In brief
Australia's unique statutory 'best method' requirement continues to get the better of patent applicants and patentees. Associate Claire Gregg looks at two recent decisions that provide some insight into the requirement of disclosing the best method known to the applicant of performing the invention at the time of filing the complete patent specification.
The cases
The Australian Patent Office in Kineta, Inc. [2017] APO 45 and the Full Federal Court in Sandvik [2017] FCAFC 138 highlight the fatal consequences for both applications and granted patents in failing to disclose the best method. These decisions also reiterate that the nature of the invention around which the claims are drawn, as determined from the specification as a whole, is critical to determining what is 'best' in the circumstances.
The relevant law
Section 40(2)(aa) of the Patents Act 1990 (Cth) (the Act) requires that 'a complete specification must disclose the best method known to the applicant of performing the invention'. Importantly, the best method must be disclosed at the complete specification filing date. An amendment to introduce the best method at a later date is at serious risk of being refused on the basis of added subject matter.
Current s40(2)(aa) was introduced as a result of the Raising the Bar amendments to the Act that came into effect on 15 April 2013. Prior to this, the best method requirement was found in s40(2)(a), which stated that 'a complete specification must describe the invention fully, including the best method known to the applicant of performing the invention', and was therefore not a separate ground of examination. Accordingly, best method was seldom considered by the Patent Office.
Best method also received little judicial consideration in Australia until 2016, when the Full Federal Court considered former s40(2)(a) in Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27. In Servier, the invention was directed to the arginine salt of perindopril, however the specification merely stated that the salt was 'prepared according to a classical method of salification of organic chemistry'. The Full Court held that Servier had not disclosed the best method known to it of performing the invention because it had used particular methods and parameters that 'produced a guaranteed result', whereas the broad, general method described in the specification left the skilled person to select from a large range of variables.
Notably, despite the absence of the best method of performing the invention, the requirement under former s40(2)(a) to describe the invention fully was found to be satisfied because the method disclosed in specification was sufficient to enable a skilled person to carry out the invention without further inventive effort.
The Patent Office in Kineta, Inc
Background
The patent application at issue in Kineta, Inc. [2017] APO 45 related to compounds and methods for treating viral infections. Claim 1 was directed to novel compounds represented by a general formula that are useful for the treatment of such infections.
The applicant, Kineta, Inc identified a lead compound via a high-throughput screening of a library of compounds purchased from Life Chemicals Inc and the inventors designed a number of derivatives for synthesis and biological testing. Life Chemicals was contracted to synthesise these derivatives, which were then tested for viral activity by Kineta. Kineta did not provide any instructions to Life Chemicals on how to prepare the compounds, and Life Chemicals did not provide any details of how the compounds were synthesised to Kineta.
Kineta was unable to overcome the Examiner's objection under s40(2)(aa) that the complete specification did not disclose the best method known to the applicant of performing the invention because the specification did not disclose any method for making or obtaining the compounds of the invention. Kineta therefore requested a hearing before the Patent Office, which was heard on the basis of written submissions.
The decision
Arising from the relevant case law, the Deputy Commissioner in Kineta concluded that there were three matters to be considered in determining whether the specification discloses the best method of performing the invention under s40(2)(aa):
- What is the nature of the invention?
- What method is described in the specification?
- Was the applicant aware of a better method?
The nature of the invention
In considering the nature of the invention, the Deputy Commissioner referred to the UK decision in Illinois Tool Works Inc v Autobars Co (Services) Ltd [1974] RPC 337, in which the claims were directed to an article having a certain shape. In Illinois Tool Works, the court found that the invention lay in the conception of the shape of the article and the patentee was not required to describe how the article was made; it was enough that the patentee had described the formation of the article having the required shape.
However, the Deputy Commissioner in Kineta did not consider that the invention was merely the conception of the shape (ie, molecular structure) of the compounds, stating:
…Until the applicant was in possession of the compounds, as distinct from merely conceiving their structure, it was not able to do the work to determine whether or not it had solved the problem. It is clear that the invention lies in the compounds and the fact that they can be made. In order for the public to have the full benefit of the invention they must be able to prepare the compounds and then use them for their beneficial properties...
The nature of the invention was therefore found to lie in both the compounds and their use.
The method described in the specification
The specification described the invention generally, including disclosing various embodiments of the compounds of the invention. However, there was no general description of how the compounds were made, nor were there any specific synthetic methods described in the examples.
Kineta provided expert evidence from one of its employees, Dr Goldberg, that the specification, in combination with the common general knowledge of a person skilled in the art, provided all of the information needed for the skilled person to perform the invention (ie, to make the claimed compounds). However, while it was accepted that Dr Goldberg was capable of preparing the compounds due to his expertise, the Deputy Commissioner was not satisfied that the skilled addressee, who is 'incapable of a scintilla of invention', would be able to do so upon reading the specification in light of the common general knowledge.
Was the applicant aware of a better method?
