Meat & Livestock Australia loses its appeal against Branhaven’s selective breeding patent

The Full Court has refused Meat & Livestock Australia leave to appeal from Beach J’s rulings to grant Branhaven’s[1] patent for the use of genetic information in the selective breeding of cattle. MLA did not seek leave to appeal the ruling that the claims to uses of the genetic information were patentable subject matter.

Image by VIVIANE MONCONDUIT from Pixabay

In its amended form as allowed by Beach J, claim 1 reads:

  1. A method for identifying a trait of a bovine subject from a nucleic acid sample of the bovine subject, comprising identifying in the nucleic acid sample an occurrence of at least three single nucleotide polymorphisms (SNPs) wherein each of the at least three SNPs are significantly associated with the trait, with the degree of statistical significance being p?0.05, and wherein the at least three SNPs occur in more than one gene; and wherein

[and wherein] (a) at least one of the SNPs corresponds to position 300 of any one of SEQ ID NOS: 19473 to 21982, or

(b) the SNP is about 500,000 or less nucleotides from position 300 of any one of SEQ ID NOS: 19473 to 21982 and is in linkage disequilibrium with the SNP at position 300 with an r2 value of ?0.7.

(The [ ] indicates deletions and the italics insertions from the original claim.)

In his Honour’s first ruling, Beach J held that claim 13[2] was invalid as a claim to genetic information, but otherwise rejected MLA’s attacks based on manner of manufacture, novelty and inventive step. His Honour, however, found that the claims lacked clarity. So Branhaven came back with the amended form.

In his Honour’s second ruling, MLA argued there was no power to amend and, in any event, the proposed amendments were not fairly based. In the result, his Honour rejected MLA’s attacks and directed the patent in amended form proceed to grant. MLA sought leave to appeal.

Did the Court have power to permit amendment?

Following the Raising the Bar Act, the power of the Court to deal with amendments was expanded by the addition of s 105(1A):

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.[3]

At [91] and [93], the Full Court considered the plain meaning of this provision was to confer on the Court power to deal with amendments of patent applications under appeal.

The Full Court considered MLA’s argument that Beach J had decided the appeal in his Honour’s first decision and so was functus officio “untenable”.

When handing down his first reasons for judgment, Beach J had simply ordered:[4]

Within 14 days of the date of these orders, each of the parties file and serve proposed minutes of orders and short submissions (limited to three pages) to give effect to these reasons, including on the question of any steps necessary to deal with any application to amend the claims of patent application no. 2010202253 and on the question of costs.

The Full Court accepted that this order did not dispose of the appeal and so Beach J still had jurisdiction over the patent application in its amended form. At [87]:

The order made by his Honour at the time did not dispose of the appeal but was instead a procedural order requiring the parties to file and serve proposed minutes of order and short submissions to give effect to his Honour’s reasons including in relation to any application to amend the claims of the patent application. There is no substance to the applicant’s submission that either the publication of his Honour’s first set of reasons or the making of that order brought the proceeding to an end.

and [90]:

However, as his Honour correctly observed, the publication of his first set of reasons did not dispose of the appeal since no order to that effect was made. Nor could the publication of his Honour’s first set of reasons amount to an order disposing of the appeal. His Honour made it clear in his reasons that he would refrain from making any such order until any question in relation to amendment had been dealt with.

The Full Court turned then to the substantive argument about whether Beach J erred in allowing the amendments.

Were the amendments permissible?

As already noted, his Honour had found in his first reasons that the relevant claims lacked clarity. The main issue here was that claim 1 did not explicitly state the requirement of “linkage disequilibrium” (LD) for the relevant single nucleotide polymorphisms (SNPs) or what degree of LD was required: see [348] – [362] reproduced at [69] of the Full Court’s reasons.

As the elements were not disclosed in the claim, MLA argued the amendments were impermissible as they introduced new matter into the claims. Beach J, however, allowed the amendments on the grounds that they were limiting amendments and had been in substance disclosed in the specification.

