When compared to other innovations, medical technologies and drugs undoubtedly have a more vital place in patent law. Even if the economic advantages of patents for inventors outweighs its other gained protections, when the patent subjects are medicines, drugs and other medical technologies, the perspective changes in a more sensitive way for public interest.
Public health and its progression are inherently a global goal, and both have high importance and priority on the international arena. Since protection of human health, providing everyone access to health services and sufficient medical technologies in needed quantity and in required quality, providing these health services, medicines, medical equipment and devices in affordable costs and in a timely manner, are directly related to and a part of people’s fundamental and inviolable right to life and to enjoy this right in the minimum required standard befitting with human dignity; even though there is no denying of the commercial interests and market competition in pharmaceutical and the medical device industry, providing equality in the access of medical drugs and devices is an essential aim to not to ignore.
However, development of medical technologies and drugs differs greatly from many other sectors with the risks they contain, requiring high-priced research and development activities, workforce, and time, the necessity of well-qualified workforce, fully-equipped R&D centres, laboratories and test environments, high priced materials, repeatedly made experiments and dealing with tons of long legal and procedural requirements not only during the stage of production and market release, but also as of the beginning of the research and development stage, as well as bearing all these material and moral efforts while keeping the probability of failure in mind because there is always a risk of all these high priced and full-fledged R&D to turn into a total waste if the products do not meet the legal requirements and/or targeted qualifications at the end of the day.
In this respect, despite all, some incentives and protections must be granted to these real and legal persons, who intend to make research, development and investment in medical technology sector, in order to promote technological progress in medical technologies, and to serve to the global aim of providing equal and affordable health services. Granting “patent rights” comes at first of these incentives. Patent protection of an invention gives its holder a right to exclude others from exploiting the invention. The rationale behind patent protection is to make the investment in R&D more attractive since patents can be used to prevent free enjoyers from launching copycat products, without even bearing the costs and efforts of R&D.
Patent is an exclusive right granted to the “inventor” in respect of an “invention” that is susceptible to industry, which may be a product or a process that provides a “new” and “inventive” way of doing something, or offers a new and inventive technical solution to a problem. The owner of a patent may, in principle, exclude others in the territory covered by the patent from making, using, offering for sale, importing or selling the invention without her/his consent. However, all these protections are provided for a limited period of time. The term of patent protection is twenty years, and it is not possible to renew such period.
Even though patent protection promotes investments and R&D, it can also inhibit competition in drug market, for example, it can hinder market entry for generic medicines. However, as mentioned above, the main and global goal behind patenting medicines is to provide everyone affordable health-care services. That is why, distortion of competition in drug market is far beyond being only a competition problem, however, is crucial for providing access to affordable medicines and of course, for protection of the right to life.
Patent systems provide public access to technological information. The patent owner is obliged to disclose the claimed invention and all necessary information. This system enables society to obtain information about the invention and formulations. After expiration of the patent protection, generic companies can make use of the information and formulations, contained under patent documents, to produce their generic ones. Generic medicines have a very important role in the production of affordable medicines since they tend to be way much cheaper than originator medicines, in other words, the medicines produced by the “patent owner” /or the licensee or the assignee who holds these patents related economic rights.
What is “evergreening”? Why is it defined as a problem?
It is very common for patent owners to carry out R&D activities to improve the effectiveness of their already patented medicines used for a specific cure. There might be some changes found in the patented formulation which are known as incremental innovations. These incremental innovations might be new dosage forms, improved and more durable storage characteristics, simplified route of usage, such as a change in the formulation derived the drug swallowed in pill rather than injection. Incremental innovations are “further” steps taken on an already existing medicine which may make it more effective, simplified and/or durable, but in any case, a development which is not known in the body of existing knowledge, which is called as “prior art”.
In principle, while the original patent will expire at the end of a specific time period and has to allow generic companies to compete duly across the market, patent holders can try to delay this by using different strategies such as investing heavily in the promotion of any new version of the medicines, and to convince doctors to switch patients to their patents’ newer “incremental” versions so the doctors will not write out the generic medicines but the incremental versions in the prescriptions. Another way employed by the originator companies in the jurisdictions where generics need an approved originator product on the market to refer to, they may withdraw the older patented version from the market which may affect market approval of older drugs’ generic versions. Sometimes the originator companies can also delay development or launch of such improved versions of drugs until the end of the patent term of the older main patented medicine to preserve their market position for a longer period.
