30 July 2011

US Appeals Court Rules Isolated Genes Patentable

The Association for Molecular Pathology & ors. v Myriad Genetics & ors. (No. 10-1406, 29 July 2011)

In a decision that may have a significant impact on the ‘gene patent’ debate in Australia, the US Court of Appeals for the Federal Circuit (CAFC) has ruled that patent claims directed to ‘isolated’ DNA molecules cover patent-eligible subject matter under 35 USC §101, because ‘the molecules as claimed do not exist in nature.’

As we reported back in June 2010, Myriad Genetics Inc, along with its co-patentees, had appealed a decision by the District Court for the Southern District of New York finding its US patents relating to BRCA1 and BRCA2 human genes – applicable to screening for breast cancer – to be partially invalid.

The CAFC also ruled that claims to methods for screening for potential cancer therapeutics via changes in cell growth rates are, likewise, patent eligible subject matter.  However, the three Federal Circuit Judges found that claims directed to ‘comparing’ and ‘analysing’ DNA sequences to be ineligible for patent protection because they ‘include no transformative steps and cover only patent-ineligible abstract, mental steps.’

All three Judges penned opinions, with the main opinion of the court (including a fabulous ‘tutorial’ on genetics) being written by Judge Lourie.  The three opinions are largely concurring, with the judges being in agreement that screening methods are patent-eligible, that ‘mere’ comparing and analysing methods are not patent-eligible, and that complementary DNA (cDNA) is patent-eligible.  (cDNA is a form of synthetic DNA which can be produced in the laboratory using molecules called ‘messenger RNAs’, or mRNAs, which are intermediates in the process of generating proteins for which the DNA codes.)

The most interesting aspect of the case, in our view, is the Court’s consideration of the patent-eligibility of isolated DNA – i.e. DNA sequences extracted from the genome such that they retain the same nucleotide sequence as the original, naturally-occurring, DNA.  On this issue, the court was split, with Judges Lourie and Moore finding that isolated DNA is patent-eligible, while Judge Bryson dissented.

The CAFC decision is precedential and so, for now at least, the law in the US is that isolated gene sequences are patentable.  However, the stage would appear to be well-set for a possible Supreme Court challenge!

IMPACT ON AUSTRALIAN GENE PATENTS DEBATE

This decision comes as something of a blow to the opponents of gene patents in Australia.  One of the arguments that has been quite consistently made against the patenting of biological materials – including genes – in this country has been that it is already the law that such things are not patentable, and the ‘problem’ lies primarily with the practice of the Patent Office in granting invalid patent claims.

As Dr Luigi Palombi eloquently put the case, during the public hearings held by the Senate Committee inquiry on the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Committee Hansard, Friday, 29 April 2011, p14):

…the grant of a patent by IP Australia does not necessarily reflect the true state of the law.  So patent law is what the courts say it is, not what patent offices do with it.  Accordingly, when the Australian Patent Office adopted here in Australia the policy first adopted by the United States Patent and Trademark Office in 1988—namely, that isolated biological materials, even though they are identical to what exists in nature, are patentable subject matter under US patent law—that did not mean that the policy was a true reflection of the state of patent law in either the United States or Australia. Now that the US patent office policy is being judicially scrutinised in the United States, the US government has made it clear that it, too, on reflection, agrees that it was not. The US government's position was expressed in the amicus brief of the US Department of Justice filed in the Myriad appeal in October last year.

In other words, in Dr Palombi’s submission, in 1988 the USPTO adopted a practice that was contrary to the patent law, and it was therefore wrong for the Australian Patent Office to follow suit.

However, the law is not necessarily what ‘the government’ says it is, either.  Under our democratic system of government, the parliament of course has the power to make and change law, but the parliament is comprised of both government and non-government members.  And when Dr Palombi speaks in the above passage of ‘the US government’, he is in fact speaking only of a single US government department, populated by public servants acting under the direction of the government of the day.

Even then, there is clearly no single ‘US government’ position, considering that the USPTO is itself a government agency, under the US Department of Commerce.  There must therefore be at least two, opposing, positions of the ‘US government’ – those of the Department of Justice and the Department of Commerce.  Likewise, the Australia Senate inquiry has received contrary submissions from the Department of Innovation, Industry, Science and Research, incorporating IP Australia (against the proposed amendments to the Patents Act 1990), and from the Department of Health and Aging (in favour of the amendments).
The CAFC on the US Department of Justice position
Judge Lourie had the following to say regarding the position argued on behalf of the Department of Justice (slip op., majority pp 38-39):

The government as amicus curiae does not defend the PTO’s longstanding position that isolated DNA molecules are patent eligible, arguing instead for a middle ground. Specifically, the government argues that DNA molecules engineered by man, including cDNAs, are patent-eligible compositions of matter because, with rare exceptions, they do not occur in nature, either in isolation or as contiguous sequences within a chromosome. In contrast, the government asserts, isolated and unmodified genomic DNAs are not patent eligible, but rather patent-ineligible products of nature, since their nucleotide sequences exist because of evolution, not man.