The Full Court essentially accepted this conclusion on the facts. It did note that, generally, a claim which defined an invention more narrowly than the disclosure in the specification would be fairly based, but there may be some situations where that was not the case. The overriding question was whether the claim described an invention different to the disclosure in the specification. At [104] – [105]:

All other things being equal, a claim that defines an invention in terms that are narrower than a more general description in the body of the specification would support is not likely to travel beyond what is more generally described. But there may be some situations in which what is more specifically defined results in a claim that travels beyond what is described in the specification: AstraZeneca at 244 and [285]-286 where reference is made to Sir Robin Jacob’s judgment in Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly and Co Ltd [2010] RPC 9 at [26] and [28]. In these situations a claim may be invalid if the invention more specifically defined is an invention that is different from the invention described in the specification as opposed to some narrower embodiment of the latter.

In circumstances where it can be concluded that there is an implicit disclosure of the relevant feature, it is unnecessary to inquire into whether the feature is truly limiting. But even in the absence of an implicit disclosure, a claim does not necessarily lack fair basis because it includes a matter of detail that is not described in the specification so long as it defines an invention that is not different from the invention described in the specification. The proper characterisation of the invention described in the specification is critical when determining whether the claim is to an invention different from that described in the body of the specification. Each case will depend on its own facts and on the proper characterisation of the invention described in the body of the specification. (emphasis supplied)

If the feature added to the claim was implicitly disclosed in the specification, therefore, the claim could be amended. But, amendment might be permissible even if not implicitly disclosed.

At [110] – [115], the Full Court focused on Beach J’s unchallenged findings including, in particular, that the skilled addressee “would understand that the specification requires that there be high or strong LD between the limb (a) SNP and the limb (b) SNP”, but not necessarily a very high or perfect LD. The proposed amendments gave effect to that understanding by reference to more precise rather than some less precise criteria.

The Full Court accepted MLA’s criticism that the specification (before amendment) made no mention at all of r2 values. Beach J accepted expert evidence, however, that the r2 values were broadly equivalent to LD values that might fairly be regarded as high or strong. As a result, its inclusion was permissible. Noting that high LD or strong LD were “less precise criterion” than the expressed r2 vaues, at [114], the Full Court explained:

…. 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. (emphasis supplied)

As a result, the Full Court came to “the very clear conclusion” that MLA had not made out a clear prima facie case of error where the likely result would be allowing an invalid patent to proceed to grant. Accordingly, leave to appeal was refused.

Since this is a pre-Raising the Bar patent, the old “practically certain” test applies to the opposition. That raises the question whether things would turn out differently in a revocation proceeding on the balance of probabilities. After 949 paragraphs for the first decision and 470 paragraphs for the second, perhaps the “very clear conclusion” language might help discourage that course?

Meat and Livestock Australia Limited v Branhaven LLC [2020] FCAFC 171 (Kenny, Nicholas and Burley JJ)


  1. Cargill Inc. and Branhave were joint applicants but in the course of the hearings before Beach J, Cargill assigned its interest to SelecTraits Genomics LLC.  ?
  2. Claim 13. An isolated polynucleotide identified according to the method of claim 8.  ?
  3. Sch. 3 item 6. Prior to the introduction of this amendment, the appeal to the Court was limited to the form of the specification before the Commissioner in the decision under appeal. If an application to amend was made after the Commissioner’s decision, the application could only be dealt with by the Commissioner: see e.g. Airsense Technology Limited v Vision Systems Limited [2007] FCA 828  ?
  4. Costs were also reserved.  ?

Pregabalin 2 – the invalidity appeal

In addition to clarifying infringement of method claims, the Full Court in Warner-Lambert (Pregabalin) also dismissed Apotex’ appeal against the findings that the Patent was fairly based and not invalidated by a false suggestion.

