Biosimilars Deals 2021

A recent decision of Justice Burley in the Federal Court of Australia confirms that the bar for sufficiency and support has actually been raised by Australia’s 2012 ‘Raising the Bar’ law reforms.  This is the second Federal Court decision invalidating a patent or patent application on these grounds.  The first decision[1] is presently under appeal, with the Full Federal Court’s judgment awaited.  The judgment also demonstrates some leeway in the application of Australia’s best method requirement (which, if not met, results in the invalidity of the entire patent or application).

The judgment raises two important points relevant to the drafting of Australian patent claims:

• Where a claim includes a limitation of “at least” a particular parameter, it is essential that the invention actually works when the parameter is set at that minimum. Otherwise, the claim will be invalid for encompassing an embodiment that is not enabled and not within the technical contribution disclosed.
• Where a claim requires an invention to be implemented on a larger scale than the examples provided (e.g., commercial/industrial scale), a failure to disclose the best method of practising the invention at the smaller scale (e.g., laboratory scale) may not be fatal to the validity of the application on best method grounds.

In this case, a patent application concerning the use of anti-scalant additives in a refinery process was refused for insufficiency and lack of support because the invention did not work when a parameter in the claims was set at its lower limit and the specification did not explain how it could be made to work.

Background: a Question of Scale

The ‘Bayer process’ has been used for over 130 years to extract alumina from bauxite to make aluminium.  In this process, crushed bauxite is added to a caustic liquor at high temperature and circulated around the tanks of a refinery.  The alumina dissolves in the liquor, separating it from other minerals in the bauxite, which remain in a slurry.  Those minerals include silica, which is deposited on tank surfaces as scale.  Eventually, this scale must be removed from the tanks, which is costly.

Nalco’s patent application claimed methods for reducing scale by adding to a Bayer process a mixture comprising at least one small molecule selected from a group of molecules, that mixture resulting from a reaction between specified compounds.  Nalco’s competitor Cytec opposed the grant of the application.

At first instance, the Commissioner found all claims of the patent application invalid on several grounds.  Nalco appealed that decision to the Federal Court and amended the claims of the application seeking to overcome the Commissioner’s objections.  Burley J heard the appeal.

Sufficiency and Support

Burley J considered that the amended claims included within their scope a reaction mixture containing only one of the small molecules recited in the claims.  The expert witnesses agreed that the reaction would produce an extremely large variety of small molecules, including all of those in the group of molecules in the claims.  It was a virtual impossibility that the reaction would result in only one member of the group of small molecules in the claims (as one expert said, this would be “like trying to win the lottery in every country in the world with the same six numbers on the same weekend”).  In consequence, the lower limit of the claims was not enabled and all of the claims were invalid.

In relation to the support requirement post-Raising the Bar, Burley J unsurprisingly endorsed his own statement of the law in Merck Sharp & Dohme v Wyeth (No 3) [2020] FCA 1477, including that the technical contribution to the art of the specification must justify the breadth of the monopoly claimed.  Based on the Judge’s view of the technical contribution made by the patent application, he concluded that the application did not disclose how to make a reaction mixture containing only one of the small molecules from the group of molecules recited in the claims.  Therefore, for essentially the same reason as the claims were insufficient, all claims of the patent application were invalid for lack of support.

Best Method

The experts also agreed that the examples in the patent application disclosed methods for making reaction mixtures in the laboratory but did not provide enough detail to enable the examples to be replicated.  Cytec submitted that the omitted details were part of the best method of practising the invention known to Nalco when it filed the application, so the whole application was invalid.

Burley J was not persuaded, considering that the claimed invention was an industrial process and that the laboratory synthesis methods in question could only provide a rough starting point for developing the process on an industrial scale; they were not a proxy for it.  The missing details of Nalco’s laboratory method were not therefore part of the best method.  And because Nalco had not in fact made reaction mixtures on an industrial scale, somewhat curiously, there may not have been a best method for it to withhold.

Implications

The judgment raises two important points relevant to the drafting of Australian patent claims.

First, where a claim includes a limitation of “at least” a particular parameter, it is essential that the invention actually works when the parameter is set at that minimum.  Otherwise, the claim will include within its scope an embodiment that is not enabled.  It is also important to ensure that the technical contribution includes practising the invention when the parameter is set at the minimum.  This may require patent applicants to determine and disclose the lower limits at which their inventions can be implemented.

Second, where a claimed invention can only be implemented on a larger scale (e.g., industrial or commercial scale) than is disclosed in a patent application, a failure to disclose the best method of practising the invention at a smaller scale (e.g., laboratory scale) may not be fatal to the validity of the application.  That is, unless the evidence indicates that the parameters used at the smaller scale can be scaled up for use at the larger scale, in which case these parameters are likely to be part of the best method.

[1] Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477