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Nicholas J has ruled that Myriad’s patent for isolated gene sequences relating to BRCA1 are patentable subject matter for the purposes of Australia’s Patents Act 1990.

Claim 1 of the Patent (No. 686004 entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene”) is for:

An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:l one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

At [70], Nicholas J explained the scope of this claim:

Claim 1 extends to isolated DNA, RNA and cDNA that has a BRCA1 polypeptide encoding sequence as shown in SEQ ID No.1 with one or more of the mutations or polymorphisms specified in the relevant tables.

To qualify as patentable subject matter in Australia s 18(1)(a) prescribes that the claimed invention must be a “manner of manufacture”.

This term, much to the chagrin of modernising law reformers, derives from s 6 of the Statute of Monopolies 1623. In the “watershed” NRDC ruling in 1959, Dixon CJ, Kitto and Windeyer JJ declared that the meaning of “manner of manufacture” is not to be derived as a matter of mere etymology. Rather it poses a question:

“Is this a proper subject of letters patent according to the principles which have been developed for the application of s. 6 of the Statute of Monopolies?”

and in answering that question, it must be recognised that the concept has a “broad sweep” intended to encourage developments that are by their nature unpredictable. Hence, their Honours indicated the processes at issue in that case were patentable subject matter because they led to, or resulted in, an artificially created state of affairs, that had some discernible effect, which had economic significance.  A very teleological approach from the supposed patron saints of strict legalism!

Nicholas J found that the isolated gene sequences claimed in Myriad’s patent were an artificially created state of affairs having economic significance.

His Honour at [105] rejected Myriad’s first line of defence claiming that there was a change in chemical structure simply by the process of isolating the gene sequence. Rather, more generally, the nucleic acid or gene sequence in its isolated form was sufficient to qualify as an artificially created state of affairs:

First, the concept of patentable subject matter is expressed in very expansive language.

Secondly, at [108] the nucleic acid did not exist in isolated form in the cell:

in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell. Extraction of nucleic acid requires human intervention that necessarily results in the rupture of the cell membrane and the physical destruction of the cell itself. And purification of the extracted nucleic acid requires human intervention that results in the removal of other materials which were also originally present in the cell. It is only after both these steps are performed that the extracted and purified product may be properly described as “isolated” in the sense that word is used in the disputed claims.

Thirdly, at [109] isolating the substance could require “immense research and intellectual effort”.

In that case, it was only as a result of an intensive research effort that the isolated micro-organism in question could be made available for use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it was its employees who were first to isolate the new micro-organism and first to deploy it in the manufacture of the new drug. That will not always be so. It would lead to very odd results if a person whose skill and effort culminated in the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could not be independently rewarded by the grant of a patent because the isolated micro-organism, no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.

His Honour had earlier noted at [75] that, while the isolated substances contained genetic information, the patent did not claim information per se, rather, it was for a substance. Furthermore, at [76] because the claim was limited to the gene sequences in isolated form, it did not cover or extend to the naturally occurring DNA or RNA.

Nicholas J also noted that it was longstanding practice for the Commissioner to grant patents over gene sequences. Both ACIP (pdf) and the ALRC had recommended that this not be changed. The Government had announced (pdf) it accepted those recommendations and Parliament had implemented a different range of measures through the Raising the Bar Act, especially by introducing an explicit experimental use exception in s 119 C and the extension of the usefulness requirement by the introduction of new s 7A which was likely to affect the patentability of ESTs or expressed sequence tags.

Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

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Last week, the US Supreme Court unanimously rejected the patentability of Prometheus’ “diagnostic”, characterising it as an impermissible attempt to patent a law of nature.

Claim 1 of the Patent was:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

“(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

“(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

“wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently admin istered to said subject and

“wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently ad ministered to said subject.”

The Supreme Court characterised that part of the claims dealing with the relationship between concentrations of certain metabolites in the blood with the effectiveness of particular dosages as a law of nature, which was unpatentable. The additional features did not overcome that exclusion as they were in effect already well-known and practised. In his Honour’s overview, Breyer J explained the rationale:

[The cases] warn us against up holding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112– 120; Benson, supra, at 71–72. And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to signifi cantly more than a patent upon the natural law itself. ….

We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws them selves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk dis proportionately tying up the use of the underlying nat- ural laws, inhibiting their use in the making of further discoveries.

Patently-O has a more substantive consideration: Natural Process + Known Elements = Normally No Patent. The Commissioner of Patents has issued new guidelines indicating his understanding here; and criticisms have been propounded here and here.

The Supreme Court subsequently remitted the Myriad “gene patent” case to the Federal Circuit and Patently-O thinks their patent is going down too.

Our law is in many respects rather different. Section 18(2) of the Patents Act contains an exclusion from patentability only for human beings and the processes for their generation. Under s 18(1) and (1A), however, a patentable invention must be a “manner of manufacture within the meaning of s 6 of the Statute of Monopolies”.

