Answer ... Poland is a signatory to all major international treaties, agreements and conventions regarding the protection of intellectual property, including:

• the Paris Convention for the Protection of Industrial Property;
• the Agreement on Trade-Related Aspects of Intellectual Property Rights;
• the European Patent Convention (EPC);
• the Patent Cooperation Treaty;
• the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure; and
• the Convention on Biological Diversity.

The Polish legal system is based on statutory law. This means that the case law of Polish courts and administrative authorities, such as the Polish Patent Office (PPO) has no binding force, except in the specific case under consideration. Nevertheless, case law of the Supreme Administrative Court or the Supreme Civil Court may be used in analogous factual and legal circumstances as a useful source of argumentation.

The hierarchy of sources of law in Poland is as follows:

• the Polish Constitution;
• ratified international agreements;
• EU regulations, directives and decisions; and
• statutes, orders and acts of local authorities.

As Poland is also a member state of the European Union, its legal system is bound by the EU judicial system – in particular, EU regulations. Furthermore, Poland is obliged to harmonise its national law with EU laws. However, in case of discrepancy, the Polish Constitution provides that the respective international or European law provisions shall prevail over national law.

The most important national statutory provisions on the protection of industrial property rights are set forth in:

• the Act on Industrial Property (as amended);
• the Act on the Filing of European Patent Applications and Effects of European Patents in the Republic of Poland; and
• the Polish Seed Act on the Legal Protection of Plant Varieties.

These acts are supplemented by procedural regulations, such as:

• the Regulation of the Prime Minister on Filing and Processing Industrial Design Applications;
• the Regulation of the Prime Minister on Filling in an Electronic Form of Applications for the Protection of Inventions, Medicinal Products and Plant Protection Products, Utility Models, Industrial Designs, Trademarks, Geographical Indications and Topographies of Integrated Circuits, and on Carrying Out Correspondence in an Electronic Form;
• the Regulation of the Prime Minister on the Registers maintained by the Polish Patent Office;
• the Regulation of the Prime Minister on the Submission and Consideration of Requests for Supplementary Protection Rights for Medicinal and Plant Protection Products; and
• the Ordinance of Council of Ministers on Charges relating to the Protection of Inventions, Utility Models, Industrial Designs, Trademarks, Geographical Indications and Topographies of Integrated Circuits.

Some aspects of industrial property rights are regulated directly by EU regulations, which are directly applicable in Poland. These include:

• EU Regulation 469/2009 on Supplementary Protection Certificates for Medicinal Products;
• EU Regulation 44/2001 on Jurisdiction and the Recognition and Enforcement of Judgments in Civil and Commercial Matters; and
• EU Regulation 1383/2003 on Action against Counterfeit and Pirated Goods.

Poland is also bound by the following EU directives:

• Directive 98/44/EC on Legal Protection of Biotechnological Inventions;
• Directive 91/250/EEC on the Legal Protection of Computer Programs;
• Directive 2000/29/EC on the Harmonisation of Certain Aspects of Copyright and Related Rights in the Information Society; and
• Directive 2004/48/EC on the Enforcement of Intellectual Property Rights.

Answer ... According to the Act on Industrial Property, the right to obtain a patent for an invention belongs to the inventor. If an invention has been made jointly by several persons, the right to obtain a patent belongs to them jointly. However, if an invention has been made by an inventor in the course of employment duties or in the execution of any other contract, the right to obtain a patent belongs to the employer or the commissioner, unless otherwise agreed by the parties. If an invention has been made by an inventor with the assistance of an economic entity, the latter may enjoy the right to exploit the invention in its own field of activity. However, in the agreement on the provision of assistance, the parties may stipulate that the right to obtain a patent belongs fully or partially to the economic entity. The right to a patent for an invention is transferable and may be subject to succession. A contract for the transfer of such right must be executed in writing, under pain of invalidity.

In proceedings before the PPO in matters relating to patent filing and prosecution, as well as maintenance of the protection of inventions, medicinal products and plant protection products, a party may be represented by a patent agent or a person providing cross-border services within the meaning of the Act on Patent and Trademark Attorneys 2001. A natural person may also be represented by a joint rights holder or by his or her parents, spouse, siblings or descendants (whether biological or by adoption). However, parties which are not domiciled in Poland, the European Union, a member state of the European Free Trade Association (EFTA), a signatory to the Agreement on the European Economic Area or the Swiss Confederation must be represented by a patent agent, attorney or legal counsel with the right to practise in Poland.

In accordance with the EPC, a European patent application may be filed by any natural or legal person, or by any equivalent to a legal person by virtue of its governing law. For the purposes of proceedings before the European Patent Office, the applicant is deemed to be entitled to exercise the right to the European patent. The application may be in the name of one applicant or joint applicants. The application may also be filed by two or more applicants designating different contracting states. It is possible that a first applicant may designate one group of contracting states and a second a different group of contracting states, while both applicants jointly designate a third group of contracting states.

Answer ... A Polish patent confers on the holder the exclusive right to exploit the invention, for profit or professional purposes, throughout the territory of Poland. The scope of patent protection is determined by the claims; however, the patent specification and drawings may be used to interpret the claims. A patent on a manufacturing process also covers products directly obtained through that process. In the case of new products, or where the rights holder proves that it was unable through reasonable efforts to identify the manufacturing process actually used by another party, products which may be obtained through the patented process are deemed to have been obtained through that process. A patent on an invention relating to the use of a substance comprised in the state of the art to obtain a product eligible for a new use also covers products specifically prepared for such use by means of that invention.

