D'Arcy v Myriad Genetics Inc

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FEDERAL COURT OF AUSTRALIA

D’Arcy v Myriad Genetics Inc [2014] FCAFC 115

Citation: D’Arcy v Myriad Genetics Inc [2014] FCAFC 115
Appeal from: Cancer Voices Australia v Myriad Inc [2013] FCA 65
Parties: YVONNE D'ARCY v MYRIAD GENETICS INC and GENETIC TECHNOLOGIES LIMITED
File number: NSD 359 of 2013
Judges: ALLSOP CJ, DOWSETT, KENNY, BENNETT & MIDDLETON JJ
Date of judgment: 5 September 2014
Catchwords: PATENTS – Patent including claims for isolated nucleic acid – whether claims to composition comprising isolated nucleic acid are for a manner of manufacture for purposes of s 18(1)(a) of Patents Act 1990 (Cth).
Legislation: Patents Act 1990 (Cth) s 18(1)
Statute of Monopolies s 6
Cases cited: Advanced Building Systems Pty Limited v Ramset Fasteners (Aust) Pty Limited (1998) 194 CLR 171
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1
Association for Molecular Pathology v Myriad Genetics, Inc, 596 US 12-398 (2013)
Association for Molecular Pathology v United States Patent and Trademark Office and Myriad Genetics, Inc, 689 F.3d 1903 (2012)
Bilskiv Kappos, 561 US 08-954 (2010)
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232
Diamond vChakrabarty, 447 US 303 (1980)
Funk Brothers Seed Company v Kalo Inoculant Company, 333 US 127 (1948)
Genentech Inc’s Patent [1987] RPC 553
Grant v Commissioner of Patents (2006) 154 FCR 62
Hill v Evans (1862) 1A IPR 1
Kirin-Amgen Inc v Board of Regents of University of Washington (1995) 33 IPR 557
Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 169
Mayo Collaborative Services, dba Mayo Medical Laboratories v Prometheus Laboratories, Inc, 566 US 10-1150 (2012)
Merck & Co. v Olin Mathieson Chemical Corp, 253 F.2d 156 (1958)
National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252
Parke-Davis & Co v HK Mulford Co, 189 F 95, 103 (SDNY 1911)
Re BA’s Application (1915) 32 RPC 348
Re Standard Oil Development Co’s Application (1951) 68 RPC 114
Reynolds v Herbert Smith & Co Ltd (1903) 20 RPC 123
Dates of hearing: 7 and 8 August 2013
Date of last submissions: 31 January 2014
Place: Sydney
Division: GENERAL DIVISION
Category: Catchwords
Number of paragraphs: 219
Counsel for the Appellant: Mr D Catterns QC with Dr P Cashman
Solicitor for the Appellant: Maurice Blackburn
Counsel for the Respondents: Mr D Shavin QC with Ms C Welsh
Solicitor for the First Respondent: Jones Day
Solicitor for the Second Respondent: Wrays Lawyers Pty Ltd

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 359 of 2013
ON APPEAL FROM THE FEDERAL COURT OF AUSTRALIA
BETWEEN:

YVONNE D'ARCY
Appellant
AND:

MYRIAD GENETICS INC
First Respondent

GENETIC TECHNOLOGIES LIMITED
Second Respondent

JUDGES:

ALLSOP CJ, DOWSETT, KENNY, BENNETT & MIDDLETON JJ

DATE OF ORDER:

5 september 2014

WHERE MADE:

SYDNEY

THE COURT ORDERS THAT:

1.The appeal be dismissed.

Note:Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.


IN THE…

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Details
Case
[2014] FCAFC 115
Decision Date

CaseChat Overview and Summary

The case of D'Arcy v Myriad Genetics Inc involved a dispute regarding the patentability of claims for isolated nucleic acid. The respondent, Myriad Genetics Inc, sought to patent claims for an isolated nucleic acid coding for a mutant or polymorphic protein, characterised by the coding sequence of SEQ ID No:1 and containing one or more mutations. Myriad Genetics Inc argued that the claims were patentable as they represented a manner of manufacture within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth). The primary judge found in favour of Myriad Genetics Inc, concluding that each of the disputed claims was to a chemical composition and not to naturally occurring DNA and RNA as they exist inside the cells of the human body. The primary judge also found that the isolated nucleic acid was itself an artificial state of affairs, removed from the genome and from the cell. The appellant, Ms D'Arcy, appealed the decision, arguing that the isolated nucleic acid did not produce an artificial effect or artificially created state of affairs in the relevant sense. However, the court found that the isolated nucleic acid was an artificial state of affairs, and that the principles discussed in NRDC are equally applicable to products. The court also found that the isolated nucleic acid had economic utility and could bring benefit to mankind. The appeal was ultimately dismissed, and the decision of the primary judge was upheld.