As you will recall, Warner-Lambert’s patent claimed methods for treating pain using pregabalin. The methods included claims 16 – 30 which were Swiss claims.

Apotex argued that the claims were not fairly based and had been obtained by false suggestion.

The main basis for these attacks stemmed from the parties’ acceptance that the point of the patent was the use of pregabalin to treat humans. However, the examples in the patent related to tests conducted on rats. Apotex argued that it was not certain that a compound shown to be efficacious in rats would necessarily work for humans or, if it did, what a “therapeutically effective amount” for humans would be without a considerable amount of testing and experiment. Apotex argued that the “prolonged research, inquiry or experiment” involved fell well short of what was required for a sufficient description of the invention. (This was the pre-Raising the Bar Act version of s 40(2)(a)). Accordingly, as laid down in Kimberly-Clark:

The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?

The Full Court accepted that it would be a complicated and expensive business to produce from the information in the Specification a medicament for the treatment of humans. After all, we are talking about a drug. However, the Full Court agreed with the trial judge that the work involved was nonetheless “routine” and did not require invention. For example, at [126] the Full Court accepted:

The need to produce “new inventions or additions” or to carry out “prolonged study of matters presenting initial difficulty” may mean that a description is insufficient. The need for time, cost and detailed work will not; at least where, as here, the work involved is of a routine and conventional kind.

“Routine” in this context was not merely simple and easy. The skilled addressees were scientists with Ph Ds and considerable experience.

An important consideration in reaching this conclusion was the nature of the claimed invention. According to the Full Court, the invention lay in the broad recognition that pregabalin, otherwise a known drug, could be used in the treatment of pain. It was not concerned with any particular dosing regime.

It also appears that (see [39] of the Full Court’s reasons) Apotex’ evidence did not identify any particular problems that would be encountered if one were to embark on formulating the drug for the relevant purpose.

In reaching this conclusion, the Full Court was also highly critical of Apotex’ attempt to characterise the work involved as imposing an “undue burden”. This formulation was derived from EPO and English cases in which the statutory test was close to the Raising the Bar Act formulation:[3]

(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and

So it was irrelevant to the test under the pre-Raising the Bar Act form of s 40(2)(a) and, in any event, was an unhelpful gloss on the terms of the statute.

Bearing in mind the history of the terminology adopted in the Raising the Bar Act version of s 40 and the similarity of the wording to the EPC / UK Act, it is to be hoped that the High Court’s warnings in Lockwood v Doric not to get entangled in English cases post–1977 will fall away when a case arises under the new form of the provision.

Dr Summerfield addresses the invalidity issues of the appeal here.

Warner-Lambert Company LLC v Apotex Pty Ltd (No 2) [2018] FCAFC 26 (Jagot, Yates and Burley JJ)

Five Judges speak with one voice on Australian Patent Law Construction and Fair Basis*

The Rosuvastatin case is that rare beast – a decision of a 5 member Full Bench of the Federal Court. It canvases many issues and, no doubt, we shall be picking over it for years to come. Susan Gatford, at the Victorian Bar, has kindly provided a guest post on the section 40 issues. Take it way Sue:

The judgment in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 is an authoritative statement by a Full Court of the Federal Court of current patent law in Australia on novelty, obviousness, fair basis and indirect infringement. Further, neither the parties nor the Full Court at [37] demurred from the primary judge’s summary of the relevant authorities as to what constitutes common general knowledge and the attributes of the hypothetical skilled addressee. Likewise, neither the parties nor the Full Court at [90] disagreed with the primary judge’s exposition of the principles governing the construction of the claims and body of a specification of a patent.

The Full Court was principally constituted with five justices so as to address issues in regard to obviousness[1]. But the decisions at first instance and on appeal, taken together, also provide a “go to” exposition of most of the legal issues that commonly arise in Australian patent cases.

The Court’s views on the different validity grounds and on indirect infringement each warrant separate commentary and analysis. This article considers one of the construction issues, the decision as to fair basis and the interplay between construction and fair basis.

