Browsing by Author "Kaipiainen, Juulia"

Biopharmaceuticals play a very important role in today’s health care as they provide treatment for, inter alia, different types of cancer, autoimmune diseases and diabetes. Patent protection has always been of utmost importance to the whole pharmaceutical industry, as they are the only way to protect the results of research and development projects apart from secrecy. However, the incentives on the biopharmaceutical industry are currently distorted by various challenges arising from the development of techniques and also from the competition on the market that is increasing due to biosimilar and biobetter pharmaceutical development. At the same time, the industry is claimed to be suffering from innovation troubles as well as too broad patent protection resulting from patent thickets. These problems can be addressed by adjusting the breadth of protection provided by patents. The inventive step requirement has a particularly relevant role in determining the breadth of patent protection. Accordingly, the breadth of patent protection is smaller if the requirement is applied strictly. At the same time, however, the breadth of prior art protection grows on the opposite direction: when the inventive step is set high, the prior art protection will be broad. While the question of sufficient protection scope is rather difficult to answer, some analysis can be derived from examining the biopharmaceutical industry’s current state and the case law of the European Patent Office in relation to the assessment of the inventive step. As the requirement of inventive step is not usually a straight-forward decision to be made, the case law has established a number of approaches and principles which help in the assessment. As regards biopharmaceutical patents, the EPO’s approach is rather flexible and thus makes it possible to consider all relevant factors of the case. Presumably in consequence of the EPO’s “Raising the bar” strategy, the inventive step assessment has developed towards a slightly more stringent evaluation. The need for the adjustment of the inventive step can be then analyzed by considering the consequences of different amendments to the biopharmaceutical industry. Sufficiently wide breadth of protection helps companies to survive from the competition in the market. On the other hand, too broad protection can deter innovation by blocking follow-on research.