The Pharmaceutical Intellectual Property and Competition Law Review: Poland
As a Member State of the European Union, Poland has generally aligned its regulations in the pharmaceutical sector and competition law with the measures applicable in the European Union. Although generic and food supplement manufacturers maintain undisputed quantitative superiority in the pharmaceutical market in Poland, a few Polish companies with significant innovation capacity, also operating on foreign markets, have grown. Some tensions between manufacturers of generic and innovative medicines can be observed primarily in connection with reimbursement processes and in the area of patent law claims. Poland is a party to the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) and the European Patent Convention, which makes the crucial Polish patent law measures compliant with the above convention. As a result of the recent amendment to patent law in Poland, a significant extension of the scope of the patented invention exploitation under the Roche Bolar exemption has been introduced, which will allow generic manufacturers to speed up their market entry.
In relation to other European countries, Poland has introduced in its regulations on the marketing of medicinal products separate measures pertaining to the pharmacy sector as regards operating authorisations and the permitted advertising of pharmacies.
However, as regards the Polish market, there have been few competition law cases related to the pharmaceutical industry.
This chapter describes the practical aspects of the registration of medicines, their marketing, as well as the specific character of patent protection with special reference to the competitiveness aspects of innovative and generic medicines.
Legislative and regulatory framework
i The main legislation providing for authorisation
The provisions on granting marketing authorisations for medicinal products are laid down in the Polish Act on Pharmaceutical Law (the Pharmaceutical Law), adopted in 2001 and subsequently amended in a number of ways (unified text of the Polish Journal of Laws of 2020, item 944). This law is almost entirely based on Community law and implements all EU directives on medicinal products for human and veterinary use. Naturally, numerous Community Regulations governing the market of medicinal products are directly applicable.
National marketing authorisations for medicinal products are granted by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, while the marketing of medicinal products is subject to the Chief Pharmaceutical Inspector.
ii Pricing policy
The pricing policy for medicinal products is one of the most sensitive issues. Drugs and foodstuffs intended for particular nutritional purposes and medical devices reimbursement policies are governed by the Act of 12 May 2011 (i.e., the Polish Journal of Laws of 2020, item 357). The impact of Directive 89/105/EEC on the reimbursement policy as well as measures regulating the pricing of medicinal products is evident, as it was transposed in its entirety in the Reimbursement Act. The drug reimbursement decision-making process is undertaken by the Minister of Health and is subject to judicial review. A reimbursement decision should be taken within 180 days of the date of the submission of a completed application form. Prior to the decision, the Minister of Health conducts negotiations with pharmaceutical companies in compliance with the principle of transparency. The criteria that inform the Minister's reimbursement decisions are specified in the Reimbursement Act. In exceptional circumstances, the Reimbursement Act provides for the reimbursement of medicines obtained by means of import, as well as for off-label indications. To ensure their social adequacy, reimbursement notices are issued on a bi-monthly basis. So far, the total reimbursement budget has not exceeded 17 per cent of the total public funding allocated to financing guaranteed benefits. Theoretically, prices of generic medicines should be lower than prices of innovative medicines; however, the differences are not always significant.
iii Public purchasing of pharmaceuticals
There is either retail or wholesale marketing of medicinal products and it requires authorisation by the competent pharmaceutical inspection authority on a case-by-case basis. In the context of the operation of pharmacies in Poland, the recently imposed demographic restrictions (the number of inhabitants in a municipality per pharmacy), geographic restrictions (the minimum distance between pharmacies) and subjective restrictions (the permit to operate a pharmacy is granted only to a pharmacist, a registered partnership or a professional partnership whose sole core activity is the operation of pharmacies and in which the partners are only pharmacists) are the key issues that are still widely discussed. The absolute prohibition of advertising pharmacies is also debatable. In accordance with Article 94a of the Pharmaceutical Law, advertising pharmacies and their activity is forbidden. It is only the information about the location and opening hours of a pharmacy that does not constitute an advertisement. The prohibition of advertising pharmacies is interpreted very strictly by the regulatory authorities, which has resulted in numerous penalties imposed on pharmacies, and has been the subject of administrative court judgments. Most legal scholars and commentators consider the absolute prohibition of advertising pharmacies to be an excessive restriction of the freedom to conduct business. It has been the subject of a notification submitted to the European Commission regarding the incompatibility of the Polish measures with EU law.
