Patentability of Biotech Inventions in Europe

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Patentable Subject MatterThe discussion with respect to patentability of biotech inventions in Europe has been limited to the European Patent Convention (EPC). As per the European Patent Convention, any invention is patentable unless it falls within the list of excluded inventions. According to Article 52 of EPC, any invention irrespective of the technology to which it belongs can be considered as patentable subject matter so long as it is new, inventive and has an industrial applicability and does not fall within the list of excluded inventions provided in Article 53 of the EPC.

Along with inventions contrary to public order or morality, the list of exclusions also include plant and animal varieties, essential biological processes for the production of plants and animals and methods of treatment. The EU Biotechnology Directive passed in 1998 clarified the scope of patentability of biotech inventions to a large extent. Though the directive is not binding on the European Patent Office, the implementing regulations have been modified to make the EU Directive on Biotechnology as a supplementary source for interpreting patentability of biotech inventions under the EPC.

As per Article 53 (b) of EPC, plant and animal varieties and essential biological processes for the production of plants and animals are not patentable subject matter but micro-organisms are patentable. Rule 27b of the Implementing regulations of EPC provides that plants or animals are patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. In the light of the said rule, genetically modified animals and plants have been held to be patentable as they fall outside the scope of animal or plant variety.
In the Novartis case relating to patentability of transgenic plants into which DNA had been inserted using recombinant technology, the Technical Board of Appeals stated that if a genetic modification can be applied to more than one variety then the invention is patentable subject matter as it falls outside the scope of exclusion of plant variety.

In the Oncomouse case, the Technical Board of Appeals held that a genetically altered mouse, which involved inserting an activated oncogene to develop cancer in the mouse was patentable subject matter. In the light of Oncomouse case, non human multicellular organisms including rodents and mammals can be considered to be patentable subject matter in Europe.

Gene sequences have also been held to be patentable subject matter in Europe. As per the implementing regulations, biological material, which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature, is patentable. Rule 29 (2) specifically mentions that gene sequences are patentable. It provides that though the sequence or partial sequence of a gene, cannot constitute a patentable invention, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Human beings or parts of human beings are not patentable subject matter in Europe.

Industrial ApplicabilityAccording to Article 57 of the EPC, it is sufficient that the invention is capable of being industrially produced in order to fulfill the industrial application requirement. The ascertainment of industrial applicability for biotechnology inventions is challenging because the field is filled with ambiguities. According to the Implementing regulations, partial and complete gene sequences are considered to be patentable under the EPC. However, Rule 29 (3) of the Implementing regulation explicitly poses a requirement that the industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. Moreover, the preamble of the directive specifically mentions that a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. Thus, it can be concluded that biotech inventions and specifically gene sequences are patentable under the EPC only if the function of the invention is explicitly mentioned in the application and the protection is limited to the function thus mentioned.

In the Max Planck decision, which related to a Brain Derived Phosphatase, the board stated that industrial applicability could be satisfied only if a “practical” application of the invention was disclosed. The Board inferred in the case that a vague and speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool described in the patent application was not sufficient for fulfillment of the requirement of industrial applicability. To summarize, biotechnology inventions can satisfy industrial applicability requirement only if they have known uses, which are practical and specifically mentioned in the patent application.

Novelty
Novelty of biotechnology inventions has been the subject of uncertainty at the European Patent Office. The Implementing regulations to EPC provide that biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature, is patentable. The regulations specifically provide that an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. As per the regulations, a gene sequence isolated from nature would be considered to be novel in the light of what exists in nature even if its structure is same as the one existing in nature.

The principle was applied by the board in the Relaxin Decision. The Relaxin case dealt with a process for obtaining H2-relaxin, the DNA encoding it, their chemical structure and use of the protein. The Board pointed out in the case that isolation of a gene of a known protein for the first time through conventional methods would make the gene sequence novel. The Board further stated that natural existence of genes would not anticipate their isolation, as the isolated genes containing only the coding regions were different from their natural counterparts. It can be inferred from the case that just like in USA, the threshold for novelty determination for biotechnology invention is relatively low and an isolated gene sequence with slight difference from the prior art can be considered as novel.

Inventive Step
Tests for Determination of inventive step of biotechnology inventions have been ambiguous due to uncertainty in the field. The European Patent Office and Boards have been striving to frame clear guidelines for determining inventive step of biotechnology inventions. In the Relaxin case which dealt with a process for obtaining H2-relaxin and the DNA encoding it, the Board pointed out that as the proprietor was not preparing a known substance by conventional means, but providing to the public for the first time a product whose existence was previously unknown, the claimed invention must be regarded as inventive irrespective of the methods used to prepare the product.

The non-obviousness determination is always done from the point of view of a person with ordinary skill in the art. The knowledge of the person skilled in the art in case of biotech inventions had been aptly discussed in R. v. Genentech , a case concerned with interferon-gamma and the DNA sequence coding for it. In this case the Board stated that Skilled person in the art must be considered as that of a team of the appropriate specialists, who know all the difficulties still to be expected when considering cloning a new gene. The board also inferred that a skilled person must be assumed to lack the inventive imagination to solve problems for which there do not exist already routine methods of solution, the appropriate comparison being not with a team but with a highly skilled technician carrying out a project where the initial instructions received were already adequate to tell the technician how to overcome any problems likely to arise.

Also in R. v. Chiron decision, which dealt with inventive step of a DNA molecule comprising a specified nucleotide sequence encoding insulin-like growth factor II (IGF-II), the court inferred that lack of sufficient information in prior art can be supplemented by the knowledge of the person skilled in the art while determining obviousness. In this decision the board stated that an invention would lack inventive step even if the prior art reference lacks complete description, provided the reference can be supplemented by information available to a person with ordinary skill in the art. As per the Board, reasonable likelihood of success can make an invention obvious and showing low expectation of success can rebut it. The Board pointed out that reasonable likelihood of success can be proved by prior art information, experiments, expert testimony and so on.