It should be emphasized that, an incremental innovation on the patented medicine does not extend the term of the original patent. However, the inventors can apply to patent the further innovation, and can grant the patents when the patentability criteria are completely met. Granting a patent on an incremental innovation is independent from the patent of the original product. It has its own term of 20 years, and does not extend the term of the original patent. While the second patent protects the modified form of the medicine, the patent protection of the original version will end upon the date of expiration.
In time, patenting the “incremental innovations” turned into a way for drug companies to maintain their dominancy across the market, and hold their patents of a specific drug for a very long period of time, by making dispensable changes on their innovations or very small improvements, displaying limited inventiveness with no added therapeutic value and granting 20-year-of patent protection. This strategy used by drug companies to prolong their patented medicines are called as “evergreening”.
The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) defines evergreening as “when, in the absence of any apparent additional therapeutic benefits, patent holders use various strategies to extend the length of their exclusivity beyond the 20-year patent term” (WHO, 2006(b)).
The European Commission has also identified another strategy used by pharmaceutical companies called “patent clusters” which is conducted by filing numerous additional patents for the same medicine. Companies file a significant number of additional patents on variations of the same product, when the main patent is about to expire. The Commission stated that this is a common way for the originator companies to keep generic companies out of the drug market and make it more difficult for them to evaluate whether it is possible to develop a generic version of the original drug without infringing one of the numerous patents filed around one medicine, in other words the “patent clusters”. The number of patents granted for the same drug raises the risk of potentially costly litigation for generic companies, which ends up with more expensive drugs, even if the ones produced by the generic companies.
How to differ “incremental innovations” from “evergreening” intentions?
It is crucial to avoid patents being used as barriers in market entry and competition. Demarcating the line between incremental innovations that confer real therapeutic advantages or manufacturing improvements, and those that offer no therapeutic benefits or remarkable improvements is not an easy task. The governments should take consistent actions to avoid barriers to legitimate competition. They can discuss to develop guidelines for patent examiners on how properly to implement patentability criteria and, if appropriate, consider changes to national patent legislation. But how the line will be drawn between the modifications made for “evergreening” and the incremental innovations which really bring remarkable improvements? When does an adaptation of a first patented invention itself become separately eligible for a patent?
It is important to evaluate every individual invention claimed in a patent on its own merits. Most innovations are already incremental by their nature as a result of technology which is naturally in progress in incremental steps. To distinguish these natural progresses from valuable improvements, some additional criteria should be requested to be met, further than the inventive step/non-obviousness and all other patentability criteria already regulated under the applicable laws.
“Significant improvement in therapeutic efficiency of patented drugs” is an additional criterion discussed by the health-policy makers. In order to prevent evergreening, the patent protection for incremental innovations should be granted only if they have sufficient additional therapeutic benefits. If the therapeutic value of a product has been improved and significant advantages have been procured over what already exists in the prior art, these can be accepted as inventive steps for incremental innovations. Besides additional criteria, the other patentability criteria of novelty, inventive step, and industrial applicability should also be ensured to be met.
It is strongly recommended for the countries to adapt a way to revise their patent legislations to prevent evergreening and help generic companies to be placed across the market. Every country has the flexibility to design their national IP systems in accordance with their policy needs. WTO Members are bound by the minimum standards set by the TRIPS Agreement, in cognizance of a country’s economic, developmental, and other objectives. This includes the right to define the patentability criteria. Countries may add additional criteria for granting incremental innovations or re-define the patentability criteria or spare patentability criteria for medicines and medical devices from other innovations.
If such solution would be adapted by countries, then the patentability criteria applied by examiners should also be checked to determine that whether they are in the line with the established definition and interpretation, or not. Some regional patent offices have already set up search and examination guidelines to support the examiners’ patentability check with a view to ensuring high quality of granted patents. WIPO has published a collection of links to a range of patent offices’ guidelines for easy access to this information, which is needed to be regularly updated.
However, it is still discussed whether the task of ascertaining incremental innovation meets the criteria for patentability offers therapeutic benefits or serves for “evergreening” and deters competition should be assigned to patent offices or would better be done by competition or health authorities.
Situation in Turkey
Even though the terminology “evergreening” has not been placed as a behaviour arising criminal and civil liability, it is quite possible for such companies to be liable under the terms of competition law. Employers' Association of Pharmaceutical Industry declared a report on “The Barriers to Market Entry of Generic Drugs” whereby it was clearly stated that evergreening is obviously a problem for protection of patent rights, not only a problem seen in Europe or the drugs imported from Europe, but also in Turkey and between Turkish drug companies.
