The idea of patenting life forms was first discussed back in the 1980s, in the US Supreme Court case of Diamond v Chakrabarty, 447 U.S. 303 (1980). Since the ruling of this decision that bacterium is patentable subject matter, many have recognized the value in protecting inventions within the Life Sciences arena. Over the last decade, there has been a significant interest in filing patents within this space, particularly in light of constantly evolving scientific technology and medical advances.
The challenges faced by scientists when seeking patent protection in the Life Sciences space are unique in many ways. This article discusses some of these difficulties, and the considerations that need to be taken into account by inventors or applicants before a patent application is even filed.
From conception to patent
To briefly revisit the fundamentals to patentability, it is crucial that the invention concerned satisfies the criteria for novelty. Essentially, this test asks the question of whether or not the invention was known to the public before its priority date. In other words, the date of filing of a patent application.
Often in research, dissemination of data is encouraged and the publication of results in journals is much celebrated. However, frequently forgotten in the race to publish research first is that there may be intellectual property value in the research undertaken. Whilst it is well-known that human beings and the biological processes for their generation are not patentable subject matter, patents have been filed to protect a range of inventions, ranging widely from synthetic nucleic acids (not naturally found in the genome of any living organism), isolated and/or genetically modified microorganisms, proteins including antibodies, cell lines, vectors (including higher plants or animals) containing transgenes, plant varieties as well as others.
Intellectual property protection strategies
In many instances, discovery of new molecules and new therapeutic treatments, involves undertaking research and conducting clinical trials. In Australia and New Zealand, it is a requirement according to the Declaration of Helsinki that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject”. The type of information that is made publicly available includes key trial information, as well as details on patient recruitment criteria, which means that even prior to commencement of the trial, information of such is already released into the public domain. This poses challenges in relation to seeking patent protection.
Crucially, in Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd  HCASL 234, it was ruled that “it is not a requirement for a patentable invention that the invention, as claimed, be based on scientific proof or substantiation…. What is required is that the prior document discloses that which is subsequently claimed as an invention. If that is disclosed, the invention cannot be new” (at 106). Essentially what this means is that in Australia, the disclosure of clinical trial hypotheses has the potential to render a patent invalid, even though the hypotheses may not have been confirmed to work. In coming to this conclusion, the Court utilized the “reformulated Cripps question”, which asked the question of whether a person skilled in the art would be directly led as a matter of course to try the claimed invention with the expectation that it might produce a useful or better result. The level of expectation only needs to a reasonable level of expectation.
In light of this case, it may seem like a good idea to file patent applications early. However, care must be taken to ensure that patent applications are filed at the ideal time when an applicant is equipped with sufficient information. This is because it is a requirement that a patent application must provide an enabling disclosure to support the claims of the application, such that a person skilled in the art would be able to produce the invention as claimed in the specification, without undue burden.
As long as a patent application is filed prior to any events or situations that might be novelty destroying, for example through media releases, poster and conference presentations, as well as in journal publications, this would offer the best precautionary measures against any self-disclosures that could otherwise occur. However, understandably there may situations whereby filing a patent application during those times may not be feasible, whether it be for reasons of finance or other considerations. In that case, we suggest filing non-disclosure agreements where possible, to prevent leaking of confidential information into the public domain that might otherwise jeopardize the patentability of an invention.
Nevertheless, in the event that disclosures have been made, there exists some provisions in Patent law, known as grace periods, that allow certain types of information to be disregarded when considering novelty and inventive step. In Australia, these include:
- Publications concerning the invention made at a recognized exhibition;
- Publications concerning the invention made before a learned society;
- The workings of the invention made in public, for a reasonable trial; and
- Any unauthorized disclosures made publicly available by a person other than the nominated person or patentee, within 12 months prior to the date of filing a standard patent application.
Please note however that grace periods vary between countries. For example, in Europe there is a 6 month grace period from the time of an unauthorized disclosure to filing a patent application.
If you have any questions or concerns in relation to the above article, or if you are thinking of filing a patent application in the area of Life Sciences, please do not hesitate to get in contact with our team. We will be pleased to provide strategies for patent protection and/or discuss any aspects of this article further.