While determining inventive step of biotechnology inventions under EPC various factors such as obviousness in the light of combination of prior art to a person with ordinary skill in the art, reasonable expectation of success and secondary considerations such as commercial success and expert testimony are considered. The standards of non-obviousness are higher in Europe when compared to USA and it is therefore comparatively difficult to satisfy this requirement in Europe.

Enablement
The threshold for disclosure and enablement requirement in Europe is much higher for biotechnology inventions when compared to other technologies. Assessment of the sufficiency of a disclosure depends on the correlation of the facts of the case to certain general parameters such as the character of the technical field, the average amount of effort necessary to put into practice a certain written disclosure in that technical field, the time when the disclosure was presented to the public and the corresponding general knowledge and the amount of reliable technical details disclosed in a document. In the Weyershaeuser Case that dealt with microbiologically produced reticulated cellulose the board stated that the disclosure should be sufficiently clear such that it can be enabled by a person skilled in the art without undue burden on that person.

Further, in R. v. Massachusetts Institute of Technology decision, the board stated that in case of gene based inventions, the requirement of trial and error to carry out the invention would make the disclosure non-enabling. To work biotechnology inventions involves several molecular biology techniques and requires extensive experimentations for standardization of experiments. Also, the time taken for successful completion of an invention would depend on the level of skill of the technician performing the experiment. Thus, in many cases, several attempts may be required to complete an enabled invention. This issue has been addressed in R v. Genentech case, which related to sufficiency of disclosure in a patent concerning amino acid sequence and DNA sequences of interferon-gamma. In this case the Board stated that a patent application relating to a gene would be enabling even if the experimentation required is burdensome, so long as undue experimentation is not required. It further stated that deposit of biological materials is not compulsory as long as an application can be enabled based on written description.

Later, in the Biogen Decision the Board laid down that disclosure can rely on functional characteristics in case of genetic inventions. This decision reduced the burden of patent disclosure for biotechnology inventions. To summarize, the written description and enablement requirement for biotechnology inventions must satisfy higher standards than other inventions with a few exceptions. While deposit of biological materials can supplement a written description, it is not compulsory to deposit materials. Furthermore, disclosure of biotech inventions must be specific and broad disclosures are not sufficient.

Morality
Unlike the US Patent Law, the European Patent Convention provides provisions relating to morality for grant of patents. Article 53 of EPC provides that European patents shall not be granted in respect of inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States. The EU Biotechnology Directive also lays sufficient emphasis on morality as a factor to be considered before granting patents in biotech inventions.

The European Patent Office has expounded the morality provision under Article 53 in its decisions involving biotechnology inventions. In the Harvard Mouse Case , the invention relating to a genetically modified mouse was held patentable despite moral concerns. After reviewing the moral concerns, the Board held that the mouse was patentable though it is put through suffering because the benefit to human beings outweighs the suffering of the animal. The Board in this case stated that the utility of the mouse model for cancer treatment makes it moral and therefore, patentable.

Another important case on morality is the Relaxin case. The Relaxin case related to a process for obtaining H2-relaxin and the DNA encoding it. It was argued that the claimed invention was not patentable under Article 53(a) as the patent required taking of the tissue from a pregnant woman. It was argued that it amounted to an immoral act, which was against human dignity because it involves making use of a female condition (pregnancy) in a technical process oriented towards profit. It was also argued that the patenting of human genes such as that encoding H2-relaxin amounted to a form of modern slavery since it involved the dismemberment of women and their piecemeal sale to commercial enterprises throughout the world and that the patenting of human genes means that human life was being patented, which was intrinsically immoral.

The Opposition Division rejected the arguments stating that there was no reason to perceive the isolation of mRMA from the tissue of pregnant woman as immoral because it was taken by consent. As human tissue, blood, bone and so on have been the subject of isolation for medical purpose, the Opposition Division pointed out that such practice was accepted by the public. It then pointed out that patents covering DNA encoding human H2-relaxin, or any other human gene do not confer on their proprietors any rights to individual human beings and therefore, no woman would be affected in any way by the present invention and was free to live her life as she wished and had exactly the same right to self-determination as she had before the patent was granted. In addition, the Opposition Division stated that the exploitation of the invention does not involve dismemberment and piecemeal sale of women because gene cloning could be done in unicellular organisms and a woman was only required initially for isolating the tissue for which consent was taken.

Finally, the Opposition Division pointed out that the allegation that human life was being patented was unfounded because DNA was not ‘life’, but a chemical substance, which carried genetic information and could be used as an intermediate in the production of proteins, which might be medically useful. It further stated that the patenting of a single human gene had nothing to do with the patenting of human life. In the light of its reasoning, the Opposition Division concluded that the invention was not against widely-accepted moral standards of behaviour by promoting slavery, the sale of women, and so on, nor was there a clear consensus among members of the public in the Contracting States that patenting human genes such as that encoding H2-relaxin was immoral and therefore could be patented.

The cases elucidate that morality determination forms an integral part of patentability analysis with regard to biotechnology inventions. This provision has been invoked regularly by the European Patent Office while deciding upon patentability of such inventions. An invention will not be granted a patent if evidence can be shown that it or its exploitation is against public order or morality. Patents will be granted over genetically modified animals only if the benefit to mankind outweighs the suffering caused to the animals. Potential unknown danger to society or environment will not be fatal to patentability of an invention.

Note: The term Board referred in this Blog is either Board or Appeals or Technical Board.

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