Meat and Livestock Australia Limited v Branhaven LLC

[2020] FCAFC 171

Branhaven’s patent application, for a method for identifying a trait of a bovine subject from a particular assessment of features of the genetic code of the subject, was found by the trial judge to lack clarity. The trial judge then directed that Branhaven make any application to amend its patent application to overcome that ground of invalidity, to the Court. Branhaven did so.

In opposition to the amendment application, Meat and Livestock Australia (“MLA”) argued, among other things, that the Court did not have power to direct Branhaven to make an amendment application because the Court had already decided the appeal or that the appeal was no longer on foot. MLA also argued that the proposed amendment was in any event not allowable pursuant to section 102(1) of the Patents Act 1990 (Cth) because, by reason of the amendment, the specification would claim matter not in substance disclosed in the specification as filed and pursuant to section 102(2)(b) because the specification would not comply with section 40(3) of the Act by reason of the claims not being fairly based on matter disclosed in the specification. The trial judge allowed the proposed amendments to the patent application.

MLA sought leave to appeal. The application for leave to appeal was heard concurrently with arguments on the appeal should leave be given.

On the power point, MLA argued that the trial judge had fallen into error in finding he had power under section 105(1A) of the Act to direct Branhaven to make application to the court to amend its patent application and to consider such an application to amend, because the trial judge had already, in his reasons on the opposition to grant of the patent application, found that the claims were not clear. MLA’s point was that section 105(1A) does not contemplate the making of amendments in order to overcome the Court’s decision on appeal.

Section 105(1A) provides that:

If an appeal is made to the Federal Court against a decision or direction of the Commissioner in relation to a patent application, the Federal Court may, on the application of the applicant for the patent, by order direct the amendment of the patent request or the complete specification in the manner specified in the order.

MLA’s submission was to the effect that, once the trial judge had handed down reasons explaining why a claim included in the patent application the subject of the appeal would be invalid if the application were to proceed to grant, the Court was functus officio and so could not direct that an application be made pursuant to section 105(1A) to address that invalidity.

The Full Court disagreed. The Full Court held that the Court was not functus officio because reasons for judgment are not a final decision, and the appeal from the Commissioner did not come to an end simply by the giving of those reasons. The primary judge made clear that he was not bringing the proceeding to an end until such time as the question of any amendment to the patent application had been dealt with. The Full Court concluded that the purpose of section 105(1A) is to give the Court power to decide upon proposed amendments while the appeal is still on foot, and at the time the trial judge made orders for Branhaven to make application to amend the patent application and consider that amendment application, the appeal from the Commissioner was still on foot.

As to the section 102 ground of opposition to the amendment application, the trial judge had originally found that the claims lacked clarity in that claim 1 failed to specify a requirement that the relationship between certain genetic markers (single nucleotide polymorphisms or “SNPs”) as required in the claim must be one of “linkage disequilibrium” (“LD”), not simply a certain number nucleotides distance in the genetic code. The specification made clear that such SNPs needed to be in linkage disequilibrium for the invention to work but the claim only referred to one SNP being +/- 500,000 nucleotides of another SNP.

Branhaven’s proposed amendment was to require the SNPs in the claim to be “in linkage disequilibrium […] with an r2 value of ≥0.7”. MLA’s complaint was that the patent specification did not disclose a requirement for linkage disequilibrium that was: (i) measured other than by distance; (ii) measured using an r2 value; (iii) having an r2 value greater than 0.7 or 0.8. MLA therefore argued that the claim after amendment was not in substance disclosed in or fairly based on matter disclosed in, the specification as filed, as required by sections 102(1) and (2) of the Act.

The Full Court held that, generally speaking, a claim that defines an invention in terms that are narrower than what a more general description in the body of the specification would support is not likely to travel beyond what is more generally described. Furthermore, where there is an implicit disclosure of the relevant feature, it is unnecessary to consider whether the feature is truly limiting.

The Full Court accepted that the trial judge, in his original decision regarding the validity of the claims, found that the specification did not provide guidance as to the degree of LD required between the two SNPs. But their Honours considered that the trial judge was there referring to “the absence of any express reference in the specification to the degree of LD required or the means by which it should be measured” (emphasis added). Their Honours accepted that the patent specification did not discuss the statistical measures of LD. But they went on to observe that evidence of such measures as would have been known to the skilled addressee at the priority date was given by experts on the amendment application.

Importantly, the trial judge found, and MLA did not challenge, that the skilled addressee would understand that the reference to a need for linkage disequilibrium between the SNPs in the specification “is, practically, a reference to a need for “high” or “strong” LD”. The trial judge then found, on the basis of expert evidence, that such a reference equated to an r2 value of 0.7 and above. The Full Court concluded:

To hold that it is not open to use the r2 statistic or the 0.7 value for the purpose of ascertaining whether there is a high or strong degree of LD between the limb (a) SNP and the limb (b) SNP would involve, in our view, the very kind of over meticulous verbal analysis that should be eschewed when determining whether a proposed amended claim satisfies the requirements of s 102(1) of the Act. This is particularly so in circumstances where the amendment is propounded for the purpose of clarifying an ambiguity that would otherwise prevent the patent application proceeding to grant. In the present case we do not think the use of the r2 statistic in limb (b) results in a claim that defines an invention different from that which is more generally disclosed in the body of the specification as filed.

Accordingly, MLA’s application for leave to appeal was dismissed.

 

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