Case 2 - Medical Research (Public Health – Modelled on BRCA1/2 and CCR5)

Summary

A.1.CASE

Mary, owner of a small biotech company, was granted a patent on the gene BRAU-7. As a utility, the patent accounts for cardiovascular diseases. Five years after the patent was granted, her competitor John found out that the gene BRAU-7, in conjunction with the gene BLIB-5, is responsible for healing wounds. The proportional relationship to which each gene accounts for the healing process is scientifically unclear. John is also granted a patent on his invention. He sets up a business and starts producing an ointment. Does Mary have a claim for injunction against John?

A.2. EDITORIAL NOTE

For EU member states, the patentability of human genes and the scope of such patents, as the gene patent regime, is predetermined by EU law since 1998. It determines the action radius of Mary.

1. Patent protection for genes

All selected jurisdictions provide patent protection for human genes. This approach is based on national legislation transposing the Biotechnology Directive of 1998. The approach is based on Article 3 Biotechnology Directive, which allows patentability of inventions which are new, which involve an inventive step and which are susceptible of industrial application even if they concern a product consisting of or containing biological material (e.g. Estonia). Alternatively, the approach is based on Article 5 Biotechnology Directive, allowing patentability of elements isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, even if the structure of that element is identical to that of a natural element (e.g. Belgium).

Given the fact that human genes are regarded as inventions in the jurisdictions at hand, and assuming that Mary’s invention further fulfils the criteria of novelty, inventive step and industrial application, Mary’s patent is not in question.

2. Scope of gene patents

The EU Directive gives leeway to member states as to the exact scope of gene patents. The BIP project is interested in how national legislatures have designed the scope, and how courts have adjudicated. Arguably, absolute patent protection for genes is suggested by Article 9 Biotechnology Directive. The basic idea is to conceive gene patents as product patents.