Regulations of patent law in relation to generic drugs – international aspects and Polish law

Publication date: February 23, 2023

What is a generic drug?

A generic drug is one that has been created in the same way as a branded drug in terms of dosage, safety, efficacy, route of administration, quality, properties of action and intended use. These similarities help demonstrate adequate bioequivalence, meaning that the medicine will work in the same way as the original medicine. In other words, the original drug is equal to the generic substitute.

Generic drugs typically cost significantly less than their original counterparts because they take much less time to produce and eliminate the costs associated with animal testing and clinical trials. Often such a shortened drug registration path is called “shortened application of a new drug”. As a result of reducing the research costs associated with generic drugs, their final price is much lower than the price of the original product (usually they are 80 to 85% cheaper than the original ones), which makes them much more willingly bought by customers and generate much higher profits than generic products original. According to the IMS Health Institute, these drugs saved more than $2.2 trillion to the healthcare system between 2009 and 2019.

Regulations of patent law concerning generic drugs

Pursuant to Article 64 (1) of the European Patent Convention, a European patent grants its holder the same rights as those granted to a national patent granted in a given country. In addition, the provisions of the Munich Convention extend the legal scope of the European patent and, for example, in Article 63 we can find information about the duration of the European patent (20 years). In addition, in Article 64 par. 2 in the Munich Convention we will also find the scope of protection of an invention, the object of which is a manufacturing method. Other patent rules are determined by national legislation.

The effect of granting a patent is the creation of an effective ergo omnes subjective right on the part of the entitled person. The content of such a right is presented in art. 63 sec. 1 of the Polish Industrial Property Law, which states that by obtaining a patent, you acquire the right to exclusive use of the invention for profit or professionally. In addition to the above-mentioned right, Article 66(1) of the Polish Industrial Property Law contains a catalogue of activities that are prohibited without the rightholder’s consent – a negative enumeration. A patent is a right based on intangible assets, therefore it has statutory territorial, time and objective boundaries. It is worth noting that Article 63 par. 1 of the Polish Industrial Property Law is applied in accordance with the principle of patent territoriality only within the territory of the Republic of Poland.

The term of the patent may be up to 20 years from the date of filing the invention application with the Polish Patent Office, provided that the required fees are paid on time. Thanks to such a long period of time granted for a patent, inventors are able to recover the costs incurred during the research phase. In addition, as part of the patent granted for medicinal products, there is a possibility of supplementary protection certificate. Information on such a benefit can be found in Regulation 469/2009. It is worth noting that the supplementary protection benefit is directly applicable in all EU Member States. In Poland, this benefit has been supplemented with a procedural regulation contained in Chapter 5 of the industrial property law. Having such a benefit may extend the exclusivity period of the rightholder by the time that elapsed between the date of filing the basic patent application and the date of the first authorization to market the product in the EU, reduced by five years. However, this period may not exceed five years.

Patent limitation for generic drugs

A limitation of a patent means that the holder of the patent is deprived of the prohibitive powers that he could have imposed on the patent. The conditions for such exclusions are provided for in Art. 30 of the TRIPS Agreement. In the light of this provision, members of the World Trade Organization are able to make restrictions on the rights conferred by a patent, provided that they do not unreasonably prejudice the interests of the patent owner and take into account the legitimate interests of third parties [1].

