- What is the definition of compulsory licensing?
- What are the applicable sources of law relating to compulsory licensing?
- What type(s) of products or technologies do compulsory licensing applies to?
- Who can apply for a compulsory licence? Are foreigners or foreign companies allowed to apply for a compulsory licence?
- What are the legal grounds to grant a compulsory licence under the local laws of your jurisdiction and any applicable international treaties?
- Are there any preconditions to apply for a compulsory licence?
- Are there any limits on the number of compulsory licensees?
- Will there be any limitation on the scope of the compulsory licence, for example limitations on the time and the territory?
- Which authority has the competency to grant a compulsory licence?
- What are the application procedures to get a compulsory licence?
- Can the competent authority grant a compulsory licence without hearings under an urgent situation?
- Can a compulsory licence be revoked/terminated or automatically revoked/terminated?
- Does the compulsory licensee have to pay a royalty to the right holder?
- Are there any legal remedies for the party who is not satisfied with the compulsory licensing decision of the competent authority?
- In order to implement the compulsory licence, for example, to manufacture the licenced product, is the right holder required to provide necessary support, such as know-how and training as in a voluntary agreed licence agreement?
- Is the compulsory licensee subject to any confidentiality obligation?
- Is the compulsory licensee allowed to export their products under the compulsory licence?
- Have the laws on compulsory licensing been used in previous health emergencies and/or in the present COVID-19 pandemic in your jurisdiction?
- Is it possible for third parties to use the current laws on compulsory licensing in your jurisdiction to facilitate the treatment of patients infected by COVID-19?
- Are there any recent major regulatory exemptions and/or amendments made following COVID-19 to regulations governing compulsory licensing?
- Can a compulsory licence be transferred or assigned?
- Does the issuance of a compulsory licence have any impact on the previously agreed licence?
- Is there any special labelling requirement for the products made under the compulsory licence?
- Is there any special distribution channel requirement for the products made under the compulsory licence?
- Is there any price requirement for the products made under the compulsory licence?
jurisdiction
1. What is the definition of compulsory licensing?
According to Article 82 of the Act of 30 June 2000 Industrial Property Law, a licence for exploiting a patented invention of another person is defined as a compulsory licence. This regulation applies to utility models, industrial designs and topographies.
2. What are the applicable sources of law relating to compulsory licensing?
- Act of 30 June 2000 Industrial Property Law;
- Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS;
- Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.
3. What type(s) of products or technologies do compulsory licensing applies to?
A compulsory licence applies to another person’ patented invention, utility model, industrial design and topography.
3.1 Has any compulsory licence ever been issued in your jurisdiction? If yes, on what type of technology?
We are not aware of any compulsory licence issued under Polish law.
4. Who can apply for a compulsory licence? Are foreigners or foreign companies allowed to apply for a compulsory licence?
Any person, including foreigners or foreign companies, can apply for a compulsory licence.
5. What are the legal grounds to grant a compulsory licence under the local laws of your jurisdiction and any applicable international treaties?
In accordance with Article 82 of the Act of 30 June 2000 Industrial Property Law, the Patent Office may grant a licence to exploit a patented invention of another person (compulsory licence) when:
- a threat to state security, particularly in respect to defence, public order, protection of human lives and health, and the natural environment must be prevented or remedied;
- the patent is found to be abused; or
- the proprietor of a patent granted with earlier priority (i.e. a prior patent) prevents, by refusing to make a licence agreement, domestic market demand from being satisfied through the exploitation of a patented invention (i.e. dependent patent), the exploitation of which would exceed the extent of the prior patent; in this case, the proprietor of the prior patent may request the granting of a licence for the exploitation of the invention that is the subject of a dependent patent (i.e. cross-licence).
The above regulation applies also to utility models, industrial designs and topographies.
Under Regulation (EC) No 816/2000 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems: the granting of compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products is available when such products are intended for export to eligible importing countries in need of such products in order to address public health problems.
6. Are there any preconditions to apply for a compulsory licence?
6.1 Any negotiation required between the applicant and the right holder before applying for a compulsory licence?
A compulsory licence may be granted if an applicant proves that he has made, in good faith, previous efforts to obtain the licence. This requirement does not have to be met in order for a licence to be granted to prevent or remedy a threat to state security, or if an announcement is issued stating that applying for a compulsory licence is possible and the motion for a compulsory licence was submitted within one year from the date of this announcement.
6.2 Any urgent situation required in order to grant a compulsory licence?
One of the situations for granting a compulsory licence is the prevention or remedy of a threat to state security, in particular in respect to defence, public order, protection of human lives and health, and the natural environment.
6.3 Any minimum number of years required for the patent to be granted and/or implemented in order to be subject to compulsory licensing?
Under Polish law, the time limit for a patent to be able to initiate a compulsory licence occurs only in relation to one of the conditions for establishing a compulsory licence (i.e. the patent is abused). According to Polish law, within three years of the patent being granted, the proprietor’s action may not be considered an abuse of rights. Moreover, the three-year period begins the date the decision to grant the patent became final.
7. Are there any limits on the number of compulsory licensees?
Not specified.
8. Will there be any limitation on the scope of the compulsory licence, for example limitations on the time and the territory?
There are no such limitations. However, the purpose of the compulsory licence and the duration of the patent (i.e. right to utility model, industrial design, topography) should be taken into account when granting such a compulsory licence.
9. Which authority has the competency to grant a compulsory licence?
Under Polish law, the Patent Office has the competence to grant a compulsory licence.
