Biotechnology, research and intellectual property law andrew j allen

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Vi. The Importance Of Intellectual Property Rights For Biotechnology

Intellectual property rights aim to promote innovation while facilitating the free dissemination of new knowledge. There are two incentives operating within the patent regime. First, the opportunity to enjoy a market monopoly for an innovative product is an incentive to develop new products. For a new product to qualify for a patent monopoly it must involve an inventive step; that is, a contribution to the existing stock of public knowledge. Thus, a patent is an incentive to develop new knowledge, and an incentive to invest the necessary funds to pay forthe research needed to do so. Evidence from the USA suggests that significant private investment in biotechnological research is lured by biotechnology companies' stocks of patents.30

Secondly, the patent system is an incentive to publish information about new inventions. Publication of the details of anew invention is compulsory in order to obtain a patent. The incentive to do so arises because patents are not the only option available to an inventor to protect his or her intellectual achievement. The law of confidentiality offers some protection for trade secrets, but this is reliant on secrecy being maintained. Maintenance of the secret of invention is very difficult for biological materials which carry their own genetic blueprints within them. Seeds, plants, animals and microbes can all self replicate. Copying of these innovations is easily achieved; therefore, strong intellectual property rights are important to protect these innovations. Patents offer a certain term of market exclusivity, compared to the uncertainty of trade secret protection. Thus, there is an incentive for inventors to avail themselves of the patent system and make a full public disclosure of the new invention. Disclosure of the information relating to new inventions benefits biotechnology by adding to the stock of existing knowledge upon which further new discoveries are based. An example may be illustrative: a patent on a cloned gene encoding atherapeutically useful protein offers exclusivity in the market for that protein. The patent will be granted when the applicant makes a full specification revealing the details of the invention available to the public. This information is then in the public domain. However, during the term of the patent monopoly, only the patent holder may commercially exploit the invention.

A strong system of intellectual property rights has encouraged the investing of significant amounts of money in the biomedical sciences in the USA, where the term biotechnology is synonymous with both a scientific discipline and a rapidly growing industry. This investment has, since the 1970s, increasingly come from the private sector as government funding has declined.31 One of the goals of the patent system is to promote the advancement of human knowledge. It achieves this in two ways. First, by requiring the disclosure of full details regarding every patented invention. Secondly, the exclusive right to commercially exploit an invention acts as an incentive to encourage the basic research from which patentable innovations may spring. In biotechnology, the distinction between basic and applied research is blurred because many basic discoveries have immediate commercial application. For example, many biological innovations are simply tools for further research. Therefore, it is important that intellectual property rights are available as an incentive to further the growth of knowledge in this discipline. The benefits to society are particularly important in the areas of biomedical research for new therapeutic treatments, and in agriculture where research is aimed at improving human nutrition. Traditionally, patent protection could not be obtained for basic research discoveries. In theory, no patent is available for theoretical or abstract discoveries, laws of nature, products of nature, principles, mathematical formulae or algorithms. Some courts have even noted the irony of denying patent protection to the discoverers of scientific principles while extending protection to lesser geniuses who put such discoveries to practical uses.32 Where the fields of pure and applied research are distinct, this line between discovery and invention is easily drawn. In biotechnology the distinction becomes blurred.

Recombinant DNA research can lead immediately to new products. For example, the discovery of how a specialised cell controls the production of a certain protein may also provide a means of industrially producing that protein for commercial use. The investment of private money into basic research means new scientific discoveries may be made in commercial laboratories. The elusive distinction between pure and applied research means that patentable inventions may be developed in universities. In many universities, the securing of intellectual property rights on research results is encouraged. How patents create an incentive to invent may be re-evaluated in the light of increased commercial involvement in basic research. Has the time come when it should be acknowledged that the distinction between discovery and invention is arbitrary and, in accordance with the incentive function of intellectual property law, require entrepreneurs who apply new knowledge to commercial purposes to pay royalties to those who contribute to the stock of human knowledge?

VII. Plant Variety Rights

In New Zealand, the Patents Act 1953 and the Plant Variety Rights Act 1987 govern intellectual property rights in biological materials. Plant variety rights were established, in accordance with the 1961 UPOV Convention, to provide protection for the products of plant breeding. There was a need for an alternative to the patent system because plant material was seen as incapable of meeting the requirements of novelty, inventive step and disclosure. In recognition of the importance of plants in the human food chain, the scope of the monopoly right is limited. The use of new plant material for research and breeding does not infringe the plant variety right. A second limitation on the scope of the plant variety right is the so-called farmers' privilege. A farmer who grows a protected variety may hold back some of the resulting seed for replanting the following season. New Zealand has not yet ratified the 1991 version of the UPOV convention. This updated version extends the scope of protection to include essentially derived varieties. An essentially derived variety is one that is distinct from the initial variety in one characteristic but otherwise has all of the characteristics of the initial variety. There is a concern that new techniques available for novel plant development make it easy for breeders to take protected varieties, make minor modifications to them, and commercially exploit the new variety while so avoiding infringing the initial plant variety right.33 This issue illustrates a problem for the traditional methods of securing intellectual property protection over biological materials. Descriptions of biological inventions are usually made in general terms, while the actual invention may be narrower in scope. A plant variety right for a Royal Gala apple tree encompasses all of the characteristics of that tree. The scope of protection extends to all trees that have those characteristics in that particular combination.

It is suggested that when property rights are granted in biological materials, the scope of the right must be commensurate with the size of the contribution made by the breeder. Extending protection to essentially derived varieties is a step towards giving the right holder a property right in each of the characteristics of the whole organism individually. Arguably, this is granting a right of wider scope than is warranted by the breeder's actual achievement. It may be preferable to allow patent rights for specific genes that are made available for breeding, and which confer specific characteristics.

No inventiveness is required to obtain a plant variety right. They were designed to reward the effort that is needed to breed new varieties or new combinations of existing characteristics. New technologies have made it possible to apply some human inventiveness to the field of plant breeding, and inventiveness has traditionally been the hallmark of patentability. Therefore, patents may be the appropriate form of protection to use for plant innovations which meet the patentability criteria of inventive step, novelty and utility. Patent protection carries the advantage for the inventive plant breeder of stronger protection than the plant variety right, and more accurately matches the scope of the right granted to the actual contribution made by the inventor. The challenge of stating the invention at the right level of generality commensurate with the actual contribution made by the inventor is discussed below in Part XII.

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