17 June 2013

Molecules, Information, Artificiality, Genes and Patents

InformationOn 13 June 2013, the US Supreme Court issued its much-anticipated ruling in Association for Molecular Pathology v Myriad Genetics, Inc.  The full ‘slip’ opinion is available from the Supreme Court’s website [PDF, 147kB].

As has been widely reported, the decision was unanimous in finding Myriad’s isolated DNA claims to be unpatentable.  Justice Thomas authored an opinion on behalf of eight judges, and Justice Scalia concurred with the majority judgment (and concurred in part with the reasoning).

The judgment addresses the fundamental question of whether ‘isolated DNA claims’ are directed to molecules uniquely brought into being by human endeavours, or to information content encoded in those molecules which is simply extracted from nature.  The Supreme Court has taken the opposite view on this issue from the majority in the US Court of Appeals for the Federal Circuit (CAFC).  A single judge of the Australian Federal Court decided the equivalent case back in February of this year, reaching the same conclusion as the US CAFC, although for different reasons.

With the Australian decision going on appeal, and due to be heard before five judges of the Federal Court (Chief Justices Allsop, with Justices Dowsett, Kenny, Bennett and Middleton) on 7 and 8 August 2013, the question now naturally arises as to whether the Australian court will be influenced by the US decision.

What the Supreme Court Did, and Did Not, Decide

Broadly speaking, the Supreme Court has settled the US law relating to the patenting of genes as follows: naturally-occurring gene sequences are not patent-eligible, even when isolated by means of human intervention; however, synthetically-created DNA, such as ‘complementary DNA’ (cDNA) is patent-eligible when (as is normally the case) it comprises molecules including sequences of genes which are not naturally-occurring.

The Court was at pains to point out the limitations of its decision, which does not address the full range of issues and controversy associated with so-called ‘gene patents’.  In particular, the judgment does not address method claims (e.g. therapeutic methods or diagnostic tests).  It also does not address patent claims directed to new applications of knowledge about the BRCA1 and BRCA2 genes which were discovered and isolated by Myriad.  Nor does it address patent-eligibility of DNA in which the order of the naturally-occurring nucleotides has been altered.

I would add that the Supreme Court was not asked to, and did not, look at any of the other criteria which must be satisfied by a valid patent claim, such as whether the claimed invention has been shown to have a specific use, whether it is adequately supported by the level of disclosure in the patent specification, and whether it is new and nonobvious in view of the prior art.

The decision stands for the relatively narrow proposition that ‘genes and the information they encode are not patent eligible … simply because they have been isolated from the surrounding genetic material’ (emphasis added).

‘Molecularists’ and ‘Informationists’

I have long considered that the fundamental difference between those who argue that isolated genetic sequences should be patent-eligible, and those who take the opposite view, comes down to the way in which claims directed to isolated DNA sequences are interpreted.  Explicitly or implicitly, opponents of gene patents adopt the position that the claims are directed to the ‘information content’ of the isolated sequence.  Supporters, on the other hand, focus on the molecular structure.

The majority on the CAFC panel (Judges Lourie and Moore) twice came down on the side of the ‘molecularists’ – initially on appeal from the District Court for the Southern District of New York, and then again after the case was remanded back by the Supreme Court for reconsideration in light of its intervening decision in Mayo v Prometheus.  As Judge Lourie put it (in both CAFC opinions):

Isolated DNA … is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. … Accordingly, BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.

… Although isolated DNA must be removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. (Emphasis added.)

A contrary position is commonly adopted by ‘informationists’.  Sometimes the ‘information content’ argument is explicit, as in Judge Bryson’s dissenting opinion in the second of the two CAFC decisions:

Neither isolation of the naturally occurring material nor the resulting breaking of covalent bonds makes the claimed molecules patentable….The functional portion of the composition—the nucleotide sequence—remains identical to that of the naturally occurring gene.

The majority suggests that I have “focus[ed] not on the differences between isolated and native DNAs, but on one similarity: their informational content.” In light of Mayo, that approach seems appropriate.

The Supreme Court was even more direct in its reasoning that molecular differences are irrelevant to the question of patent-eligibility because, when properly understood, patent claims directed to isolated genetic sequences are claims to the encoded information, and not to the isolated molecules:

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes … by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

To my mind, people who hold moral objections to gene patents are also ‘informationalists’, albeit often implicitly.  The sense that it is ‘wrong’ to allow private interests to ‘own’ our genes is fundamentally rooted in the notion that those genes embody a genetic heritage, which is, on the one hand, an element of the individual identity of each person who carries those genes and, on the other hand, part of a common body of human inheritance which is a product of nature and rightly belongs in the public domain.  These beliefs are essentially founded on the conception of genes as information-carriers.

What Does This Mean for the Australian Case?

The position in Australia is very interesting, in light of the approach taken in the US.

