The case of Bio-Rad Laboratories, Inc. [2017] APO 38 was decided on 24 July 2017 by the Australian Patent Office and decided that computer-implemented claim 1 of Australian standard patent application 2016200387 was not a manner of manufacture within the meaning of section 6 of the Statute of Monopolies i.e. the claimed invention did not constitute patentable subject matter.

The invention provides ‘a method of establishing a statistically valid assay mean and assay range for a particular lot of a quality control material’ because the U.S. Food and Drug Administration had issued recent guidance requiring that published assay means and ranges for quality control materials be statistically valid.

This case continues to exemplify that patent-eligibility of computer-implemented subject matter is still a contentious area because the substance and contribution of the claimed invention must be ascertained for each case, and the range of factors to be considered (or disregarded) is still evolving.

Figure 1 below generally depicts the claimed invention:

The Delegate found that “the inventors have used considerable ingenuity in devising their algorithm, which is based upon the idea of using historical data for a portion of its calculations”.

At paragraph 30 of the Decision, the Delegate found that “the substance of the presently claimed invention … is a mathematical algorithm for, firstly, calculating an assay mean of test result values for a number of samples of a lot of quality control material, and, secondly, for calculating an assay range for this lot of quality control material. An element of this algorithm is the exploitation of historical test results to predictively calculate, with a specified target probability, a range of test result values within which a result from a qualification test of a sample from the particular lot of the quality control material is expected to fall”.

At paragraph 32: “The computational steps broadly defined by the claim (computing a mean of test results, computing a variability estimate from historical test results and computing a range of test result values within a specified probability) do not appear … to involve any more than straightforward mathematical operations … there is nothing to the computational characteristics of the described invention, as evidenced by the use of the expression “may” to refer to every item of computer hardware and software employed in an “exemplary computer system 500 in which embodiments of the present invention may be implemented.” … the computer is merely an intermediary or tool for performing the method while adding nothing of substance to the idea”.

The Delegate found that the invention “clearly” lies “in the generation, presentation, or arrangement of intellectual information … no matter how ingenious, economically advantageous or useful the invention is”.

Therefore the Delegate found that the claimed invention is not a manner of manufacture and thus not directed to patentable subject matter. Ingenuity and economic advantages of the invention are not considered persuasive if the substance of the claimed invention is deemed a mathematical algorithm.