Today's world offers numerous inventions making life easier. Considering the development process of inventions such as from wheel to automobile, from balloon to airplane, from telegram to phone or from aspirin to paracetamol, the point of innovation is incredible. However, when it comes to invention or innovation, besides easing life, drugs developed as a cure against diseases which is the biggest trouble of human beings, are undoubtfully of great importance.
Thanks to research and development in the pharmaceutical industry, many diseases that could not be treated in the past can be easily treated or prevented today. However, the development of a drug requires long-term laboratory studies, clinical trials, and licensing steps. Therefore, drug development is a costly and time-consuming process. In the event that a drug or active ingredient/molecule developed as a result of long efforts is not protected by patent registration, third parties may carry out the necessary investigations and incorporate that drug into their own production as soon as the drug is brought into the market. Therefore, if a new drug/active ingredient is developed or new indication of an existing active ingredient is the subject of the invention, it is very important to apply for patent.
A pharmaceutical patent serves as a shield that protects either a drug, production method of a drug or indication of the drug that has the patentability criteria against the third parties. Pharmaceutical patents can be classified into three main categories: product patents, process patents and indication patents. While the product patents are related to molecules/active ingredients, derivative, crystal form, the methods for synthesis or preparation of these products can be protected by process patents. However, surgical, therapeutic or diagnostic methods are among the non-patentable inventions. An indication patent, on the other hand, refers to a patent for the first medical use of a drug or active ingredient/molecule, or the second/further medical use of a known drug or active ingredient/molecule where the further use differs from existing one(s).
Although the protection of pharmaceutical patents in Turkey came into force in 1995, it began processing as of January 1, 1999. The first granted pharmaceutical patent in Turkey is related to a drug for treatment of disorders of the stomach and intestines.
Pharmaceutical patents always have been a matter of debate. Because a granted pharmaceutical patent provides a monopoly right to the applicant within the country where it is applied, and third parties cannot produce or sell the drug without permission of the applicant or cannot possess it for any commercial reason. At this point, two basic concepts need to be explained: original drug and generic drug.
An original drug is the first new drug on the market where the therapeutical effect of the drug have been proven in long-term studies and clinical trials by the innovator and which have been patented. The original drugs that benefits from patent protection for 20 years, prevent third parties from obtaining any rights on this drug in countries where patent is granted, except trial-based actions and personalized production by a pharmacist.
Generic drugs, on the other hand, are those containing the same active ingredient/molecule as the original drugs in the same amount and the same pharmaceutical form, which the bioequivalence with the original drug has proven. Unlike original drugs, clinical trials on living organisms for generic drugs are not conducted. Therefore, generic drugs are sold at cheaper prices than the original ones. In order to introduce a generic drug into the market, the patent protection period of the original drug must expire. For this purpose, patent periods of some drugs are monitored, bioequivalence and licensing studies are initiated by generic firms as the patent(s) approach the expiry date.
In this context; considering the ethical rules, two opposing views on drug patents arise. One side advocates the protection of the original drug/active ingredient or the synthesis method of the drug or the indication as a result of clinical trials due to the long-term and costly drug research and development process that lasts for about 13 years, justifies high prices of this mentioned drugs, and upholds patent protection for the sustainability of innovation in the pharmaceutical sector. Moreover, the originator firms also make patent applications for the indication, route of administration, dosage form, or administration to the different patient groups of the active ingredient/molecule before the patent protection period expires, and they continue to protect the drug indirectly by patent registration. In addition, these companies can benefit from the Supplementary Protection Certificate (SPC), which is not available in Turkey.
Another perspective regarding the subject does not find it right to have a monopoly on the rights of patent-registered drugs, since human health is of concern and defend that the right to health must be attainable to everyone and at an affordable way for everyone. When viewed from this aspect, this can be considered as a barrier to health, a fundamental right for patients. However, without the original drugs that have developed as a result of long-term and significant investments, treatment of many diseases could not be found yet.
In fact, both views can be considered to be right from their own aspects. As a solution to this problem, a system can be proposed in which the rights of both the originator company and the rights of patients will be protected at an appropriate level.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.