The patent holder also has the right to prevent any unauthorised third party from exploiting its invention for profit or for professional purposes by:

• making, using, offering or putting on the market a product that is the subject matter of the invention, or importing such a product for such purposes; or
• employing a process that is the subject matter of the invention, or using, offering, putting on the market or importing for such purposes a product directly obtained by that process.

In accordance with the latest amendment to the Act on Industrial Property as adopted on 16 October 2019, which will enter into force in the first quarter of 2020:

• the list of actions in the first bullet above will be expanded to include the stockpiling, storage and export of products that are the subject matter of the invention; and
• the list of actions listed in the second bullet will be expanded to include the stockpiling, storage and export of products obtained directly through the patented process.

Patentees or licensees must not abuse their rights – in particular, by preventing the invention from being exploited by a third party if such exploitation is necessary to meet home market demands and is dictated by public interest considerations, and if consumers are being supplied with the product in insufficient quantities, of inadequate quality or at excessively high prices. The prevention of third parties from exploiting the invention in the three years following grant of the patent is not considered to constitute abuse.

The rights conferred by a patent shall not extend to acts relating to a product that incorporates the invention or is manufactured using the invention – in particular, including offering such a product for sale or putting on the market – if that product has been put on the Polish market by, or with the consent of, the patent holder. Likewise, a patent is not infringed by the import into the territory of Poland of, or another act in relation to, a product that was previously put on the market in the territory of the European Economic Area by, or with the consent of, the patent holder.

Answer ... A patent holder may enforce its rights by initiating patent infringement proceedings before a district civil court. The Act on Industrial Property provides that infringement claims are heard by the district civil courts in accordance with the general principles of law. There are no specialised patent courts in Poland. The following claims are decided in civil law proceedings in accordance with the general principles of law:

• determination of inventorship of an invention;
• determination of the rights to a patent;
• remuneration for the exploitation of an invention;
• compensation for the transfer to the State Treasury of a right to a patent for a secret invention;
• infringement of a patent or a supplementary protection right;
• determination of the right to exploit an invention; and
• determination of the unauthorised transfer of a patent.

The holder of a patent or a supplementary protection right may demand cessation of the infringement or threatened infringement of its right. It can also enforce patent rights through customs border measures against potentially infringing goods.

Answer ... Generally, patent rights are enforceable for 20 years from the date of filing of the patent application or, where priority is claimed, for 21 years from the priority date, provided that the patent is maintained by payment of the annuity fees and is not surrendered by the patent holder or revoked in opposition or invalidation proceedings. Claims for patent infringement may be enforced after grant of the patent. The prescription period for claims for patent infringement is three years. In any case, the prescription period does not exceed five years after the date on which the infringement has occurred. The prescription period is suspended during the period between the filing date of the patent application and the patent grant. The prescription period runs separately in respect of each individual infringement, from the date on which the patent holder learns of the infringement and the identity of the infringer.

Answer ... Patents valid in Poland are granted by the Polish Patent Office (PPO) or the European Patent office (EPO), in the latter case where a European or Patent Cooperation Treaty (PCT) application designates Poland and a petition for validation of the European patent has been duly filed with the PPO following grant of the European patent. If the European patent is duly validated in Poland, it gives the patent holder the same rights as a Polish national patent granted by the PPO and is subject to the same limitations as a national patent.

Answer ... The official filing fee for a standard Polish patent application is PLN 550 for a hard-copy filing and PLN 500 for an electronic filing, provided that the application does not exceed 20 pages (description, claims and drawings). For each page above this limit, an additional fee is due. If the application claims earlier priority, an additional fee of PLN 100 for each priority claimed is due. After patent grant, a fee of PLN 90 for publication of the details of the grant and patent specification is due, provided that the specification – including claims and drawings – does not exceed 10 pages. For each page above this limit, an additional fee of PLN 10 is due.

The official fee for publication of information on the validation of the European patent in Poland is PLN 90, provided that the specification – including claims and drawings – does not exceed 10 pages. The fee for each additional page over this limit is PLN 10.

To maintain patent protection after grant, annual fees must be paid. For national patents, an initial annuity fee of PLN 480 covers the first three years of protection (as of the filing date). Further annuity fees ranging from PLN 250 to PLN 1,550 are then payable on an annual basis. Annuity fees for European patents validated in Poland become due in Poland upon publication of the details of the patent grant by the EPO; the amounts are the same as those for national patents.

The annual fee for each year of protection under a supplementary protection certificate is PLN 6,000.

The registration costs for European applications are much higher and usually amount to at least €4,565, including the costs relating to filing and grant. Additionally, during prosecution of an application, renewal fees for a European patent application must be paid from the third anniversary of the date of filing of the European patent application until patent grant. The amount of these renewal fees ranges from €470 to €1,575, depending on the anniversary year. After grant of a European patent, it must be validated in Poland through separate national proceedings.

Answer ... Patents are granted by the PPO – regardless of the field of technology – for any inventions which are new, involve an inventive step and are susceptible of industrial application. The following in particular are not recognised as inventions:

• discoveries, scientific theories and mathematical methods;
• aesthetic creations;
• schemes, rules and methods for performing mental acts, doing business or playing games;
• creations or methods which are incapable of exploitation as evidenced under generally accepted and recognised principles of science; and creations or methods whose capacity for exploitation cannot be proved, or whose exploitation will not yield the result expected by the applicant, in light of commonly accepted principles of science;
• computer programs; and
• presentations of information.