10. What are the application procedures to get a compulsory licence?
The Patent Office grants or refuses to grant a compulsory licence to exploit an invention, utility model, industrial design or topography, in contentious proceedings, upon a written motion submitted by the applicant to the Patent Office.
If the compulsory licence is granted, the Patent Office indicates in its decision the scope and term of a compulsory licence, the detailed requirements for the performance of the licence and the licence fee (according to the market value of the licence), as well as terms and methods for the payment of the licence fees.
10.1 What materials need to be submitted to the competent authority?
The applicant shall submit a written motion to the Patent Office with the request for a compulsory licence to be granted.
The motion will contain:
- an identification of the parties and their addresses;
- a brief presentation of the case;
- a clearly stated request;
- the legal basis for the request;
- an identification of evidence;
- the signature of the applicant and the date.
The motion will be accompanied by:
- a power of attorney, if relevant;
- copies of the motion in the number corresponding to the number of parties to the contentious proceedings;
- proof of payment of the official fee.
10.2 How long will it take to get a compulsory licence?
No time limit is specified for granting the compulsory licence.
11. Can the competent authority grant a compulsory licence without hearings under an urgent situation?
Yes, only when it is necessary to prevent or remedy a threat to state security, particularly in respect to defence, public order, protection of human lives and health, and of the natural environment.
12. Can a compulsory licence be revoked/terminated or automatically revoked/terminated?
Polish regulations do not provide for revocation/termination of a compulsory licence, but they regulate the possibility of the amendment of the compulsory licence.
12.1 What are the conditions for the revocation/termination of a compulsory licence?
The decision on granting a compulsory licence, in the part referring to the scope and term of the licence or the licence fee, may be amended at the request of the interested party, two years after the issuance of the decision.
The circumstances justifying the change of a decision must be indicated in the written motion of the interested party. The decision may be amended in justified cases. Not every change of circumstances may in practice justify the motion – only significant changes that affect the content of the compulsory licence. The reasons justifying the amendment of the decision to grant the licence include the licensee’s infringement of the conditions for using the compulsory licence specified in the administrative decision.
The motion may be submitted by the proprietor whose patent (utility model, industrial design, topography) has been encumbered by a compulsory licence, and by the licensee.
Moreover, the provision does not exclude the possibility of multiple changes to the decision on granting a compulsory licence. However, each time it is necessary to indicate the specific circumstances justifying this change.
12.2 How should products made under a compulsory licence be treated if the compulsory licence is terminated/revoked?
There are no such specific requirements.
13. Does the compulsory licensee have to pay a royalty to the right holder?
Yes, a compulsory licence is always a paid licence. A person exploiting an invention (utility model, industrial design, topography) under a compulsory licence shall pay a licence fee to the proprietor of the patent (right to utility model, industrial design, topography).
13.1 If the compulsory licensee is required to pay a royalty, how is the amount of royalty determined and who will decide the amount of the royalty?
The amount of the licence fees should be determined while taking into account the market value of the licence. Both the amount of the licence fee and the method and terms of payment are specified by the Patent Office in the decision on granting a compulsory licence.
13.2 Is there any remuneration available for the right holders other than royalty?
Not specified.
14. Are there any legal remedies for the party who is not satisfied with the compulsory licensing decision of the competent authority?
Yes, parties to the proceedings may appeal decisions of the Patent Office with the administrative court.
15. In order to implement the compulsory licence, for example, to manufacture the licenced product, is the right holder required to provide necessary support, such as know-how and training as in a voluntary agreed licence agreement?
The regulations do not directly address these issues. These aspects may be agreed between the parties.
16. Is the compulsory licensee subject to any confidentiality obligation?
The regulations do not directly address these issues. These aspects may be agreed between the parties.
17. Is the compulsory licensee allowed to export their products under the compulsory licence?
The allowed territorial scope of the export of products manufactured under the compulsory licence is specified in the decision of the Patent Office on granting the licence.
17.1 If the compulsory licensee is permitted to export products under the compulsory licence, are there any requirements and limitations on the export of such products?
Such requirements and limitations on the export of such products may be specified in the decision of the Patent Office.
18. Have the laws on compulsory licensing been used in previous health emergencies and/or in the present COVID-19 pandemic in your jurisdiction?
We are not aware of any such situations.
19. Is it possible for third parties to use the current laws on compulsory licensing in your jurisdiction to facilitate the treatment of patients infected by COVID-19?
Yes.
20. Are there any recent major regulatory exemptions and/or amendments made following COVID-19 to regulations governing compulsory licensing?
We are not aware of any major regulatory exemptions and/or amendments made following COVID-19 to regulations governing compulsory licensing.
21. Can a compulsory licence be transferred or assigned?
A compulsory licence may only be transferred jointly with an undertaking or the part of the undertaking where it is executed. A compulsory licence for an earlier patent may only be transferred to another person in conjunction with a dependent patent.
22. Does the issuance of a compulsory licence have any impact on the previously agreed licence?
Not specified.
Article 83 of the Industrial Property Law provides only that a compulsory licence is non-exclusive, which means that that the patent holder and persons to whom the licence to use the invention was granted may still use the invention.
This regulation also applies to utility models, industrial designs and topographies.
23. Is there any special labelling requirement for the products made under the compulsory licence?
There is no such special labelling requirement in the statutory provisions relating to compulsory licensing in Poland.
24. Is there any special distribution channel requirement for the products made under the compulsory licence?
There is no such special distribution channel requirement in the statutory provisions relating to compulsory licensing in Poland.
25. Is there any price requirement for the products made under the compulsory licence?
There are no express price requirements in the statutory provisions relating to compulsory licensing in Poland.