European Patent 242236 was first filed in March 1986. However, it did not issue until 10 years later (21 Aug 1996). Bibliographic information is presented below.
|EP 242236 B2|
|Title||Plant cells resistant to glutamine synthetase inhibitors, made by genetic engineering|
|Issue Date||21 Aug 1996|
|Assignees||Plant Genetic Systems NV and Biogen NV|
|Inventors||Leemans J, Botterman J, de Block M, Thompson C, Mouva R|
|Appl No and Filing Date||EP 87/400141 21 Jan 1987|
|Priority||EP 86/400521 11 Mar 1986|
|Abstract||The invention relates to a DNA fragment containing a determined gene, the expression of which inhibits the antibiotic and herbicidal effects of Bialaphos and related products. It also relates to recombinant vectors, containing such DNA fragment, which enable this protective gene to be introduced and expressed into cells and plant cells.|
As mentioned previously, the claims in this patent are extremely broad. The patent claims seek to cover transformation of plant cells with the bar gene. Independent Claim 1 covers the introduction of a foreign coding gene that inhibits glutamine synthetase (bar gene) in plant cells (transformation). Importantly, this claim does not indicate the source of the engineered foreign coding gene sequence and therefore the foreign gene to be inserted is literally not restricted to any particular enzyme or gene source. The foreign gene to be introduced is only described in terms of its function, i.e. a gene encoding a product capable of inactivating the inhibitor (see actual claims). Recent court decisions in the U.S. suggest that if this claim was included in a U.S. patent application it would be considered indefinite in its meaning and therefore fail the U.S. enablement requirement for patentability.
In dependent Claim 2 a preferred embodiment of the foreign gene sequence is revealed as an acetyl transferase. Claim 2 recites:
“…a process wherein an acetyl transferase capable of inactivating PPT or its derivatives is used.
Hence this claim restricts the foreign gene sequences to those encoding an acetyl transferase enzyme. Claim 2 is written broadly enough, however, to include acetyl transferases capable of inactivating a novel, not yet identified derivative of PPT. There is no restriction in the claim with respect to the source of the enzyme. The enzyme can be isolated from any microorganism.
Further dependent claims limit this process to situations where the foreign nucleotide sequence is derived from the genome of an antibiotic-producing Streptomyces strain or another nucleotide sequence that encodes the same antibiotic-producing activity (Claim 3). This broad claim also includes antibiotic-producing organisms that have not yet been identified.
Independent claims 7, 11, 14, 18 and 23 extend protection to the application of the process outlined in Claim 1 to developing herbicide resistant plants. The claims cover non-biologically transformed plant cells and plants displaying resistance to glutamine synthetase (Claim 14) as well as suitable DNA fragments and recombinants containing sequences encoding resistance to glutamine synthetase inhibitors (Claim 31).
A remarkable feature of this patent is that the method of inactivation of PPT is not identified. This gives the patent a broad, far reaching scope and potentially covers all processes and methods by which PPT is broken down and inactivated.
This patent has equivalents in numerous countries including Austria, Germany, Denmark, Hungary, Portugal, Spain, Israel, Australia, Brazil, Finland, Hong Kong, Greece, Japan and South Africa.
Opposition of EP 242236
The European patent EP 242236 B1 was granted in 1990 by the European Patent Office (EPO). In 1991, Greenpeace formally opposed the issue of the patent. The EPO Board of Appeals (BOA) considered the opposition by Greenpeace in 1993 (decision T 356/93) and, as a result, an amended version of the patent (EP 242236 B2) was granted in 1996.
A number of objections in relation to EP 242236 B1 were raised by Greenpeace in the opposition procedure. Greenpeace argued that transgenic plants were outside the scope of patent protection. In making their decision the EPO board had to address the following questions.
Is genetic manipulation an essentially biological process and therefore not patentable?
Essential biological processes are not patentable under the law. Greenpeace argued that some steps involved in obtaining a transgenic plant, such as the regeneration of plant callus tissue, were based on an “essentially biological process”. Part of the Board’s discussion surrounding this point focused on defining the amount of human intervention required to execute the “essentially biological process”. In the present case, the Board concluded that without human intervention the transgenic plant wouldn’t be obtainable, even though some steps, like regeneration of a plant from callus tissue, did not require human intervention. Human intervention was therefore required in carrying out the process and, as a result, genetically modified cells were deemed patentable.
Can plant cells be patented?
The Board found that plant cells as such do not fall under the definition of a plant or of a plant variety, both of which are patentable under the European Patent Convention (EPC). Rather, plant cells are considered to be ” microbiological products” in the broad sense and are therefore patentable.
Can a patent be allowed where the subject matter is contrary to public opinion?
In this argument Greenpeace provided evidence based on public surveys in Sweden and in Switzerland. Public perception and speculative data about potentially serious damage to the environment were not deemed to support the argument made, therefore this point was rejected.
While the EPO quashed these grounds of rejection put forward by Greenpeace, Claim 21 of the patent in contention played a central role in the proceedings. Claim 21 sought to cover:
“A plant, modified by introducing a gene encoding an enzyme capable of inactivating or neutralizing an inhibitor of glutamine synthetase, a key enzyme in nitrogen assimilation.”
In its decision the Board held that Claim 21 was directed to transgenic plants and, as a result, embraced plant varieties, even though no plant variety was individually claimed. In later years, the Board has revised their standing in this area, largely as a result of the European Directive 1998 and The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which requires that biotechnological process are patentable provided that no individual plant varieties are claimed. To comply with the interpretation of the law at the time, some claims were eliminated from the original application after the opposition procedure (abandoned claims) and EP 242 236 B2 was granted three years later in 1996