[pp.int.general] Fwd: [The IPKat] Excluded Subject Matter American Style - <i>Association of Molecu...

[Amelia Andersdotter]

exceptions to patentable subject matter are interpreted narrowly. not 
seldom at the expense of all that is reasonable.

-------- Original Message --------
Subject: 	[The IPKat] Excluded Subject Matter American Style - 
/Association of Molecu.../
Date: 	Wed, 3 Aug 2011 11:50:04 -0700 (PDT)
From: 	Matt <matt.ipkat at gmail.com>
Reply-To: 	matt.ipkat at gmail.com
To: 	ipkat_readers at googlegroups.com



Important patent things have been happening ‘across the pond’ from the 
muggy and badly-ventilated London sweathouse that this particular Kat’s 
office has become over the past few days. (Readers will appreciate that 
this is not a reference to an actual pond – there little room for such 
an installation in the immediate vicinity of his office, and the 
inhabitants of the surrounding rooms would probably be less than 
impressed to find an impromptu water feature quite literally springing 
up under their desks (although given the weather in London at the moment 
the Kat is prepared to be proved wrong on this point). In any case, the 
Kat struggles to think of what patent related matters could be enacted 
on the other side of an actual pond that would: (a) be sufficiently 
important to grace the pages of this blog; and (b) have come to the 
Kat’s attention in any case. But I digress…). No, the reference to the 
pond (and things happening across it) is in fact an allusion to 
developments in the U.S. on patent matters in recent days). The Kat 
refers, in particular, to the decision of the Court of Appeals for the 
Federal Circuit (CAFC) in /The Association of Molecular Pathology & Ors 
v The USPTO and Myriad Genetics Inc/, __ F.3d __ (available here 
<http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf>) 
(CAFC, 2011).

The decision is relatively page-heavy, weighing in at 105, but of only 
modest heft in terms of words (in the region of 27,000 – a 5.1 if you’re 
interested). It concerns, in part, the heated question of whether 
patents should be allowable in principle on isolated forms of naturally 
occurring DNA molecules – the short answer from the majority being “yes”.

*Background*
In essence, the Association of Molecular Pathology and a selection of 
other parties (collectively ‘the plaintiffs’) brought a suit against 
Myriad challenging the patentability of certain composition and method 
claims relating to human genetics. The challenged patents concerned two 
isolated human genes, BRCA1 and BRCA2, and certain mutations in these 
genes associated with a predisposition to ovarian and breast cancer – 
women with BRCA mutations, for example, apparently face a cumulative 
risk of between 50 to 80% of developing breast cancer (compared to the 
U.S. national average of 12-13%). The patents’ claims related to the 
isolated gene sequences themselves and to diagnostic methods of 
screening, analysing and comparing a patient’s BRCA sequence to the 
‘normal’ sequence.

Having overcome the hurdles relating to standing (in contrast to the 
position in the UK, where there is no requirement of standing – s72 PA 
1977 simply states that the “court… may by order revoke a patent for an 
invention on the application of any person” (emphasis supplied) – under 
U.S. law in order to bring a declaratory judgment suit challenging the 
validity of a patent a party must demonstrate that there is a “a case of 
actual controversy” of the type justiciable under Article III of the 
U.S. Constitution. In patent cases, this has been interpreted to mean 
that there must be a “definite and concrete” dispute that touches “the 
legal relations of parties having adverse legal interests,” which is 
“real and substantial,” and which admits of “specific relief through a 
decree of a conclusive character, as distinguished from an opinion 
advising what the law would be upon a hypothetical state of facts.” (See 
/MedImmune v Genentech/, 549 U.S. 118, at 127 (Sup Ct, 2007)), the Court 
moved to consider the main issue at play in the case: patentable 
subject-matter.

*Patentable Subject-Matter*
Myriad had argued that the lower court’s rejection of its claims to 
“isolated” DNA sequences under §101 as “products of nature” was 
incorrect on a number of grounds. In particular, it alleged that the 
district court had: misread “Supreme Court precedent as excluding from 
patent eligibility all “products of nature” unless “markedly different” 
from naturally occurring ones”; and incorrectly focused on the 
similarity in the informational content between isolated and native DNAs 
rather than on their marked differences in other areas. Accordingly, it 
argued that “an isolated DNA molecule is patent eligible because it is, 
as claimed, “a nonnaturally occurring composition of matter” with “a 
distinctive name, character, and use.”