As far as wholesale marketing is concerned, a direct sale of medicinal products to a pharmacy has become the main unresolved issue. In such a model of distribution, the medicinal product remains the property of the manufacturer until it is purchased by the user, while the wholesaler is only an intermediary. Having been extensively discussed, this model has been eventually approved as it prevents excessive drug export, which may sometimes prove profitable due to price differences within individual EU countries. Such export naturally conflicts with the interests of innovative drugs manufacturers, as it prevents them from taking advantage of the possibility of market-sharing in terms of prices.
However, selling medicines by pharmacies to wholesalers who then resell them abroad (the reverse drug distribution chain) has been found unlawful, as pharmacies are authorised to sell medicines exclusively to the end user.
The sale of medicinal products via mail orders is permitted only with respect to over-the-counter products.
iv Specific measures for innovative products
As in other European countries, Poland has introduced measures to promote bringing innovative medicines into the market.
These measures include regulations providing for data exclusivity and market exclusivity, which have been entirely based on EU directives.
Marketing authorisations for generic medicinal products for human use based on a reference medicinal product that is or has been authorised in Poland, a Member State of the EU or the EEA and may be granted if a period of eight years has elapsed between the date of granting the first marketing authorisation for a reference product in any of these countries and the date of applying for a marketing authorisation in Poland. If an indication constituting a significant clinical benefit is added, this period may be extended by a further 12 months. After eight years, an application for a marketing authorisation for a product can be submitted; however, only 10 years after granting the first marketing authorisation may the product be placed on the market (market exclusivity). Data exclusivity protection is currently independent of patent protection.
v Liability for infringement of data protection and market exclusivity provisions
If a marketing authorisation has been granted for a medicinal product that is a generic version of the reference product within the period of exclusive data use, with reference to the data in question, and without the consent of the holder of the right to exclusive data use, or within the period of the reference product market exclusivity, the State Treasury incurs liability for the damage caused by granting such an authorisation under the provisions of the Civil Code. Any party with a legitimate interest can have access to the register (of medicinal products) and the documents submitted in the proceedings on market authorisations; however, the provisions on the protection of classified information and industrial property must be respected (Article 39(3) of the TRIPS Agreement and Article 8(3) of the Pharmaceutical Law). As regards the applicant's liability for unjustified referring to the reference product within the period of data exclusivity, this liability can be derived from the protection of business secrets provided for in Article 11 of the Act on Combating Unfair Competition (Act of 16 April 1993, i.e., the Polish Journal of Laws 2003, item 153).
vi Supplementary protection certificate
Both the essential conditions for granting a supplementary protection certificate (SPC) and the scope of its protection have been laid down in Regulation (EC) No. 469/2009, which is directly applicable in Poland. Procedural issues of granting an SPC are regulated in the Polish Act on Industrial Property Law of 30 June 2000, as subsequently amended (i.e., the Polish Journal of Laws 220, item 286 (the Industrial Property Law)).
In the Polish context, there have been a few disputes concerning the interpretation of the criteria of granting an SPC, with the Patent Office of the Republic of Poland and courts referring in this regard to the interpretation developed in the Court of Justice of the European Union rulings.
New drugs and biologics – approval, incentives and rights
Since full harmonisation of the EU pharmaceutical law is complete, and the Member States are obliged to refrain from introducing regulations on marketing authorisations for medicinal products that have no basis in Community law, Polish registration and medicinal product marketing procedures are in full compliance with the existing EU directives. Therefore, medicinal products with marketing authorisations granted by the Council of the European Union or the European Commission, products granted national authorisations, as well as products with parallel import licences are authorised for marketing in Poland. Package labelling of such products should be presented in Polish; however, in exceptional circumstances, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may issue consent for a foreign language content of package labelling of orphan drugs. Borderline products are subject to the provisions of the pharmaceutical law if they meet the criteria for a medicinal product and for a product that is, for example, a food supplement, cosmetic product or medical device. In Poland, relatively abundant administrative case law has developed regarding the issues of advertising such products and protecting consumers against misleading information about their therapeutic properties. Control over the marketing of borderline products is exercised by the Chief Sanitary Inspector.
