CASRIP Newsletter - Spring 1995, Volume 2, Issue 2
In Europe, biotechnology stands out from other fields of technology. The legality of changing the nature of plant and animals through biotechnology with respect to the public order or morality has never been more emotionally disputed in any jurisdiction other than Europe. The following two recent EPO decisions deal with an ethical question in patenting new plant cells and human genes and stimulated vigorous debates. Interestingly, the opposition of the second case is lodged by some members of the European Parliament who have voted to prohibit the patenting of human genes in the draft "Directive on the legal protection of biotechnological inventions" in the European Union.
Beside the ethical question, the first case deals with a legal issue unique to the European Patent Convention (EPC), exceptions from patentable subject matter which are covered by the protection of the plant variety registration under the International Convention for the Protection of New Varieties of Plants (known as the UPOV Convention.) The case clarifies the scope of exception.
Decision of Boards of Appeal of the EPO, February 21, 1995
Case No.: T 0356/93
This case relates to an opposition challenging the patentability of an European patent directing to plant cells newly created through a recombinant DNA, plants having the new plant cells, and the processes for producing new plants having such new cells. The opponent's grounds of opposition are based on (1) the exploitation of the patented invention is contrary to the public order or morality; and (2) the patented invention directs to plant varieties and biological methods excluded from patentable subject matter under the EPC.
The EPO board rejected both grounds, emphasizing that the concept of European patent law must be interpreted to cover as wide a scope of subject matter as possible. The ethical reason exception must apply only if the actual threat to the environment or the accepted moral standards of European culture is substantiated. The Board rejected the survey presented by the opponent to indicate such threat to the accepted standard, stating that the document produced by the opponent could not substantiate such threat since they indicate only a possibility of harming the environment by misusing the patented invention. The Board concluded that a biotechnological process should not unfairly discriminate against traditional plant breeding methods in creating new and useful plants.
With respect to the plants and biological processes excepted from patentability, the Board ruled that plant cells were not under the excepted plants under the UPOV Convention, but constitute "microbiological products" which are excepted from the exception of the patentable subjected matter under the EPC. It also ruled that plant producing processes are not excepted from patentability as "essentially biological processes" if they have a technical nature, involving a step which cannot be carried out without human intervention and which has a decisive impact on the final result. Then the Board turned to the interpretation of "biotechnological processes" and "the products thereof" excepted from the patentability exception under the EPC and concluded that the legislation included the exception to the exception to make possible patents on biotechnological processes such as those involving genetic engineering processes. In applying the above rules, the Board affirmed the patentability of the disputed claims except one directing to plants with distinguishable characteristics. To support the claim, the patentee disclosed genetically transformed patent varieties and admitted that the claim covers existing and future varieties excepted from the patentability under EPC. The Board found that the exception of the patentability should apply to the claimed plant, stating that a whole plant should be distinguished from a plant cell because its development is influenced not only by the initial microbiological step but also by subsequent traditional biological steps.
Decision of the EPO Opposition Division, January 18, 1995
Not yet reported
The patented invention directs to DNA fragments encoding relaxin and its precursors, i.e., cDNAs which are DNA copies of relaxin existed in female human body. With respect to the traditional arguments against newly- isolated natural substance presented by the opponents, the EPO Opposition Division simply ruled that cDNA encoding relaxin was unknown and novel, and that the cDNA involves the inventive step by providing a new product to the public for the first time. It also rejected the opponent's argument that the subject matter of the patent is not an invention but a discovery, and stated that whenever a substance found in nature is first isolated from its surrounding, the substance is per se patentable as long as the substance provides an industrially applicable solution to a technical problem and can be reproduced without undue burden.
With respect to the ground of opposition that the patented invention is contrary to the public order, the EPO Opposition Division ruled that the opposition should be rejected unless the grant of patent to the invention would universally be regarded as outrageous. Although patenting of human genes is controversial, there is no overwhelming consensus that the exploitation or publication of human genes related inventions is immoral. After emphasizing that DNA is not "life" but a chemical substance, the Opposition Division rejected the opposition and decided that the patent be maintained as granted.