Background

Statins are a group of drugs that reduce the levels of cholesterol in the blood. Rosuvastatin (marketed in Australia as CRESTOR) is a very successful statin. No patent was ever filed in Australia for the rosuvastatin chemical compound. But AstraZeneca (Az) owns a number of secondary Australian patents relating to rosuvastatin. Two such patents are the subject of the appeal decision. One (the low dose patent) is for the administration of a particular dose or dosage range of rosuvastatin for the treatment of excess cholesterol in the blood stream. The other (the cation patent) is for a pharmaceutical composition (combination) of rosuvastatin mixed with certain inorganic salts.

The Full Federal Court’s decision affirms, although with some differences of reasoning and grounds, Apotex’s victory last year before Justice Jagot, in which it obtained orders revoking both patents.

The outcome of the appeal

The low dose patent was held:

  • to have named the wrong inventor (with a discussion of the current and former entitlement provisions of the Patents Act);
  • to be obvious (with a discussion of the starting point at which obviousness is to be considered and the impact of section 7 of the Patents Act); and
  • not to have been infringed (with a discussion of section 117 of the Patents Act)
  • 

However, reversing the decision of the primary judge, the Full Court held that the low dose patent was novel despite the existence of prior publications disclosing both rosuvastatin and a dosage range that covered the dosage range the subject of the claims.

The cation patent was held:

  • to have impermissibly claimed too early a priority date;
  • to have been anticipated (not novel);
  • to be obvious; and
  • not to be fairly based on the specification (despite the presence of claim 1 as a consistory clause within the body of the specification).

The five judges agreed with each other on all issues. Justices Besanko, Foster, Nicholas and Yates wrote a joint judgment which dealt with all issues except obviousness. Justice Jessup wrote a separate judgment on obviousness with which the rest of the Court agreed.

Patent construction and section 40 issues in relation to the cation patent.

The cation patent was for rosuvastatin mixed with certain multivalent cation inorganic salts. The salts were not therapeutic – their role was said to be simply to stabilize the rosuvastatin and prevent it from degrading. The patent specification described rosuvastatin and various salts being mixed together into a tablet which was then coated.
There was a disagreement between the parties as to the meaning of the words “pharmaceutical composition” in claim 1 of the cation patent. Apotex submitted that in the context of the cation patent “pharmaceutical composition” referred only to the rosuvastatin-salt mixture, and did not include the tablet coating. This was because the proposed Apotex product did not have a rosuvastatin-salt mixture – in its tablet the salt was placed into the coating, not mixed with the rosuvastatin.

Az, in order to maintain its infringement case, argued that the words “pharmaceutical composition” in claim 1 meant the whole tablet i.e. the means by which rosuvastatin is administered or delivered to the patient, whatever form that takes. The primary judge agreed with Az, as did the Full Court.

But, Apotex said, if this is what claim 1 means then it is not fairly based on the specification, as there is no real and reasonably clear disclosure in the specification of a pharmaceutical composition in which the relevant inorganic salt is contained solely within the coating of the pharmaceutical composition and not mixed with the active ingredient, being rosuvastatin. They noted that every disclosure in the cation patent of the use of a relevant salt, including in each of the examples, involved the salt being mixed or blended with rosuvastatin. They also noted that the only theory advanced in the specification to explain how the multivalent cation salt improved the stability of rosuvastatin was that it stabilised its chemical structure, which the experts’ evidence confirmed required “intimate mixing”.

Az did not dispute this evidence but submitted that the fact that claim 1 was repeated in the body of the specification as a consistory clause was itself sufficient for fair basis, relying on statements in Lockwood Security Products Pty Limited v Doric Products Pty Limited (2004) 217 CLR 274 (Doric No 1) at [38] and [91] to [93]. The primary judge had agreed with that submission.

