Protection of intellectual property

Protection of intellectual property is a central factor in the success of the research-based pharmaceutical industry in Switzerland and an important element in creating incentives for the sector to continue investing in research and the development of new medicines to treat diseases that are currently incurable. Different instruments are used to protect different types of intellectual property.

Medical discoveries are usually protected by patents. The data generated during the process of authorising medicinal products can be protected against use by competitors for a certain time through first applicant protection. And finally, a trademark confers on the holder the right to use that mark to identify goods and services and to use it as they see fit.

Disclosure in return for rights of use

A patent is a protected title granted by the state for a technical invention. In legal terms, an invention is a solution to a technical problem. Inventions are patentable if they are new and not obvious to an expert in the matter and can be exploited commercially. The holder of a patent has a maximum of 20 years during which they can exclude others from exploiting the invention commercially. During this period, third parties can be prevented from, for example, manufacturing, using, selling or importing the invention without permission. In return for this exclusive right, the invention must be explained in exact detail and disclosed publicly. The patent holder can then use the technical solution as an important source of information for further developments.

Protection as an incentive to invest

In addition to patent protection, the research-based pharmaceutical industry can also benefit from first applicant protection. This is a separate form of intellectual property protection granted for confidential data that is independent of patent law. In the pharmaceutical industry, these data are compiled during the course of a clinical trial to demonstrate the safety, quality and efficacy of an active ingredient, a task that is time-consuming and cost-intensive. First applicant protection can provide additional legal protection for the patent holder, provided this person was the first to notify the invention. However, in many situations first applicant protection is the only form of protection available, and thus the only incentive for investment. First applicant protection and its duration are independent of the validity of a patent and the length of protection it provides. First applicant protection obliges the competent authorities to protect the confidential documentation and study results that have been submitted by the first applicant as part of the authorisation process from disclosure and unfair commercial use by third parties.

The most significant role played by the trademark in the pharmaceutical industry is the confidence it generates in doctors and patients, who can be sure that they are obtaining a product that will meet their expectations in terms of quality and provenance.

Patents

Comprehensive patent protection is of fundamental importance for Switzerland as a research and pharma hub. The research and development process for a new medicinal product is long, complex and expensive – this is why so few sectors are so heavily dependent on strong patent protection.

Patent protection allows the pharmaceutical industry to finance the high investment expenditures that are necessary for research and development, since the patent protects the inventor against unauthorised commercial use of the patented invention by a third party. In this way, patent protection creates a balance between the interests of the inventor and the public good. By disclosing their invention, the researcher provides the public with access to technical progress and generates knowledge. In return, the researcher is granted a period of patent protection limited to a maximum of 20 years. In the medicines sector, practical considerations mean that this protection lasts between 10 and 15 years from the date on which the product is granted marketing authorisation.

Incentive for medical innovations

The innovations produced by the research-based pharmaceutical industry contribute to the high quality of our healthcare system. Patent protection, and the associated incentive to innovate, is a very important factor in creating a regulatory environment that is conducive to research and innovation. Digitalisation is an aspect on which great attention is focused; it is already bringing about a fundamental change in the way medicinal products are developed and used.

There is still no adequate form of protection for data, algorithms and the results of the data analyses that lead to innovative therapies. There is therefore a need to develop the legal framework for intellectual property (IP) in a direction that ensures adequate protection for innovations. Close cooperation between the sector and the Swiss authorities and other partners will therefore play a central role in establishing a world-leading data-protection and IP landscape for the future.

The generation of clinical data as a precondition for the authorisation of new medicinal products is a time-consuming and cost-intensive endeavour. The creator of these data is entitled to relevant compensation that must continue to be ensured in the future through modern document protection. Document protection is of elementary importance in situations in which a therapy cannot be patented.