At oral argument, the government illustrated its argument by way of a “magic microscope” test … if an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers unpatentable subject matter. The government thus argues that because such a microscope could focus in on the claimed isolated BRCA1 or BRCA2 sequences as they exist in the human body, the claims covering those sequences are not patent eligible. In contrast, the government contends, because an imaginary microscope could not focus in vivo on a cDNA sequence, which is engineered by man to splice together non-contiguous coding sequences …, claims covering cDNAs are patent eligible.

In sum, although the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. … [W]e conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.
Isolated gene sequences are ‘markedly different’ from native DNA
In considering whether isolated DNA is patent-eligible, Judge Lourie looked to the chemical differences between naturally-occurring DNA and isolated DNA, and drew a contrast between this and a comparison of information content.

In a strict chemical sense, the Court found, isolated DNA is not the same compound that occurs naturally in the human (or other) body (slip op., majority p 42):

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.)

The Court found, however, that the absence of a marked difference in information content is not relevant to the assessment of patent-eligibility, although  it might be a factor in assessing obviousness (slip op., majority p 44):

Plaintiffs argue that because the claimed isolated DNAs retain the same nucleotide sequence as native DNAs, they do not have any “markedly different” characteristics. This approach, however, looks not at whether isolated DNAs are markedly different—have a distinctive characteristic—from naturally occurring DNAs, as the Supreme Court has directed, but at one similarity: the information content contained in isolated and native DNAs’ nucleotide sequence. Adopting this approach, the district court disparaged the patent eligibility of isolated DNA molecules because their genetic function is to transmit information. We disagree, as it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit. Uses of chemical substances may be relevant to the non-obviousness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material that embodies it.
Relevance to proposed Australian legislation
The CAFC discussion is highly pertinent to the issues currently before the Senate Committee.

The Patent Amendment (Human Genes and Biological Materials) Bill 2010, in its original form, sought to distinguish unpatentable biological materials as those which are ‘identical, or substantially identical to such materials as they exist in nature’.

During the public hearings, Senator Heffernan submitted a revised Bill, removing the potentially ambiguous reference to ‘substantial’ identity, and defining ‘identical’ as ‘structurally and functionally identical’ (see Update on the Australian Senate Gene Patent Inquiry).

If an Australian court were to take the same approach as the CAFC, then isolated DNA could well fail to satisfy either of these tests, since that which is ‘markedly different’, according to the CAFC’s analysis, is neither ‘substantially identical’, nor ‘structurally and functionally identical’.

In other words, on this analysis, the Bill would not achieve even its most basic stated objective.

COMMENT

Proponents of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 will no doubt seek some comfort in the dissenting opinion of Judge Bryson, and even in the concurring opinion of Judge Moore, who suggests (slip op., Moore J p 14): ‘Although the different chemical structure does suggest that claimed DNA is not a product of nature, I do not think this difference alone necessarily makes isolated DNA so “markedly different” … from chromosomal DNA so as to be per se patentable subject matter.’

For Judge Moore, the patentable distinction lies not in chemical difference per se, but in ‘whether these differences impart a new utility which makes the molecules markedly different from nature’ (Moore J p 15).  And, in her view, these differences are sufficient to confer patentability because ‘[t]he shorter isolated DNA sequences have a variety of applications and uses in isolation that are new and distinct as compared to the sequence as it occurs in nature.’

Ultimately, therefore, Judge Moore finds a substantial difference from naturally-occurring DNA, albeit by a different path.

We have previously expressed sympathy with the views of those members of the Australian community who oppose the patenting of genes on essentially moral grounds (see Why IP Professionals Must Take ‘Gene Patent’ Opponents Seriously).  However, we maintain that a problem grounded in ethical concerns requires cannot be solved by attempting to target a specific technology.

In the terms of the CAFC’s analysis, the moral objections to gene patents are largely based on the information represented by a gene, which many people view as an aspect of our very identify as individual human beings.  These concerns are completely unrelated to the actual chemical structures of the native and isolated genetic sequences.

The US patent law (35 USC §101) provides that ‘whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…’.  The Australian ‘manner of manufacture’ test covers similar ground.  Neither approach to patent-eligibility is concerned with whether or not any ‘information content’ represented by a novel composition of matter (e.g. a chemical compound) is itself new, although this may certainly be relevant to questions of novelty and inventive step.

The problem is unquestionably real – there are many citizens with deeply-felt objections to the patenting of genes.  But the Patent Amendment (Human Genes and Biological Materials) Bill 2010 is the wrong solution.

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