The patentability of genes
8/10/2008

In order to be patentable, an invention must be new, it must involve an inventive step and it must be capable of being used or applied in trade, industry or agriculture. For mechanical inventions, unlike biotechnological inventions, it is more often than not quite clear whether or not an invention is capable of industrial application.

It used to be that some companies would form consortiums with other biotechnology-based companies such as Human Genome Sciences (HGS) with the aim of sequencing and patenting as many genes as possible. SmithKline Beecham formed a consortium with HGS, and this consortium resulted in the sequencing of about 850 000 DNA fragments which resulted in the filing of about 200 US patent applications for genes. The impact that such patents have on researchers is that when a company obtains a patent for a gene, researchers who established the role of that gene were not allowed to conduct any further research involving that particular gene without a patent license. In order to avoid costly law suits, the researchers had to buy a license from the company holding the patent rights to the gene. Such practices caused an uproar as some critics are of the opinion that “Genes derive from millions of years of evolution and are, in the deepest sense, products of nature. They are not the inventions of individuals, corporations, or institutions.” Others criticise the practice as they are of the opinion that human gene patents “impede access to genetic innovations in health care and stifle research. “

On the other hand, supporters of the idea of patenting human genes believe that such patents promote investments worth billions of dollars specifically for gene research.

Recently, Ely Lilly applied for the revocation of a patent belonging to HGS. The patent was directed to the nucleotide (A building block of DNA or RNA) and polypeptide (protein) sequences of Neutrokine-α, a member of the TNF ligand super family of cytokines. The gene was discovered through homology comparisons with other members of the TNF ligand family. Through these homology comparisons, HGS was able to list a number of potential uses of the sequence. No laboratory experiments were conducted to confirm these uses. HGS did not know the diseases which could be treated using the gene and, thus, they did not know whether or not the gene was capable of industrial application.

South African Patent law is very similar to that of UK, in that it is a requirement in both countries that an invention must be capable of industrial application in order for it to be patentable. In Justice Kitchen’s (of the UK courts) words “A patent is not a hunting licence to find a use for the claimed product. It is a reward for the successful conclusion of research.”

In the case of Carnegie Mellon Univ. versus Hoffmann-La Roche Inc., the court decided that Roche did not infringe three US patents filed by Carnegie. The patents covered a recombinant plasmids containing a DNA sequence (from any bacterial species) encoding DNA Polymerase I (the enzyme). In one of the patents, a specific DNA sequence encoding “an enzyme with either DNA Polymerase or nick-translation activity” is claimed; the patent claimed the sequence in all bacterial species. Such patents can be construed as being “reserves for unexplored fields of research” to the patentee, because only one bacterial species was disclosed in these patents. It is also known that the enzyme is not just a single enzyme, but is part of a family of enzymes encoded by a family of genes that vary from one bacterial species to the other, the differences between the sequences may occur at positions in the sequence which play a very important part in the working of the invention. This implies that altering the sequence of the gene in the same position in different bacterial species would yield different results. These patents thus did not comply with the written description requirement for chemical and biotechnological inventions.
In order to avoid revocation of a patent, one must ensure that the sequence and micro-organism claimed are disclosed and that such disclosure will permit a person skilled in the art to perform the invention and obtain the results as set out in the specification. If one claims a sequence in a number of different bacterial species, then one must ensure that, for instance, deleting a sequence at a specific position in a gene, will yield the same results in all bacterial species claimed. If the results obtained are different, the patent may be revoked on the ground that the invention as illustrated or exemplified in the specification cannot be performed or does not lead to results and advantages set out in the specification.

Kutlwano Hutamo
Candidate Attorney
kutlwano-h@adamsadams.co.za