生物醫藥
基因改造作物與其於IP管理之重要角色

郭史蒂夫 /北美智權 教育訓練處 歐洲專利律師
陳鴻易 中文翻譯/北美智權教 育訓練處 專利工程研究員

2013.06.17
         

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

世上最傑出的農業化學公司之一 - 孟山都 (Monsanto)公司,似乎經常處於法律糾紛的中心。最近一次的爭議是美國堪薩斯州的小麥被發現包含能抵抗草甘膦 (或嘉磷塞,glyphosate) 的基因,而這種基因當初是由孟山都公司所發明。

在堪薩斯州西南方莫頓縣 (Morton County) 種植小麥的農夫歐內斯特·巴恩斯(Ernest Barnes),於美國堪薩斯州威奇塔 (Wichita) 地方法院向孟山都提起訴訟(下稱巴恩斯案),宣稱因發現孟山都未經批准種植的生物科技(基因工程)小麥,造成他與其他種植該等小麥的農夫經濟損失。而此種小麥是孟山都於9年前即宣稱停止試驗並擱置研發的。

於巴恩斯案中,堪薩斯州的農夫巴恩斯控告孟山都將能抗草甘膦 (glyphosate) 的基因引入美國,意味著最終農夫會喪失「非基因工程」(GE-free)認證,並損失其小麥作物的收入。而目前仍未清楚該抗草甘膦 (glyphosate) 基因被引入堪薩斯州之特定小麥作物的成因,究竟是因為孟山都所不能控制之純自然機制所造成的,或是其他更普通的原因所造成 - 例如,因為孟山都公司本身出的差錯。

有趣的是,筆者注意到,巴恩斯案是緊接著「鮑曼(Bowman) v 孟山都」案件(以下簡稱鮑曼案) 之後發生。在鮑曼案中,孟山都使用智財權 (尤其是關於基因工程科技的美國專利) 來強制執行其獨占權,制止農夫於授權許可範圍之外種植其經基因改造之大豆作物。有些分析家注意到,一方面孟山都起訴鮑曼為「蓄意」的(留種)重製基改作物時,一方面孟山都卻在巴恩斯案中採取不同立場~否認他們對此不受其控制而生長的基改作物需負有責任。

筆者認為這是將數個議題混為一談。智慧財產權,尤其是專利,是被用來作為商業工具以禁止他人從你的發明效益裡謀利(無論是金錢或其他利益)。這與要求專利權人為發明所帶來的後果負責是不同的~例如於鮑曼案,孟山都認為他們的整個商業模式為~向鮑曼這樣的農民收取授權金,以回收其研究發明基改作物的成本。可是,以巴恩斯案為例,如果重製基改作物是意外雜交育種的結果,雖然這並不是孟山都發展出的概念,但因為其授權實施上的錯誤,則可能仍應歸責於孟山都。這部份的議題則與生物安全、美國農業部門以及其他相關部門的相關性較高,相較起來,與美國商務部和美國專利商標局的相關性較低。

重要的一點是,即使分別看待智財權與生物安全性兩種議題,但基改作物的智財議題和生物安全性的兩者的問題仍然是息息相關的。我們在製藥業就可以發現一個清楚的例子~在製藥業案例中,由於沙利竇邁 (thalidomide) 之管理醜聞,美國政府於1950年代後期和60年代早期,定義了如FDA、EMEA和ICH…等,臨床試驗以及嚴格監管的架構。為了要遵守這些規定,製藥公司不得不花費巨額的資金,而他們只能透過該醫藥的成功獲准上市與取得專利的壟斷來保障其投資之回收。在某些情況下,這些投資回收機制還不夠回本,所以有些國家甚至推出了對於特定市場區隔的壟斷權以茲延伸因應。

 隨著乾旱/洪水越見頻繁,基改作物的重要性似乎變得越來越重要,甚至如同藥物般的必要。而基改作物廠商也需要花費大筆金錢,以其基因工程科技之智權(IP)保護,來確保其產品的安全性,並取得隨之而來的高利潤。我們是否也能於農業化學產業看到類似製藥業的折衷方案呢?

後記:最新判決

西元2013年6月10號,美國聯邦巡迴上訴法院對Organic Seed Growers and Trade Ass'n與孟山都公司之訴作出決定。

於此案件中,原告並無意要種植基改作物,但害怕承擔若不經意間種植到專利授權種子就會產生的損賠結果。而到目前為止,孟山都公司已經作出承諾,只要農民不利用其抗草甘膦 (glyphosate) 特性,且只要農民不是故意重製種植基改作物的後代(即留種種植),就不會起訴那些不經意種植其專利授權作物的農民。然而,孟山都公司還沒有提供任何明確的「保證不起訴契約」(covenant-not-to-sue),保證不起訴如此之不經意的種植行為。因此,”有機種子種植者與貿易協會”(Organic Seed Growers and Trade Ass'n)就對孟山都提起專利無效之訴。

聯邦巡迴上訴法院基本上已接受了孟山都公司其具約束力的陳述和其保證不起訴不經意種植的農民的承諾,且認為其足以發生法律效力。此判決的先前評論指出~值得注意的是,這些農業化學公司對於其與個別農民發生的爭議,已打贏許多官司,尤其是經過美國法院系統(至少藉由智財權訴訟)。但這是否也意味著農業已經走到了一個關鍵點,將如醫藥業一般,開始成為被智慧財產權所主導的產業呢?

