Biotechnology company Kineta recently had its Australian patent application declined on the ground of failure to disclose the best method of performing the invention. Best method issues are rare, and given the increasing standards of the Australian and New Zealand Patents Acts, we may see more applications failing on the contents of the written description.
A common question from patent applicants when drafting a patent application is:
What or how much do we really need to disclose?
The best strategy is to include as much information as possible that is available at the time of filing an application. This is to ensure that there is sufficient information to allow the public to fully work the invention at the end of the 20-year monopoly provided by a granted patent. Failure to provide enough information can result in refusal of a patent, or invalidation – as has happened in Kineta’s case. [i]
So what is the law around best method disclosure?
'Best method’ issues don’t come up very often and there is little case law on the issue in Australia and New Zealand. But, the issue is an important one.
The law in Australia requires that a patent specification should describe the best method to work and perform the invention that is known to the applicant at the time of filing. The New Zealand statute has the additional requirement of “…and for which there is an entitlement to claim protection”.
What happened in Kineta’s case?
Kineta’s patent application was directed to chemical compounds. The compounds were exemplified within the specification as being active as modulating the RIG-I pathway and consequently treating infections caused by RNA viruses.
However, during examination in Australia, the examiner raised an objection that the specification did not describe the best method of working the invention because the synthesis of the compounds was not described. An impasse was reached with the examiner and a hearing was requested.
Importantly, Kineta had exemplified the activity of the compounds, but had not included a method for the synthesis of the compounds and this was the subject of the hearing.
Kineta’s inventors had identified a small compound library. A lead compound was identified and a number of variations were designed on paper. The synthesis of the variants was contracted out to a third party. Kineta provided no instructions to the sub-contractor on how the compounds should be made.
Kineta did not include the synthesis of the compounds in the specification because, not having synthesised the compounds, it did not have that information. Kineta considered that a person of skill in the art could readily synthesise the compounds from their basic understanding of chemistry and from chemical transformations known in the literature. This viewpoint was supported by evidence from its expert who was internationally recognised in the field of medicinal chemistry and drug discovery.
However, this argument failed to convince the hearing officer.
In making his decision, the hearing officer noted there were three points that needed to be addressed:
- Identify the invention for which a best method must be provided;
- Identify the method described in the specification; and
- Was the applicant aware of a better method?
The hearing officer considered that the invention lay in the compounds and the fact that they could be made. But for the public to have full benefit, the invention lay in the compounds and their uses, and it was this that should be described.
In addition to its argument that the transformations would be known, Kineta also argued that the method described provided the variables and preferred embodiments, and contained all of the information a skilled person required. It also argued that it was absurd to suggest that the best method requirement would fail because the reader was not directed to a generic scheme.
Kineta pointed out that it had not withheld any information. It had not synthesised the compounds and everything that it knew, was included in the specification. The argument was also supported by their expert.
Unfortunately for Kineta, the hearings officer disagreed with its submissions and with its expert. He believed a skilled person could not arrive at the compounds from the disclosure of the specification, combined with the common general knowledge. While the hearings officer accepted that Kineta did not know how the compounds were made, it was critical to his decision that Kineta had not disclosed that the only method known to obtain the compounds, was to purchase them. Importantly, the hearings officer considered that this information should have been included in the specification.
Consequently, the specification failed on disclosure of the best method because no method was apparent when the specification was read in light of the common general knowledge. Whether the additional requirement in New Zealand of “…and for which there is an entitlement to claim protection” would change the result is a question that remains to be determined.
In preparing a patent specification, applicants should provide as much information and experimental support as possible. Especially in respect of features critical to the working of the invention: even if that is only a simple statement of where a component was obtained from.
Given the increasing examination standards under the Australian and New Zealand Patents Acts, we may see closer scrutiny of the description and more cases where the description fails to meet those standards.