Pharmaceuticals have been an inseparable part of medicine during history. Archaeologists have found remains in archaic terra cotta jars and stone jars which proves our point. Humans have been producing drugs from very early on. Recipes of ancient drugs could be found in many civilization’s scripts.
Today, pharmaceutical industry is global and commercially income-generating. The industry is responsible for the research, development, production, and distribution of medications. The market has experienced significant growth during the past decades, and pharma revenues worldwide totalled 1.48 trillion USD in 2022.
Drugs are a subject to patent by being considered as an “invention”. In perspective of patenting, drugs are distinguished since drugs have a close relation to welfare and commercial aspects of mass production.
Turkish Constitution has provided a protection over the right to health as per articles 17 and 56. Article 17 provides the regulation for immunity, material, and spiritual existence of the person and, Article 56 provides for health care and environmental protection.
There is no specific drug related code in existence that regulates the framework and fundamental pharmaceutical legal issues although general regulations are endured in different statues and guidelines.
To define pharmaceuticals in a medical aspect, drugs are a combination of synthetic and/or natural substances that are applied to people to prevent and/or cure an illness, to procure a diagnosis; rectify, regulate, or change a physiologic function.
Although the legal definition of a drug would be a premixture for commercial sales and use that is a product of industrial production, produced with a certain standard and marketed under the umbrella of producer’s brand.
In accordance with the law the authority of observation and auditing of the production, protection and safekeeping, controlling, distribution is titled to Turkish Ministry of Health and relevant institutions.
To get to the area of pharmaceutical patenting, we must define patent and invention. A definition that has been granted by WIPO is “A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.”
Cambridge Dictionary defines invention as “Something that has never been made before, or the process of creating something that has never been made before.”
To be precise, an invention according to IP law, would be to design, invent something that could be in use and or the subject of the patent application. An invention is a product that is industrially utilizable and different from prior inventions that is thought of to provide a technical solution for a problem that nature brings upon and involves the creativity of the inventor and is new to an expert of the area.
Patenting a drug would not give the patent-owner the right to produce and market that drug. To produce and market the now patented drug, the approval of Ministry of Health must also be obtained. To specify and give a candid example, the owner of production and marketing rights would not necessarily own the patent of the drug as well resulting in not being able to produce the drug. To summarize, the formula being produced and marketed would require a two-step action. One would have to own the patent of the formula as well as owning the approval of the Ministry of Health to produce and market.
The importance of patenting has been favorably explained in HICKTON’S PATENT SYNDICATE V. PATENTS AND MACHINE IMPROVEMENTS COMPANY LD.:
“Every invention to support a patent must no doubt be a new manufacture- that is to say, it must either suggest a new way of making something- a means of constructing an old thing in a new manner- or it may mean the way of producing a new article all together; but I think you are losing grasp of the substance and seizing the shadow when you say that the invention is the manufacture as distinguished from the idea. It is much more true to say that the patent is for the idea as distinguished from the thing manufactured. No doubt you can not patent an idea, which you have simply conceived and have suggested no way of carrying out, but the invention consists in thinking of or conceiving something and suggesting a way of doing it
Patents would provide the owner with the right to restrain the production, use and export of the invention in subject. To obtain such effect, the patent must be registered and declared in the relevant public records. The subject of patent must be clearly explained in the application. Any deficiency in the application may result in lack of protection. The effect will be attained to the first applicant. An invention might need a priorly patented invention to exist. In such cases, the inventor may not use the needed invention to create theirs without the approval of the needed invention’s inventor during the period of the prior patent.
To briefly explain the criterias, a patent is given upon application for inventions that surpasses the current technique in a new way and is utilizable industrially.
First criteria for an invention to be a subject to patenting is novelty. European Patent Convention Art. 54 regulates novelty in a detailed form. Turkey is a signing party of the Convention therefore the regulations are parallel to these descriptions. According to the Convention, an invention shall be considered to be new if it does not form part of the state of the art. In 551 s. KHK Art. 7, an invention is described as “ the invention is new if it is not included in the current known technique.” . Keeping that in mind, for the invention to fulfill the novelty criteria, the state of the invention shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.
Current state of the technique would mean the availability of finding out information about the invention by public from anywhere in the world before application. Therefore, the invention shall be new at the date of patent application. According to 551 s. KHK Art. 7, current state of technique is the published texts of Turkish Patent and Petty Patent applications prior to applying for patent. Any third party being able to reach information upon research about the invention before application would cancel the novelty criteria.