The latest amendment to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, provides that the following will not be recognised as inventions:

• discoveries, scientific theories and mathematical methods;
• aesthetic creations;
• schemes, rules and methods for performing mental acts, playing games or doing business;
• creations or methods whose capacity for exploitation cannot be proved, or whose exploitation will not yield the result expected by the applicant, in light of commonly accepted principles of science;
• computer programs; and
• presentations of information;

However, this will be the case only if the application refers to such subject matter as such.

The following are also excluded from patent protection:

• inventions whose exploitation would be contrary to public order or morality – in this regard, the exploitation of an invention is not deemed to be contrary to public order or morality merely because it is prohibited by law;
• plant and animal varieties, and essentially biological processes for the production of plants or animals – this provision does not apply to microbiological processes and products obtained through such processes. Under the latest amendment to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, products produced directly through essentially biological processes for the production of plants or animals will also be excluded from protection; and
• surgical, therapeutic and diagnostic methods for treatment of humans or animals – although this provision does not apply to products, in particular substances and compositions, applied in diagnostics or treatment.

Currently, a patent application may be rejected if:

• it does not comply with the formal or patentability requirements, such as novelty, inventive step, industrial susceptibility or sufficiency of disclosure; or
• the subject matter of the application is not recognised as an invention.

In accordance with the latest amendment to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, the above list of grounds for rejection of a patent application will be expanded to encompass the following:

• failure to disclose the invention in a manner that is sufficiently clear and complete for it to be carried out by a person skilled in the art;
• lack of a clear and concise definition of the subject matter in the patent claims; and
• lack of support in the description for the claims in their entirety.

Before issuing a refusal, the PPO will invite the applicant to file observations or correct deficiencies within a specified timeframe. This is usually two months from notification of the invitation and may be extended once by a further two months.

Analogous grounds for rejecting a European application are set forth in the European Patent Convention (EPC) and such applications may be rejected due to non-compliance with the EPC.

Answer ... There are two options to accelerate proceedings before the PPO:

• the Patent Prosecution Highway programme, including the Global Patent Prosecution Highway (GPPH) programme: and
• accelerated publication of an application.

Both are available on the applicant’s request.

Under the GPPH, it is possible to accelerate grant proceeding by filing a request for accelerated processing at any participating office based on work products – including PCT work products – from another participating office. The PPO has signed bilateral agreements with the China National Intellectual Property Administration and the Taiwan Intellectual Property Office. Moreover, as of 6 January 2017 the PPO jointed the GPPH programme.

The patent offices currently participating in the GPPH programme are:

• the Intellectual Property Office of the United Kingdom;
• the Intellectual Property Office of Singapore;
• the Intellectual Property Office of New Zealand;
• the Superintendence of Industry and Commerce of Colombia;
• the Danish Patent and Trademark Office;
• the Estonian Patent Office;
• the Finnish Patent and Registration Office;
• the Federal Service for Intellectual Property of the Russian Federation;
• IP Australia;
• the Icelandic Patent Office;
• the Israel Patent Office;
• the Japanese Patent Office;
• the Canadian Intellectual Property Office;
• the Korean Intellectual Property Office;
• the National Institute for the Defence of Free Competition and the Protection of Intellectual Property of Peru;
• the National Institute of Industrial Property of Portugal;
• the Nordic Patent Institute;
• the Norwegian Industrial Property Office;
• the Austrian Patent Office;
• the PPO;
• the Swedish Patent and Registration Office;
• the Spanish Patent and Trademark Office;
• the Hungarian Intellectual Property Office;
• the United States Patent and Trademark Office; and
• Visegrad Patent Institute.

The prerequisites to participate in the GPPH programme are as follows:

• A patent application with the same content and the same filing date or priority date must previously have been filed with a GPPH partner office; and
• The office of first filing must have considered the invention to be patentable – at least for one patent claim (ie, it has granted a patent or issued a positive search report).

Regardless of where the earlier application was filed, an office of later examination may, on the applicant’s request, use the results of the earlier examination performed by the office of earlier examination, thus accelerating the national proceedings.

A second option to accelerate the proceedings is to file a request for earlier publication of the patent application. This request must be filed within 12 months of the claimed priority date. This will result in publication of the patent application within 18 months of the priority date claimed and thus the earlier start of examination proceedings.

For European applications, there are three options to accelerate proceedings:

• the accelerated procedure under the PPH;
• earlier publication; and
• accelerated prosecution of a European patent application using the PACE programme. A PACE request must be filed online and may be filed once only during each stage of the procedure (ie, separate requests must be filed for search and examination, and for one application at a time).

Answer ... Both the PPO and the EPO consider that certain claim formats are not permissible. Their practice in this regard is to a large extent harmonised. Accordingly, claims directed to subject matter which cannot be recognised as an invention or which is excluded from patent protection are not permissible. Furthermore, claims directed to inventions which are excluded from patent protection by law are not permissible.

