The Breeding Exemption in Patent Law: Analysis of Compliance With Article 30 of the TRIPS Agreement

Abstract

The breeding exemption limits the right of patent holders by allowing plant breeders to use freely patented biological material for creating new plant variety types. Three European countries, France, Germany, and Switzerland, have already adopted this type of exemption into their patent laws, and the Netherlands is expected to amend its patent law by 2013. The debate in the Netherlands included the introduction of a “comprehensive breeding exemption” as well, that is an exemption that allows the commercialization of plant varieties containing patented elements. The proposal for amendments to patent law did not go unnoticed. The industry itself raised concerns with respect to the compliance of patent exceptions with the European directive on the legal protection of biological inventions (98/44/EC) and the TRIPS Agreement. Being all European Union (EU) countries signatories of the TRIPS Agreement, the EU directive provisions reflect the ratio and voluntas legis of TRIPS. Thus this paper focuses on article 30 of the TRIPS Agreement, the only provision that explicitly provides for exceptions to patent rights at international level. In this context, the analysis aims at proffering a solution to the high legal uncertainty characterizing the debate on patent exceptions for the plant‐breeding sector.

Sharing aquatic genetic resources across jurisdictions: playing ‘chicken’ in the sea

“…For example, some Members have a narrow experimental use exception, only allowing the investigation of a patented genetic resource invention for the purposes of testing and further developing the invention (experimenting 'on' the invention) (Australian Law Reform Commission 2004). This would not allow the use of some genetic materials such as patented gene promoters (like the AFP in the transgenic tilapia example) because the material itself is not being investigated, but rather is being used as a research tool to introduce the chinook salmon growth hormone gene into the tilapia genome (Prifti 2013). The latter would require a broader experimental use defence that allows experimenting 'with' the invention.…”

A patent defence approach to sharing aquaculture genetic resources across jurisdictional areas

“…Under patent law, protection generally extends to every plant or animal containing the inventive element or resulting from a patented process (Prifti, , p. 218). This means that a broad patent claim over a gene or gene carrier (vector) of a plant or animal may have the same outcome as patenting the whole plant or animal and a breeder would need permission from the patent holder to use it (Nuffield Council on Bioethics, , p. 88).…”

A Stewardship Approach to ‘Legitimate Interests’ in Deep Sea Genetic Resources for Use in Aquaculture

“…204 In the aquaculture context, protection for a patentee's exclusive rights 205 over a genetic resource invention generally extends to every plant and animal containing the inventive element or resulting from a patented process. 206 A broadly worded patent claim over a plant or animal's gene or gene carrier (vector) may have the same outcome as patenting the whole plant or animal. 207 The holder of a patented invention may then be able to prevent others from using it for breeding purposes because the act of breeding is 'making' the invention again by replicating the patented gene, vector or trait in the new product (or offspring).…”