The Strategic Importance of Patent Protection in the

Pharmaceutical and Medical Device Sectors

Author : Att. Bengü Halavut Yıldırım

Industrial property rights, are intangible rights that enable the registration of inventions, innovations, new designs and original works in industry and agriculture on behalf of the first implementers of new designs and original works, or on behalf of the owners of signs that will distinguish the manufacturer or seller of goods produced and sold in the field of commerce, and prevent the production and sale of these rights by third parties without the permission of the owners for a certain period of time.

Therefore, increasing the awareness and knowledge level of industrial property throughout the country and contributing to the transformation of industrial property into economic benefit are some of the objectives of our Turkish Patent and Trademark Authority's 2019-2023 Strategic Plans. Our priority is to ensure that these inventions are protected from a legal point of view, whether individually or institutionally, to those who made R&D works and/or to distinguish their goods produced and sold. Trademark and Patent protection issues present some difficulties, both in terms of procedure and in terms of application. In particular, the patent for pharmaceuticals has some unique features.

For example, patent in pharmaceuticals can be listed under in 7 different patent types such as Compound Patent, Salt, Hydrate and Polymorph Patent, Formulation Patent, Combination Patent, Usage/Indication Patent, Procedural Patent, and Dosage Patent. Inventions or patents other than compound patents do not prevent generics from entering the market; for this reason, it is argued that other patents do not provide absolute protection. However, patents under these types are no less valuable to patent legislation than compound patents. As you can see, even pharmaceutical patenting is a separate field of law on its own.  For this reason, our advice to those who have individual or corporate inventions, will be to consult with expert lawyers in this field.

As you know, the pharmaceutical and medical device industry develops, manufactures and markets pharmaceuticals and medical devices licensed for use in medical treatment. In many aspects, pharmaceuticals and medical devices have their special characteristics, which are subject to many laws, regulations and legislation regarding their patenting, licensing, testing and the marketing of medicines. As the primary purpose of pharmaceutical industry is public service and public health, the sector takes its job very seriously, as it is regulated by relevant institutions as an internationally regulated sector as well as binding itself to many strict ethical rules and conditions.

When it comes to public health, every decision taken in pharmaceutical and medical device companies can be vital both for patients, public health, the company and therefore for the country itself.

Unlike other industries, the invention and development of pharmaceutical pharmaceuticals is an extremely expensive and long-lasting activity. The process of releasing a new pharmaceutical pharmaceutical product from the research laboratory to the pharmacy shelf or hospital, takes an average of 12 to 15 years. Of every 5,000 molecules tested, only 250 promising new substances will undergo preclinical testing; 10 will enter the clinical development phase and only 1 will enter the market by being licensed by regulators. Half of the pharmaceutical phramaceuticals that reach the final stage of clinical trial are stuck in the clinical research process, and only 3 out of 10 pharmaceutical pharmaceutical s entering the market by passing this stage meet or generate income above average R&D expenditures, before losing patent protection and facing stiff generic competition.

When the costs of these failed pharmaceutical pharmaceuticals are taken into account, the cost of developing a successful new pharmaceutical product (excluding marketing-related expenses) is estimated at approximately USD 1 Billion or more.

However, given that it takes about 12-15 years for a patent-pending molecule to be converted into a marketable pharmaceutical product, the actual period of patent protection is reduced to 5-8 years.

Due to these significant and large investments, patent protection on the pharmaceutical product should be affective in this short term so that these investments pay off for companies and researchers and in this way new studies are carried out on new pharmaceutical products for public health. Ultimately, patent protection returns act as a service to public health that concerns everyone, through pharmaceutical companies.

As you know, biotechnology in the field of pharmaceuticals is important in developing many innovative techniques for diagnosing, treating and preventing diseases. The significance of biotechnology was well displayed during the COVID-19 pandemic, and we have saw the importance of investing in biological technology through our experiences. In order to prevent this epidemic and similar incidents that we may encounter from now on, we need to do very important research in this field of technology. Now we see that not only pharmaceutical companies but also countries have brought the field of biological technology to the forefront and concentrated their investments in this field in order to better protect public health as soon as possible and to prevent similar situations from happening again.

What we have said about the protection of patent rights as a good example for this particular topic. Pursuant to the Article 85 of the Law on Industrial Property (“Law”), “It is intended to protect all commercial interest during the protection period, in order to ensure that the patent and utility model owner is compensated for the work and expenditures he has done to realise the intention…”. Pharmaceutical companies serving public health are also of course, commercial companies. In order to invest, this investment needs to be repaid. At this point, patent protection is a legal protection that prevents commercial rights losses for at least a certain period of time and pays off the investment.

While pharmaceutical patenting is a very niche legal field, patent protection of biotechnological products in the pharmaceutical field is an even more specific issue. According to Article 82 of the Law, patentable inventions and exceptions to patentability are determined, and discoveries are listed as exceptions that cannot be patented. Since biotechnological products in the field of medicine are technologies used to develop plants, animals and microorganisms with the help of different branches of science and DNA technology to obtain new rare substances (products) that do not exist naturally or cannot be produced as much as we need, some of the inventions on them cannot be patented as they can be considered discoveries, and some can be classified as inventions with processes other than discovery and can be protected with patent rights. For example, in a decision the Supreme Court ruled that it would not be possible to patent an existing gene in the human body for a biotechnological product that is the subject of a pattern case, however, the method of using the discovered gene in a diagnosis and treatment of a particular disease can be patented by isolating it in its natural environment and explaining its technical effect, provided that certain conditions are met. As displayed, there are thin lines in this area.

Our humble advice for individuals or companies that do the R&D and produce innovative pharmaceuticals would be to apply to specialist law firms to protect industrial property rights and therefore commercial returns of these products in Turkey if they are foreigners and to protect them in many countries around the world if they are Turkish.

According to the World Intellectual Property Organization data, Turkey ranks 14th in the world in domestic patent applications, 8th in trademark applications and 5th in design applications.

Att. Bengü Halavut Yıldırım

JURLEGAL Özcü & Halavut