Patentable technical fields of chemistry and biotechnology, and the restrictions to consider

When talking about patenting, attention these days is often focused on utilizing AI and on new digital technologies.

At the same time, patenting is constantly solving issues that combine science, business and a very specific regulatory environment, where it might not be enough to rely on interpretations by AI.

In the fields of chemistry and biotechnology, many limitations on patenting relate to technical character and ethics – exclusive rights are not granted to discoveries found in nature, or to methods for maintaining life.

Medical inventions – where to draw the line between patentable and non-patentable inventions?

In Europe, the methods of treatment themselves cannot be patented. Surgical, therapeutic and certain diagnostic methods applied directly to human patients or animals are excluded from patent protection. Patents are therefore not granted for methods used, for example, by a physician when treating a patient. The aim is to ensure that the work of healthcare professionals is not restricted by patents.

Instead, patent protection may be obtained, e.g., for:

•    pharmaceuticals and medicinal products

•    new uses for known substances such as pharmaceuticals

•    medical devices and many diagnostic solutions

Whether an invention is described as a product or a method of treatment is often crucial.

There is typically more freedom on the cosmetic side, but the distinction between cosmetic and therapeutic use of a product can be surprisingly challenging.

Also in diagnostics, there are similar challenges related to borderlines. Methods that directly target the patient, including all diagnostic steps, may fall outside the scope of protection, while laboratory analyses, equipment, and test systems are typically patentable.

Methods in the field of biotechnology – when is there enough technicality?

In biotechnology, one key issue is the technical character of the invention. Purely biological crossbreeding and selection, generally, does not enjoy patent protection in Europe. Similarly, discoveries, such as naturally occurring agents, cannot be protected as such. However, biological material that has been isolated from nature may be patentable, since biotechnology-related patents generally cover technically controlled solutions that utilize microbiological or genetic engineering techniques. A component isolated from the human body or produced by means of a technical process, such as a gene sequence or partial gene sequence, may be patentable. In addition, inventions concerning plants or animals are patentable if their application is not technically confined to a single plant or animal variety. In inventions related to the field of biotechnology, there is also a specific requirement that the biological material be deposited in an approved depositary institution. This measure ensures the reproducibility of the invention. It is possible to request a sample from the deposited material.

When it comes to biotechnology, ethical considerations often have to be taken into account. It is good to be aware that not all biological material of human origin or its use, for example, can be protected, at least not without precise boundary conditions.

The patent strategy is sector-specific

In chemical and biotechnology inventions, very formal details can determine whether protection is available at all. Therefore, in these areas, patent strategy goes hand in hand with technical understanding and knowledge of industry-specific regulation.

Well-designed protection supports product development, investor discussions and international growth and ensures that valuable innovation protects exactly what it should.


Any questions? Please contact Kathy kathy.wasstrom@laineip.fi or Jasmin jasmin.kaivola@laineip.fi