Patent protection of medical products in Poland

The patent protection of a medical product lasts 20 years. However, the time-consuming process of registering drugs results in the fact that the manufacturer of the patent-protected drug takes advantage of the patent monopoly for a much shorter time. For this reason, instruments have been introduced by which pharmaceutical companies can benefit from market exclusivity for a longer time.

In August 2015, the pharmaceutical company Turing Pharmaceuticals acquired the exclusive distribution license for Daraprim in the United States [1]. Shortly thereafter, Turing raised the price of the drug in the US market by 5500%, from USD 13.5 to USD 750 for one pill which led to an angry public outcry [2]. Interestingly, similar counterparts available in India could then be purchased for less than 10 cents [3]. The social outburst was even higher, as Daraprim is an antiparasitic drug used to treat people with impaired immune systems, including AIDS patients, and patients with some types of cancer, for whom no access to the drug would be life-threatening [4]. As a result of this controversial move, Martin Shkreli, the founder and president of Turing Pharmaceuticals, was named “the most hated person in the United States” by the press [5]. It must be noted that Daraprim is an old drug and its patent protection expired in the 1970s. However, due to the lack of a counterpart in the US market, Turing held a monopoly, which allowed them to set high prices. Although in this case the monopoly was not derived from a patent; the presented situation illustrates very well the possible effects ofpatent monopolies. This also contributed to the introduction of patent protection of medicinal products in Poland.

Because of the socially significant importance of drugs, pharmaceutical inventions are a specific type of invention, and the provisions of Polish and European patent law govern certain aspects of their protection in a particular way. Like any invention, medicinal products must meet the criteria of patentability. They must therefore be novel, inventive, and industrially usable. The patentability criteria for pharmaceutical inventions generally do not differ from the criteria envisaged for inventions in other fields. However, the law provides for an exception for medicines, namely the relaxed premise of novelty for the first and subsequent medical applications. The novelty of the invention means that the notified technical solution may not be the state of the art, that is to say, solutions already known. The second premise, the inventive stage, is sometimes called “the premise of non-uncertainty”. In accordance with it, the new technical solution, i.e. the invention, should be characterized by a proper degree of innovation.  It aims to reduce the number of trivial inventions that are characterized by low level of innovation, which is intended to prevent trivialization of the patent law. If industrial utility is concerned, the invention must not be of a purely theoretical nature – it must be useful in the practical activity of a human being, and its result must be reproducible. If it comes to pharmaceuticals – as a mass-produced product and used in the treatment of humans and animals – they fulfil it by their nature.

How long does patent protection of medical products take?

Duration of protection of medicinal products is no different from that of other inventions and it is 20 years. However, due to the fact that medicinal products, as a means of strongly affecting the body, are subject to time-consuming and restrictive admission procedures, the effective time of the exclusivity period is significantly shortened. The release process, including the time needed for testing, may take from eight to a dozen or so years, while the protection period runs from the date of application of the invention to the patent office [6]. To compensate drug manufacturers for this time, a supplementary protection certificate has been introduced; an institution that can extend protection for up to five years, depending on how much time the registrations took. In addition, data exclusivity and market exclusivity have been introduced, which, although they belong to pharmaceutical law, also help to maintain a monopoly.

The specificity of patent protection of medicinal products is manifested by the fact that, for ethical reasons, the use of surgical or therapeutic methods and diagnostic methods for human and animal use are excluded. As in other areas of inventions, we distinguish two basic categories of inventions: the registration of the product and the registration of its manufacture. However, there are two further categories for medicines: the registration of the first medical use and the second (and subsequent) medical uses. While prescribing a medicinal product, we obtain a patent for a substance or mixture with a specific effect on the body. In turn, a patent on the manufacturing process protects the specific chemical process that result in the production of the product; what is important, is the fact that the protection is not limited to the process itself, but it also protects the result. Patent categories for new applications were created due to the slowdown of technological development in the pharmaceutical industry, which was associated with the difficulty of synthesizing new chemicals. Pharmaceutical companies, encouraged by the possibility of protection, have begun to improve known medicinal products (e.g. by reducing side effects), as well as by examining chemicals for their utility in medicine. The first medical use allows the use of a chemical known for science, but for which therapeutic use has since been discovered. Such a solution constitutes the relaxation of the criterion of novelty – after all, a substance known to science is not “new” as such. In the case of further medical use, new properties for substances already present in the medicinal product are protected [7].

