Importance of intellectual property generated by biomedical research at universities and academic hospitals

Abstract

Biomedical research has many different facets. Researchers and clinicians study disease biology and biochemistry to discover novel therapeutic targets, unravel biochemical pathways and identify biomarkers to improve diagnosis, or devise new approaches to clinically manage diseases more effectively. In all instances, the overall goal of biomedical research is to ensure that results thereof (such as a therapy, a device, or a method which may be broadly referred to as "inventions") are clinically implemented. Most of the researchers' efforts are centered on the advance of technical and scientific aspects of an invention. The development and implementation of an invention can be arduous and very costly. Historically, it has proven to be crucial to protect intellectual property rights (IPR) to an invention (i.e., a patent) to ensure that companies can obtain a fair return on their investment that is needed to develop an academic invention into a product for the benefit of patients. However, the importance of IPR is not generally acknowledged among researchers at academic institutions active in biomedical research. Therefore this paper aims to (1) raise IP awareness amongst clinical and translational researchers; (2) provide a concise overview of what the patenting trajectory entails; and (3) highlight the importance of patenting for research and the researcher. Importance for patients: Adequate patent protection of inventions generated through biomedical research at academic institutions increases the probability that patients will benefit from these inventions, and indirectly enables the financing of clinical studies, mainly by opening up funding opportunities (e.g. specific grants aimed at start-ups, pre-seed and seed capital) that otherwise would not be accessible. As a consequence, patented inventions are more likely to become clinically tested and reach the market, providing patients with more treatment options.

Keywords: commercialization; innovation; invention; medical; patents; pharmaceutical; protection; research; technological.

Figure 1. Typical pharmaceutical product development timeline and num of compounds needed in the different phases to obtain one FDA-approved drug. Adapted from [1].

Figure 2. (Top panels) In 1964 a Dutch patent NL6514306A was filed based on the idea by the Danish inventor Krayer that sunken ships could more easily be salvaged by using air-filled balls to increase their buoyancy (the top right panel was taken from [3]; the top left panel can be found in [4]). (Bottom panels) The patent was not granted, as the invention had already been disclosed in a 1949 Donald Duck episode, entitled ‘The Sunken Yacht’. Interestingly, the popular TV show Mythbusters recently confirmed the feasibility of the approach taken by Donald and his nephews (https://www.youtube.com/watch?v=lKKu0DA5lvM). Permission to use the images in the bottom row were granted by Disney under a copyright license.

Figure 3. Typical patent timeline from application until expiry (20 years from the filing date of the PCT application).

Figure 4. (Too) early filing of a patent application can be costly as most revenues are made at the end of the life time of the patent. Revenues collapse after patent expiry due to the introduction of generic alternatives by competitors.