In the ‘watershed’ NRDC case, the High Court confirmed that a ‘mere’ discovery was not a manner of manufacture, but an application of a discovery in a field of economic endeavour would be. A ‘mere’ discovery being “some piece of abstract information without any suggestion of a practical application of it to a useful end” at [8].

On this approach, Prometheus’ patent appears to have moved beyond the ‘mere discovery’ stage. The question might be, therefore, whether the additional integers were obvious or, may be, we have moved into Microcell territory: nothing but “nothing but a claim for a new use of an old substance” (see NRDC at [7].

A role for that approach was preserved (reinstated?) under the 1990 Act by the High Court in Phillips v Mirabella. Now, given the overlap between the Mirabella court’s analysis and the statutory requirements for novelty and inventive step (or an innovative step), that raises a whole set of issues. First, there is a question whether Mirabella would be decided the same way given the High Court seemed to have cut the legs out from under it in Advanced Building Systems - although, as the Full Federal Court pointed out in BMS v Faulding, Advanced Buidling Systems was decided under the 1952 Act and distinguished Mirabella on the grounds that the 2 Acts were different.

In trying to make sense of that, the Full Court went on to find that the “lack of newness” must be apparent on the face of the specification. As that appears to depend on the text of the specification, the approach taken by the US Supreme Court might not be open: the Faulding court found the dosage type regime a manner of manufacture although, in the end, it failed the novelty test.

In Arrow v Merck, Gyles J struck down a dosage regime on the grounds that it lacked subject matter. On appeal, the Full Court upheld invalidity, but only on grounds of lack of novelty and inventive step. Subsequently, Gyles J also accepted that the lack of subject mater ground could not be made out if it was necessary to resort to extrinsic evidence.

I guess we’ll see where the Myriad litigation in Australia takes us in due course.

Mayo Collaborative Services v. Prometheus Labs., Inc. (Supreme Court 2012) (pdf)

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The Commonwealth Senate’s Community Affairs committee tabled its report into the patenting of genes towards the end of last month.

After commenting on the still continuing cases (in both the USA and here), the Committee noted:

The Committee will continue to monitor these important international and national legal developments, and notes that these cases may bring greater clarity to the application of the invention-discovery distinction to isolated genetic materials. As part of its watching brief on this area, the Committee may wish to revisit this issue if the area remains problematic following the outcomes of these cases.

The, after referring to the private members bill (see below), the Committee recommended:

The Committee believes that the introduction of the Bill to the Senate will provide a further, and much-needed, opportunity for the arguments and questions around the impacts and effectiveness of an express prohibition on gene patents to be considered. The Committee is of the view that a Senate inquiry into the Bill should be undertaken, with a focus on the specific terms of the proposed amendments and the implications of their implementation for human health and other potentially affected fields of innovation. The Committee notes that its inquiry into gene patents has served a valuable purpose in bringing the issue of gene patenting to the light of public interest and attention, and provides a sound basis on which a targeted inquiry into the Bill can build. Accordingly, Recommendation 3 of the report requests that the Senate refer the Bill to a relevant Senate Committee for inquiry and report.

Then, there are a bundle of recommendations:

Recommendation 9 appears directed at the Lockwood No 1 ruling:

5.175    The Committee recommends that the Patents Act 1990 be amended to introduce descriptive support requirements, including that the whole scope of the claimed invention be enabled and that the description provide sufficient information to allow the skilled addressee to perform the invention without undue experimentation.

Recommendation 16 called for the establishment of a patent audit committee.

Patentology commented here.

In the same week, Senators Heffernan, Coonan, Stewart and Xenophon and introduced their private members’ bill, Patent Amendment (Human Genes and Biological Materials) Bill 2010, which (according to the Parliamentary bills summary) is intended prevent the patenting of biological materials which are identical or substantially identical to materials as they exist in nature.

As Patentology reports here, it has been referred to the Senate’s Legal and Constitutional Affairs Committee for inquiry. Your comments are requested by 25 February 2011 and the Committee is scheduled to report by 16 June 2011.

In a different environment, the US Justice Department, perhaps surprisingly, filed an amicus brief in the Myriad appeal supporting the District Court’s conclusion that the patent was invalid.

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District Court Judge Robert Sweet has ruled that Myriad’s patents for the BRCA1 and 2 isolated gene sequences are invalid on the grounds that isolation of the “pure” form of the gene is insufficient to confer patentability.

The New York Times has a lengthy report.

Patently-O summarises, with a link to the 152 page judgment. Prof. Crouch goes on to note that the reasoning effectively invalidate almost all gene patents but expresses the view that the Federal Circuit will reverse, setting up the matter for the US Supreme Court.

These are the patents which sparked controversy in Australia in 2008 and 2009 as a result of which the Senate is now holding an inquiry, currently due to report by 17 June 2010. The ALRC had earlier in 2004 recommended that patents should continue to be available for genetic material.

Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010) (Judge Sweet)

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