The first class of non-permissible claims constitutes claims pertaining to inventions whose exploitation would be contrary to public order or morality. The second class constitutes claims directed to plant or animal varieties or essentially biological processes for the production of plants or animals. Once the latest amendments to the Act on Industrial Property enter into force in the first quarter of 2020, this class will also include products obtained by essentially biological processes for the production of plants or animals. The third class relates to surgical, therapeutic or diagnostic methods for the treatment of humans or animals. This third class does not encompass claims directed to products, and in particular to substances or compositions used in diagnostics or treatment.

Claims directed to inventions relating to any of the following are also non-permissible:

• the human body at the various stages of its formation and development;
• the simple discovery of an element of the human body, including the sequence or partial sequence of a gene;
• the cloning of human beings;
• modification of the germ line genetic identity of human beings;
• the use of human embryos for industrial or commercial purposes; and
• modification of the genetic identity of animals which is likely to cause them suffering without any substantial medical benefit to humans or animals, and any animals resulting from such processes.

Answer ... In the case of medicinal products and plant protection products, patent protection may be extended by applying for a supplementary protection certificate (SPC) in accordance with EU Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products and EU Regulation 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, respectively. SPCs take effect on the expiry of a national or European patent valid in Poland, and can extend the term of protection for a product protected by a basic patent by up to five years. The purpose of the SPC is to compensate the patent holder for the reduced duration of its patent monopoly due to the need to obtain marketing authorisation, which is a protracted process. The duration of an SPC for a medicinal product may be extended by a further six months under certain conditions in the case of paediatric clinical trials. This regulation aims to incentivise the pharmaceutical industry to investigate and develop medicines that are suitable for use in children.

Answer ... Neither the Act on Industrial Property nor the EPC provides a legal definition of an ‘invention’. They merely state that in order to be eligible for patent protection, an invention:

• may fall within any field of technology; and
• must be new, involve an inventive step and be susceptible of industrial application.

However, both include a non-exhaustive list of solutions which are not considered to be invention. These are generally as follows:

• discoveries, scientific theories and mathematical methods;
• aesthetic creations;
• schemes, rules and methods for performing mental acts, doing business or playing games;
• creations whose incapability of exploitation may be proved under generally accepted and recognised principles of science;
• creations or methods whose capability of exploitation cannot be proved, or whose exploitation will not yield the result expected by the applicant, in light of commonly accepted principles of science;
• computer programs; and
• presentations of information.

At present, the EPO excludes the patentability of the above subject matter only to the extent to which a European patent application or European patent refers to it as such. Likewise, the latest amendments to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, will further provide that the exclusion of such subject matter is valid only to the extent that the application refers to it as such.

Furthermore, both the Act on Industrial Property and the EPC set out a non-exhaustive list of inventions which are excluded from patent protection. These include:

• inventions whose exploitation would be contrary to public order or morality – in this regard, the exploitation of an invention will not be deemed to be contrary to public order or morality merely because it is prohibited by law;
• plant and animal varieties, and essentially biological processes for the production of plants or animals – this provision does not apply to microbiological processes and products obtained through such processes. Under the latest amendment to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, products produced directly through essentially biological processes for the production of plants or animals will also be excluded from protection; and
• surgical, therapeutic and diagnostic methods for treatment of humans or animals – although this provision does not apply to products, in particular substances and compositions, applied in diagnostics or treatment.

In the biotechnology field, the following subject matter is also excluded from patentability:

• the human body at the various stages of its formation and development;
• the simple discovery of an element of the human body, including the sequence or partial sequence of a gene;
• the cloning of human beings;
• modification of the germ line genetic identity of human beings;
• the use of human embryos for industrial or commercial purposes; and
• modification of the genetic identity of animals which is likely to cause them suffering without any substantial medical benefit to humans or animals, and any animals resulting from such processes.

Answer ... If the PPO rejects a patent application, the applicant may file a request for re-examination within two months of notification of the PPO’s decision. The decision is not liable to execution during this period. Another option is to file a complaint with the Administrative Court in Warsaw against a decision or order of the PPO within 30 days of notification of this decision. Effective filing of a request for re-examination or complaint depends on payment of a specific fee within the same timeframe. The Administrative Court will not examine the case on the merits, but will only examines whether the PPO’s decision was issued correctly (ie, in accordance with both procedural and material law).

If the EPO rejects an application, the applicant has a right to appeal. At the first stage –interlocutory revision – if the examination department whose decision is appealed considers the appeal to be admissible and well founded, it will rectify its decision. Otherwise, the appeal will proceed to the second stage – consideration by the Boards of Appeal.

Answer ... Patents valid in Poland are either national patents granted by the Polish Patent Office (PPO) or European patents granted by the European Patent Office (EPO) which are duly validated in Poland.

The validity of a patent granted by the PPO may be challenged before the PPO in either post-grant opposition proceedings or invalidation proceedings.

The validity of a European patent granted by the EPO may be challenged either:

• after validation in Poland in invalidation proceedings before the PPO, in the same way as a national patent granted by the PPO; or
• in centralised opposition proceedings before the EPO.

Answer ... The validity of an issued patent may be challenged in either opposition or invalidation proceedings.

An opposition against a national patent granted by the PPO may be filed by any party, without any need to show a legitimate interest, within six months of publication of the details of the patent grant in Wiadomości Urzędu Patentowego. The opposition must be reasoned and based on the same grounds on which a patent may be invalidated under the Act on Industrial Property.