In his February judgment, Federal Court Justice Nicholas rejected both the molecular and informational positions in reaching a conclusion that claims directed to isolated genetic materials are patent-eligible under Australian law. 

As Justice Nicholas explains (at [76]):

…the disputed claims are not to genetic information per se. They claim tangible materials. Much emphasis was placed by the applicants upon the informational character of DNA as a storehouse of genetic information. But the disputed claims are not to information as such. They could never be infringed by someone who merely reproduced a DNA sequence in written or digitised form.

I do not think that this is necessarily inconsistent with the opinion of the US Supreme Court.  When that Court says that Myriad’s claims ‘focus on the genetic information encoded in the … genes’, I do not think it means that the claims are actually directed to the information as such.  Rather, the claims are directed to the tangible embodiment of the information in molecular form.  The Court’s point is that Myriad is not claiming one or more particular molecules.  It intends to claim any molecule which embodies the genetic information in question.

However, things become more interesting when we look at how Justice Nicholas dealt with the ‘molecularist’ position.  Firstly, he reasoned (quite rightly, in my opinion) that the Australian law in relation to patent-eligibility is quite different from that of the US.  The controlling case on the Australian ‘manner of manufacture’ test remains the NRDC case (National Research Development Corporation v Commissioner of Patents [1959] HCA 67).  And, as Justice Nicholas stated (at [88]):

It is apparent from [the NRDC case] that a product that consists of an artificially created state of affairs which has economic significance will constitute a “manner of manufacture”. … In the present case, the question of economic significance may be put aside because, as I have previously mentioned, the applicants accepted that this aspect of the requirements of patentability established by NRDC was satisfied.

Now, while a new molecular structure created through human technology and ingenuity would normally be regarded as ‘an artificially created state of affairs’, this is not the only way in which the requisite artificiality might come about.  In the case of the Myriad BRCA claims, Justice Nicholas did not find it necessary to resolve whether the isolated DNA was structurally or chemically different from the equivalent DNA found in the cell (at [105]):

In my opinion the patentability of the isolated nucleic acids referred to in the disputed claims does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated. In particular, the question of whether these substances constitute patentable subject matter does not depend upon the type of chemical bond that may have been broken in the process of isolating them. It is inevitable that some bonds will be broken in the course of isolating nucleic acids, but it is not apparent from the evidence that these will necessarily include covalent bonds. As I have already explained, the disputed claims do not require that the isolated nucleic acids they describe differ from those found in the cell in this or any other respect so far as their chemical composition is concerned. (Emphasis added.)

Again, this is broadly consistent with the US Supreme Court’s reasoning that Myriad was not seeking to claim any specific molecule, but rather all molecules encoding the relevant genetic information.  But here Justice Nicholas found the Australian law to depart from the US law, in that structural difference is not, in his view, essential to the existence of an ‘artificially created state of affairs’.  As he says at [108]:

…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.

In other words, for the claim to define a ‘manner of manufacture’ under Australian law, it is sufficient that it recite ‘isolated DNA’.  The act of ‘isolation’ in and of itself is sufficient to confer patent-eligibility.  Although, as Justice Nicholas is careful to point out (at [137]), this says nothing about ‘the possible invalidity of the disputed claims on any other ground’ (e.g. lack of utility, lack of novelty, or lack of inventive step).

Conclusion

It will be interesting to see how the Full Court deals with this issue on appeal.  The seriousness with which the appeal court will approach the question of patent-eligibility of isolated DNA is apparent from the fact that five judges appear to have been appointed (it is more usual that the ‘full bench’ comprises only three judges).

In many respects, Justice Nicholas reached similar factual conclusions to those on which the US Supreme Court has based its decision.  In both cases, for example, the courts concluded that Myriad’s ‘isolated DNA’ claims are directed to any molecule embodying the genetic information in the relevant gene sequence.  However, for the US Supreme Court this meant that Myriad was effectively seeking to claim nothing more than naturally-occurring DNA, which is unpatentable.  For the Australian court, on the other hand, it was important the take into account the fact that the claimed DNA is ‘isolated’.

Another way of looking at this is that the Australian court gave substantive patentable weight to the term ‘isolated DNA’, whereas the US Supreme Court did not.  This differing treatment of the claim ‘preamble’ is actually quite consistent with the general practice in the two countries.  At least one US commentator has already suggested that the Supreme Court decision might be overcome by including structural limitations within the body of a claim defining, in broad terms, the characteristics distinguishing ‘isolated’ DNA from ‘genomic’ DNA.

It is not therefore apparent that the Full Bench of the Federal Court of Australia will have anything new to learn from the Supreme Court decision when it comes to consider the Myriad claims in August.  Any attempt to predict the outcome is likely to be little better than a guess, but for the sake of putting something out there I am going to punt on a 3-2 split, marginally upholding Justice Nicholas’ decision.  Either way, however, I think there are good prospects of this case continuing on to the High Court.

Image Copyright (c) 123RF Stock Photos

No comments:

Post a Comment