Kineta also submitted that it had not withheld any information from the specification because it did not know how Life Chemicals had produced the compounds. However, Kineta knew that the compounds could be purchased from Life Chemicals. As this information had not been included in the specification, it was held that 'the applicant has not disclosed that the only method known to it (and thus the best method known to it) was to purchase the compounds from Life Chemicals Inc'.
In light of the purpose behind the best method requirement, ie, to protect the public from patentees who would withhold the consideration of knowledge from the public while still obtaining the benefit of a patent monopoly, the Deputy Commissioner stated that:
…Any other conclusion would allow an applicant to obtain a patent for these novel substances without providing any information as to how to obtain the substance. This would be the antithesis of the quid pro quo at the heart of the patent system.
The Deputy Commissioner also noted that even if the claims were amended so that they were directed solely to the use of the compounds, rather than the compounds per se, the best method requirement would still not be satisfied. Although it has been established that it is not necessary to disclose how starting materials for a process are to be obtained, the Deputy Commissioner noted that this is only the situation when the starting material is not the invention.
The Deputy Commissioner afforded Kineta the time remaining for acceptance (allowance) in order to overcome the best method objection, but warned Kineta that any amendment to overcome this objection would also need to satisfy the sufficiency requirement under the Act.
The relationship between 'best method' and sufficiency
Current s40(2)(aa) remains closely linked with current s40(a), which now specifies that a complete specification must 'disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art'.
As demonstrated in Servier, a specification can satisfy the requirement for sufficiency under s40(a) while failing to disclose the best method under s40(2)(aa). However, in Kineta, the Deputy Commissioner considered that the specification lacked sufficiency because, unlike in Servier, it does not disclose any method of preparing the compounds. As noted above, the Deputy Commissioner did not consider that the skilled person could make up for this lack of disclosure from the common general knowledge alone.
The Full Federal Court in Sandvik
Background
The patent at issue in Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138 is directed to the development of a drilling system for use in semi-automatic drilling rigs. The patentee (Sandvik) alleged that Quarry Mining & Construction Equipment Pty Ltd (Quarry Mining) had infringed a number of the claims of their patent, and Quarry Mining cross-claimed for revocation on a number of grounds, including best method.
In Sandvik [2016] FCA 236, the primary judge considered whether the complete specification disclosed the best method of performing the invention under former s40(2)(a) because it did not include drawings that were prepared before the filing date showing an improved sealing member for use with the drilling system. Notably, the specification did not provide any indication that the seal was an important feature of the invention, nor did the claims specifically refer to the seal.
In evidence provided by one of the inventors, the design of an effective water seal was said to be 'a real issue which needed to be overcome'. The inventor described the seal as 'the ultimate evolution of the seal' and as 'a superior design'. The primary judge held that the 'the inventors themselves took the view that the particular water-sealing arrangement described above was critical to the efficacy and quality of the ultimate form of the invention' and thus, by omitting the drawings, the best method of performing the invention had not been disclosed.
The appeal decision
Sandvik appealed the decision of the primary judge on the basis that the detailed characteristics of the seal did not relate to a method of performing the invention, and therefore the best method requirement did not extend to the sealing member.
Sandvik sought to rely on the Federal Court decision in Firebelt [2000] FCA 1689 (endorsed by the Full Court in Servier). In Firebelt, a 'lid opening device' was an essential feature of the claims, but was disclosed only in very general terms in the specification. However, the court held that the best method requirement was satisfied because the invention was 'not of a particular type of lid opening device operating at any particular time', ie, the lid opening device did not strictly relate to the invention.
The Full Court stated that the appropriate starting point is to identify the invention described by the specification as a whole. Despite the fact that the particular sealing member in question was not a feature of the claims, the primary judge's findings made it clear that the use of an effective water seal was considered 'necessary and important to perform the invention'.
The Full Court noted that under the heading 'Best Modes of Performing the Invention' in the specification Sandvik had described two preferred embodiments and had put forward a particular type of sealing member in the drawings of those preferred embodiments. However, the drawings were not of the best sealing member known to Sandvik at the complete filing date. The Full Court stated that:
…in circumstances where the specification purported to address the best method requirement by providing a detailed description of two preferred embodiments, it was incumbent on Sandvik to describe the best embodiment known to it.
In contrast, the Full Court noted that 'the complete specification in Firebelt did not purport to describe a particular type of lid opening mechanism'.
Sandvik also referred to Servier, in which it was acknowledged by the Full Court that, in certain circumstances, there is an obligation on the patentee to provide the method that will best fulfil the promises of the invention, and submitted that it was not necessary to disclose the best sealing member known to it because the sealing member did not relate to the promised advantages of the invention. However, the Full Court in Sandvik noted that the emphasis in Servier was on what was described in the specification as a whole and thus it is the specification as a whole (not just the promise of the invention) that must be considered in assessing whether it was incumbent on Sandvik to describe the best form of sealing member known to it.
As the best form of the sealing member was not disclosed in the specification, the Full Court upheld the decision of the trial judge to revoke the patent on the ground of best method.