Today, 1 March 2021, a whole new Guidelines section focusing on antibodies will enter into force.
Of the top 10 blockbuster drugs by global sales, at least six are antibodies. Clearly antibody-based therapies are of significant importance to human health and of significant commercial importance.
The fact that antibodies will now have their own section in the Guidelines for examination in the European Patent Office (EPO) may be a reflection of the value of antibody technologies plus the numerous challenges Applicants could experience in obtaining desirable patent protection before the European Patent Office.
The new Guidelines section offers Applicants various ways in which antibodies may be successfully defined, but then sounds a note of caution for each type of definition.
The new Guidelines section also emphasis that "structural non-obviousness" does not equate with inventive step in EPO practice and that it is necessary to show a new antibody has either a surprising technical effect, or that there were technical difficulties to overcome in producing the new antibody.
In our article on this topic we explore what this development means for seeking patent protection for antibody technologies.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.