Since the beginning of the Modern Age, creative people and ingenious entrepreneurs have sought to protect their inventions through the granting of patents, in order to benefit from the legal advantages that this exercise offers. 

The first patent in Europe was granted on March 19, 1449. It was granted by King Henry VI of England to John of Utynam, a Flemish glass maker. This patent gave him a 20-year monopoly to make glass using a process he had brought from Flanders. This event is considered one of the first examples of a modern patent, granting exclusive rights to an inventor to protect his invention. To date, in the European Economic Community alone, more than 3 million powerful 

The first patent granted in the United States dates back to 1790. It was granted on July 31, 1790 to Samuel Hopkins for a method of manufacturing potash (a chemical compound used in the manufacture of soap, glass and fertilizers). In the United States, more than 11 million patents have been granted. 

The first patents protected relatively simple ideas, although ingenious and very relevant for the time of application. Over the years, inventions, like technological advances, have become more complex and specific without necessarily implying the appearance of a transcendental discovery. In fact, many patents granted in the last 25 years turn out to be the “atomization” of the same field of study, with small incremental contributions, only particularly protecting a minimal portion of the object of study. 

Nowadays, the activity around the application, approval and use of patents is constantly growing and inventors, sponsoring companies, universities, research centers and national and international government entities that deal with them participate in them. the associated legislation 

A patent confers a defined and expiring period of protection of 20 years. There are exceptions, such as in the field of pharmaceutical sciences, where there are specific alternatives that allow the validity to be extended for another 5 years. 

There are several benefits for inventors and companies who are assigned a patent: 

Exclusive rights: Allows the owner to exclude others from making, using, selling or importing the invention without permission. 

Competitive advantage: Protects the invention, giving an advantage over the competition. 

Income generation: Possibility of licensing the patent or selling it. 

Innovation incentive: Promotes investment in research and development. 

Market value: Increases the value of the company and attracts investments. 

These benefits help protect and monetize technological innovations. 

Although patents for inventions have many benefits, they also present some disadvantages for science: 

Restricting access: They limit access to new technologies and knowledge, which can delay research and development. 

High costs: Patenting and maintenance processes can be costly in time and financial resources, making it difficult for researchers and small businesses. 

Barriers to collaboration: Patents can prevent cooperation and the exchange of information between scientists and institutions. 

Incremental innovation: They can encourage more conservative innovation focused on incremental improvements rather than disruptive advances. 

Monopolies: the awarding of a patent, although there are international protection measures, the opportunity for monopolization of the marketing of a product, process, system, treatment, etc. 

To obtain a patent for an invention, several key requirements must be met: 

Novelty: The invention must be new and not have been publicly disclosed before the application. 

Inventive activity: Must involve a step that is not obvious to someone knowledgeable in the field. 

Industrial application: It must be useful and applicable in industry or commerce. 

Sufficient description: The application must include a detailed description of the invention, allowing others to reproduce it. 

Clear claims: You must clearly define the scope of the protection requested. 

These requirements ensure that the invention deserves legal protection and can be used effectively. 

In today’s era, all fields of industrial interest are working hard to get protection. However, in industries with high technological renewal such as electronics, automotive, software and hardware, where renewal cycles are very dynamic and short, waiting to obtain patent protection can be counterproductive for their economic and commercial purposes, therefore, although they apply for patents, they do not wait to obtain it before putting their innovations on the market. 

In the field of the pharmaceutical industry, one of the most active industries in intellectual protection, there are practically no cases of new medicines, processes, devices and treatments that come to market without being protected by patents. The long regulatory approval times and the high research costs that companies invest in innovation favor this strategy. 

When the cycle of research, approval and patenting is closed, products marketed under these conditions are positioned with solidity and durability in the market. Profits are generated that repay the investment and generate significant profits, often based on the high price associated with these innovative medicines. 

In the field of pharmaceutical development, patents can be seen from the angle of the inventor or from the angle of those who are interested in developing a product equivalent to an innovative product. 

For the first case, the advantages have been exposed and it is appropriate to mention the risks, intellectual efforts and economic resources that this undertaking represents and that, only after several years, will be reflected in the industrial and commercial exclusivity of the protected asset. 

In the second case, the existence of patents represents a great challenge when facing the development of an intellectually protected product. 

Although the existence of a patent is usually interpreted as an insurmountable barrier, there are cases where the punctuality and specificity of the protected technical space offers opportunities to develop a product that evades the scope of the patent and allows obtaining an alternative product that does not infringe the intellectual property and that it is as effective and safe as the innovative medicine. 

For the case of transdermal patches, there is a particularly complex scenario, since it is one of the pharmaceutical forms that most patents usually protect the same product, although with small contributions in the incremental inventiveness, they generate an intricate, tortuous technical space of interpret and establish clearly to evaluate the possibility of redefining a field of work outside of infringement. 

In fact, it happens in transdermal patches that there are generic products that do not infringe the patent of the innovative product and even have their own patent granted. 

A meticulous, qualified and specialized analysis is required, not only of existing patents, but also of patent applications submitted for evaluation, to define the feasibility of a technical space for action and consider it appropriate or not to undertake pharmaceutical development in those areas. conditions. 

The key to success in this scenario is to find vulnerability in the claims of the associated patents, define a technical workspace and then verify if, with the components, processes and devices that are outside the protected space, it is feasible to meet all the conditions. enough to be presented as equivalent to an innovative product. This is understood as a product that is industrially feasible, safe, effective, stable and not inferior to the reference product. 

Amarin Technologies faces these challenges in its development routine from both scenarios. 

It has patents that protect Fentanyl, Buprenorphine, Rotigotine, Selegiline and Rivastigmine patches. 

On the other hand, it faces the challenge of carrying out developments that escape the associated patents with the objective of being competitive and timely.