有關該生物科技指令侵權條款的第一個判決是由歐洲法院 (Court of Justice，前身為European Court of Justice)審理孟山都科技公司 (Monsanto Technology)控告Cefetra公司的侵權案所作出，Monsanto控告Cefetra侵犯其歐洲專利(EP0546090)。Monsanto的這個歐洲專利主要和耐嘉磷塞基因有關，用這個基因改造後的黃豆可以具有抗農藥的特色，其中包括常見的年年春除草劑。Monsanto從一批由阿根廷進口到荷蘭的黃豆枌(黃豆的下游加工製品)中檢驗出含有Monsanto專利的抗農藥基因序列，而Monsanto在阿根廷當地並沒有相對應的專利保護。在法庭上，雙方都承認這批進口黃豆粉中所含的基因序列已經是沒有生命的物質(Dead Material)，因此無法產生抗藥性，此外這批黃豆粉的黃豆原料是在阿根廷以Monsanto的抗農藥基因改造黃豆所栽種出來的。
About the Author:
Stefano John European Patent Attorney
Experiences：
European Patent Attorney, Bryers
Trainee European Patent Attorney, Bugnion SpA
Trainee European Patent Attorney, Notabartolo & Gervasi
Internship, EPO
The European Court's judgment in the Monsanto case gives its first ruling on how to interpret the scope of DNA sequence claims and the infringement thereof
Stefano John NAIP Education & Training Group / European Patent Attorney
If it is possible, it is always advisable to draft a product claim when dealing with chemical/biotechnology products. This is because it is easier to prove infringement for a product claim than a method/use claim. It is common practice to draft the independent claim (the one with the widest scope of protection) as the product on which the invention is based by itself, thus covering the product in any embodiment.
Due to what was happening with the Human Genome Project and sequence listings in the late 1990s and early 2000s, the European Union felt it was necessary to introduce a limitation on the ability of patent applicants to file patent applications containing many claims to DNA sequences. As part of the Biotechnology Directive, it became common practice that DNA could only be claimed if a specific function had been proven to be associated with it. Article 9 of the Directive stated that material could be protected ‘in which the genetic material is incorporated and in which the genetic information is contained and performs its function’
In its first decision on the infringement provisions of the Biotechnology Directive, the Court of Justice (CJ) (formerly the European Court of Justice) gave its judgment in the case of Monsanto Technology v Cefetra. The court case revolved around infringement of Monsanto’s European patent (EP0546090) which covered a DNA sequence encoding for a glyphosate tolerant synthase and this conferred resistance upon soybean plants to certain herbicides, including RoundUp. The DNA in question was found in trace amounts in soy meal (a downstream product of soy bean plants) imported into the Netherlands from Argentina. Monsanto did not have a patent corresponding to EP0546090 granted in Argentina. It was accepted as fact that the DNA in the imported soy meal was in essentially dead material where it was no longer performing its function and that the soy meal had been derived from soy bean harvested in Argentina from Monsanto’s RoundUp Ready variety of soybean plant.
The Court of Justice decided that Art. 9 of the Directive does not allow a patent claim to cover a patented DNA sequence when it is contained in soy meal because it does not perform the function for which it was patented. This is regardless of the fact that it did perform that function previously in the soy plant, of which the meal is a downstream product, and that the DNA could again perform its function after extraction from the soy meal and insertion into the cell of a living organism.
Many in the patent and plant biotechnology profession were alarmed with such a strict interpretation of Art.9 of the Directive because, they would argue, it would expose them to unfair competition in the European market whereas a similar patent right in an analogous field (not under the remit of the Biotechnology Directive) would protect their invention. While such arguments are correct and will be tested in Courts in the future, the one positive to take away is that we now have a clear position on how all of the EU should interpret the validity of DNA sequence claims. The drafting patent attorney cannot rely on a simple DNA sequence by itself as a product claim for his biotechnological invention involving DNA sequences to best protect the applicant’s invention, but that he has to protect downstream products thereof to make sure that he protects the client’s commercial interests better.
