Patent Monopoly: est Modus in Rebus?

During the long journey from the Statute of Anne and early French patents to the strong patent systems for today’s high-tech inventions, humanity has at various times facing the problem of striking a proper balance between the scope of intellectual property rights and the need to sustain scientific and technological prog­ress. Current law-enforcement practices de­monstrate that despite harmonized IP legislation globally, the issue of uniform understanding of cases of legal limitations on patent owner exclusive rights (patent monopoly) triggers numerous dis­cussions.

As we know, owners of patents on inventions, utility models and industrial designs possess exclusive rights. One can consider these exclusive rights as granting a patent owner the right to use the relevant intellectual property.

For the purpose of evolutionary development of science and technology, this monopoly is usually limited by relevant laws and regulations.

The first level of limitations are universally applicable to all exclusive rights and include limitations on their use period and territory. The next level of limitations is related to actions that do not qualify as patent right infringement. “Such laws are like spiders webs: they catch the weak and poor, but the rich can rip right through them,” the ancient Greek anarchasis Solon, who articulated this opinion at some point, was right because numerous legal proceedings and controversial opinions regarding the appropriateness of their interpretation are related to the above-mentioned limitations on patent monopoly. In this connection we would suggest considering in more detail such patent monopoly limitations as the right of prior use and use of a patented item for scientific purposes or for experiment, and trying to unravel this tangled legislative “spiders web”.

Granting the right of prior use is representative for patent law and stems from the possibility of parallel invention; hence, there is a compromise, since in this case the novelty criterion is not pre­sent¹. The results of legal analysis of Article 31(1) of the Law of Ukraine On Protection of Rights to Inventions and Utility Models suggest that the right of prior use arises where the following conditions are met simultaneously:

1) a technology solution identical to the claimed invention was created diligently as a result of the entity’s intellectual activity;

2) a person claiming the right to such technology solution has already been using it or has taken considerable measures to prepare for its use;

3) actions specified in para. 2 have already been taken on the territory of Ukraine;

4) actions specified in para. 2 were taken before the date of filing of the pa­tent application or before the priority date.

However, the scope of exclusive rights granted to a prior user is narrower than the scope of rights granted to the patent owner². This happens because the law limits the prior user’s right to the scope of use of the article identical to the claimed invention, which was in effect as of the date of the patent application.

In addition, neither the Civil Code of Ukraine nor the relevant subject-specific legislation regulate relations between a prior user and a patent owner. Thus, the parties are free to determine the methods and framework for the use of their rights on the basis of the general principles of contract law.

The regulator has not established the manner or the document to be used to confirm the prior user’s right to the pa­tent’s use. In Ukraine, the issue as to whether such rights are available arises during a court dispute regarding the infringement of the patent owner’s exclusive rights. At the same time, the laws and regulations of numerous European countries providefor a special mechanism confirming the prior user’s right. For example, para. 4 of section 23 of the Austrian Patent Act 1970³ provides for the patentee’s issue of a special certificate to the prior user. However, as already mentioned, based on national realities, the right of first use can be confirmed only by a court decision, including where it covers a settlement agreement between a patentee and a prior user. The said circumstance adds a degree of importance to the attorney’s role in such legal proceedings, since the success of a dispute between a prior user and a patentee depends on the choice of proper litigation strategy and the quali­ty of substan­tiating all material circum­stances.

Another disputable issue in the practices of limiting the patent owner’s right is the usability of a patented invention for scientific purposes or for experimental use. In this case, proving the scientific credibility of the purpose of use of the invention and the relevant entity’s capabi­lity to conduct scientific activity is a major problem.

The content of the terminology ca­tegory “use for scientific purpose” can be articulated by analyzing the provisions of subject-specific laws and regulations that govern scientific and scientific-and-technical activities. Any activity invol­ving the use of a patented invention would qualify as an activity carried out for scientific purposes when the follo­wing three basic conditions are simultaneously met:

1) the entity that conducts scientific and scientific-and-technical activities has the relevant legal capacity;

2) the person holds a proper le­vel qualification as an “academic rese­archer”;

3) an approved scientific project is available and its implementation takes into account the requirements of the Law of Ukraine “On the Protection of Rights to Inventions and Utility Models”.

Due to the completeness of the legal definition of “scientific activity”, one question that arises in court practice is: does the regulator allow for the possibility of legal use of a patented article in applied scientific research?

With regard to distinguishing between fundamental research and applied research, we would note that under Frascati Manual⁴ the difference between them is illustrated by two phrases: for basic research — “without any particu­lar … use in view”; for applied research — “directed… towards a specific practical aim…”.

In our opinion, the type of scientific research is decisive for proper qualification of the actions of a person intending to use a patented invention without obtai­ning the right holder’s permit. Fundamental studies of a technical solution may be treated as permitted use of a patented article. However, applying a patented article during applied research, where the goal differs from obtaining new knowledge, should qualify as an infringement of exclusive rights⁵.

In addition, the law cannot be pro­perly applied without prior in-depth ana­lysis of the prerequisites for paving the legal way to the provisions limiting patent protection.

The issue of using the limitations on patent monopoly as a tool to promote competition in the pharmaceutical industry arose for the first time in the early 1980s in the United States. This was in 1984, during consideration of the high-profile Roche Products, Inc. v Bolar Pharmaceutical Co case⁶. That decision was a catalyst for  approval by the US Congress of amendments to the law during that same year. These amendments enshrined the provisions permitting the use of a patented original pharmaceutical until the expiry of the relevant patent lifetime, where such actions are taken for purposes essentially related to the development and receipt of  information in accordance with federal law (through compulsory licensing).

Some countries still do not support the idea of compulsory licensing. ­However, there are countries that in addition to having recognized the Declaration on the TRIPS Agreement and Public Health, which grants each WTO member the right to issue a compulsory license on pharmaceuticals and the freedom to determine the reasons for granting the same, successfully exercised such a right in practice (e.g. India). Typically, such countries associate the potential limitation of  a patent owner’s rights with the presence of public interest.

The above considerations suggest the conclusion that limitations on the patent owner’s exclusive rights should be sufficiently clear and based on the principles of proportionality and reasonableness, thereby providing an ­adequate balance between the interests of participants of legal relations and public interest.

¹ Kryzhna V. Right of prior use in the patent law of Ukraine/Entrepreneurship, business and law (in Ukrainian: Крыжна В. Право преждепользования в патентном праве Украины/Предпринимательство, хозяйство
и право), 1999. –No. 2. — pages 37-39.

² Basai О.V. Conditions for creation of the right of prior use of industrial property (in Ukrainian: Басай О.В. Умови виникнення права попереднього користування на об’єкти промислової власності)/Scientific Journal of Uzhhorod University, 2012. — Issue 18. — page72

³ hi-edu.ru/e-books/xbook/078/01/part-004 htm

⁴ Proposed Standard Practice for Surveyson Research and Experimental Development. (2002) Frascati Manual. OECD Publishing.

⁵ Petrenko O.B. Patent monopoly exception and framework for patent rights protection (in Ukrainian: Петренко О.Б. Виключення з патентної монополії та межі захисту патентних прав)//Journal of Khmelnytsky Institute of Regional Management and Law. –2004 .- No. 1-2 (9-10). — pages 104-116.  page 111

⁶ https://law.justia.com/cases/federal/appellate-courts/F2/733/858/459501/