The validity of a patent granted by the PPO may be challenged once six months have expired since publication of the details of the patent grant in Wiadomości Urzędu Patentowego. The petition for invalidation must be reasoned show a legitimate interest of the petitioner. If no legitimate interest is evidenced, the petition for invalidation will be dismissed. There is no legal definition of a ‘legitimate interest’ in the Act on Industrial Property; therefore, the assessment is based on the general rules valid in administrative proceedings. However, under the latest amendments to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, the requirement to show legitimate interest in invalidation of a patent will be abolished and any third party will thus be entitled to file a petition for invalidation.

The same invalidation procedure applies to European patents which have been granted by the EPO and validated in Poland. The grounds for invalidation of European patents which have been validated in Poland are set forth in the European Patent Convention (EPC).

European patents granted by the EPO may also be challenged through centralised opposition proceedings before the EPO. The timeframe for filing a centralised post-grant opposition before the EPO is within nine months of publication of the details of the patent grant in the EPO’s official gazette. A successful centralised opposition may result in revocation of the European patent in all EPO jurisdictions, with ex tunc effect.

Answer ... According to the Act on Industrial Property, a Polish patent granted by the PPO may be invalidated in whole or in part if any of the following is proven:

• The requirements for the grant of a patent have not been satisfied (ie, the invention lacks novelty, inventive step and/or industrial applicability);
• The invention has not been disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art; or
• The patent has been granted for an invention that is not covered by the contents of the application or of the original application.

According to the EPC, a European patent validated in Poland may be invalidated, in whole or in part, based on the following grounds stipulated in the EPC:

• The claimed subject matter is not patentable (ie, it lacks novelty, inventive step or industrial applicability, is excluded from patentability or does not constitute an invention);
• The invention is not disclosed in a manner that is sufficiently clear and complete for it to be carried out by a person skilled in the art;
• The subject matter of the patent extends beyond the content of the application as filed or, if the patent was granted on a divisional application or on a new application, beyond the content of the earlier application as filed;
• The protection conferred by the European patent has been extended; or
• The holder the European patent is not entitled to the patent grant.

Answer ... Requests for invalidation are decided by the PPO within the framework of the petition for invalidation and are bound by the legal grounds indicated therein. This means that the burden of proving the grounds for invalidation of the patent rests with the petitioner.

Answer ... A third party may oppose a patent granted by the PPO by filing a notice of opposition within six months of publication of details of the patent grant in Wiadomości Urzędu Patentowego. Once this six-month timeframe has expired, a third party may file a petition for invalidation of a patent, as long as it can show that it has a legitimate interest in the matter. If a legitimate interest is not evidenced, the petition for invalidation will be dismissed. Under the latest amendment to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, the requirement to show legitimate interest in invalidation of a patent will be abolished, so any third party will be entitled to file a petition for invalidation without needing to prove a legitimate interest.

The same invalidation procedure applies to European patents granted by the EPO and validated in Poland.

Moreover, in the case of European patents, any third party may file a notice of opposition with the EPO within nine months of publication of details of the patent grant in the EPO’s official gazette. The grounds and reasons for the opposition must be specified; however, there is no requirement to have a legitimate interest.

Answer ... An opposition against a Polish national patent granted by the PPO may be filed by any third party, without any need to show a legitimate interest. However, the right to file an opposition does not serve the patent holder.

In case of an opposition against a European patent, any third party may file a notice of opposition; however, this does not include the patent holder.

Answer ... Both oppositions and petitions for invalidation are filed after the publication of details of the patent grant in the respective official gazette. An opposition against a national patent granted by the PPO may be filed with the PPO within six months of publication of this information in Wiadomości Urzędu Patentowego. An opposition against a European patent granted by the EPO may be filed with the EPO within nine months of publication of this information in the EPO’s official gazette.

After the expiry of the timeframes for filing a post-grant opposition, a third party may file a petition for invalidation of a patent.

Answer ... According to the Act on Industrial Property, the grounds for opposition are the same as those invalidation, as follows:

• lack of patentability, including lack of novelty, inventive step and/or industrial applicability;
• failure to disclose the invention in a manner that is sufficiently clear and complete for it to be carried out by a person skilled in the art; and
• extension of the subject matter of the patent beyond the contents of the original application.

In the case of a European patent, an exhaustive list of grounds of opposition is set forth in the EPC. According to the EPC, the grounds for opposition are as follows:

• lack of patentability within the terms of Articles 52 to 57 of the EPC;
• failure to disclose the invention in a manner that is sufficiently clear and complete for a person skilled in the art to carry it out; or
• inadmissible extension of the subject matter of the European patent beyond the content of the application as filed.

Answer ... In opposition proceedings before the PPO, an opposed patent may be maintained in force in unamended form, or may be invalidated in part or as a whole. At present, the possibilities to amend patent claims during opposition are very limited; usually, the only possibility is to cancel one of the claimed categories, while maintaining the others (eg, cancelling a product claim and maintaining a method claim). However, under the latest amendment to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020, it will be possible to file a request for limitation of a patent after grant. In case of opposition, this request must be filed before filing observations on the opposition. This possibility will also be available during invalidation proceedings, although in this case the request for limitation must be filed before an oral hearing.

In case of opposition proceedings before the EPO, an opposed patent may be maintained in force in unamended form, maintained in force in amended form or invalidated. Contrary to the practice before the PPO, claim amendments are allowed under certain conditions during opposition proceedings before the EPO.

