Patents and Trademarks
Read all about the legal situation around patents and trademarks in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The main Portuguese legal framework for industrial property rights is enshrined in the Industrial Property Code (CPI), as approved by Decree-Law 36/2003, 5 June 2003, and amended by Law 16/2008, 1 April 2008.
Portugal is a TRIPS-standard jurisdiction with a pre-grant opposition, absolute novelty patent system where all technical fields are eventually patentable.
According to CPI, any pharmaceutical product may be patent protected provided that it is (i) new; (ii) inventive; and (iii) industrially applicable.
As for trademarks, the basic requirements are distinctiveness of the sign and the lack of confusable registered trademarks or applications to identify competitive linked products or services.
2. What agencies or bodies regulate patents and trademarks?
Regulation over patents and trademarks is centralized at the Portuguese National Industrial Property Institute (Instituto Nacional da Propriedade Industrial), better known as INPI. More information available at https://inpi.justica.gov.pt/.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Patents can protect:
- Products, substances or compounds used in surgery or therapy and diagnostic methods for treating the human body.
- New processes for obtaining new known products, substances or compositions.
Patents cannot protect:
- Discoveries, scientific theories and mathematical methods.
- Materials or substances already existing in nature and nuclear materials.
- Aesthetic creations.
- Schemes, rules or methods for intellectual acts, playing a game or doing business and computer programs.
- Presentations of information.
- Processes for cloning human beings.
- Processes for modifying the germinal genetic identity of human beings.
- The use of human embryos for industrial or commercial purposes.
The following can be registered as trademarks:
- a sign or set of signs which is capable of being represented graphically – in particular, words, including personal names, designs, letters, numerals, sounds or the shape of goods or their packaging – provided it is also capable of distinguishing the goods or services of one company from those of others.
The following cannot be registered as trademarks:
- Trademarks that are devoid of any distinctive character.
- Signs that exclusively consist of the form:
- imposed by the nature of the product itself;
- of the product necessary for obtaining a technical result; or
- that confers a substantial value to the product.
- Signs that are exclusively made up of indications that may serve in commerce to designate the type, quality, quantity, purpose, value, geographic origin, period or means of production of the product or the service, or other characteristics of it.
- Trademarks that exclusively consist of signs or indications that have become common use in modern-day language or in the habitual and constant habits of commerce.
- Colours, except those that are combined with graphics, wording or other particular and distinctive elements.
4. How can patents and trademarks be revoked?
A patent can be revoked by a court and in specific cases by the Portuguese National Industrial Property Institute, following a request by the Public Prosecutor’s office or by any interested party, including the patentee, on any of the following grounds:
- The object of the patent cannot be protected.
- If, when granted, procedures or formalities essential to the grant of the right were omitted.
- If public rules were breached.
- If the right does not belong to the patent holder.
- Failure to pay fees.
- Renunciation by the patent holder.
- If the patent is not exploited within four years of the date of the patent application or three years of the grant date, whichever is later, a third party can apply to the INPI for the grant of a compulsory license relating to the patent.
A trademark can be revoked on the following grounds:
- The trademark was not the object of serious use for a period of five consecutive years.
- The grounds for registration were not fulfilled.
- The trademark may mislead the public, particularly as to the quality, nature or origin of the goods or services.
5. Are foreign patents and trademarks recognized and under what circumstances?
In each of the contracting states for which it is granted, a European patent has the effect of and is subject to the same conditions as a national patent granted by that state, unless otherwise provided in the European Patent Convention (EPC).
If the European patent is not validated in Portugal, then it has no effect in Portugal and it cannot be enforced through the Portuguese courts.
For a Trademark European Community registry request, it is necessary to fill an appropriate form made available by European Union Intellectual Property Office (IPIEU), in which the request process is singular and centralized. An international request should be made to the World Intellectual Property Organization (WIPO), through the National Institutes, i.e., in Portugal to INPI or IPIEU.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
The Medicinal Products Act provides exclusivity periods for medicinal products according to the “8+2+1” approach in Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as follows:
During the first 8 years from the grant of the originator company’s marketing authorization, data exclusivity applies.
After the 8 years have expired, a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.
After a period of 10 years from the grant of the originator company’s marketing authorization, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity.
This additional 1 year may be obtained in a number of circumstances, such as where the innovator company is granted a marketing authorization for a significant new indication for the relevant medicinal product. In such a situation, the generic company can only market their product after 11 years from the grant of the innovator company’s marketing authorization.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There are no restriction of medicines or devices that could be protected through patents or trademarks different from the ones already described.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
License agreements do not require a government approval; however, licenses must be draw up in writing and if the grant of sublicenses is not authorized by license, these can only be granted with the written authorization of the right holder.
In order to be made enforceable against third parties, License agreements must be registered before the Portuguese National Industrial Property Institute.