Patents

Animals are called “transgenic” when DNA from other species has been artificially introduced into their genome. Transgenic animals have been created for potentially useful applications, such as medical research, increased food production, and the production of proteins or organs.

Patent law excludes both plant varieties and animal breeds from patentability, meaning that animal or plant varieties and essentially biological processes for producing animals or plants cannot be patented. The law does not provide a definition of animal breeds. However, transgenic animals are patentable because what is protected is not the animal, but the gene that is introduced into the animal, which is the essence of the invention.

Law 10/2002, of April 29, amending Law 11/1986, of March 20, on Patents, to incorporate into Spanish law Directive 98/44/EC of the European Parliament and of the Council of July 6 on the legal protection of biotechnological inventions.

In turn, Law 9/2003, of April 25, establishes the legal regime for the contained use, deliberate release, and marketing of Genetically Modified Organisms, to prevent risks to human health and the environment.

At the European level, biotechnology patents are covered by the European Patent Convention and Directive 98/44/EC of the European Parliament and of the Council of July 6 on the legal protection of biotechnological inventions.

The aim of the Directive is to clarify the distinction between what is and what is not patentable. Specifically, it confirms that the human body at different stages of its formation and development, procedures for cloning human beings, and germ line genetic intervention in human beings cannot be considered patentable inventions. Therefore, this Directive:

• Confirms the patentability of biological material and its scope of protection.
• Establishes exceptions to patentability, due to lack of industrial application and/or ethical reasons.
• Establishes the conditions for the deposit, storage, and preservation of biological material.
• Regulates compulsory licenses due to dependency between patents and patents and plant varieties.

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure seeks, first, to facilitate the disclosure requirement for interested parties by replacing the description with the delivery of the microorganism itself; and second, to establish a series of international depositary agencies (IDAs) as recipients and administrators of such microorganisms.

In the case of Spain, the World Intellectual Property Organization (WIPO) recognized the Spanish Type Culture Collection (CECT) as the international depositary authority (IDA) for microorganism strains.

The Convention on Biological Diversity, which emerged from the Rio de Janeiro Summit (1992), recognizes the legitimate role of intellectual property in achieving the objectives of biological diversity conservation, sustainable use of genetic resources, and fair and equitable sharing of benefits between suppliers of biological material and biotechnology innovators.

TRIPs agreements require any country joining the WTO to recognize minimum standards for intellectual property rights in all areas of technology, including biotechnology. It mandates the “protection of plant varieties either by a patent system, an effective sui generis system, or a combination of both.”

Internationally, biotechnology patents are covered by the Agreements on Trade-Related Aspects of Intellectual Property Rights (TRIPS), derived from the Uruguay Round of the GATT and incorporated into the regulations of the World Trade Organization (WTO).

• In the area of human health, there are currently regulations on the human genome, as well as on the evaluation and control of medicines.
• In the Animal Health Area, veterinary medicines and the use of animals for research purposes are regulated.
• In the Agriculture sector, the rights of breeders of new plant varieties are protected (UPOV Convention) and organic farming is regulated. In the Food and Nutrition sector, food quality is controlled to protect consumers.
• Finally, in the area of the environment, biodiversity and the release of genetically modified organisms (GMOs) are protected.

Biotechnology is regulated by international, European, and national regulations.

The scope of protection of biotechnology patents is the same as that of invention patents, namely:

• National patent.
• European patent.
• International patent via PCT.

Biotechnology patents have the same requirements as invention patents. Therefore, for a biotechnology patent to be granted, it must be new, involve an inventive step, and be susceptible to industrial application.

The field of application of biotechnology is very broad. However, we can highlight the following:

• therapeutic applications, pharmaceutical products, antibiotics, vaccines, hormones, gene therapies, diagnostics, diagnostics for human health, diagnostics for agriculture and livestock, food quality testing, environmental quality testing, food, improvement of traditional food and beverage production processes, new foods and beverages, nutraceuticals (foods with specific nutrient profiles and for health improvement), food additives, the environment, urban, agricultural, and industrial waste treatment, bioremediation and bioremediation, and energy production from biomass.