From the point of view of the pharmaceutical industry, the regulation described as the Roche-Bolar clause (Bolar exception) is of great importance. Thanks to it, manufacturers of generic drugs can use patented medicinal products to the extent necessary to perform the activities required to obtain registration. This name was created when a dispute between Roche Products Inc. and Bolar Pharmaceutical Co. Inc. arose[2]. The judgment held that the actions taken by Bolar Pharmaceutical Co. Inc. do not fall within the scope of activities of fair scientific use. The fair use in question is treated as research privilege. In national jurisprudence, it was included in Article 69 par. 1 point 3 of the Polish Industrial Property Law, which says that “The patent shall not be infringed by using the invention for research and experimental purposes, for its evaluation, analysis or teaching”. In the case between Roche Products Inc. and Bolar Pharmaceutical Co. Inc, it was recognized that the use of a previously patented substance by Bolar Pharmaceutical Co. Inc was commercial, ultimately profit-making. As a result, the US Congress decided to introduce the Hatch-Waxman Act, according to which it is possible to use a previously patented substance for purposes related to the development or transfer of information regarding the use or sale of medicinal products. In Polish jurisprudence, the Bolar exception has been included in Article 69(1)(4) of the Polish Industrial Property Law, according to which “The patent shall not be infringed by the use of the invention consisting in the production, use, storage, offering, marketing, exporting or importing in order to perform activities that are required under the law to obtain, also by a third party, registration or authorization, which is a condition for marketing certain products due to their intended use, in particular medicinal products in the territory of the European Economic Area or in another country.” It is worth noting that the Bolar exception allows manufacturers of generic drugs to start research while the patent protection for the innovative drug is still in force. Thanks to this, the monopoly on the original drug is shortened and it is possible to introduce a generic drug to the market immediately after the protection of the innovative drug expires.

Patent registration procedure in Poland and the European Union

Currently, a European patent is registered by the European Patent Office based in Munich, on the basis of the European Patent Convention. The European procedure allows you to obtain a patent in 38 EPC member states. This procedure is divided into two parts. The first one is divided into several stages; formal and legal examination of the application, issuing an opinion by an EPO expert on the patentability of the invention, substantive examination and issuing a decision on granting a patent. The next stage is the European patent validation procedure. In order to validate a patent in a selected country, the patentee is obliged to submit a translation of the patent into the official language to the national patent office of the country and pay the appropriate official fees. Due to the high costs associated with the entire procedure, usually a European patent is valid only in certain countries selected by the right holder. It is worth noting that a patent registered in this way is treated on an equal footing with a patent registered under the national procedure. To sum up, a European-registered patent is actually a collection of national patents that are independent of each other. However, the European patent will undergo significant changes. In June 2023, the so-called “unitary patent protection” will be introduced. This system will establish a European patent with unitary effect and a Unified Patent Court. This patent will significantly reduce the complexity and cost of patent validation as it will have unitary effect in 17 countries. The Member States that will belong to the unitary patent system are: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia and Sweden. This change does not apply to the procedure for examining European patent applications, but only introduces an additional option that arises after receiving a decision to grant a European patent. Thanks to this, the person applying for a European patent will be able to validate it using the normal European patent procedure or immediately take advantage of the opportunities offered by the unitary European patent and later extend the protection of the patent by carrying out additional validation in countries not belonging to the unitary patent protection system. In the case of Poland, there is still no clear answer as to whether it will want to join this system. At the moment, Poland is not listed as a member of the unitary patent system, but European patents are still valid in Poland, subject to validation by the Patent Office of the Republic of Poland. Possibly, the most likely scenario is that Poland will assume a passive role as an observer and watch how this system will work in practice.

The national procedure in Poland begins with the submission of an appropriate application to the Patent Office of the Republic of Poland. The procedure for granting a patent is divided into several stages[3]: assigning a date to the application and checking whether the application contains all the necessary elements, classifying the invention and preparing a report on the state of the art, formal and legal examination, possible examination of applications infringing Art. 28 and 29 of the Industrial Property Law, announcement of the invention application in the Bulletin of the Patent Office (the announcement is made immediately after 18 months from the date of priority to obtain a patent), substantive examination of the application during which the patentability is examined, the process ends with the issuance of a decision on granting rights and payment of the protection fee, followed by entry in the patent register and publication of the patent in the Bulletin of the Patent Office.

[1] International Multilateral Agreement of April 15, 1994 on the Agreement on Trade-Related Aspects of Intellectual Property Rights. Marrakesh. 1994.04.15 (Journal of Laws of the EU. L. of 1994, No. 336, p. 214, as amended).

[2]733 F.2d 858 (Fed. Cir. 1984)