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2011年6月2日 星期四

Biological Inventions and Passive Infringement: Policy and Legal Analyses

Biological Inventions and Passive Infringement: Policy and Legal Analyses

Wen-Cheng Huang

1. Introduction: Factual Contexts



Percy Schmeiser has grown canola on his fields in Canada for many years and has beenbreeding his own plants that have proven to be relatively resistant to various types of disease.He harvests and keeps his own seeds that he replants year after year. Unlike his neighbours he does not plant so-called Roundup ready canola. Roundup is a herbicide produced by thebiotech giant Monsanto. Monsanto has been granted a patent in Canada in 1993 for “man-madegenetically engineered genes, and cells containing those genes which, when inserted in plants,in this case canola, make those plants resistant to glyphosate herbicides such as Monsanto’sproduct Roundup”. After an anonymous tip Monsanto collected some canola plants from PercySchmeiser’s fields in 1997 and sprayed them with Roundup. Percy’s plants proved to beRoundup tolerant. Further DNA testing proved the presence of the patented gene. Percy is suedfor patent infringement.




Given the factual context, in this paper, I would like to first discuss the policy concerns regarding the patentability of genetic material, and to analyze the position of Schmeiser and Monsanto.




2. Policy Concerns

Article 27.2 of the TRIPS provides that, Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their domestic law[1]. In terms of the use of ‘including’, health and environment are illustrative examples. Thus, this provision is not a close list[2]. While, order public and morality are not defined in the TRIPS Agreement, the patentability of biological inventions incurs a lot of policy concerns[3].

2.1 Environment, Human and Animal health concerns

Some observers asserted that, releases of GM crops may result in ecological damage, and in particular, may be prejudice to human health or animal welfare[4].

In addition, the impacts brought by genetic modified crops on environment are as follows[5]:
l Encouraging excessive use of herbicides may kill other plant varieties and species;
l Excessive use of herbicides accelerates the development of resistance among pests;
l Excessive use of herbicides may create the possibility of herbicide resistant genes crossing over to other plants including the weeds.

2.2 Economical Exploitation

Representatives of traditional societies had condemned that, it is economically exploitative to protect the monopoly of products derived from communally-held resources[6].

2.3 Consumer Rights and the Business of Organic Agriculture

Recently, more and more consumers prefer agricultural products without any chemical. However, the effect of this Canadian case, would force the farmers to buy the patented seeds from Monsanto, and thus consumers would be forced to buy the genetic modified food. This tendency to use patented seeds would also impede the growing business of organic agriculture. Finally, the market would be monopolized by life-science companies like Monsanto and thus impair the social welfare.

3. Legal Analysis

3.1 Whether biological invention can be seen as the subject-matter of patent

3.1.1 On behalf of Monsanto
Monsanto may argue that, though the mere discovery of a gene is not patentable, its patent has found the unknown function of a gene and has made it accessible for further exploitation, to fulfill the requirement of the application of knowledge[7]. Also, the requirement of the novelty of a gene patent can be satisfied by discovering a new purpose of an old thing used in old ways[8].

3.1.2 On Behalf of Percy Schmeiser
Percy Schmeiser could argue that, the object of Monsanto’s gene is living material and has existed in the environment. Furthermore, a mere discovery is not patentable because it does not have the application of knowledge[9].

3.2 Whether Percy Schmeiser’s act has infringed Monsanto’s patent

3.2.1 On behalf of Monsanto
Monsanto claimed that, whether there are the existences of the knowledge or intention of the defendant or not are irrelevant, when determining patent infringement[10].

Monsanto could also argue that, the definition of its patent did not include its purpose or its end-use. Instead, using the essence of the invention without getting consent from the holder of the patent constitutes infringement[11].

Monsanto may argue that, though the invention is mainly used to resist glyphosate, the scope of its patent was not limited in terms of its purpose[12].

Monsanto could state that, it has adopted any available measure to prevent the spread of canola contain their patented gene[13].

Finally, Monsanto could assert that, Percy Schmeiser knew very well about the contamination, and would like to utilize Monsanto’s patent without any payment. Thus, the court should order the respondent exemplary damages[14].

3.2.2 On behalf of Percy Schmeiser
Percy Schmeiser may contend that, though he confessed that Monsanto’s patented plants have contaminated his field, he never intended to plant any seeds licensed by Monsanto[15].

Percy Schmeiser may also contend that, he did not use any Roundup on his crop, and thus he did not benefit from his act[16]. All of the results he got from his work are based on the traditional techniques he developed over the past 30 years.

Percy Schmeiser argued that, the plaintiff had successfully waived its right to enforce the patent by failing to control the patented plant and releasing its patented plant into the environment.