It can be defined as the use of whole marine organisms, their cells, or molecules to provide solutions that are useful to society.

Some of the most obvious applications are: the design of more effective vaccines that reduce fish mortality from infectious diseases and avoid the administration of expensive and ineffective drugs; the characterization of genetic markers associated with commercially interesting traits, allowing the selection of breeding stock with the desired characteristics in their DNA.

White biotechnology refers to the branch of biotechnology dedicated to optimizing industrial processes, seeking to replace polluting technologies with cleaner ones. Biotechnology tools are applied to the sustainable production of chemical compounds, biomaterials, and biofuels through the use of living cells or their enzymatic systems.

Means of production, the development of new products, and the reduction of the environmental impact of industrial activities.

Green biotechnology contributes to more efficient and sustainable agriculture by providing producers with different tools.

A good example of this collaboration is biological pest control.

It therefore helps improve competitiveness in the agricultural, livestock, and forestry sectors by increasing the resistance and productivity of both animal and plant species, as it focuses on agriculture and forestry production, functional foods, and food control technologies.

Red biotechnology is applied to the prevention, diagnosis, and treatment of numerous known or new diseases, i.e., it focuses on the development of therapies for human and animal health, research and development of products and services in the area of human and animal health diagnostics, etc.

• Red or health biotechnology.
• Green or agri-food biotechnology.
• White or industrial biotechnology.
• Blue or marine biotechnology and aquaculture.

Biotechnology is defined as the set of techniques that modify living organisms (or parts thereof), transform substances of organic origin, or use biological processes to produce new knowledge or develop products and services.

On the other hand, the Rio de Janeiro Convention on Biodiversity (1992) also defines biotechnology as: “Any technological application that uses biological systems, living organisms, or derivatives thereof with the aim of producing or modifying products or processes for a specific use.”

Within six months of the first marketing authorization being granted for the medicinal product or plant protection product in Spain, or
if the patent has not yet been granted when the marketing authorization is obtained, the deadline for submitting the SPC is six months from the date of grant of the patent.

Supplementary Protection Certificates are covered by the following regulations:

• Regulation (EEC) No. 1768/92 of June 18, 1992, concerning the creation of a supplementary protection certificate for medicinal products, amended by Regulation (EC) No. 1901/2006 of December 12, 2006.
• Regulation (EC) No. 1610/96 of July 23, 1996, creating a supplementary protection certificate for plant protection products.

Companies that develop chemical or pharmaceutical products, once they have applied for a patent, need to make a significant investment and conduct clinical trials in order to obtain marketing authorization as a prerequisite for marketing the product. This process reduces the effective period of protection conferred by the patent. The SPC is intended to compensate for this reduction in the effective period of protection.

The following products are eligible for protection as SPCs:

• An active ingredient in a medicine.
• An active substance in a plant protection product.
• Combinations of active ingredients/substances.
• Mixtures of two substances in which at least one is active.

A Supplementary Protection Certificate (SPC) is an intellectual property right that extends, for a maximum period of five years, the protection conferred by a patent to an active ingredient or combination of active ingredients present in a pharmaceutical or phytosanitary product after the patent has expired.

The international patent application must contain the following documentation:

• A petition.
• A description.
• One or more claims.
• One or more drawings (when necessary).
• An abstract.

The application can be submitted:

• At the Spanish Patent and Trademark Office (OEPM).
• At post offices.

It gives the interested party a period of thirty months to consider whether to proceed with the application or withdraw it, in view of the results of the search and examination carried out by WIPO.

The provisional publication of applications grants the same provisional protection rights as the European Patent Convention (EPC). Currently, more than 140 countries are members of the Patent Cooperation Treaty (PCT).

This body conducts an international search of the state of the art corresponding to the subject matter of the application and, where appropriate, a preliminary international examination, as well as publication of the application. All the documentation relating to the international application, together with the results of the international search and, where applicable, the preliminary examination, is forwarded to the national or regional patent offices (e.g., EPO), which then process the applications as if they were originally national or regional applications.

