Patenting The Life Sciences

What can you patent in the life sciences field?

The answer to this question depends on the country concerned, as different countries have different laws and rules as regards what can and cannot be patented. For example, in the United States, nearly any novel and inventive product or process may be patented. In Europe, on the other hand, there are quite a few things excluded from patentability, such as discoveries, diagnostic and surgical methods, plant and animal varieties, and essentially biological processes for the production of plants or animals.

Can you patent genes and proteins?

Yes, provided that you know of at least one use (utility) for the gene or protein, and that the use is written into the patent application when it is first filed. As an example, if you discover a new gene, but do not know the function of the gene, this would be a discovery as opposed to a patentable invention. However, if you discover that the gene is involved in the pathology of obesity, and you have data showing that modulation of the expression level of the gene can attenuate the development of obesity, then you would have an invention. Thus, the identification of a novel gene without a known function would be a discovery in the context of patent law.

In the United States, the use assigned to a patent application has to be substantial, specific and credible.

Can you patent animals?

In Europe, animal varieties are not patentable. However, if your invention is not restricted to a particular variety of animal, then this exclusion would not apply. For example, if your invention involves genetically engineering a gene construct for expressing insulin into the mammary gland of a sheep, but the technical feasibility of the invention is not restricted to a particular variety of sheep (i.e. it could be applied to different varieties of sheep, or different mammals), then the invention would not be deemed to be a animal variety and would therefore not be precluded from patentability.

A further provision of patent law in Europe is that animals are deemed unpatentable if the suffering to the animal caused by the invention outweighs the potential benefits the invention provides to mankind. This aspect of European law arose due to an invention called the Harvard Mouse, or Oncomouse, a mouse genetically engineered to develop cancer; the purpose of the invention was to provide a readily available source of laboratory animals for testing cancer drugs. The patent was initially rejected by the European Patent Office Examiners on the basis that it was immoral, before finally being granted. It was then opposed by 18 different parties including various sections of the German Green Party and animal rights activists, before being finally granted some 18 years after it was filed. In the final decision by the legislators of the European Patent Office, the EPO decided that the benefit to mankind provided by the laboratory mouse outweighed the suffering to the animal (Harvard mouse PDF) .

Can you patent human beings?

In the United States, the patenting of human beings is prohibited under the 13 th amendment to the US Constitution which prohibits slavery and thereby any proprietory right in human beings. In Europe, it is prohibited by the EU Biotechnology Directive, which also prohibits the patenting of germ line therapy, human cloning, and the commercial use of human embryos .

Can you patent bacteria and virus?

The simple answer is yes, provided that you are the first person to isolate them from their natural environment or produce them by means of a technical process (i.e. genetic engineering), and they have a substantial, specific, and credible use. In situations where the characteristics of the novel microbe are difficult to adequately describe in writing, or where the microbe is difficult to reproduce, it is essential that a viable deposit of the microbe is made at a Depository Institution recognised under the Budapest Treaty prior to the filing of the first patent application for the cells, and the reference number of the deposit is referenced in the first patent application.

What about cell lines and stem cells?

Like bacteria and virus, cell lines and cell models of disease can be patented provided that you are the first person to isolate them from their natural environment or make them by means of a technical process, and they have a substantial, specific, and credible use. The comments above regarding the filing of a deposit of the microbes at a Depository Institution apply likewise to cells lines.

In the United States, stem cells are deemed to be patentable. In Europe, there is some debate as to what type of stem cells are patenable. The EU Biotechnology Directive (which is written into European patent law), prohibits the patenting of anything that involves the commercial use of human embryos. In a recent test case before the Examiners of the European Patent Office (EPO), this exclusion was deemed to encompass embryonic stem cells, with the effect that at present the EPO will grant patents for adult stem cells, but not for embryonic stem cells ( Edinburgh patent PDF) . Interestingly, this approach has not been followed by the UK Patent Office which has indicated that they will not exclude from patentability all embryonic stem cells, but only those that have the ability to develop into a full human being (totipotent stem cells).

What about SNP’s, haplotypes, and other mutations?

SNP’s and haplotypes are patentable subject matter, provided they have a use or utility. In many cases, it would not be the mutation(s) (or gene including the mutation(s)) that you would patent, but a diagnostic method involving assaying for the mutation, or a specific kit or reagent for assaying for the mutation. An example of this is a SNP in a specific gene which is shown to be a pharmacogenomic marker of response to a particular type or class of drugs (Pharmacogenomic patent PDF) . In this case, you would patent the SNP as a pharmacogenomic marker of drug response.

And Biomarkers?

In the 1980’s and 1990’s, many patent applications were filed for novel genes and proteins. More recently, however, less patents are being filed for the proteins and genes themselves, and more are being filed for the use of these proteins and genes in diagnosing and treating clinical conditions. Genome and proteome profiling research has generated an enormous amount of data relating to the choreography of biological molecules in human and animals, and how this choreography changes as in response to pathological changes. This has resulted in the identification of biological molecules that function as “markers” of disease and are useful in predicting if a person is at risk of developing a particular disease, predicting the severity of the disease, and predict whether a patient will have a good or poor outcome from a particular disease. The biomarkers may be single genes or protein, panels of genes or proteins, whole genome analysis, or levels of expression of particular genes or proteins.

How much data is required to file a patent application?

Generally, it is good practice to defer filing a patent application until you have at least proof of principle data. In the field of human therapy, this may be in-vitro data. In the biomarker field, this may be data showing an association between the biomarker and the human condition in a small cohort of patients or from cell models of the human condition. Within one year of filing a first patent application, it is possible to add further data to the patent application, and it is at this stage that strong data, supporting and validating the invention, should be added to the patent application. In the case of therapeutic inventions, it is strongly advisable to add animal model data to the patent application at this stage; if animal model data is not available, it is important that data from a well accepted cell model of the disease is included. This is especially important for US patents.