INTELLECTUAL PROPERTY AND THE HEALTH SECTOR

Intellectual Property and the Healthcare Sector: Pharmaceutical Patents and Public Health

Entrance

Intellectual property rights are legal instruments created to protect and encourage innovative work. In research and development (R&D) intensive sectors such as the pharmaceutical industry, patents play a critical role in securing the investments necessary for the development of new drugs. However, pharmaceutical patents also give rise to significant debates regarding public health. While patent protection can accelerate the introduction of new drugs to the market, it can also increase their prices, leading to access problems.

This article examines the balance between pharmaceutical patents and public health, analyzing how these two areas interact within the framework of relevant legal regulations. The impact of pharmaceutical patents on the healthcare sector will be discussed in light of national and international legislation such as the Industrial Property Law No. 6769 and the TRIPS Agreement.

1. The Place of Pharmaceutical Patents in Intellectual Property Law

Pharmaceuticals, as products developed as a result of innovative research, are protected by patents. Patents grant the inventor the right to produce, use, sell, and import their invention for a specified period. In Türkiye, pharmaceutical patents are protected by Law No. 6769 on Industrial Property. This law defines the principles of patent protection and safeguards the rights of inventors.

Article 82 of the Industrial Property Law No. 6769 states that inventions, including pharmaceuticals, can be subject to patent protection. This protection grants the inventor exclusive rights for a period of 20 years, during which time unauthorized use, production, or sale of the invention is prohibited. While patent protection offers pharmaceutical companies the opportunity to recoup their R&D investments, it can also restrict the public's access to new and effective treatment methods.

2. The Effects of Pharmaceutical Patents on Public Health

Drug patents have a twofold impact on public health. On the one hand, patent protection encourages the development of new and effective drugs. Pharmaceutical companies can invest in R&D to offer innovative solutions for treating diseases. On the other hand, patent protection can lead to high prices for these drugs and create access problems, especially in low-income countries and for individuals.

The high cost of patented drugs is often a factor that negatively impacts public health. The fact that drugs used to treat life-threatening illnesses are patented can make access to them difficult. This situation is criticized by the World Health Organization (WHO) and other international health authorities. The WHO emphasizes that problems with access to medicines deepen health inequalities worldwide.

3. TRIPS Agreement and Compulsory Licenses

At the international level, various regulations have been established to strike a balance between pharmaceutical patents and public health. The most important international regulation in this context is known as the Agreement on Trade-Related Intellectual Property Rights (TRIPS). The TRIPS Agreement sets minimum standards for intellectual property rights for World Trade Organization (WTO) members and includes provisions relating to pharmaceutical patents.

Article 31 of the TRIPS Agreement allows for compulsory licensing. A compulsory license is a type of license granted by the state to third parties for the public good, without the permission of the patent holder. This practice is used to ensure that medicines reach a wider audience in situations that threaten public health, especially during epidemics or health emergencies.

In Türkiye, Article 129 of the Industrial Property Law No. 6769 regulates the compulsory licensing practice. According to this article, if a drug is needed for the protection of public health, the relevant ministry may request a compulsory license. Compulsory licensing restricts the exclusive rights of the patent holder, allowing the drug to be made available to a wider audience. This regulation is an important tool for maintaining a balance between public health and patent rights.

Compulsory license
ARTICLE 129- (1)

A compulsory license may be granted if at least one of the following conditions is met
:
a) Non-use of the patented invention in accordance with the provisions of Article 130.

(b) The subject matter of the patents specified in Article 131 must be dependent on each other.

c) The existence of a public interest as specified in Article 132.

c) Export of pharmaceutical products due to public health problems in other countries, provided that the conditions specified in the Protocol Amending the Agreement on Trade-Related Intellectual Property Rights, to which we were deemed eligible by Law No. 6471 dated 30/4/2013, are met.

d) The breeder cannot develop a new plant variety without infringing on a previous patent.

e) The patent holder
engaging in activities that prevent, distort, or restrict competition while the patent is being used.

(2) Compulsory licenses to be granted under subparagraphs (a), (b) and (c) of the first paragraph shall be requested from the court; compulsory licenses to be granted under subparagraph (e) shall be requested from the Competition Authority. In compulsory license requests made pursuant to subparagraph (c) of the first paragraph , except for emergency situations and subparagraph (e) of the first paragraph, evidence shall be attached to the request that the applicant for compulsory license has not been able to obtain a contractual license from the patent holder within a reasonable period of time, despite having requested it under reasonable commercial terms . The court shall send a copy of the compulsory license request and copies of the attached documents to the patent holder without delay. The patent holder shall be given one month from the date of notification to submit their arguments and evidence against these

(3) The court shall notify the applicant of the patent holder's opinions, if any,
and decide within one month to reject the request or grant the compulsory license. This period
cannot be extended. If the patent holder has not objected to the compulsory license request, the court
shall decide on the compulsory license without delay.

(4) The decision granting the compulsory license shall specify the scope of the license, its cost, its duration,
the security provided by the licensee, the time of commencement of use, and the measures that ensure the serious and effective
use of the patent.

(5) If the evidence presented by the patent holder to stop the compulsory licence application is deemed sufficient by the court when legal remedies are sought against the court decision , the use of the invention is postponed until the decision regarding the license becomes final.

(6) The situation where the patent holder cannot exercise his patent right without infringing the breeder's right of a previous plant variety
may be subject to compulsory licensing. In this case, the provisions of Law No. 5042
shall apply.