Answer ... The PPO decides on opposition or invalidation proceedings within the framework of the notice of opposition or petition for invalidation, and is bound by the legal grounds indicated therein. This means that the burden of proving the grounds for invalidation rests with the opponent or petitioner.

In case of opposition proceedings, the EPO decides on the balance of probabilities, based on the grounds and evidence provided by the opponent. The burden of proving the grounds for revocation rests with the opponent.

Answer ... In litigation proceedings before the PPO, a decision on the merits issued after an oral hearing may be challenged by filing a complaint to the Administrative Court in Warsaw within 30 days of notification of the reasoned decision.

Decisions issued by the EPO in opposition proceedings are subject to appeal before the Technical Boards of Appeal. Only a party to proceedings that has been adversely affected by a decision has a right to appeal. If an appeal is duly filed, any other parties to the proceedings are parties to the appeal as of right.

Answer ... Invalidity makes a patent unenforceable. If a patent is valid, it is enforceable.

Answer ... Neither the Act on Industrial Property nor the European Patent Convention (EPC) sets out specific inequitable conduct requirements.

Answer ... Neither the Act on Industrial Property nor the EPC requires a specific duty of candour.

Answer ... Any unauthorised exploitation of a patented invention for professional or commercial purposes constitutes patent infringement. This includes:

• making, using, offering or putting on the market a product that is the subject matter of the invention, or importing such a product for such purposes; and
• utilising a process that is the subject matter of the invention, or using, offering, putting on the market or importing for such purposes a product directly obtained through that process.

In accordance with the latest amendments to the Act on Industrial Property adopted on 16 October 2019, which will enter into force in the first quarter of 2020:

• the list of actions in the first bullet above will be expanded to include the stockpiling, storage and export of products that are the subject matter of the invention; and
• the list of actions listed in the second bullet will be expanded to include the stockpiling, storage and export of products obtained directly through the patented process.

Answer ... A doctrine of equivalents for defining the scope of a patent is not explicitly stipulated in the Act on Industrial Property. The scope of protection is determined by the claims contained in the patent specification; the patent specification and drawings may be used to interpret the claims.

As Poland is a contracting state of the European Patent Organization, it is bound by the EPC and the Protocol on the Interpretation of Article 69 EPC of 5 October 1973, as revised by the Act revising the EPC of 29 November 2000 (the so-called ‘Munich EPC Act’), is applicable in Poland. Thus, for the purpose of determining the extent of protection conferred by a patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

Answer ... Yes – in accordance with the prescriptions of the Brussels Ibis Regulation applicable in Poland, a party can be liable if the patent infringement takes place outside the jurisdiction.

Answer ... In professional business, ‘wilful infringement’ may be understood not only as intentional actions (ie, undertaken in the knowledge the solution is patented), but also as a lack of due diligence in checking whether a solution is patented.

Whether an infringement is wilful will determine which compensatory remedies may be sought (see question 6.13).

Answer ... An infringement action may be initiated by the patent holder or by an exclusive licensee which is registered in the Patent Register of the PPO, where the exclusive licence agreement does not preclude this.

Answer ... Because of the expiration of claims, there is a limited timeframe within which to file a patent infringement suit. Claims expire three years after the date on which the patent holder learns of the infringement; and this cannot be more than five years after the infringement occurred.

Answer ... In the statement of claims, the claimant should outline the scope of its patent, the alleged infringement and why and how the infringement took place. All claims, demands, evidence and formal requests should be included in the statement of claims. The claimant should also calculate the value of claims and pay the relevant court fee (which is calculated based on the value of claims).

Answer ... All IP matters are heard at the district civil court level. In determining jurisdiction, the general rule of actor sequitur forum rei applies.

However, plans are underway to establish specialist IP courts in Poland. The relevant regulations are under preparation, although what this system will ultimately look like and when it will become operational are as yet unknown.

Answer ... The fact finder in an infringement action is the district civil court that examines the matter. However, to clarify technical issues relating to the patent, the court may appoint a court expert and base its judgment on his or her opinion.

Answer ... No.

Answer ... According to a new regulation which will enter into force in November 2019, once the claimant has filed its statement of claims and the defendant has filed its response, a preparatory court session shall took place. At this session, the court will accept or dismiss the evidence and formal requests presented by the parties, and set out a plan for the trial (eg, number of hearings).

Answer ... The patent holder or another person permitted by law may demand:

• cessation of infringement;
• recovery of unlawfully earned profits; and
• in case of wilful infringement, compensation for damages – either:
• • on general terms (ie, the patent holder must prove the loss caused by the infringement); or
  • based on the corresponding licence fee or other remuneration which would be have been payable to obtain authorisation to exploit the invention.

Answer ... Yes. An appeal may be brought against both factual and legal findings of the first-instance court which the appellant believes are incorrect.

Answer ... Yes – some forms of discovery in a broader sense (understood as a procedure through which one party can obtain evidence from another by means of specific court orders) are available in patent infringement cases in Poland. They have recently been the subject of various legislative changes, aimed at improving compliance with the IP Enforcement Directive.

The latest amendments to the Act on Industrial Property adopted on 16 October 2019, which are expected to enter into force in the first quarter of 2020, provide for a special procedure for preserving evidence of IP infringements. This is separate from the general procedure for preserving evidence under the Civil Procedure Code (although some of the respective provisions of the Civil Procedure Code apply mutatis mutandis). It is also separate from the so-called ‘right to information’ procedure, which is available under another section of the Act on Industrial Property.