3.3 A Short Conclusion: Passive Infringement

To determine the existence of patent infringement, the intention of the respondent is irrelevant. Infringement is the act interfering with the full enjoyment of the monopoly rights of the patent holder.[17]

Although patent infringement is based on the rule of strict liability[18], the rationale behind the strict liability is in the context that the invention is inert, static, and immutable. While, compared with mechanical inventions, biological inventions are dynamic and active. It is very hard for the defendants to avoid infringements[19].

The author suggests introducing a new defense to protect innocent infringers, in particular, those who do not benefit from the patented invention[20].

4. Terminator Gene: A Possible Solution[21]?
4.1 Merits

l Control of gene expression can avoid passive infringement;
l This technology can prevent seed saving;
l This technology also encourages investment in the development of new varieties of self-pollinated crops[22].

4.2 Demerits[23]

l This technology could eliminate the age-old practice of seed saving, which enable millions of poor farmers and farming communities to survive;
l Considering the needs of using both modern varieties and landraces when breeding in the fields, being unable to save seed to breed also become a disincentive for farmers to purchase the patented seed.



[1] The language of Article 27.2 of the TRIPS is close to Article 53 of the European Patent Convention.
[2] Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases and Materials, (Cambridge, 2008), at p. 785.
[3] Similarly, morality is not defined under the Article 53 of the European Patent Convention, see Holyoak & Torremans, Intellectual Property Law, (Oxford, 2010), at pp. 95-96.
[4] Graham Dutfield, Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Planrt Varieties, Background Paper, June 1999, at p. 16.
[5] Graham Dutfield, Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Planrt Varieties, Background Paper, June 1999, at p. 32.
[6] Graham Dutfield, Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Planrt Varieties, Background Paper, June 1999, at p. 16.
[7] Holyoak & Torremans, Intellectual Property Law, (Oxford, 2010), at p. 91.
[8] Brad Sherman, ‘Biological Inventions and the Problem of Passive Infringement’, in Health/Sanders, Industrial Property in the bio-Medical Age: Challenge for Asia, (Kluwer Law International, 2003), at p. 110.
[9] Holyoak & Torremans, Intellectual Property Law, (Oxford, 2010), at p. 91.
[10] Brad Sherman, ‘Biological Inventions and the Problem of Passive Infringement’, in Health/Sanders, Industrial Property in the bio-Medical Age: Challenge for Asia, (Kluwer Law International, 2003), at p. 108. In the context of a product, there is no knowledge requirement. It means that even the innocent infringer can be liable when conducting any act constituting infringement. See MacQueen, Waelde, and Laurie, Contemporary Intellectual Property-Law and Policy, (Oxford, 2006), at p. 465.
[11] Monsando v. Schmeiser, 2001 FCT 256, para. 122.
[12] Monsando v. Schmeiser, 2001 FCT 256, para. 26.
[13] Monsando v. Schmeiser, 2001 FCT 256, para. 97.
[14] Monsando v. Schmeiser, 2001 FCT 256, para. 141.
[15] Brad Sherman,’Biological Inventions and the Problem of Passive Infringement’, in Health/Sanders, Industrial Property in the bio-Medical Age: Challenge for Asia, (Kluwer Law International, 2003), at p. 108.
[16] Monsando v. Schmeiser, 2001 FCT 256, para. 30.
[17] Brad Sherman, ‘Biological Inventions and the Problem of Passive Infringement’, in Health/Sanders, Industrial Property in the bio-Medical Age: Challenge for Asia, (Kluwer Law International, 2003), at p. 109.
[18] It is so-called absolute liability, and see Merell Dow v. Norton〔1996〕RPC 76, at 92.
[19] Brad Sherman, ‘Biological Inventions and the Problem of Passive Infringement’, in Health/Sanders, Industrial Property in the bio-Medical Age: Challenge for Asia, (Kluwer Law International, 2003), at p. 114.
[20] Brad Sherman, ‘Biological Inventions and the Problem of Passive Infringement’, in Health/Sanders, Industrial Property in the bio-Medical Age: Challenge for Asia, (Kluwer Law International, 2003), at p. 115. And, Article 30 of the TRIPS can be used as a legal basis to support Members to provide limited exceptions to the exclusive rights conferred by a patent.
[21] Stephen Hubicki and Brad Sherman, ‘Terminator Genes as “Technical” Protection Measures for Patents?’, in Health/Sanders (eds.), New Frontiers of Intellectual Property Law: IP and cultural heritage, geographical indications, enforcement, overprotection, (Oxford, 2005), at pp. 267-289.
[22] Graham Dutfield, Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Plant Varieties, Background Paper, June 1999, at p. 34.
[23] Graham Dutfield, Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Plant Varieties, Background Paper, June 1999, at p. 34.


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