Patenting in biotechnology

Many products of nature (e.g. specific antibiotics, microorganisms, proteins, etc.) have been successfully patented. It might be argued that simply to find any substance naturally occurring on the Earth is categorized as a discovery and would be unpatentable because it lacks true novelty or any inventive step. However, if you enrich, purify or modify a product of nature such that you make available the substance for the first time in an industrially useful format, that product/process is generally patentable. In other words, patenting is possible if the 'hand of man' has played an obvious part in developing the product.

In the USA, purity alone often facilitates patenting of a product of nature (Table 4.1). The US Patent and Trademark Office (PTO) recognizes purity as a change in form of the natural material. For example, although vitamin B12 was a known product of nature for many years, it was only available in the form of a crude liver extract, which was of no use therapeutically. Development of a suitable

Table 4.1 Some products of nature that are generally patentable under US patent law. Additional patenting criteria (e.g. utility) must also be met. For many products, the patent will include details of the process used to purify the product. However, 'process' patents can be filed, as can 'use' patents. Refer to text for further details

A pure microbial culture Isolated viruses

Specific purified proteins (e.g. EPO)

Purified nucleic acid sequences (including isolated genes, plasmids, etc.) Other purified biomolecules (e.g. antibiotics, vitamins, etc.)

production (fermentation) and purification protocol allowed production of pure, crystalline vitamin B12 which could be used clinically. On this basis, a product patent was granted in the USA.

Using the same logic, the PTO has granted patents, for example, for pure cultures of specific microorganisms and for medically important proteins (e.g. Factor VIII purified from blood (Chapter 12) and EPO purified from urine (Chapter 10)).

Rapid technological advances in the biological sciences raises complex patenting issues, and patenting law as applied to modern biotechnology is still evolving.

In the late 1980s, the PTO confirmed they would consider issuing patents for non-human multicellular organisms, including animals. The first transgenic animal was patented in 1988 by Harvard University. The 'Harvard mouse' carried a gene that made it more susceptible to cancer and, hence, more sensitive in detecting possible carcinogens.

Another area of biotechnology patent law relates to the patenting of genes and DNA sequences. Thus far, patents have been issued for some human genes, largely on the basis of the use of their cloned products (e.g. EPO and tPA). A consensus has emerged that patent protection should only be considered for nucleotide sequences that can be used for specific purposes, e.g. for a sequence that can serve as a diagnostic marker or that codes for a protein product of medical value. This appears to be a reasonably approach, as it balances issues of public interest with encouraging innovation in the area.

The issue of patenting genetic material or transgenic plants/animals remains a contentious one. The debate is not confined to technical and legal argument: ethical and political issues, including public opinion, also impinge on the decision-making process. The increasing technical complexity and sophistication of the biological principles/processes upon which biotechnological innovations are based also render resolution of legal patenting issues more difficult.

A major step in clarifying European Union (EU)-wide law with regard to patenting in biotechnology stems from the introduction of the 1998 European Patent Directive. This directive (EU law) confirms that biological material (e.g. specific cells, proteins, genes, nucleotide sequences, antibiotics, etc.) that previously existed in nature are potentially patentable. However, in order actually to be patentable, they must (a) be isolated/purified from their natural environment and/or be produced via a technical process (e.g. rDNA technology in the case of recombinant proteins) and (b) they must conform to the general patentability principles regarding novelty, non-obviousness, utility and sufficiency of disclosure. The 'utility' condition, therefore, in effect prevents patenting of gene/genome sequences of unknown function. The directive also prohibits the possibility of patenting inventions if their exploitation would be contrary to public order or morality. Thus, it is not possible to patent:

• the use of human embryos for commercial purposes;

• modifying germ line identity in humans;

• modifying the genetic complement of an animal if the modifications cause suffering without resultant substantial medical benefits to the animal/to humans.

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