Today, more than ever, the unstoppable advance of innovation in biotechnology demands ensuring the protection of inventions developed in this field. Patents in the biotechnology sector play a fundamental role by granting inventors exclusive rights over their creations. This condition facilitates the defense of their advancements and the continuity of an environment that promotes investment, collaboration, and scientific progress.
Importance of Patent Protection in the Biotechnology Sector
Biotechnology is at the forefront of advancements in health, agriculture, and sustainability, continuously transforming how we address these global challenges. In this context, patents in the biotechnology sector offer a solid legal basis for protecting innovations. This figure allows inventors to maintain exclusivity over the use and commercialization of their developments for a period of 20 years from the filing date.
But the impact of patents is not limited solely to safeguarding ideas. By requiring detailed disclosure of inventions, patents contribute to the dissemination of knowledge, allowing other researchers to be inspired, adapt, and improve existing technologies. Precisely, this exchange of information creates a collaborative environment that drives the collective advancement of the industry.
Additionally, patents are a powerful attraction for investors and strategic partners. A solid intellectual property portfolio reinforces the perception of security and viability of biotechnological projects, incentivizing the injection of resources to bring disruptive ideas to market. The exclusivity they grant, besides protecting the interests of innovators, guarantees a return on investments in research and development, thus consolidating a virtuous cycle of economic and scientific growth.
Aligning with the Patent Law: The First Challenge for Patents in the Biotechnology Sector
Spain’s Patent Law 24/2015, of July 24, includes specific provisions for inventions in the field of biotechnology and other scientific areas. Specifically, it defines what can be patented and how the essential requirements of inventions are evaluated. Similarly, it establishes exclusions for certain applications that may conflict with ethical or social principles. Analyzing these aspects is key to understanding the limits and possibilities offered by this system.
What Is Considered Patentable
Firstly, the Patent Law specifies that an invention is patentable if it meets three fundamental criteria: novelty, inventive step, and industrial applicability. Regarding biotechnological inventions, these can include products composed of biological material or processes that use or transform it. A relevant aspect is that biological material isolated from its natural environment or produced by a technical process can also be protected, even if it already exists in nature.
According to the aforementioned Law, the term “biological material” applies to any material that contains genetic information and is capable of self-replication or reproduction in biological systems. This includes everything from microorganisms to genetic components like DNA sequences. However, the industrial applicability of these inventions must be clearly indicated in the patent application.
Exclusions from Patentability
Despite the broad possibilities for protection, there are also important exclusions. Inventions whose commercial exploitation is contrary to public order or morality cannot obtain patents in the biotechnology sector and in other areas. For example, the following cannot be patented:
- Procedures for cloning human beings.
- Modification of the germline genetic identity of human beings.
- The use of human embryos for industrial or commercial purposes.
- Procedures for genetic modification in animals that cause them suffering without significant medical or veterinary utility.
Also excluded from patentability are plant varieties and animal breeds when technical feasibility is limited to a specific species or breed. Nevertheless, inventions related to microbiological processes or products obtained through these processes can be protected.
The Importance of Novelty
Of course, for an invention to be considered novel, it must not form part of the “state of the art,” meaning everything that has already been made accessible to the public before the patent application. This includes publications, presentations, or prior use of the technology, both in Spain and abroad. However, there are exceptions: if the disclosure occurred within twelve months prior to the application due to a presentation at an official exhibition, this will not be considered detrimental to novelty. The same applies to disclosure that occurs due to an abuse against the applicant.
Inventive Step and Industrial Applicability
Precisely, the inventive step requires that the invention is not obvious to a person skilled in the art from the existing state of the art. This criterion ensures that patents in the biotechnology sector, for example, are granted only for developments that represent a true advance.
Finally, industrial applicability implies that the invention can be manufactured or used in any industrial field, including agriculture. This requirement reinforces the practical nature of patents and ensures their potential impact on society.
If you want to know the steps to patent an invention in Spain, we suggest visiting this link.
Patent Protection in the Biotechnology Sector by SMEs
In the biotechnology sector, small and medium-sized enterprises (SMEs) represent a significant proportion of the business fabric. These companies understand the strategic value that proper **intellectual property (IP)** management brings to ensure their competitiveness and protect their innovations. However, due to their size and resource limitations, most do not have specialized personnel in this area, which leads them to delegate the management of their IP portfolio to specialized agencies.
Indeed, a key aspect where biotech SMEs need to improve is in technological surveillance of their competitors’ patents. Frequently, the lack of proactive monitoring leads to situations where they identify the existence of third-party patents restricting their commercial activity too late. This can result in significant economic damage, either because it’s too late to initiate opposition proceedings or because they have received legal infringement notices.
In this case, the solution involves strengthening technological surveillance activities. This means identifying third-party rights at early stages and taking proactive measures to invalidate or limit those rights before they become established. Furthermore, intellectual property agencies – like ISERN Patentes y Marcas – offer such services. These are accessible even to companies without an internal specialized team, thus providing essential tools to protect their market position.
Strategies for Patenting in Several Countries
On the other hand, the international scope presents significant challenges for obtaining patents in the biotechnology sector, given that each jurisdiction applies its own criteria to evaluate applications. To that effect, the process generally begins with filing a single priority application that serves as a basis for extending protection to other territories through international agreements.
This initial application must be prepared carefully, considering not only the requirements of the country of origin but also the criteria that will be applied in the territories of interest. A critical decision is the timing of filing: if done without sufficient experimental support, it may be rejected in jurisdictions with strict criteria. Conversely, if delayed too long to gather more robust data, there is a risk of prior disclosures compromising patentability in other territories.
A common option is to use the Patent Cooperation Treaty (PCT) system, which allows for filing an international application. As of today, this procedure is recognized by 158 countries, thanks to the recent accession of Uruguay to the PCT in October 2024. Indeed, this mechanism facilitates protection in multiple jurisdictions and defers prosecution costs, such as fees and translations. This provides a time window to optimize the protection strategy.
Generally, before filing the PCT application, a national or regional application is filed, granting a right of priority. This first stage allows for obtaining a preliminary opinion on the viability of the invention. In this way, it is feasible to refine the documentation to successfully face examinations in international patent offices.
Bioinformatics Inventions: Another Challenge for Obtaining Patents in the Biotechnology Sector
In the field of bioinformatics, inventions face additional challenges. Depending on their nature, they may be evaluated under criteria applied to computer-implemented inventions, an area where patents tend to be more restrictive. In Europe, computer programs are considered non-patentable unless they can demonstrate a technical effect that transcends mere mathematical calculation.
Specifically, this implies that companies must carefully formulate their applications to avoid patentability exclusions and ensure compliance with the requirements established by patent offices. In this regard, adequate planning and specialized advice are essential to overcome these obstacles and effectively protect your innovations in the bioinformatics field.
ISERN Provides Comprehensive Support for Patent Applications in the Biotechnology Sector
With over a century of experience in protecting patents, trademarks, and **intellectual property** rights in Spain and Europe, at ISERN we consolidate our leadership in the sector. Our commitment translates into specialized legal advice and continuous support throughout the entire patent application process. Of course, these services are applicable to developments in the biotechnology field.
For this purpose, we have a team of highly qualified experts who will guide you from the initial steps to obtaining the patent. Likewise, after the grant and marketing authorization, we remain vigilant to ensure your rights are protected against any unauthorized use. We act with determination to defend your **intellectual property**!
We invite you to contact us and visit any of our 12 offices located in major cities across Spain. At ISERN, we work with you to ensure success in obtaining your patents in the biotechnology sector.