Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011
File number:
VID 611 of 2016
Judge:
BEACH J
Date of judgment:
27 June 2019
Catchwords:
PATENTS – non-invasive prenatal diagnosis – detection of fetal DNA in maternal serum or plasma samples – detection of fetal abnormalities for chromosomal aneuploidies or simple mutations – detection and monitoring of pregnancy-associated conditions such as pre-eclampsia – asserted grounds of invalidity – manner of manufacture – lack of inventive step – lack of utility – lack of fair basis – lack of sufficiency – false suggestion or misrepresentation – invalidity grounds rejected – Harmony Test – construction – infringement – infringement established
[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.
[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.
[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.
Consideration
[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.
[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.
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Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011
Case
[2019] FCA 1011
Decision Date
CaseChat Overview and Summary
The case before the court was between Sequenom, Inc. and Ariosa Diagnostics, Inc., with related claims involving Sonic Healthcare Limited and Clinical Labs Pty Ltd. The dispute centred around the validity and infringement of patents related to non-invasive prenatal diagnostic techniques for detecting fetal DNA in maternal serum or plasma samples, primarily for chromosomal abnormalities such as Down syndrome and Edwards syndrome, as well as for monitoring pregnancy-related conditions like pre-eclampsia. The patents in question were related to the Harmony Test, a technology developed by Sequenom. The respondents contested the validity of these patents on several grounds, including lack of inventive step, lack of utility, and lack of fair basis, while Sequenom sought to establish infringement by Ariosa, Sonic, and Clinical.
The legal issues the court had to resolve were primarily whether the patents were valid and, if so, whether they had been infringed by Ariosa, Sonic, and Clinical. The court had to determine the construction of the patents, assess the validity based on the respondents' arguments, and examine whether the respondents had infringed the patents. The respondents challenged the validity of the patents on multiple fronts, including the lack of inventive step, utility, fair basis, and sufficiency, as well as false suggestion or misrepresentation. Sequenom, on the other hand, needed to demonstrate that the respondents had performed acts that constituted infringement of the patents.
The court found that the patents were valid and had been infringed by Ariosa, Sonic, and Clinical, except for the claim concerning the infringement of claim 26. The court rejected all grounds of invalidity presented by the respondents. In its construction of the patents, the court found that the claims were clear and unambiguous. The court also established that Ariosa, Sonic, and Clinical had indeed performed acts that constituted infringement, except for the claim relating to claim 26. The court's reasoning was grounded in detailed analysis of the patent specifications, the technical context, and the arguments presented by both parties. The court's findings on the validity and infringement of the patents were pivotal in determining the outcome of the case.
The final orders of the court directed the parties to file minutes of orders reflecting the reasons for judgment and to address any questions regarding costs. The interim confidentiality order was extended, with the exception of the court's reasons. The court also granted liberty to apply for further orders as necessary. The outcome of the case was a partial victory for Sequenom, as it succeeded in establishing infringement except for claim 26, while the respondents' challenges to the validity of the patents were rejected. The detailed findings and orders provide a clear roadmap for the further conduct of the proceedings, including the handling of costs.
Orders
Orders of the court
1. Within 21 days of the date of these orders, the applicant file and serve minutes of orders and submissions (limited to 3 pages) to give effect to these reasons, on costs and for the further conduct of these proceedings.
2. Within 14 days of receipt of such minutes and submissions, the respondents file and serve responding minutes of orders and submissions (limited to 3 pages).
3. The interim confidentiality order made in Order 1 of the orders dated 9 June 2017 be extended until further order, save that nothing therein applies to the Court’s reasons for judgment.
4. Liberty to apply.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Background
Background to the litigation
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Evidence
Evidence Before The Court
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Decision
Reasons for decision
Finally, I would note that it is not now in dispute that Ariosa authorised the relevant conduct of Sonic and Clinical that I have referred to above and that it is a joint tortfeasor with them, assuming relevant infringement is established.CONCLUSION Sequenom has succeeded on its infringement case save for its case on infringement concerning claim 26. The respondents have failed on their invalidity case save that they have established that claim 26 is invalid for lack of fair basis. I will direct that the parties bring in minutes of orders to reflect these reasons and for the further steps to be taken in this matter. I will also hear the parties on any question of costs.
Ratio Decidendi
Legal Principle Established
Denaturation: A process where proteins or nucleic acids such as DNA or RNA lose their structure. In the case of DNA, denaturation results in the disruption of the complementary base pair bonding (i.e. A – T and C – G) and separation of the double stranded helix into two single strands. Discriminating Region: A section that is designed to allow the Harmony Test [Redacted] Down syndrome: An aneuploidy of chromosome 21, with three chromosome 21s present instead of the normal two, typically associated with physical growth delays, characteristic facial features and mild to moderate intellectual disability. Down syndrome also includes cases in which the extra copy of all or part of the chromosome 21 is not a separate, third chromosome but is translocated or joined to another chromosome. Edwards syndrome: Edwards syndrome is a chromosomal abnormality caused by the presence of all, or part of, an extra chromosome 18. Electrophoresis: A method that separates fragments of DNA based on their size which can be stained to enable visual detection. Erythrocytes: Red blood cells. Fetal blood sampling: See Cordocentesis. Fetal Fraction: The proportion of DNA in a sample deriving from the fetus (as opposed to the mother). Fibrinogen: A blood clotting agent. FISH or fluorescence in situ hybridisation: This technique is more targeted than conventional karyotyping. It utilises DNA probes which bind to specific and selected regions of interest on particular chromosomes (e.g. chromosome 21), which are then fluorescently labelled to reveal, with the aid of a fluorescent microscope, the presence, absence, relative positioning and / or copy number of the specifically targeted DNA segments. FORTE: The Harmony Test’s bioinformatics algorithm (Fetal-Fraction Optimized Risk of Trisomy Evaluation) used to calculate risk scores for aneuploidy and determine fetal fraction and fetal sex. Genotype: The genes in an individual’s DNA. Now this definition is very broad. In clinical practice, it would be more usual to use the term genotype to refer to the molecular genetic characteristics of an individual at a specific locus. Heterozygous: A diploid organism is heterozygous at a gene locus when its cells contain two different alleles of a gene. The cell or organism is called a heterozygote specifically for the allele in question, and therefore, heterozygosity refers to a specific genotype. h-index: The h-index is an author-level metric that attempts to measure both the productivity and citation impact of the publications of a scientist or scholar. The index is based on the number of the scientist’s most cited papers and the number of citations that these have received in other publications. Homozygous: Where an individual has two copies of the same allele. Informative locus: A polymorphic locus where the fetus has a different pair of alleles compared to its mother. Karyotyping: The conventional form of chromosomal analysis, which is used to detect numerical and / or structural chromosome abnormalities in a sample of cells which have first been grown in culture. The method, broadly speaking, involves the use of various dyes which selectively stains the chromosomes in the sample.