The concept of patent protection is based on granting a patent monopoly to a patentee, which is intended to stimulate the pharmaceutical industry to invest in research into new medicines. The monopoly of the patent is intended to allow drug manufacturers for the return on the investment for the development of the product and to obtain funds for research into subsequent products [8]. However, it should be taken into consideration that medicines are essential for the state’s health protection, which is guaranteed in many international agreements, as well as the Constitution of the Republic of Poland. For this reason, the state must create conditions to ensure the availability of medicines while taking into account the need to protect innovation. The resulting conflict of interests between the sick and the pharmaceutical industry is, however, more complex. While it may seem that a patient should be affected by the weakest and shortest possible patent protection, as the appearance of equivalent medicines results in a fall in prices, one must also take into account that the vast majority of new drugs come from pharmaceutical companies that invest in research and incur the costs of placing the product on the market. It should be noted that strong patent protection can also be beneficial for patients [9].

Can the protection of the same medicinal product be extended several times?

In recent decades, there has been a tendency to strengthen patent protection. This is manifested by the creation of the above patent categories for medical applications. In addition, the scope of protection has been extended by the possibility of extending patent protection through the additional protection by law. Furthermore, the pharmaceutical law institutions that are subsidiary to patent protection increase the scope of protection available to pharmaceutical companies. To illustrate the expansion of the protection of medicinal products it is worth mentioning that still in the 80s of the 20th century patent protection of medicinal products was not standard, and the only patent category provided for medicines was often easy to circumvent the competition by patenting the manufacturing process. Due to the concerns about the availability of drugs, the described state of affairs may raise legitimate doubts. On one hand, it is important to recognize that wider protection stimulates innovation. On the other hand, however, it may lead to limiting the availability of medicines, which is in contradiction with the implementation of the constitutional right to health. In addition, a wide range of patent protection can result in the emergence of undesirable phenomena, such as evergreening, that is, multiple extensions of the protection of the same invention to delay the entry of competing products to the market.

As it is easy to see, the task of the state does not end with the creation of a sustainable system, because the pharmaceutical market is extremely dynamic. The legislature must continually revise patent law and regulations governing medicinal products to provide patients with the widest possible access to effective and safe medicines. At the same time, it must also take into account the interests of the pharmaceutical industry, which, by investing in drug research – which of course is not done out of pure altruism – requires the extension of protection for the effects of drug research that save the lives of the next group of patients.

[1] http://www.prnewswire.com/news-releases/turing-pharmaceuticals-ag-acquires-us-marketing-rights-to-daraprim-pyrimethamine-300125853.html (access: 10.08.2017)

[2] https://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html (access: 10.08.2017)

[3] http://www.ibtimes.co.uk/daraprim-like-drug-costs-less-0-07-india-1521144 (access: 10.08.2017)

[4] http://reference.medscape.com/drug/daraprim-pyrimethamine-342668 (access: 10.08.2017)

[5] http://www.bbc.com/news/world-us-canada-34331761 (access: 09.08.2017)

[6] A. Nowicka, Dodatkowe prawo ochronne, Studia Prawa Prywatnego (Additional Protection Law, Private Law Studies), Warsaw 2009, issue 3-4, p. 84

[7] Ż. Pacud, Ochrona zastosowań medycznych (Medical Application Protection) in: J. Kępiński (ed.), Zarys Prawa Własności Intelektualnej, Rynek farmaceutyczny a prawo własności intelektualnej. (Outline of Intellectual Property Rights, Pharmaceutical Market and Intellectual Property Law). Vol. IV, Warsaw 2013, pp. 7-10.

[8] M. du Vall, Prawo patentowe. (Patent Law), Warsaw 2008, p. 289.

[9] M. Barczewski, Prawa własności intelektualnej w Światowej Organizacji Handlu a dostęp do produktów leczniczych (Intellectual Property Rights in the World Trade Organization and Access to Medicinal Products), Warsaw 2013, p. 11 and subsequent.