The fees payable in relation to placing medicinal products on the market in Poland have been set in an annex to the Regulation of the Minister of Health of 16 June 2015 regarding the fees payable in relation to placing medicinal products on the market (the Polish Journal of Laws of 2015, item 958); the fees vary depending on the type of application for marketing authorisation and range from 10,000 to 84,000 zlotys (the highest fee of 84,000 zlotys concerns the marketing authorisation for a reference medicinal product). Separate fees are charged for submitting several applications at the same time and for changes applied for in the registration. National registration is granted for a period of five years, with the possibility of renewal for an indefinite period provided the party responsible submits a relevant application no later than six months before the expiry date of the authorisation. From the date of submission of a complete application form, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has 210 days to issue a decision, which is subject to review by the administrative court. The marketing of orphan medicinal products is governed by Regulation (EC) No. 141/2000 and Polish law does not contain any specific regulations in this regard. The registration procedure does not take into account issues concerning possible patent infringements. If the patent holder considers that its rights will be infringed by placing the medicine subject to registration on the market, it cannot suspend the registration procedure and can only avail itself of a special claim laid down in Article 285 of the Industrial Property Law in the case of a threat of patent infringement. The regulation provides that the patent or SPC holder may require the cessation of activities posing a threat of infringement. The claimant does not have to prove the fault of the alleged infringer; indication of the existing law and a threat of infringement is enough. Likewise, it is not necessary to prove the danger of damage. The claim laid down in Article 285 of the Industrial Property Law may be secured in a safeguard procedure initiated prior to bringing a legal action. In the application for precautionary measures, it is vital that the actions to be provisionally prohibited and that pose a threat of infringement be precisely specified.
ii Generic and follow-on pharmaceuticals
A generic medicinal product, as defined in Article 15(8) of the Pharmaceutical Law, is a product that has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence to the reference product has been demonstrated with an appropriate bioavailability study. In principle, a prospective holder of marketing authorisation for a generic product should submit the results of a bioavailability study to demonstrate bioequivalence with the reference product. However, the Pharmaceutical Law allows such studies to be dispensed with if the marketing authorisation holder proves that the equivalent of the reference medicinal product meets the criteria set out in the EU guidelines.
Facilitating the market entry of generic medicines – research exemption and the Roche Bolar exemption
Patent law provides for two patent exclusivity rules that facilitate the manufacture and marketing of generic medicines: the exemption allowing the use of invention for research and experimental purposes, and the Roche Bolar exemption. So far, there have been no court decisions that would settle disputes concerning the classification of a specific action as falling within the scope of research exemption; theoretical studies stress the purpose of the study as the decisive factor: if the purpose is to discover something new or to test a hypothesis of whether a patented invention is feasible, it should be considered that such actions fall within the research exemption. It is quite difficult to draw the limits of research exemption since a large part of research is carried out for commercial purposes; however, this does not preclude the application of this exemption.
The Roche Bolar exemption is governed by Article 69(1)(4) of the Industrial Property Law. As a result of the recent amendment, this provision has significantly extended the scope of the acts permitted under the exemption. This change was brought by Judgment IV CSK 92/13 of the Supreme Court of 23 October 2013, whereby the court ruled that the Roche Bolar exemption applies only to the acts necessary for registration in the country where the patent was granted. This interpretation excluded the export of an active substance to another country where the substance was to be used for the purposes of a drug registration procedure. Article 69(1)(4) of the Industrial Property Law now provides that the use of an invention consisting in the production, application, storage, offering, placement on the market, export and import of substances to take steps required by law to register a medicine or to obtain a marketing authorisation in the EEA or another country, also by a third party, does not constitute a patent infringement. Following this amendment, a third party is permitted under Polish law to both produce in Poland and to offer and export the substances that are necessary for registration or for obtaining an authorisation within the EEA or other countries. This enables the manufacturer of the active substance to produce and export it to another country in the quantities necessary to carry out registration procedures.2
iii Biologics and biosimilars
Chapter 9 of the Industrial Property Law Act is dedicated to the protection of biotechnological inventions. The provisions contained therein align Polish patent law with Directive 98/44/EC and do not deviate from the provisions set out in the said Directive. There are currently no doubts as to the feasibility of patenting the production or use of biotechnological material or any isolated biological material. This has been confirmed for many years by the practice of the European Patent Office, and the Patent Office of the Republic of Poland does not form a separate policy in this regard.
