Australia’s best method requirement – when best isn’t necessarily better

Declan McKeveney

For more information about best method requirements, contact Dr Declan McKeveney.

Recent decisions from both the Australian Patent Office and the Full Federal court appear to indicate that Australia is becoming something of an international outlier in terms of the onus placed upon the requirement that a complete patent specification must “disclose the best method known to the applicant of performing the invention”, at the time of filing.

Best method has long been a part of Australian law but has received relatively little consideration both at the Patent Office and court levels. We have previously discussed a significant Full Federal court decision which issued in 2016 on the matter and, in light of the two decisions discussed in this article, it appears likely we have not seen an end to best method difficulties in Australia unless we see legislative change.

Patent Office hearing decision

In Kineta, Inc. [2017] APO 45 best method was considered in relation to composition of matter claims directed to compounds useful for modulating the RIG-I pathway and so to operate as potential therapeutics for RNA viral infections. The case is an interesting one in that the claims of the patent application were rejected when, apparently, a simple statement as to where the relevant compounds were purchased could have avoided the deficiency.

Kineta had asked to be heard after multiple examination reports had issued alleging that their specification failed to disclose the best method of performing the invention. The issue was addressed by a Hearing Officer on the basis of written submissions.

The compounds being claimed had come about by Kineta, firstly, using a small library purchased from Life Chemicals Inc. in a high throughput screening approach to identify a lead compound. On the basis of the structure of this lead compound Kineta then designed, on paper, some variations on the compound structure which they then asked Life Chemicals Inc. to synthesise for them. Kineta did not offer any guidance to Life Chemicals Inc. as to the approach to the synthesis and Life Chemicals Inc. simply made the compounds and sent them back to Kineta to continue their project i.e. it was a simple fee-for-service arrangement.

While the patent specification contained results on the testing of the compounds as antivirals, the specification was silent as to how the compounds had been made or that they had been purchased from Life Chemicals Inc.

In their submissions, Kineta tried to argue against the lack of best method objection on two fronts. Firstly, they suggested that a person skilled in the art of medicinal chemistry would have known how to synthesise the compounds upon seeing their structure and so the best method of performance was implicitly disclosed. This view was supported by declarations from the Director of Drug Discovery Research at Kineta, an internationally recognised expert in medicinal chemistry and drug discovery. Secondly, Kineta argued that since they did not actually know how to synthesise the compounds themselves they could not be accused of not having disclosed that information, it representing the best method, at the time of filing the complete patent application.

The Hearing Officer set out that the proper approach to settling the matter was to consider the below three issues:

  1. What is the invention for which a best method must be provided;
  2. What method is described in the specification; and
  3. Was the applicant aware of a better method

The Hearing Officer noted that the invention lies in the compounds and the fact 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. In terms of the method described in the specification, the Hearing Officer noted Kineta’s submissions centred around the compound structures being identified and the person skilled in the art then having the knowledge to synthesise such compounds. While the Hearing Officer accepted that Kineta’s expert may have been able to undertake such a synthesis he was not willing to believe that the uninventive notional person skilled in the art could, and so the first argument was rejected

Kineta’s second argument ties in with the third issue above. While Kineta argued they did not have any information on the synthesis of the compounds, the Hearing Officer stated that “what they knew was that the compounds could be purchased from the contractor”. This second argument was therefore rejected on the basis that Kineta did not disclose the only method known to it (and hence the best method) of achieving the compounds, which was to purchase them from Life Chemicals Inc. The Hearing Officer also commented that even claims directed to the therapeutic use of the compounds suffered from the same problem. Even though there is authority to state that it may not be necessary to disclose how the starting materials for a method or process are obtained, this was not the case with the present invention where the starting material of the treatment claims (i.e. the compounds themselves) were an essential component of the invention.

Full Federal court decision

A number of issues were raised on appeal from the first decision of the Federal court in Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138 but only the best method ground will be discussed here.

Sandvik had accused Quarry Mining of infringing their patent directed to an extension drilling system and in the first decision by a single judge of the Federal court the relevant claims were held not infringed and were invalid for failure to describe the best method. An interesting aspect of the case is that the best method argument centred around a water seal which was held, based on evidence led in the proceedings, to be a key aspect of the drilling system but was not actually cited as a component of the relevant claims. The evidence held that the development of a suitable seal was “a real issue that needed to be overcome”.

The patent specification did not place any great importance on the water seal but did disclose a simple horizontal seal member. Unfortunately for Sandvik, evidence from one of the inventors made it clear that a far superior water seal had been developed prior to filing of the complete specification and that they considered it to be key to the efficient working of the invention.

On appeal, the Full Federal court found that the invention should be identified from a reading of the specification as a whole. The fact that the claims did not specifically recite the water seal did not assist Sandvik and the court found, in agreement with the first decision, that the seal was a necessary component of the invention. Once this decision was reached, it was inevitable that the court would find that Sandvik’s failure to include drawings or discussion of the superior seal of which they were aware prior to the complete filing date resulted in a failure to disclose the best method of performing the invention.

Conclusion

These decisions reinforce that the best method requirement has real teeth under Australian law. On first glance it appears almost absurd that Kineta’s application could be rejected simply because of a failure to state that the compounds could be purchased from a particular supplier, but it was clearly incumbent upon the applicant to disclose the best means it knew, at the time of filing, of obtaining them. Sandvik’s difficulties show that Australian courts are free to determine what the nature of the invention is, and they will not necessarily be limited by the words of the claims.

In light of these decisions, and the greater limitations on the applicant’s ability to amend the specification following the Raising the Bar changes in this area, Australia has become something of a high watermark jurisdiction when it comes to best method. Particularly considering the lack of such a requirement in Europe and movement in the U.S. to lessen the impact of this requirement, it would seem Australia is moving out of step with the patent systems of other major jurisdictions. Until this changes, it will be important to ensure that the best method requirement is front of mind when drafting patent specifications to be filed in Australia.

Fisher Adams Kelly Callinans would be happy to assist you in relation to patent and trade mark advice. Contact us on +61 7 3011 2200 or mail@fak.com.au. You can also follow all of our IP updates at www.linkedin.com/company/fisher-adams-Kelly.