生物醫藥
孟山都案件的判決首次顯示
歐洲法院對基因序列專利範圍的侵權判定原則

郭史蒂夫 北美智權 教育訓練處/歐洲專利律師
李淑蓮 中文翻譯/北美智權報 編輯部

2013.03.18
         

作者簡介:
郭史蒂夫 歐洲專利律師


現任:
北美智權教育訓練處 /歐洲專利律師

經歷:

  • Bryers事務所 歐洲專利律師
  • Bugnion SpA事務所 歐洲專利學習律師
  • Notabartolo & Gervasi事務所 歐洲專利學習律師
  • 歐洲專利局 實習生
  • 英國牛津大學生物化學、細胞與分子生物系,生化碩士
  • 英國倫敦大學瑪莉皇后學院,智財管理碩士

針對化學或生物科技類產品的專利保護,一般都是建議用產品專利範圍(Product claim)來撰寫,這是因為在法庭上產品專利範圍會比方法/用途專利範圍(Method/Use claim)更容易證明侵權行為。一般常見的做法是將產品的創新部份寫成獨立項(即保護範圍最寬廣的請求項),這樣就可以保護含有該創新部份的任何態樣。

根據1990年代末及2000年初的人類基因計畫(Human Genome Project)及後續的研究成果,歐盟認為必須對專利申請人可以提出的含有DNA(去氧核醣核酸或基因)序列的專利範圍加以限制。歐盟發出的生物科技指令((Biotechnology Directive)中規定,基因序列只有在能夠證明其與某一項特定功能有關聯時,才能夠申請專利。生物科技指令第9條指出,當專利申請人欲申請一具有特定功能之基因序列的專利保護時,其所申請保護的材料中需含有該基因材料,其內需含有該基因序列,而且該基因材料可以實現該特定功能,符合這樣條件的材料才能受到專利保護。

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。

法院於判決中指出生物科技指令第9條並不允許Monsanto具有抗藥性黃豆基因的專利可以涵蓋含有該基因成分的黃豆粉,因為該黃豆粉是死的,因此該黃豆粉中的抗藥性基因並無法產生專利範圍中所說的抗藥功能。這個判決並未考慮到當該黃豆粉還在植物狀態的時候,黃豆中的抗藥基因已經產生了抗藥功能,而黃豆粉就是黃豆的下游產物。此外,如果把黃豆粉中的抗藥基因抽取出來再注入活體的細胞,該活體就能夠再次產生該抗藥功能。

對許多專利及生技專家來說,歐洲法院對於生物科技指令第9條過於嚴格的解釋確實是一大警訊,因為他們認為這樣的判決會讓他們在歐洲市場遭受到不公平的競爭,而一個相類似的歐洲專利在一個不受生物科技指令影響的範圍內卻可以保護他們的發明,這個論點是正確的但是在未來的歐洲法庭上仍會受到考驗。但從這個案例中,我們可以清楚的了解歐洲法院是如何解釋基因專利的有效性。因此,撰寫稿件的專利律師就不能單靠一個簡單的基因序列作為專利範圍來保護申請人的發明;專利律師在撰寫專利範圍時,必須要同時顧及該基因序列的下游產品,這樣才能夠更完善的保護客戶的商業利益。

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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.

 

 

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