Like other patents, the scope of patents for biotechnological inventions is limited; however, here we have a special provision. When formulating the principles of exhaustion of the law, self-reproduction of biological material was taken into account. Pursuant to Article 93(1) of the Industrial Property Law, a single reproduction is permitted if it is an inevitable corollary to the use of biological material. Polish law also provides for authorising farmers to reproduce biological material multiple times (the farmer's exemption). From a legal point of view, this is a type of statutory licence.
The actual limitation of biotechnological patents is also the prohibition of the use of genetically modified seeds.
The manufacturer of generic medicine is not a party to the patent procedure. Prior to the notice of application for patent, the file of that application may not be disclosed without the applicant's consent. Following the publication of the notice, the Patent Office may make available to third parties a report on the state of the art to be considered in the examination of the invention. Based on this report, the generic manufacturer may therefore prepare arguments that justify the revocation of the patent granted. An application for revocation may be submitted by any party, without specifying its interest in bringing the action.
Cases for the revocation of patents (including the revocation of a European patent granted under the Munich Convention on the European patent), the SPC, the limitation of the scope of the patent and the expiry of the patent relating to biological material are examined by adjudicating boards in dispute proceedings before the Patent Office. Decisions of the board may be subject to a complaint made to the Administrative Court.
Patent protection cases are part of the civil proceedings and are adjudicated by a court of law (from 1 July 2020 by one of the four district courts designated as intellectual property courts). In the course of infringement proceedings, the defendant may raise a plea for the invalidity of the patent, but it is not possible to bring a counterclaim for a declaration of invalidity. The civil court has no competence to consider the case for revocation, but it may suspend the proceedings (the decision to suspend is left to the ruling court) until the Patent Office has considered the case. Such a distribution of competence between courts and the Patent Office can cause significant problems. The suspension of proceedings leaves the case with no adjudication and no certainty as to the result for up to several years, until a final decision on the revocation is passed. However, delivering a judgment before the end of the revocation proceedings could cause a significant damage to the defendant, against whom a judgment prohibiting production and ordering compensation would be enforced. The plaintiff may decide to obtain a precautionary order to secure his or her claim; however, if he or she ultimately loses the case, he or she may be obliged to cover the damage resulting from the submitted security. Such a provision is provided for in Article 746 of the Code of Civil Procedure.
A certain way of defending the generic manufacturer against allegations of patent infringement is to bring an action for a declaration that specific acts do not infringe a patent or SPC, as expressly provided for in the current version of Code of Civil Procedure (Article 479).
In patent infringement cases, another possibility would be mediation proceedings, which are governed by the provisions of the Code of Civil Procedure. Disputes arising from licensing agreements may also be subject to arbitration.
The executive body for competition and consumer protection is the President of the Office for Competition and Consumer Protection. The President acts under the Act of 16 February 2007 on the Protection of Competition and Consumers (the Polish Journal of Laws 2015, item 184, as amended). Following the proceedings, the President may issue a decision to declare the practice to be restricting competition if he or she finds that it has violated the prohibitions referred to in Article 6 of the Act (prohibited agreements) or in Article 9 (abuse of a dominant position), or Articles 101 or 102 of the Treaty on the Functioning of the European Union. Such a decision is often accompanied with an administrative penalty, which consists of imposing a fine on the undertaking. Prohibited restrictive practices, especially contracts, are legally invalid and affected market participants, including consumers, may seek compensation. An appeal from the President's decision may be made to the District Court in Warsaw – the court of competition and consumer protection – and, subsequently, to the Court of Appeal. Consumer protection duties are carried out by local authorities via the consumer ombudsman and consumer organisations.