This special procedure is available both before lodging a lawsuit and while a suit is pending. It may relate to any evidence of infringement, such as product samples, materials or instruments used for production or distribution, as well as related documents. The procedure aims to facilitate the preservation of evidence for examination before the court. The most important requirement when initiating this procedure is to indicate that the rights holder’s claims resulting from the alleged infringement or threat of infringement are probable (which, for obvious reasons, does not require the full presentation and examination of evidence).

Further legislative changes concerning the preservation of evidence of IP right infringements are in the pipeline, as part of a new special civil procedure for IP matters which will be introduced into the Civil Procedure Code. Their adoption is expected during 2020. As currently drafted, these amendments regulate the procedure in more detail, including options such as the involvement of court bailiffs and court experts. They also introduce a separate procedure for the defendant’s disclosure of certain types of evidence (ie, bank, finance or commercial documents), which brings this even closer to ‘classic’ discovery.

Answer ... Under the latest amendments to the Act on Industrial Property, any method which makes it possible to secure or preserve evidence of an IP infringement may be considered by the court when deciding on the preservation of evidence. This includes:

• the seizure of a reasonable amount of product samples, materials or instruments used for production or distribution; and
• the seizure of related documents (following their disclosure by the alleged infringer).

As an alternative to seizure, the respective procedure may consist of a description of a certain object (considered as evidence to be preserved).

Answer ... Under the latest amendments to the Industrial Property Law, the limitations relating to the preservation of evidence, as described in questions 7.1 and 7.2, are informed by the principles of proportionality and reasonability (ie, the amount of objects to be preserved must be reasonable), as well as by the sole purpose of the special procedure of facilitating the preservation of evidence for examination before the court (contrary to provisional and precautionary measures aimed at the prevention of infringement). Another important limitation results from the requirement to respect trade secrets and other protected confidential information.

Answer ... The scope of a patent, as determined by the patent claims, is interpreted by the district civil court in examining the infringement case. Although to some extent the doctrine of equivalents is applicable in Poland (see question 6.2), the courts tend to take a strict approach to patent claims construction, which results in a tendency towards a literal interpretation of the claim terms.

Answer ... In accordance with the Act on Industrial Property, the scope of a patent is determined by the patent claims. Descriptions and drawings may be used to interpret the claims, but this happens only in case of doubt. No provision in the act requires the description and figures to be taken into account when determining the scope of a patent. Nevertheless, as Poland is a contracting state to the EPC, the Protocol on the Interpretation of Article 69 EPC of 5 October 1973, as revised by the Act Revising the EPC of 29 November 2000, is directly applicable in Poland. Thus, for the purpose of determining the extent of protection conferred by a patent, due account will be taken of any element which is equivalent to an element specified in the claims – at least in the case of patents granted by the EPO and validated in Poland.

Answer ... There is no exhaustive list of the types of evidence that can be provided in infringement proceedings for the purpose of defining the patent claim terms.

One option is to submit an expert opinion or the declaration of an expert appointed by a party. However, such opinions or declarations are not considered as evidence, but rather as private opinions.

The court may also appoint an independent expert witness itself, if it considers this necessary in view of the complexity of the case. In such case the parties may express their preference as to the appointment of a specific expert witness; however, the court is not obliged to take this into account. The expert witness may also be heard by the court during the trial and questioned by the parties. The opinion of the court-appointed expert witness is recognised by the court as evidence.

Answer ... Yes, an injunction is available in patent infringement cases in Poland, both before trial and during the court proceedings.

Answer ... An injunction may be requested by any party to the proceedings, if it can substantiate its claim and a legal interest in grant of the injunction. A legal interest exists if failure to grant the injunction would prevent or significantly hinder the enforcement of a ruling issued in a given case, or would otherwise prevent or seriously hinder satisfaction of the purpose of proceedings in a given case. When deciding on the injunction, the court will take into consideration the interests of the parties insofar as this is necessary to ensure adequate legal protection for the patent holder (or an exclusive licensee, where the exclusive licence has been registered by the Polish Patent Office in the Patent Register and the exclusive licence agreement does not preclude this), without excessively burdening the alleged infringer.

For the court to grant an injunction, an infringement must either have been committed or be threatened at that point.

When granting an injunction prior to infringement proceedings, the court will specify a timeframe within which an initial pleading must be filed, failing which the injunction shall be cancelled. This timeframe must not exceed two weeks.

An injunction request should specify the action required to safeguard the patent holder’s rights (eg, cessation of sale of the allegedly infringing goods) and substantiate the facts justifying the request.

The court may condition the enforcement of an injunction on the provision by the patent holder of security, in case the alleged infringer suffers any loss as a result of the injunction and no infringement is subsequently found.

Answer ... Yes – according to Polish law, damages may be awarded where culpable infringement is established.

Answer ... In case of culpable infringement, the patent holder or another party permitted by law may request the infringer to remedy the damage inflicted either:

• on general terms (ie, the patent holder must prove the loss caused by the infringement); or
• based on the corresponding licence fee or other remuneration which would be have been payable to obtain authorisation to exploit the invention.

The damages should compensate the patent holder for the loss that it has suffered as a result of the infringement.