These types of applications are processed by the International Bureau of the World Intellectual Property Organization (WIPO).

The company files a single international application, without having to file multiple national or regional patent applications in one language, and pays a single set of fees. The granting of patents remains the responsibility of national or regional patent offices in what is known as the “national phase.”

The European patent application must contain the following documentation:

• A request for the grant of a European patent.
• A description of the invention.
• One or more claims.
• The drawings referred to in the description or claims.
• An abstract, and comply with the conditions set out in the Implementing Regulation.
• Claim for priority (if applicable).

The application can be submitted:

• At the European Patent Office in Munich, or at its offices in The Hague or Berlin.
• At the Spanish Patent and Trademark Office (OEPM).

European patent applications must be filed in one of the official languages of the office (English, French, and German).

The following 39 countries are currently members of the European Patent Organization (EPO countries): Albania, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Liechtenstein, Lithuania, Luxembourg, Latvia, Monaco, Montenegro, North Macedonia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovakia, San Marino, and Turkey.

It has the advantage that a single administration, namely the European Patent Office (hereinafter EPO), is responsible for processing and granting European patents, with the consequent unification of administrative procedures and requirements.

Once the European application has been granted, it must be validated in each of the countries designated in the application to which the rights granted by the European patent are to be extended, and the patent must be maintained in all those countries that were designated.

It is possible to validate the rights in fewer countries than those designated in the application , but it is not possible to do so in more countries than those contained in the application

The company files a single European patent application and may designate, at its discretion, all or only some of the countries that are members of the European Patent Convention (EPC).

To obtain a patent, you must submit:

• Application form.
• Descriptive report.

There are two types of procedures for granting patent applications:

• General procedure: only the formal aspects of the patent are examined. The SPTO prepares a report on the state of the art (IET) and third parties may submit their observations, although the patent is granted regardless of the results of the IET and the observations submitted.
• With prior examination: at the request of the applicant, the OEPM will carry out a prior examination of novelty and inventive step. In this case, third parties may file oppositions against the application. This results in stronger patents with greater guarantees of validity. Although it is called the “general procedure,” it is the least recommended type, as it is more appropriate to file the patent through the prior examination procedure.

In Spain, the application can be filed:

• At the Spanish Patent and Trademark Office (OEPM).
• At post offices.
• At Spanish diplomatic missions or consular offices abroad.

The company may apply for a national patent in each country where it wishes to obtain protection.

Yes, in most countries, publication of the invention in any forum and through any medium breaks the novelty of the invention, and therefore it is understood that it does not meet the requirement for protection.

It is important to file a patent application before publicly disclosing the details of the invention, since, in general, inventions that are disclosed before an application is filed will be considered part of the prior art, and therefore the invention would not meet the novelty requirement.

Inventions that are disclosed before an application is filed will be considered part of the prior art. If it is unavoidable to disclose the invention, for example, to a potential investor or business partner, before filing a patent application, the disclosure must be accompanied by a confidentiality agreement.

As soon as it is developed, without any prior public disclosure (publications, exhibition at trade fairs, etc.). Immediately, if there is a risk of disclosure or knowledge by third parties.

Once the company has defined the markets of interest, whether based on the existing market, the potential market, or the manufacturing means of each company, its associates, or its competitors, it will decide the countries where it wants to protect its invention as a patent.

• The patent will only be protected in the country or countries where it is applied for.
• It must be applied for as soon as it is developed, without any prior public disclosure (publications, exhibition at trade fairs, etc.).
• Immediately, if there is a risk of disclosure or knowledge by third parties.
• If the company intends to protect its invention abroad, it must apply within one year from the date of filing in Spain (priority year).

The right of priority means that the person who has filed a first patent application in one of the member countries of the Paris Union has the right to apply for a patent in any of the member countries, claiming the right of priority based on that first application, thus acquiring the filing date of the application initially filed.