The Act on Competition and Consumer Protection of 16 February 2007, as amended (i.e., the Polish Journal of Laws 2019, item 369) lays down measures to prevent competition-restricting practices and practices infringing collective consumer interests. The intent to undergo concentration should be notified before the concentration takes place. The parties that intend to undergo concentration must wait until clearance or one month after the application for notification is submitted, unless the Patent Office extends the procedure to five months, the latter being acceptable if the proposed concentration requires a deeper examination of its market impact. The implementation of concentration without the consent of the President shall result in administrative sanctions. The President may decide to impose a fine upon the parties, which does not exceed 10 per cent of the turnover obtained by the undertaking in the financial year preceding the year when the fine is imposed. A fine may also be imposed on the managers of the parties. The concentration agreements are invalid without the consent of the competition protection authority. To the best of our knowledge, the President of the Office for Competition and Consumer Protection has not imposed any penalty so far for concentration in the pharmaceutical sector without his or her consent.
In Poland, there have been no cases of abuse of a dominant position by pay-for-delay settlements. However, the Patent Office has been recently examining the imposition of fixed resale prices of food supplements by a well-known manufacturer on its distributors (this case has not been closed yet).
There are also ongoing proceedings in a case concerning the requirement, imposed on pharmacies by a distributor of medicines, to use a specific IT system or other integrated third-party systems when those pharmacies wanted to benefit from promotion schemes of certain medicines.
Outlook and conclusions
The basic regulations on the pharmaceutical market in Poland do not differ from the regulations that are binding in the European Union. A significant change to the enforcement of patent infringements took place on 1 July 2020, the date of entry into force of the Act of 13 February 2020 amending the Code of Civil Procedure and certain other laws (the Polish Journal of Laws 2020, item 288), introducing the specialised intellectual property courts. The provisions introduced by that Act will significantly facilitate the proceedings to the right holders.
First, specialised intellectual property courts (currently four district courts) have been established, which should guarantee a higher level of substantive judgments and an improvement in the speed of dispute resolution. The District Court in Warsaw will be the only court to adjudicate cases dealing with technical and IT issues. It will settle disputes regarding computer software, inventions, utility models, topography of integrated circuits, plant varieties and technical trade secrets. Second, the procedures for safeguarding and disclosing evidence and the procedure for information disclosure claim have been regulated in detail. The claim for safeguarding evidence takes account of the fact that obtaining and storing evidence is essential for future proceedings, both as regards the determination of infringement and the extent of remedies. Requests for information shall enable access to information about the origin of the infringing goods or services, about their distribution channels and about third parties involved in the infringement. The condition for a request for information is to establish credible circumstances indicating an infringement of the patent, which is not tantamount to proving the patent infringement. A request for information may be made either before or after bringing an action; it is considered on an inter partes basis. Where a request for information is examined before bringing an action, the right holder must bring an action for infringement within one month of the implementation of the decision to provide the information. The person responsible for providing information shall be entitled to bring a claim for redress of damage caused by the performance of the obligation to provide information if the holder has not brought an action for infringement within the time limit set by the court, or if the proceedings have been discontinued or the action dismissed. The use of the information for purposes other than the recovery of claims gives rise to an obligation of compensation on a general basis.
The application for evidence disclosure or release is a new measure; it may concern banking documents or commercial contracts.
The Act in question also introduces an action to assert that certain acts do not infringe a patent or an SPC. Although the Code of Civil Procedure had already provided for bringing an action to assert a right or legal relation, doubts were raised as to whether it could be applied to patents, since such an action could block the patent infringement action. Since Article 189 of the Code of Civil Procedure applies to this action, the plaintiff must demonstrate his or her legal interest in the assertion. A typical legal interest in such cases is the need to remove legal uncertainty. On the basis of the ruling in the case for assertion, it may appear that placing specific products on the market would constitute an infringement of third-party rights. In this way, high investment costs, which would then prove useless, can be reduced. This measure is therefore particularly useful for generic medicine businesses.