The applicant would have to prove how their invention is clearly different from an already patented invention. One issue within the scope of drug patents is when a patented medicine that is proven to cure a specific illness, being realized curing an irrelevant illness. For such secondary usage to be a subject to patenting, a proof that the medicine is effective exceeding the current state of technique.
According to precedents of European Patent Office, an expert of the area analysing a chemical formula and/or a product to commercially market the product would be contrary to the novelty criteria. If such a case occurs, the invention would be considered as “within the current technique”.
Exceeding the current state of technique has been explained in 551 s. KHK. It would be defined as the invention being objectively new in the area it is related to and creating something that does not exist with creativity being prominent.
The current state of technique would be information that the public could reach via research whether orally or nominally about the technique before the application for patent. The invention would have to be in a standard and a result of technical research/work. The invention should bring a drastic difference to the current technique in the form of either creating a new formula and/or product or a new and unpredictably different use to that product from the current use.
Article 56 of European Convention regulates that if an invention is considered to involve an inventive step if an expert in the area does not derive in an obvious way from the state of technique. 551 S. KHK Art. 9 regulates that the if the invention could not clearly be deduced rooting from the current state of technique by an average expert in the field, it is considered that the inventive step and thus the known state of the technique has been exceeded.
The invention should be superior to a solution that any expert in the area could provide which would conclude in exceedance of technique.551 s. KHK Art.9 regulates that an expert of the area is the deciding authority in the novelty of the invention. Although, when speaking of pharmaceutical drugs, an expert would have to be acquainted with relevant areas. If that is not possible, then experts who is up to date on relevant areas should be consulted. To provide an example on this issue, an expert, say a chemist per se, should be knowledgeable on medicine as well as pharmaceuticals specifically in secondary uses of pharmaceuticals.
The research on the current state of technique is solely on the explained part in the application. If there is a certain part about the invention which is explicit, and the applicant does not require protection for will not be considered whether exceeds the current state or not.
One other criterion for a patent is that the invention would have to be applicable to the industry. This could be explained as invention being utilizable for practical purposes. The invention would not be subject to a patent if not even if the invention passes novelty and exceedance criteria . European Patent Convention Art. 52 regulates what fields European patents could and could not be.
Industry is a broader conception than technique. Industry is a continuous operation to provide for public needs and necessities which means that industry requires favorableness where in technique is a solution on achieving dominance over nature and the problems that nature creates for humankind based on knowledge.
A solution would be a subject to a patent and considered an invention if only the solution provides a material remedy to a problem caused by nature. Pharmaceutical drugs are applicable to the industry since they are a material solution that could be marketed and is beneficiary. The solution could be a subject to patenting when the solution is created within technical magnitude becomes a material remedy . Turkish law, similar to European Patent Convention Art.57 in 551 s KHK Art. 10 has regulated that invention would have to be applicable in every field of industry including agriculture.
Being applicable to the industry would be defined as the invention being able to be used beneficially, in the sense where the invention is able to provide for a need in the industrial field it is relevant to and could be produced. Whether the invention is commercially prospering or not is inconsequential.
In pharmaceutical patents, the patenting process and marketing is distinct from each other. Even if a formula is patented, it would not necessarily mean that it is marketed for commercial sale. Even if a pharmaceutical drug is applicable to the industry, when one does not have the necessary licenses, would not be able to market and sell the drug. Therefore, when applying for a drug patent, the use of the drug and the function should be explained in detail.
The TRIPS Agreement covers the issues of protection of intellectual property in trade-related areas to a significant degree and is seen as a comprehensive new framework prescribing standards of intellectual property protection. Further, the TRIPS Agreement has the added significance of being the first international agreement concerning all types of intellectual property with numerous substantive provisions. What could and could not be a patentable subject has been regulated in Article 27/3.
“3. Members may also exclude from patentability:
(a) diagnostic, therapeutic, and surgical methods for the treatment of humans or animals.
(b) plants and animals other than micro-organisms, and essentially biological processes to produce plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.”
Parallel to TRIPS, European Patent Convention and 551 s. KHK Art 6 regulates what could not be a subject to patenting. According to that, discoveries, scientific theories, mathematical formulas, plans on commercial, mental and/or games, rules, and methods; literature and art, scientific marks, creations that has aesthetical qualities, computer software, non-technical methods created by adjusting the current known; surgical methods and treatments effecting on humans and/or animals and diagnosis methods on animals could not be a subject to patent. Keeping that in mind, any invention that is against ethics and/or public order is not a subject of patent as well.