During the discussions before enaction of the Industrial Property Law numbered 6769, dated 22/12/2016 (“IPL”), there were many critiques on why special provisions on second medical use patents were not included in the bill of the new law. This view was supporting the idea of a restriction should be regulated to prevent granting patent rights for the modified medicines after the prior one’s expiration. However, the counter-view strictly supported that since there was no barrier for second medical use in Europe for European patents that have already been registered and Turkey was also accepting these patented medicines, secondary patenting and medical use should not be restricted under Turkish laws. This view was also supporting that such restriction or barrier for second medical use would create a contrast between Turkish laws and European legislation, which should be definitely avoided to ensure our legislation’s compliance with EU law, therefore the related regulation in EPC should be directly accepted. However, the Supreme Court judges still concern regarding the tendency on prolonging the patent protection period by making very small modifications on drug patents, and support that instead of establishing a strict rule in patent law restricting the second patent use completely, the opportunity should be given to judges/practitioners to evaluate the aims and characteristics of such modifications and secondary patent in every different present case in their own terms.
However, in Article 138 of IPL, the invalidity conditions of patents are clearly stated. If the patent does not meet the requirements stated under Article 82, 83 and other procedural requirements stated in Article 138, the patent application shall be rejected. In any case, the evaluation of patentability shall be made according to Article 82 and 83; and any other claim shall not be taken into consideration in the evaluation of patentability.
In Article 82 (2) (c)), it is very clearly stated that “all treatment modalities including the diagnosis methods which are intended to be applied to human or animal bodies and surgical methods” as only the subject or the activity itself shall stay out of patentability. By this means, the judges may reject such patent claim if it only brings out a new treatment method, such as a new dosage regimen, for example. Supreme Court supports the idea of evaluating such method patents from the “novelty” and “inventory step” point of view. It should be strongly emphasized that invalidating all patents formed as new surgical and diagnosis methods shall constitute a clear breach of 82(6). Because IPL 82(6) clearly states that “(6) The provision mentioned in subparagraph (c) of paragraph 3 shall not be applied to the products, especially the substances and compositions which are used in any methods that are mentioned in the same option.” Because the purpose of this provision is ensuring the patentability of substances and preparations used in medical treatments to be evaluated apart from other diagnosis and treatment methods. In other words, the existence of Article 82(6) precludes deeming invalid the secondary drug patent which contains a new component even if the secondary drug only differs from the previous one by bringing out a new treatment method.
That is why, since IPL and EPC provisions are clear, deeming the second drug patent invalid by the reason of that they only include a different dosage regimen or a different method of treatment is not a possible way to struggle with evergreening in Turkey. However, the patentability evaluation can always be made in terms of other patentability criteria stated within the scope of IPL Article 82, 83 and 138.
There is no doubt that evergreening is a global problem, and since every country also imports medicines and medical devices from other countries, evergreening cannot be struggled properly only by local law amendments. Turkish patent law does not include any terms to prevent evergreening, even though Turkish IPL provides clear provisions on that treatment and surgical methods cannot be patented, it also provides that such term shall not be applied for the products, the substances and compositions which are used in any methods” which even closes our way to discuss the abovementioned idea about not granting patent rights for the secondary medicines which do not have any new non-therapeutic values. It would be a more decent decision to leave this part of evaluation to judges in order to let them decide in each case by obtaining expert reports indicating objective statements, instead of regulating a very clear rule to be applied as the same for all different medicines in different components.
Conclusion
The “evergreening” strategy is adapted by the originator companies to maintain their dominancy across the drug market as the patent holders, and to keep generic competitors out of the market for a longer term. The main issue while preventing evergreening is to differ the adaptations that should be awarded and protected as a patent or be defined as anti-competitive behaviour. Every invention should be evaluated on its own terms and checked if their patentability criteria are all met, which also includes the additional criteria to be determined by countries especially for the pharmaceutical sector. Countries can revise their patent laws or their patentability guidelines and determine the definition and interpretation of patentability criteria for pharmaceutical patents, especially “therapeutic value” can be determined as a compulsory criterion for the improved products which claimed to be patented.
Att. Burcu Seven
References:
WHO, WIPO, WTO, Health systems related determinants of Access, “Promoting Access to Medical Technologies and Innovation – Intersections Between Public Health, Intellectual Property And Trade”, 2016.
WIPO, 2016, “Access to Medical Technologies and Innovation”, The role of intellectual property in innovation and Access, https://www.wto.org/english/tratop_e/di spu_e/cases_e/ds114_e.htm
DRUG PATENT IN TURKEY, Aylin ACAR Selen YEĞENOĞLU, Ankara Ecz. Fak. Derg., 33 (4) 269 – 285s, 2004
İkinci Tıbbi Kullanım İstemlerinin Yeni Sınai Mülkiyet Kanunu Işığında Patentlenebilirliği
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