ABSTRACT
The present scenario of a race against time due to COVID-19 has once again heated the debate on the patenting of medical methods, including diagnostic methods. One faction of scholars strongly believes that patenting puts a lock on science as information and knowledge should flow freely in every circumstance for the greater good, while the pharmaceutical companies lobby is totally in favor of strict patent laws, citing very high costs to bring a single pharmaceutical product to the market. They argue that without patenting, no company would risk so much money in research. The present chapter focuses on the rules and regulations for patenting diagnostic methods in Europe, India and the Unites States of America. Present rules and regulations suggest that various countries have different criteria for patenting diagnostic methods, making their universal patenting a difficult and laborious task. Even within the same country, sometimes much confusion prevails due to different outcomes of patent claims in various cases. USPTO is the main body dealing with patents in the USA, but the patent law of diagnostic methods is established by case law there. In Europe, patent bundling exists for patenting in many countries at the same time via the EPO. In India, however, patenting depends upon the Patents Act 1970, which has not been interpreted much in court, leading to confusion for both the patentee as well as the court. The authors suggest the establishment of special courts and judges on the lines of the Unified Patent Court (UPC), as patents are a very specialized field, while judges are mostly generalist. The authors also agree on the need for uniform and tough laws for patenting medical methods and products across countries for better jurisdiction and easier access to health services.
