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ToolGen Incorporated v Fisher (No 2)

ToolGen Incorporated v Fisher (No 2)

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FEDERAL COURT OF AUSTRALIA
ToolGen Incorporated v Fisher (No 2) [2023] FCA 794

File number: NSD 1909 of 2018

Judgment of: NICHOLAS J

Date of judgment: 14 July 2023

Catchwords:
PATENTS – appeal against decision of delegate of Commissioner of Patents upholding opposition to patent application (“PA”) for compositions and methods using the CRISPR/Cas9 system for genome editing in eukaryotic cells – identity of person skilled in the art (“PSA”) – whether PSA comprises a team including a microbiologist with expertise in CRISPR/Cas system in prokaryotes – meaning of phrase “nucleic acid encoding a guide RNA” in the claims – interrelationship between independent claim and dependant claim – whether dependent claim lacks clarity due to inconsistency between it and independent claim – whether priority document (“P1”) provides an enabling disclosure of the invention as required by s 43(2A) of the Patents Act 1990 (Cth) (“the Act”) – whether invention disclosed by P1 when read in light of the common general knowledge at date of filing of P1 – whether certain publications were common general knowledge at date of filing of P1 – whether disclosure clear enough and complete enough for invention to be performed by a person skilled in the art – whether work required of PSA would be an undue burden – consideration of priority date – whether claims lack novelty or do not involve an inventive step at the deferred priority date – whether PA provides an enabling disclosure of invention of the claims as required by s 40(2)(a) of the Act – whether work required of PSA would be an undue burden – whether claims supported by matter disclosed in specification as required by s40(3) of the Act – consideration of who should determine the appellant’s foreshadowed application to amend the specification

Held: dependent claim lacks clarity – invention of claims not disclosed by P1 – no enabling disclosure by P1 of invention of claims – work required of PSA would be an undue burden – claims not entitled to priority based on P1 claims – claims lack novelty and/or do not involve an inventive step – no enabling disclosure by PA of invention of claims – claims not supported by matter disclosed in the specification – any application to amend the specification should be heard and determined by the Court

Legislation:
Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)

Patents Act 1990 (Cth) ss 7(1), 7(2), 7(3), 18(1)(b)(i), 40, 40(2)(a), 40(3), 43(1), 43(2), 43(2A), 43(2A)(b), 43(3), 49, 60(3A), 60(4), 105(1A), 112A

Patents Regulations 1992 (Cth) reg 3.12(4), 3.13A

Patents Act 1977 (UK) ss 14(3), 14(5), 14(5)(c), 72(1)(c)

Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)

Cases cited:
Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411

Allsop Inc v Bintang Ltd (1989) 15 IPR 686

Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) (2016) 122 IPR 17

British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221

Catnic Components Ltd v Hill & Smith Ltd

Grounds of appeal

[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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Details

Case: [2023] FCA 794
Decision Date: 14 July 2023

CaseChat Overview and Summary

ToolGen Incorporated appealed against a decision of the delegate of the Commissioner of Patents, who upheld an opposition to their patent application for compositions and methods using the CRISPR/Cas9 system for genome editing in eukaryotic cells. The respondent, Fisher, opposed the patent on various grounds, including the identity of the person skilled in the art, the clarity of certain claims, and the sufficiency of the disclosure in the patent application and priority document. The court had to determine whether the person skilled in the art would include a microbiologist with expertise in CRISPR/Cas systems in prokaryotes, the meaning of certain phrases in the claims, and whether the claims were clear, enabled, and novel.

The court found that the dependent claim lacked clarity due to an inconsistency between it and the independent claim. The court also found that the invention was not disclosed by the priority document and that the disclosure was not enabling. The court held that the work required of the person skilled in the art would be an undue burden. The court further found that the claims were not entitled to the priority date based on the priority document claims and that the claims lacked novelty and/or did not involve an inventive step. The court also found that the patent application did not provide an enabling disclosure of the invention of the claims and that the claims were not supported by matter disclosed in the specification. The court held that any application to amend the specification should be heard and determined by the Court.

The court ordered that the appellant file and serve any interlocutory application seeking an order directing that the complete specification be amended pursuant to s 105(1A) of the Patents Act 1990 (Cth) together with any affidavit in support of such application by 4.00pm, 11 August 2023. The proceeding was stood over to 9.30am on 17 August 2023 for the making of final orders in the event no application was filed pursuant to the first order, for the making of further orders in relation to any application filed pursuant to the first order, and other orders as may be considered appropriate.

Orders

Orders of the court

1. The appellant file and serve any interlocutory application seeking an order directing that the complete specification be amended pursuant to s 105(1A) of the Patents Act 1990 (Cth) together with any affidavit in support of such application by 4.00pm, 11 August 2023.

