Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101[1]
A recent Full Federal Court of Australia decision held that methods of medical diagnosis are clearly patentable subject matter in Australia. We previously reported the first instance decision of the Federal Court of Australia,[2] which on this issue, has been approved by the Full Federal Court of Australia.
This is a good decision for biotechnology innovators seeking patent protection in Australia. Whilst international harmonisation of patent laws is an important global objective, Australia has in its unique way, advanced patent protection for methods of medical diagnosis as being eligible patentable subject matter, which is contrary to the position in the United States of America. The position in the United Kingdom is similar to that of Australia but for different reasoning.
- Australia
The main claim 1 of the patent in suit was directed to:
A detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample.
The Full Federal Court of Australia held that the above-mentioned claim 1 falls firmly within the concept of a “manner of manufacture” (patentable subject matter) as that term is to be understood having regard to the existing Australian legal authorities, being an artificially created state of affairs of economic utility.[3]
In arriving at this important decision, the Full Federal Court summarised the following principles based on a long-standing thread of Australian Court decisions:[4]
Firstly, the distinction between mere discovery and an invention lies in its practical application to a useful end.
Secondly, it is important that the invention be considered as a unitary concept, not segregated artificially into parts.
The invention may arise from an idea and then be applied in a perfectly well-known way, and yet the combined effect of the idea and its application may result in patentable subject matter.
In this case, it was not possible to disaggregate the discovery of cffDNA in maternal plasma or serum from the method used to harness that discovery.[5]
Thirdly, an invention may reside in an abstract idea, such as the condensation of steam that is then put to a useful end, even though the way of putting it to that end can be carried out in many useful ways, all of which are otherwise known.[6]
The Full Federal Court of Australia further noted that there is no real prospect of falling out of step with the international community of patent decisions in reaching this conclusion, because there are disparate approaches taken abroad to the question of patentable subject matter, involving different legal tests, none of which is in the same form as that which has developed in Australia.[7]
To that end, the Full Federal Court of Australia commented on the corresponding litigation in the United States of America in the Court of Appeals for the Federal Circuit,[8] and the United Kingdom.[9]
- United States of America
In the United States of America, claim 1 was recited as:
A method for detecting a paternally inherited nucleic acid of foetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of foetal origin in the sample.[10]
The Full Federal Court of Australia noted that the United States of America Federal Circuit held that the above claim 1 was not patentable subject matter after citing United States Supreme Court authority.[11]
- United Kingdom
In the United Kingdom, claim 1 was similar to the Australian claim 1 with the following additional features marked up as follows:
A detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample, wherein said nucleic acid is a paternally inherited sequence which is not possessed by said pregnant female.[12]
The United Kingdom Court did hold that the above claim 1 was patentable subject matter, after noting that the claim was not directed to a discovery, which is not patentable subject matter. The United Kingdom Court offered differing reasons as compared to the Full Federal Court of Australia involving a four (4) part structured approach: first, properly construing the claim; secondly, identifying the “actual contribution”; thirdly, asking whether the identified contribution falls solely within the excluded subject matter; and, finally, checking whether the actual or alleged contribution is “technical in nature”.[13]
The Full Federal Court of Australia noted that apart from the diverging approaches, and different results in respect of similar claims, it is apparent that the legal analysis developed over recent years in the United Kingdom (and Europe) and the United States of America diverges from that identified in the line of authorities identified in Australia.[14]
- Conclusion
In conclusion, Australia protects methods of medical diagnosis as patentable subject matter, whereas the United States of America does not. The Australian Courts consider inventions directed to methods of medical diagnosis as a unitary concept and do not break the invention into constituent parts, and further differ in their legal method as compared to the Courts of the United Kingdom.
Adrian Trioli, Principal, Patent and Trade Mark Attorney
[1] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 dated 18th June 2021 (Middleton, Nicholas and Burley JJ)
[2] Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011 (27 June 2019) Beach J
[3] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [166] citing National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252; and D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 at [28] (plurality)
[4] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [109]-[114] citing National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252; Apotex Pty Ltd v Sanofi- Aventis Australia Pty Ltd [2013] 253 CLR 284; and D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 at [28] (plurality)
[5] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [114]
[6] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [114]
[7] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [161]-[164]citing MayoCollaborative Services v Prometheus Laboratories Inc 566 US 66, 132 S.Ct 1289 (2012)
[8] Ibid 7 citing Ariosa Diagnostics Inc v Sequenom Inc. 788 F3d 1371 (3d Cir 215) at 1373-1374
[9] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [162]-[163] citingIllumina, Inc v Premaitha Health Plc [2017] EWHC 2930 (Pat)
[10] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [164]
[11] Ibid 10 citing Mayo Collaborative Services v Prometheus Laboratories Inc 566 US 66, 132 S.Ct 1289 (2012)
[12]Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [163]
[13] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [163] citingIllumina, Inc v Premaitha Health Plc [2017] EWHC 2930 (Pat) Carr J
[14] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101 at [165] citing National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252; D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 and Apotex Pty Ltd v Sanofi- Aventis Australia Pty Ltd [2013] HCA 50; 253 CLR 284