The final orders made by the court were that the appeal be dismissed. The court noted that the entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011. The decision in this case highlights the importance of considering the artificial state of affairs created by the isolation of nucleic acid and the economic utility of the invention in determining its patentability. It also reinforces the principle that the isolated nucleic acid is itself an artificial state of affairs, removed from its natural environment and from the cellular components that enable it to function in vivo.

Orders

Orders of the court

1. The appeal be dismissed.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

These important informing principles and considerations assist in the conclusion that, for the reasons set out below, the relevant claims as analysed below are patentable as within the meaning and boundaries of s 6 of the Statute of Monopolies.THE SCIENTIFIC BACKGROUND The primary judge set out the scientific background, taken from undisputed expert evidence (at [10] to [54]) as follows:The eukaryotic cell The human body is a multi-cellular eukaryotic organism which consists of a large number of different types of eukaryotic cells. Eukaryotic cells are cells which contain a membrane-bound nucleus. These cells communicate and co-operate with each other for the common good of the organism. The process by which cells reproduce is known as “cell division”. This process is binary in the sense that each cell is able to separate into two daughter cells. The human body can sense when high rates of cell division are necessary. For example, if a particular area of the body receives a severe cut with blood loss, the body can respond by producing a number of new blood cells to replace the cells that were lost. When the cut is healing, the body is able to decrease the production of blood cells to prevent over-supply. However, cells may sometimes divide in an abnormal or uncontrolled manner. The abnormal or uncontrolled division of cells is referred to as cancer. The components of a human cell Cells found in the human body consist of three main parts: the nucleus, the cytoplasm and the cell membrane. The cell membrane defines the outer boundary of the cell and separates its contents from the environment in which it exists. The nucleus of the cell appears as a cell within a cell. The boundary of the nucleus is defined by a nuclear envelope or membrane. The cytoplasm comprises everything between the cell membrane and the nucleus. The majority of the cytoplasm is a liquid called cytosol which consists of water, salts and organic molecules. However, the cytoplasm also contains a number of components (including ribosomes) that have specific functions including protein and energy production. The nuclear envelope separating the nucleus from the cytoplasm incorporates pores through which molecules may move between the nucleus and the cytoplasm. DNA and RNA are molecules found within the nucleus of cells within the human body. DNA contains the genetic information that directs the growth, development, maintenance and reproduction of the human body. This information is made available for these purposes via RNA. The chemical structure of DNA Native DNA (genomic DNA) is an extremely long three-dimensional molecule consisting of a number of repeating monomeric units called nucleotides. These are linked end to end to form a strand (chain) of nucleotides (a polynucleotide chain). Each nucleotide is comprised of three separate chemical groups: a nitrogen-containing (nitrogenous) base, a phosphate group and a five-carbon sugar group comprising deoxyribose. In DNA, nucleotides are linked to one another by covalent bonds running from the fifth carbon (5’) of the sugar group of one nucleotide to the third carbon (3’) of the phosphate group of the adjacent nucleotide. These bonds are referred to as phosphodiester bonds. They form the “sugar-phosphate backbone” of the DNA from which the nitrogenous bases protrude.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