2. The proceeding be stood over to 9.30am on 17 August 2023 for the making of:

(a) final orders in the event no application is filed pursuant to order 1;

(b) for the making of further orders in relation to any application filed pursuant to order 1; and

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

Background

Background to the litigation

Even though the burden of proof is on the respondents, circumstances may still arise in which ToolGen’s failure to adduce any evidence or any sufficient evidence on some particular matter (eg. a fact which it asserts was common general knowledge) may ultimately lead the Court to conclude, on the totality of the relevant evidence, that the invention cannot be performed across the full scope of the claims without undue burden. This may be particularly true in relation to matters in respect of which P1 is wholly silent. BACKGROUND TO TECHNOLOGYEukaryotic and prokaryotic cells Eukaryotes are organisms comprised of one or more eukaryotic cells. A eukaryotic cell has a defined nucleus which is an organelle that contains DNA enclosed within a nuclear envelope (double membrane). Mammals (including humans) are classified as eukaryotes as they are comprised of eukaryotic cells. Prokaryotes are unicellular organisms comprised of a prokaryotic cell. A prokaryotic cell has no nucleus or membrane bound organelles, and DNA in prokaryotic cells is found in the form of supercoiled circular DNA that is not enclosed by a nuclear membrane. Bacteria are an example of a prokaryote.DNA and RNA DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) are both nucleic acids consisting of a series (or string) of nucleotides. The nucleotides in DNA and RNA each contain a sugar, a nitrogenous base and a phosphate group. In DNA, the sugar is deoxyribose whereas in RNA the sugar is ribose. The nitrogenous base in each nucleotide in a DNA molecule is either a purine (being adenine (A) or guanine (G)) or a pyrimidine (being cytosine (C) or thymine (T)). The nitrogenous bases in RNA are the same as those in DNA except that uracil (U) is substituted for thymine (T). Nucleotides are joined together to form a long chain of DNA or RNA. This long chain is termed a polynucleotide. In DNA, the sequence in which the four bases (A, C, G, T) are arranged in the polynucleotide chain comprises the DNA code. The bases in one polynucleotide chain of DNA pair with complementary bases in the other polynucleotide chain of DNA (so called “base pairing”) to form a double-stranded helical structure. In the double-stranded DNA structure, the nitrogenous base guanine (G) base pairs with cytosine (C), while the nitrogenous base adenosine (A) base pairs with thymine (T). In biological cells, molecules of RNA predominantly consist of a single polynucleotide chain or strand. However, the sugar-phosphate backbone of the chain is flexible and can fold so that self-complementary sequences within the RNA pair with each other (to form a duplex, or double-stranded structure). The nucleotide sequence of both DNA and RNA can be identified by a technique known as sequencing. Protein expression Proteins are produced (or “expressed”) in a cell by the processes of transcription (DNA to RNA) and translation (RNA to protein). In a eukaryotic cell, transcription occurs in the nucleus (where DNA is located) and translation occurs in the cytoplasm (where ribosomes are located). In a prokaryotic cell, transcription and translation occurs in the cytoplasm (where DNA and ribosomes are located). The cytoplasm is the gelatinous liquid that fills the inside of a cell that is comprised of water, salts and other organic molecules, and a ribosome is an organelle within the cytoplasm that is the site of protein synthesis.

Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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File number:	NSD 1909 of 2018
Judgment of:	NICHOLAS J
Date of judgment:	14 July 2023
Catchwords:	PATENTS – appeal against decision of delegate of Commissioner of Patents upholding opposition to patent application (“PA”) for compositions and methods using the CRISPR/Cas9 system for genome editing in eukaryotic cells – identity of person skilled in the art (“PSA”) – whether PSA comprises a team including a microbiologist with expertise in CRISPR/Cas system in prokaryotes – meaning of phrase “nucleic acid encoding a guide RNA” in the claims – interrelationship between independent claim and dependant claim – whether dependent claim lacks clarity due to inconsistency between it and independent claim – whether priority document (“P1”) provides an enabling disclosure of the invention as required by s 43(2A) of the Patents Act 1990 (Cth) (“the Act”) – whether invention disclosed by P1 when read in light of the common general knowledge at date of filing of P1 – whether certain publications were common general knowledge at date of filing of P1 – whether disclosure clear enough and complete enough for invention to be performed by a person skilled in the art – whether work required of PSA would be an undue burden – consideration of priority date – whether claims lack novelty or do not involve an inventive step at the deferred priority date – whether PA provides an enabling disclosure of invention of the claims as required by s 40(2)(a) of the Act – whether work required of PSA would be an undue burden – whether claims supported by matter disclosed in specification as required by s40(3) of the Act – consideration of who should determine the appellant’s foreshadowed application to amend the specification Held: dependent claim lacks clarity – invention of claims not disclosed by P1 – no enabling disclosure by P1 of invention of claims – work required of PSA would be an undue burden – claims not entitled to priority based on P1 claims – claims lack novelty and/or do not involve an inventive step – no enabling disclosure by PA of invention of claims – claims not supported by matter disclosed in the specification – any application to amend the specification should be heard and determined by the Court
Legislation:	Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) Patents Act 1990 (Cth) ss 7(1), 7(2), 7(3), 18(1)(b)(i), 40, 40(2)(a), 40(3), 43(1), 43(2), 43(2A), 43(2A)(b), 43(3), 49, 60(3A), 60(4), 105(1A), 112A Patents Regulations 1992 (Cth) reg 3.12(4), 3.13A Patents Act 1977 (UK) ss 14(3), 14(5), 14(5)(c), 72(1)(c) Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)
Cases cited:	Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411 Allsop Inc v Bintang Ltd (1989) 15 IPR 686 Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) (2016) 122 IPR 17 British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221 Catnic Components Ltd v Hill & Smith Ltd