As an alternative to damages, the patent holder or other party may request recovery of the unlawful profits made by the infringer as a result of the infringement. In such case, the assessment will refer to the estimation of the infringer’s profits, not the patent holder’s losses.

Answer ... Patent infringement claims may be monetary (ie, damages or delivery up of unlawfully earned profits) or non-monetary (cessation of infringement). This will affect the type of injunction that may be granted to the patent holder.

In case of monetary claims, the injunction may provide for:

• seizure of moveable property;
• remuneration for work; or
• receivables from a bank account or other receivables or other property rights.

In case of non-monetary claims, the injunction may provide for such actions as the court may deem appropriate in the circumstances, including those specified above. In particular, the court may:

• normalise the rights and obligations of the parties for the duration of the proceedings; and/or
• prohibit the sale of the allegedly infringing goods for the duration of the proceedings.

Answer ... Under Polish law, damages are intended to compensate the patent holder for the loss that it has suffered as a result of the infringement. Punitive damages are not available.

Answer ... If a party to infringement proceedings does not comply with a court order during the proceedings, then sanctions may be ordered by the court.

Answer ... Under Polish law, on the patent holder’s request, if an injunction is breached, the court may order the alleged infringer to pay a sum of money to the patent holder. This is a popular way to ensure compliance with an injunction.

There are no limits on the amount that may be ordered in this regard. In determining the amount of money, the court will consider the arguments presented by the parties and the interests of the parties, so as to ensure that the obligation is enforceable and does not overburden the alleged infringer.

In case of breach of an injunction, the court may also impose a fine or, in case of non-payment, imprisonment.

Answer ... Under Polish law, the losing party is obliged to pay the winning party’s costs on request, within the limits of the fee rates specified by law (fixed scale of costs). If the claims are only partially upheld, the costs will be mutually cancelled out or shared accordingly.

Answer ... As mentioned in question 9.9, there is a fixed scale of costs. Usually, the court will award basic attorneys’ fees as laid down in the law. However, the courts have some discretion in awarding costs: depending on the complexity of the case and the contribution of the attorneys in clarifying and resolving it, the court may multiply the basic fee by up to six. The multiplied attorneys’ fee cannot exceed value of the matter.

Answer ... Under the Act on Industrial Property, a patent holder can authorise (license) another party to exploit its invention. Supplementary protection rights may also be the subject of licence agreements. The licensed exploitation of an invention may involve:

• making, using, offering or putting on the market a product that is the subject matter of the invention, or importing such a product for such purposes; or
• utilising a process that is the subject matter of the invention, and using, offering, putting on the market or importing for such purposes a product that is directly obtained through that process.

A licence will be recorded in the European Patent Register as an exclusive licence if the applicant and the licensee so require. A licence will be recorded as a sub-licence where it is granted by a licensee whose licence is recorded in the European Patent Register.

Analogously, a European patent application may be contractually licensed. A licence may be registered by the European Patent Office in the European Patent Register. In the case of co-applicants, the registration of licences requires the consent of each co-applicant.

Answer ... In a licence agreement, the patent holder may restrict the scope of the right to exploit the invention (restricted licence). If a licence agreement does not restrict exploitation of the invention, the licensee has the same right to exploit the invention as the patent holder (full licence).

Moreover, the patent holder may restrict the duration of a licence. However, the licence will terminate at the latest upon lapse of the patent.

Furthermore, if the exclusive exploitation of an invention in a specific manner is not reserved by the licensor in the licence agreement, the licence is non-exclusive and the patent holder may grant further licences and exploit the invention itself (non-exclusive licence).

A licensee may not grant a further licence (ie, a sub-licence) without the patent holder’s consent; and further sub-licences are not permitted.

Analogously, a licence for exploitation of a European application may be geographically limited to parts of the territories of the designated contracting states. The licence may be a restricted licence or a full licence, exclusive or non-exclusive, depending on the terms of the licence agreement.

Answer ... Antitrust in Poland is regulated by the Act on Competition and Consumer Protection of 16 February 2007. This sets out the principles and procedures that apply to combat anti-competitive practices, practices that infringe collective consumer interests, inclusion of abusive clauses in standard agreements and anti-competitive concentrations of undertakings and their associations, where such practices have or may have effects in Poland. The act applies to contracts – in particular, licences – regarding industrial property, as well as to non-contractual practices concerning the exercise of industrial property rights in relation to which measures have been taken to prevent disclosure, where such contracts result in an unjustifiable restriction of the parties’ freedom to conduct business activities or in a significant restriction of competition on the market. The Office of Competition and Consumer Protection and its president are responsible for supervising compliance with this law and the appropriate EU regulations as adopted under Polish law.

In accordance with the Act on Industrial Property, an abuse of market dominance by the patent holder that contravenes the spirit of antitrust law may be remedied by the grant of a compulsory licence. A compulsory licence (an authorisation to exploit the patented invention of another person) may be granted by the Polish Patent Office if, among other things, it has been established that:

• the patent has been abused – in particular, by preventing exploitation of the invention by a third party where such exploitation is necessary necessary to meet home market demands and is dictated by public interest considerations, and if consumers are being supplied with the product in insufficient quantities, of inadequate quality or at excessively high prices; or
• a patent holder enjoying a priority right from an earlier application (the earlier patent) prevents, by refusing to conclude a licence agreement, home market demands from being met through exploitation of the patented invention (the dependent patent), whose exploitation would encroach upon the earlier patent.