The Full Court, however, disagreed. It said at [421]

“The question that must be addressed is whether there is a real and reasonably clear disclosure in the specification of an invention in which there might be no mixture of the active ingredient and inorganic salt. In our opinion, the specification, when read as a whole, does not make any such disclosure even in the most general sense.”

In other words, the claim was for a composition which contained three things – rosuvastatin, salt and a coating. The claim did not require the salt and the rosuvastatin to be mixed, so the salt could either be with the rosuvastatin or in the coating. In the invention disclosed in the specification, though, the salt and the rosuvastatin were always mixed. The possibility of the salt not being mixed with the rosuvastatin was not contemplated and not disclosed.

Section 40(3) of the Patents Act as applied to this patent (i.e. as it stood before the 2013 amendments to the Patents Act) requires that “the claim or claims must be … fairly based on the matter disclosed in the specification”.

The Court’s finding of lack of fair basis refocuses attention on the construction of claim 1 contended for by Apotex. But the Court was not prepared, in light of the authorities, to read claim 1 as requiring the salt and the rosuvastatin to be mixed, as it considered that to do so would be to draw an impermissible gloss from the specification.

The Court was, however, prepared to use section 40 to strike down what it evidently regarded as a claim that was too widely drawn. Whether the judgment will result in an increase in the number of successful challenges based on section 40 grounds remains to be seen.

AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99

 

Thanks, Sue.


  1. As to which see Mark Summerfeild’s recent blog post  ?

Scope of disclosure in an innovation patent

Patentology has a nice summary of the innovation patentee’s successful appeal in Seafood Innovations Pty Ltd v Richard Bass Pty Ltd [2011] FCAFC 83.

One point: it seems like the disclosure in the body of the specification supporting the broadest claim was at a level of generality similar to that upheld by the High Court in the first round of Lockwood. Wonder how that will hold up for future application under the (proposed) Raising the Bar legislation?

Secondly, the (now) infringer’s best line of defence (apart from invalidity) seems to have turned on trying to argue (now unsuccessfully) that incorporating additional integers in the accused gutting machine to those specified in the claim. Bennett J gave it short shrift.

Draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011

A few weeks back now, IP Australia released a draft Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (pdf) and draft Explanatory Memorandum (pdf).

You can probably guess its overall objective from the exposure draft bill’s longer short title. The range of matters covered extends across 6 schedules:

  • Schedule 1- Raising the quality of granted patents
  • Schedule 2– Free access to patented inventions for research and regulatory activities
  • Schedule 3– Reducing delays in resolving patent and trade mark applications
  • Schedule 4- Assisting the operations of the IP profession
  • Schedule 5- Improving mechanisms for trade mark and copyright enforcement
  • Schedule 6 – Simplifying the IP system

Of the many things that struck my eye, the proposals:

  • seek to introduce the diligent searcher standard for testing the obviousness of patents;
  • seek to have patent applications and oppositions (but not, so far, trade mark oppositions) tested on the balance of probabilities instead of being practically certain not to be valid
  • introduce the new statutory experimental use defence;
  • seek to introduce a presumption of registrability for trade mark applications;
  • introduce the patent opposition “pleading” system to trade mark oppositions; and
  • confer original jurisdiction in trade mark and registered design mattters on the Federal Magistrates Court.

As IP Australia’s announcement says:

Bill does not deal with gene specific issues, rather it seeks to raise patentability standards across all technologies. Gene specific issues are being considered separately by the Senate Legal and Constitutional Affairs Legislation Committee, and by the Government in its response to the Senate Community Affairs Committee’s Gene Patents report.

Over at Patentology Dr Mark Summerfield gives very detailed consideration to the pros and shortcomings of the obviousness reform, the changes to the requirement that patents be useful,  the attempt to fix the law of fair basis (at least insofar as provisional specs are concerned), the new enablement requirement. Dr Summerfield seems to be on a roll, so there may well be more to come.

Comments and submissions should be provided by 4 April 2011.