Patents can be classified according to different criteria. The criteria are as follows:

By subject matter: this criterion seeks to distinguish between the different entities that may be the subject of the invention. In this way, it is possible to distinguish between:

• Product patents.
• Process patents.
• Use patents (second use).
• Patents for combinations of known elements.
• Selection patents.

By granting procedure:

National patents.

Regional patents.

• European: with protection in Austria, Belgium, Cyprus, Liechtenstein, Germany, Denmark, Spain, Finland, France, the United Kingdom, Greece, Ireland, Italy, Luxembourg, Monaco, the Netherlands, Portugal, Sweden, and any other contracting state of the European Patent Convention.
• ARIPO: Ghana, Gambia, Kenya, Lesotho, Malawi, Sudan, Swaziland, Uganda, Zimbabwe, and any other contracting state of the Harare Protocol and the PCT.
• Eurasian: Armenia, Azerbaijan, Belarus, Kyrgyzstan, Kazakhstan, Republic of Moldova, Russian Federation, Tajikistan, Turkmenistan, and any other contracting state of the Eurasian Patent Convention and the PCT.

OAPI: Burkina Faso, Benin, Central African Republic, Congo, Côte d’Ivoire, Cameroon, Gabon, Guinea, Mali, Mauritania, Niger, Senegal, Chad, Togo, and any other OAPI member state that is a contracting state of the PCT.

• PCT applications: allows protection for an invention to be sought in each of the signatory states of the International Patent Treaty through a single application known as an international application.

By dependency:

• Independent patents: they are not related to each other.
• Dependent patents: there is some dependency between the different patents, so it is necessary to grant licenses for their possible exploitation.
• Divisional patents: a patent must solve a problem. When a single patent solves several independent problems that do not form a unit, it is necessary to divide the patent into several patents.
• Additional patents: these do not pay annual fees and do not have the status to be patents in their own right.

Supplementary protection certificates: these relate to products that require a permit from the Ministry of Health for their exploitation. Due to the delay in obtaining these permits, these certificates are granted.
ermiso del Ministerio de Sanidad para su explotación. Debido a la demora de estos permisos se conceden estos certificados.

The expiration of a patent causes the patented invention to enter the public domain from the moment the events or omissions that led to said expiration occurred. The reasons for patent expiration are as follows:

• Due to the expiration of the term for which they have been granted.
• Due to non-payment of an annual fee or the corresponding tax.
• If the invention is not exploited.
• Due to the owner’s renunciation.

• They grant the owner an exclusive right to the intellectual and commercial exploitation of the patented invention.
• They are tools for entrepreneurs to protect their innovations from competition.
• They are strategies for entrepreneurs to consolidate markets and enter new ones.
• They are a source of up-to-date technological information that promotes innovation.

In exchange for the monopoly granted by the State, the patent holder undertakes to describe their invention in sufficient detail so that an average expert in the field can reproduce it (by publishing this description, the State increases the national technological heritage).

They also have the obligation to exploit the patent either themselves or through a person authorized by them.

As mentioned above, the exclusive right of exploitation has a number of limitations:

• Time limitation: the patent as legal protection is valid for 20 years from the date of filing, after which it becomes public domain.
• Geographical limitation: the right is limited to the national territory of the country where protection has been requested.

For a patent to be granted, the invention must be new, involve an inventive step, and be capable of industrial application:

• Novelty: anything that is not included in the state of the art is considered new. Anything that has not been made available to the public prior to the date of filing the patent application.
• Inventive step: an invention is considered to involve an inventive step when, compared to existing inventions, it is not obvious to a person skilled in the art.
• Industrial application: if the invention can be manufactured or implemented in any industry.

Inventions relating to machines, apparatus, devices, processes, products, etc. can be protected by patents.

Discoveries, scientific theories, and mathematical methods, as well as plans, rules, and methods for the exercise of intellectual activities, games, or economic-commercial activities and computer programs, among others, cannot be patented.

Learn more about our solutions

An invention is defined as any process, technique, or object that is novel in nature. A patent is a title that belongs to the first person to apply for it, granting the holder exclusive intellectual and commercial exploitation rights for a period of 20 years.

Learn more about our solutions