It can be seen that the claim: ·is to an isolated nucleic acid coding for a mutant or polymorphic protein;·characterises the nucleic acid by reference to the coding sequence of SEQ ID No:1 and containing one or more mutations set forth in the tables of the specification.The decision of the primary judge The primary judge observed that the reference to “a DNA coding” is a reference to the relevant DNA sequence that encodes for a relevant mutant or polymorphic polypeptide. While the word “coding” is not defined in the Patent, the word “encode” is defined by reference to the ability of a polynucleotide in its natural state or when manipulated by well-known methods to “encode” a polypeptide. A polynucleotide that codes for or encodes polypeptides is one that exhibits the sequence of bases that can, in the natural environment of a cell, result in its expression of such a polypeptide. His Honour saw no relevant difference between “code” and “encoding” in the present context. Encoding sequences are, his Honour said at [71], those that code for polypeptides either in the natural environment of the cell or when manipulated by well-known methods. In coming to the conclusion that each of the challenged claims in the Patent is to a manner of manufacture, the primary judge observed that (at [136]):There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated. The primary judge concluded that:·Each of the disputed claims is to a chemical composition. The claims do not say anything about the length of the polynucleotide chains with which they are concerned.·There is nothing to suggest either in the claims or in the body of the specification that a complete nucleotide of DNA as originally found on chromosome 17 that has been isolated and that includes one or more of the relevant mutations, would be outside the scope of the disputed claims. The claims do not support the conclusion that every isolated DNA sequence within the scope of the claims must have had at least some covalent bonds broken as a result of the isolation process (the covalent bonds being bonds in the sugar phosphate backbone). The primary judge referred to evidence to the effect that, in the process of isolation, it would be necessary to break hydrogen bonds between nucleoside bases and that there would need to be at least some breaks in the covalent bonds so that an extract could be removed. The experts agreed that while the breaking of covalent bonds could lead to a molecule of lower molecular weight, there may not have been any corresponding loss of information content, as what is removed could still retain enough of the coding sequence to define and code for a particular polypeptide. The primary judge concluded that not every isolated DNA sequence within the scope of the claim must have had at least some covalent bonds broken as a result of the isolation process. His Honour said that to imply such ‘would require [a need] to impose an impermissible gloss upon the words of the claim’.

Ratio Decidendi

Legal Principle Established

The respondents contended that the claims were to a product that consists of an artificial state of affairs providing a new and useful effect that is of economic significance that is, that the product is a manner of manufacture within the meaning of NRDC. The respondents contended that isolated nucleic acid differs from nucleic acid found in a human cell chemically, structurally and functionally.CONSIDERATION OF THE APPELLANT’S SUBMISSIONSAn artificial state of affairs and patentability Ms D’Arcy submits that the fact that there is an artificial state of affairs is insufficient to constitute an invention or manner of manufacture within the Act and that the artificially created state of affairs discussed in NRDC was not the product per se but the effect that it produced, the end result. This, she says, contrasts with the isolated nucleic acid that has not been used to produce any artificial effect or artificially created state of affairs in the sense in which those words were used in NRDC. Ms D’Arcy agrees that the isolation requires human intervention but says that it is not artificial and, if it is, it is not sufficient to fulfil the test in NRDC which does not stand, she says, for the proposition that an artificial effect is ‘the be all and end all’ of the question. That is, she submits that while the claimed invention has economic significance, it is not an artificial effect ‘in the relevant sense’ because the coding is the same as in nature, and that the intervention by man does not cause a change in the nucleic acid sequence, which she describes as simply taking the nucleic acid out of the cell. This submission fails to recognise that the High Court has made it clear that the principles discussed in NRDC are equally applicable to products. Further, the isolated nucleic acid is itself an artificial state of affairs. It is removed from the genome and from the cell. In order to determine whether an invention claimed is a relevant product, the question is whether it consists of an artificially created state of affairs, not whether it produces or fails to produce an artificial effect. NRDC does not, contrary to what Ms D’Arcy submits, require the claimed isolated nucleic acid to produce an artificial effect or an artificially created state of affairs. This submission represents an unduly narrow understanding of the reasoning in NRDC, which is not a statute nor is it to be narrowly construed. The “artificial effect” or “artificial state of affairs” to be considered in this case is the isolated nucleic acid itself, removed from its natural environment and from the cellular components that enable it to function in vivo. That is not to say that merely demonstrating some sort of “artificial effect” always confers patentability. The principle to be taken from the High Court’s explanation in NRDC is in terms of the intervention of man to produce from, or by means of, a naturally occurring product or the laws of nature, something artificial or of an artificial effect that can bring benefit to mankind. That benefit generally has economic utility.