What can you patent in the Life Sciences field?
The law defining what can be patented in the area of life sciences differs from country to country. For example, in Europe, there is a limited list of subject matter that is excluded from patentability, such as discoveries, surgical methods, plant and animal varieties, and biological processes for the production of plants or animals. Biological subject matter is considered patent eligible, provided that the subject matter has been isolated from its natural environment or produced by means of a technical process.
In the US, following a US Supreme Court Decision (Association for Molecular Pathology v Myriad Genetics Inc), nature-identical products such as naturally occurring proteins, genes and bacteria are not considered to be patent eligible. In addition, patents that claim the use of biomarkers as diagnostic or prognostic variables of disease are considered to be patent ineligible.
What about nucleic acids and proteins?
Naturally occurring nucleic acids and proteins are currently considered to be patent ineligible in the US, but can be patented in Europe provided that at least one use (utility) for the nucleic or protein is known, and that the use is written into the patent application when it is first filed. For example, taking a newly discovered micro RNA molecule as an example, where the function of the miRNA is not known, this would be a discovery as opposed to a patentable invention. However, if the miR is shown to be involved in epilepsy, and at least in-vitro data is available making it plausible that modulation of the expression level of the miR can attenuate the occurrence or severity of epileptic fits, this would be considered an invention.
Can you patent animals?
In Europe, animal varieties are not patentable. However, if an invention is not restricted to a specific variety of animal, then this exclusion would not apply. For example, if an 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 an 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 Patent 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 (EPO) 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 EPO, the EPO decided that the benefit to mankind provided by the laboratory mouse outweighed the suffering to the animal.
Can you patent 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.
In the United States, the patenting of human beings is prohibited under the 13th amendment to the US Constitution which prohibits slavery and thereby any proprietary right in human beings.
Can you patent bacteria and viruses?
The simple answer is yes in Europe, and no for the US: in Europe, if you are the first person to isolate the bacteria or virus from their natural environments or produce them by means of a technical process (i.e. genetic engineering), and they have a substantial, specific, and credible use, then patents can be obtained for bacteria and virus. 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.
In the United States, naturally occurring bacteria and viruses are considered to be patent ineligible.
What about cell lines and stem cells?
Like bacteria and viruses, cell lines and cell models of disease can be patented in Europe provided that they have not previously been isolated from their natural environment or made 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, naturally occurring biological subject matter, including stem cells and cell lines, are considered to be patent ineligible. However, stem cells or cell lines that have been genetically engineered, are considered to be patent eligible as they are not products of nature.
In Europe, biomarker inventions can be patented by claiming the biomarker itself (if it is not described in the literature, i.e. a new micro RNA molecule or mutated gene) or, if the biomarker is already part of the literature, claiming a method of detecting a particular pathology or condition using the biomarker. Unfortunately, as both of these claims type (biomarker and use claims) are considered by the USPTO to be patent ineligible, obtaining commercially valuable patent protection in the US for biomarker inventions is fraught with difficulty, and to have any chance of success, claims have to be directed to new detection methodologies, detection reagents or equipment.
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 that makes the stated invention at least plausible. 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.
Our Life Sciences team?
Led by Barry Purdy, our Life Sciences team all have a technical background to at least primary degree level in a biological or chemical science and are qualified European Patent Attorneys. Our combination of legal and technical skills, combined with a broad range of technical backgrounds in the life sciences, makes us an ideal choice for life science clients. We have been advising clients on life science inventions for over 20 years, including many leading Irish academics and research groups.