The reason why treatment methods are not a subject to patenting is that the primary aim of treatment methods is to heal where in pharmaceutical drugs are a subject to patenting since formulas are derived as a result of massive expenditure and research.
According to European Medical Agency (EMA) indication is a medical condition that a medicine is used for. This can include the treatment, prevention, and diagnosis of a disease
In the field of pharmacology, indication would be when a formula is utilizable for secondary uses. If the secondary use of a drug is subject to patenting, this would be indication patenting. To give an example, Aspirin was primarily used as a painkiller where afterwards was found to be an antiaggregant as well which could prevent heart attacks.
The important issue in indication patents is whether it is applicable to the industry. Even if the secondary uses are beneficial for physicians, secondary uses would not be subject to a patent if the formula is not applicable to the industry, which means that the productibility of the formula is rather low.
The creative aspiration is as well looked for in secondary uses as well as the secondary uses would have to exceed the current state. If such criterias are fulfilled, secondary uses could be subject to a patent which legally is called “Indication Patents.”
Supplementary Protection Certificates are a product of European Patent Convention. Although, SPC’s are regulated locally according to the term of protection. SPC’s are not a part of Turkish Regulations.
SPC’s are mostly a pharmaceutical concept when a patent ends, in jurisdictions where SPC’s are regulated, could be extended by application. The reason why SPC’s are regulated is that patents in pharmaceutical field usually take a considerable amount of time resulting in actually reducing the base term the patent provides protection for. Patent protection term starts at the day of application. The premises for the idea of patent evaluation phase reducing the protection term is named “Patent Erosion”.
Production without launching of the formula that is subject to the patent would not be considered a breach of the patent. Trials are a part of the invention process. Although the research and trials are not a part of patent production. As it was mentioned before, Art. 27 of TRIPS regulates that scientific research could not be patented, which was also regulated in 551 s. KHK Art. 6.
The release of such formulas when in trial might result as competitors producing the same formula with a different branding and applying for patents. The occurrence is called “The Bolar Exemption”. The Bolar Exemption would not be considered a breach of patents since the idea creates competition and provides option to choose from to the consumer. The Exemption was regulated in 551 s. KHK Art. 75/f.
There is no “Drug Code” in Turkish regulations although regulations were extensively mentioned within different codes and regulations. Drug formulas are separated from other medical products due to the fact of owning pharmacological properties and such properties having treatment effects on human body.
Drug patenting has a whole other ethical aspect since it is directly related to human well-being. There has been a long lasting debate on drugs still in existance for them to whether be a subject of patenting or not. TRIPS has cleared the pathway of drug patenting. The important issue on drug patenting is while the industry is massive and brings a huge annual income, the direct effect on human health brings a social responsibility. Therefore the intellectual property rights on drugs should be balanced with the said ethical aspect.
I. https://www.statista.com/topics/1764/global-pharmaceutical-industry/#topicOverview
II. İLTER, Dilek, İLAÇLARIN RUHSATLANDIRILMASI VE PİYASAYA SÜRÜLMESİ USULÜ, Erciyes Üniversitesi Hukuk Fakültesi 1. Sağlık Hukuku Sempozyumu, İlaç Hukuku 2009, p.274 (Only Available in Turkish)
III. 1261 s. “İspençiyari ve Tıbbi Müstahzalar Kanunu” and other statues paralel
IV. https://dictionary.cambridge.org/dictionary/english/invention
V. Hickton's Patent Syndicate v Patents and Machine Improvements Co. Ltd. 26 RPC 339 (1909)
VI. CHISUM/ NARD/ SCHWARTZ, Principles of Patent Law,2003, s. 515.
VII. TEKİNALP, Fikri Mülkiyet Hukuku, 2004, s. 490.
VIII. BAINBRIDGE, Intellectual Property, 2002, s. 359.
IX. HUYSAL, İlaç Patenti, 2010, 135.
X. Introduction to Trips Agreement, Patent Office Asia-Pacific Industrial Property Center, JIII
XI. https://www.ema.europa.eu/en/glossary/indication
XII. Roche Products, Inc. v. Bolar Pharmaceutical Co. , 733 F.2d 858 (Fed. Cir. 1984)
XIII. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
XIV. European Patent Convention
XV. 551 s. KHK
Ibrahim ASLAN
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Serra YILDIRIM
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