(7) In the case of a license granted pursuant to subparagraph (d) of the first paragraph, the patent holder
for the use of the protected plant variety; in the case of a license granted pursuant to the sixth paragraph
, the breeder's right holder of the new plant variety
may request a reciprocal license under reasonable conditions for the use of the protected invention.

(8) For the licenses specified in paragraph (d) of the first paragraph and the sixth paragraph, the applicant may request a compulsory license from the court by proving that: a) he applied to the patent holder or the breeder's right holder of the new plant variety for a contractual license but was unsuccessful; b) the subsequent invention or plant variety shows a significant technical advancement resulting in substantial economic benefit when compared with the protected plant variety or the invention protected by the patent .

(9) Without prejudice to the provision of subparagraph (c) of the first paragraph, compulsory license is granted primarily
for supply to the domestic market.

4. Drug Pricing and Access Issues

The pricing of patented drugs is a factor that directly affects public health. Patent protection prevents competition in the drug market, which can lead to the persistence of high prices. This creates a major access problem, especially for low-income individuals and countries.

In Türkiye, drug pricing is regulated within the framework of drug pricing policies determined by the Ministry of Health. However, patented drugs are generally exempt from these regulations, and their prices are determined according to free market conditions. Therefore, the high prices of patented drugs can lead to increased costs in public health systems.

Furthermore, Article 27 of the TRIPS Agreement grants each member state the flexibility to establish and regulate its own pharmaceutical patent system. This flexibility includes measures such as shortening patent terms or expanding compulsory licensing practices to protect public health.

5. Pharmaceutical Patents and Biotechnology

Biotechnological drugs have gained significant importance in the healthcare sector in recent years. These drugs are produced through genetic engineering and other biotechnological methods and are generally used to treat complex diseases. However, the patenting of biotechnological drugs creates significant challenges in terms of access to healthcare services.

Biotechnology patents can also claim rights over genetic resources and biological materials. This can create ethical and legal problems for public health. For example, when a biotechnology company obtains a patent right on a particular gene, the use of that gene may be restricted, and access to treatments using that gene may be limited.

In Türkiye, the patenting of biotechnological drugs is regulated under the Industrial Property Law No. 6769. Article 82 of the law acknowledges that biotechnological inventions can be patented, while also stating that compulsory licensing procedures may be applied in cases that threaten public health.

Patentable inventions and exceptions to patentability
ARTICLE 82- (1)

for inventions in all fields of technology, provided they are novel,
involve an inventive step, and are industrially applicable.

(2) The following are not considered inventions.
If a patent application or patent relates to the following subject matter or activities, only the subject matter or
activities themselves are excluded from patentability:
a) Discoveries, scientific theories and mathematical methods.
b) Plans, rules and methods relating to mental activities, business activities or games.
c) Computer programs.
d) Products with aesthetic qualities, literary and artistic works and scientific works.
e) Presentation of information.

(3) Patents are not granted for the following inventions: a) Inventions that are contrary to public order or general morals. b) Plant varieties or animal breeds and essentially biological processes for the production of plants or animals, except for microbiological processes or products thereof . c) All therapeutic methods, including diagnostic methods and surgical methods, to be applied to the human or animal body . d) The mere discovery of the human body at various stages of its formation and development, and of one of the components of the human body, including a gene sequence or partial gene sequence. e) Human cloning, genetic modification of the human germline, industrial or commercial use of human embryos, genetic modification of animals which may cause suffering to animals without providing any significant medical benefit to humans or animals, and animals resulting from such modifications.

(4) The fact that the commercial use of the invention within the scope of subparagraph (a) of the third paragraph is prohibited by legislation does not mean that this use is contrary to public order or general morality

(5) The microbiological process referred to in subparagraph (b) of the third paragraph means any process involving microbiological material, carried out with microbiological material or resulting in microbiological material; a method of plant or animal production consisting mainly of a purely natural event such as a biological process, hybridization or selection. (6) The provision in subparagraph (c) of the third paragraph does not apply to products, especially substances and compositions, used in any of the methods listed in the same subparagraph

6. Effective Use of Pharmaceutical Patents and Their Impact on Public Health

The efficient use of pharmaceutical patents is crucial to minimize their impact on public health. In this regard, the misuse or excessive extension of patent protection can harm public health. For example, the practice known as "evergreening" involves making minor changes to existing patents to extend their terms. This can lead to drugs remaining on the market for longer periods at high prices and delay the introduction of generic drugs.

In Türkiye, regulations exist to prevent the misuse of pharmaceutical patents. The relevant provisions of Law No. 6769 on Industrial Property establish rules regarding the renewal and protection of patents. These rules aim to prevent the misuse of patents while serving the public interest.

Conclusion

Pharmaceutical patents, as one of the most critical areas of intellectual property rights, pose significant challenges in terms of both promoting innovation and protecting public health. Legal regulations enacted in Türkiye and internationally offer important tools to ensure the effective use of pharmaceutical patents and protect public health. However, maintaining this balance requires both the protection of patent rights and the safeguarding of public health. Compulsory licensing, drug pricing policies, and regulations concerning the patenting of biotechnological drugs are critical measures for maintaining this balance.

In this context, maintaining a balance between pharmaceutical patents and public health is a matter that requires careful consideration from both legal and ethical perspectives. Intellectual property law in this area needs to be continuously updated in line with evolving technologies and changing healthcare needs.

 

Student Intern

Behiye Zeynep Ozturk