 

延伸閱讀:
最高法院替基改作物的營運模式背書
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



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

Genetically Engineered (GE) crops and the crucial role of IP in its administration
Stefano John    NAIP  Education & Training Group / European Patent Attorney

Monsanto, as one of the most prominent agrichemical companies in the world, seems to be at the centre of legal disputes very often. The latest controversy revolves around the fact that wheat in Kansas has been found to include the glyphosate resistant genes that were originally created by Monsanto. Farmer Ernest Barnes, who grows wheat in Morton County in the southwest corner of Kansas, filed suit Monday in U.S. District Court in Wichita, Kansas, alleging that he and other wheat farmers have been hurt financially by the discovery of the unapproved biotech wheat that Monsanto said it stopped testing and shelved nine years ago.

The farmer in Kansas has now sued Monsanto for having introduced the glyphosate-wheat resistant gene into the US, ultimately meaning loss of GE-free (GE- Genetically engineered, also known as GM) certification for the farmer and loss of income on his wheat crop. It is not yet clear whether the glyphosate-resistant gene was introduced into the particular Kansas wheat crop because of perfectly natural causes outside the control of Monsanto or because of more mundane reasons such as error in Monsanto’s organization.

It is interesting to note that this case appears soon after the case of Bowman v Monsanto, where Monsanto used intellectual property (specifically US Patents in GE technology) to enforce their monopoly right in preventing farmers from growing GE soybean crops outside of the license provisions. Some commentators have noticed how Monsanto find themselves in the position of disowning their responsibility for this apparently uncontrolled growth of GE-crop, while suing Bowman for intentionally growing  the GE-crop.

This is conflating the issues. IP, particularly patents, are used as commercial tools to prevent others from profiting, either for money or for other advantages,   from  the benefits of your invention. That is not the same as being responsible for the consequences of the invention. Thus in the case of Bowman v Monsanto, Monsanto argued that their entire business model relied on farmers, such as Bowman, to pay for a license to recoup their cost in research for creating the GE-crop. In the case of accidental cross-breeding such as the example of farmer Ernest Barnes, the liability possibly lies with Monsanto, though not because it developed the idea, but due to errors in its practice. The issues decided in this appear more relevant to bio-safety and US Dept. of Agriculture and relevant agencies than to the US Dept. of Commerce and USPTO.

It is important to note that, even though separate, the issue of IP and bio-safety in GE crops could still be related. A neat parallel can be found in the pharmaceutical business. In that case, the scandal deriving from administration of thalidomide in the late 1950’s and early 60’s was defining in the setting up of clinical trials and strict regulatory frameworks such as the FDA, EMEA and ICH. To comply with these requirements, pharmaceutical companies have to spend huge sums of money that they can only recoup when a successful pharmaceutical medicine is granted authorization to market and is protected by patent monopoly. In some cases, this is not even enough and some countries have introduced sector specific monopoly right extensions as a result.

With the advent of more frequent droughts/floods, the use of GE-crops seems to become more important, to the point of becoming itself a necessity in the same way as medicines. May we see a similar compromise in the agri-chemical business, where GE-producing entities may have to expend large sums of money to ensure safety of their products in return for IP protection, and therefore high profits, of their GE-technology?

Note: The latest Judgment

On 10th June 2013, the US Federal Circuit issued its decision  in Organic Seed Growers and Trade Ass'n v. Monsanto Company (Fed. Cir. 2013).

In the present case, the plaintiffs did not want to grow genetically-engineered crops, but are in fear of becoming liable for inadvertently growing patented seeds. Thus far, Monsanto has promised that it will not sue farmers who inadvertently grow its patented crops so long as the farmers do not take advantage of their glyphosate resistant properties and so long as the farmer's do not intentionally re-plant GE progeny. However, Monsanto has not offered any clear covenant-not-to-sue for inadvertent growing. As a result, the Organic Seed Growers and Trade Ass'n took them to court to invalidate the patent.

The Federal Circuit has basically accepted Monsanto's binding representations and assurances not to sue inadvertant farmers and that this should suffice. Early comments on the decision note especially how the agri-chemical companies seem to be winning many of the controversies going through the US courts, at least in IP,  against the independent farmer, but will it reach the point that farming could start becoming a business dominated by intellectual property in a similar manner to the pharmaceutical business?

 

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