit existing.
However, this limit is not absolute. The case of the oncogenic mouse, an animal genetically modified to develop cancer quickly and facilitate oncological research, is a key example. Although the patent was initially denied, the European Patent Office ended up granting it after applying the bonus/malus principle: evaluating if the benefit to society outweighed the animal suffering. In this case, the advance in the fight against cancer prevailed.
In such a way, the legal framework attempts to balance scientific progress with the protection of animals, allowing patenting when the innovation offers clear advantages in terms of human or veterinary health.
Plants, animal breeds and biological processes: another frontier of pharmaceutical patents
Limitations also reach the plant and animal world. It is not possible to patent plant varieties or animal breeds as such. However, the law clarifies that inventions related to living beings can be registered when their application is not limited to a specific variety or breed, but has a broader technical scope.
As an illustration, an innovation applicable to different types of plants or animals could be patentable, provided it is not restricted to a single specific species.
Regarding essential biological processes, such as crossing or natural selection, the law also excludes them from protection. It is understood that these practices are natural phenomena and do not imply an inventive step. Nevertheless, it is permitted to patent non-essentially biological procedures, that is, those in which there is relevant human intervention.
Curiously, this exclusion does not apply to microorganisms. Thus, inventions related to bacteria, viruses, or fungi can be patented as long as they involve an innovative technical procedure. This opens the door for developments in microbiology and biotechnology to have a place within pharmaceutical patents.
Therapeutic and surgical methods: a necessary limit
Another relevant exclusion affects surgical or therapeutic treatment methods applied to the human or animal body. The logic behind this prohibition is clear: if such procedures could be patented, access to health would be severely restricted. Furthermore, they do not meet the “industrial application” requirement, as it is not a repeatable process in terms of production.
But here it is important to distinguish between the procedure and the products used. Despite not being able to patent surgical or therapeutic methods, it is feasible to register the drugs, substances, compositions, instruments, and apparatus used in those treatments. In this way, innovation is protected without hindering medical practice.
The human body and its elements
Spanish law also prohibits patenting the human body in any of its developmental stages, as well as the simple discovery of one of its elements, including complete or partial genes. The idea is simple: the human body and its components cannot be considered an invention.
However, an important exception opens up: an element isolated from the human body, obtained through a technical procedure, can indeed be the subject of a patent. This includes DNA sequences as long as a specific biological function is indicated and a technical method was used to obtain it.
What is not admitted is the mere sequencing of DNA without providing functional information. Certainly, this distinction seeks to avoid the appropriation of basic scientific discoveries that actually belong to common knowledge and must be available to the entire research community.
We accompany you during the entire pharmaceutical patent application process
At ISERN Patentes y Marcas, we provide you with over a century of experience in the field of industrial and intellectual property, both in Spain and in Europe. The goal we set for ourselves is clear: to offer comprehensive advice so that the pharmaceutical patent application process is agile, secure, and adapted to the needs of your company.
In this sense, our team of experts accompanies you at every stage, from preparing the application to the granting of the patent. Even in the subsequent phase, when it is essential to protect it against possible misuse. Once your pharmaceutical patents are granted and you have the marketing authorizations, we stay by your side, actively overseeing the defense of your rights. If you are looking for a trusted ally to protect your innovation, at ISERN you will find experience, solidity, and proximity.