THE ROLE OF THE REQUIREMENT OF INDUSTRIAL APPLICATION IN GENE PATENTING: PRACTICAL IMPLICATIONS AND POTENTIAL IMPACT ON THE PROGRESS OF INNOVATION

Abstract

The major advances in the identification of the human genome that took place from the early 1990s onwards triggered a significant increase in the number of patent applications concerning newly discovered human gene sequences that nevertheless failed to disclose the function of the isolated material, and thus did not meet the patent law requirement of industrial application. In order to address this issue the 1998 Directive on the legal protection of biotechnological inventions (Biotech Directive) 1 required patent applicants to disclose the industrial applicability of inventions covering human gene sequences and related proteins at the time of the patent application. Furthermore, the Biotech Directive established functionality-related protection for all types of genetic inventions, thus restricting the scope of protection granted to human genetic inventions to their ability to perform the industrial application disclosed by the applicant.

This thesis analyses the implications of the Biotech Directive’s approach towards the industrial application of human genes and fragments thereof in respect of three issues: the assessment of the industrial applicability of inventions concerning sequences or partial sequences of human genes; the distinction between discoveries and patentable inventions when the claimed subject matter is human genetic material; and the determination of the scope of protection awarded to patents over genetic information.

The thesis argues that the requirement of industrial application can act as an efficient checkpoint for preventing the grant of patents over human genetic discoveries of no practical benefit to society, but also for impeding the issuance of overly broad patents in this field. At the same time, a strict interpretation of this requirement does not imply that patent authorities will systematically overlook the interests of private