Myriad argued that as isolated DNA does not exist in nature, it could 
not be considered to be a “product” thereof. Furthermore, any 
categorical interpretation of this exception to patent eligibility would 
not only be “unworkable, as every composition of matter is, at some 
level, composed of natural materials”, but would also be contrary to 
precedent.

The plaintiffs, on the other hand, argued that claims to isolated DNA 
molecules failed to satisfy the §101 standard as “such claims cover 
natural phenomena and products of nature.” Accordingly, they asserted 
that Supreme Court precedent stated that a product of nature was not 
patent eligible even if it had undergone some highly useful change from 
its natural form. The critical question was whether the composition of 
matter had a distinctive name, character, and use, making it “markedly 
different” from the natural product. Only then would it be patent 
eligible. On the current facts, the plaintiffs argued that because the 
isolated DNAs retained the same nucleotide sequence as native DNAs, they 
did not have any “markedly different” characteristics.

Circuit Judge Lourie, giving the opinion for the court, explained that 
the distinction “between a product of nature and a human-made invention 
for purposes of §101 turns on a change in the claimed composition’s 
identity compared with what exists in nature. Specifically, the Supreme 
Court has drawn a line between compositions that, even if combined or 
altered in a manner not found in nature, have similar characteristics as 
in nature, and compositions that human intervention has given “markedly 
different,” or “distinctive,” characteristics.”

Accordingly, the fact that Myriad was claiming isolated DNAs – “a 
free-standing portion of a native DNA molecule” – was determinative. As 
Judge Lourie explained, isolated DNA is not simply purified DNA:

    “Purification makes pure what was the same material, but was
    previously impure. 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. It has not been
    purified by being isolated.”

Discussing the approach of the district court, Judge Lourie considered 
it had fallen into error in considering not whether the isolated DNAs 
were markedly different, in that they had a “distinctive characteristic” 
to distance them from naturally occurring DNAs, but rather whether they 
had the same informational content as native DNA sequences.

    “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.”

Nevertheless, the CAFC considered that the district court was correct in 
holding that Myriad’s claims directed to comparing and analysing gene 
sequences were patent ineligible, as these claims contained no 
transformative steps and covered only patent ineligible abstract steps. 
Finally, the claims directed to methods of screening potential cancer 
therapeutics via changes in cell growth rates were considered to be 
patent eligible, presenting, as they did, ““functional and palpable 
applications” in the field of biotechnology”

Circuit Judge Moore, concurring in part, noted that

    “DNA is a chemical polymer. In principle, a polymeric DNA sequence
    is no different than any other well known polymer, for example,
    nylon. Like any polymer, DNA is made up of repeating monomer units,
    connected by chemical bonds to form one larger molecule.”

Nevertheless:

    “Isolation of a DNA sequence is more than separating out impurities:
    the isolated DNA is a distinct molecule with different physical
    characteristics than the naturally occurring polymer containing the
    corresponding sequence in nature.”

According to Circuit Judge Moore, the fact that human action had 
“whittled the chromosomal DNA molecule down” to a shortened version of 
its natural self, “defining the parts to be retained and discarded” 
rendered it “entirely different” from the naturally occurring gene from 
which it was obtained.

Circuit Judge Moore explained that whilst she might conclude that and 
isolated DNA sequence that includes most or all of a gene was not 
patentable subject matter if she was approaching the factual matrix from 
a blank canvas, this was not in fact the case. There was a “substantial 
historical background” with the courts having been authorised by 
Congress to approach the issue of patentable subject matter expansively. 
The established practice was to allow patents on isolated DNA sequences 
– such patents having being allowed by the USPTO for “decades” according 
to the Judge.

Accordingly, the Judge explained that she considered that “we must be 
particularly wary of expanding the judicial exception to patentable 
subject matter where both settled expectations and extensive property 
rights are involved. Combined with my belief that we should defer to 
Congress, these settled expectations tip the scale in favor of 
patentability.”

Nevertheless, as numerous 
<http://www.patentlyo.com/patent/2011/07/federal-circuit-isolated-human-dna-molecules-are-patentable.html> 
commentators 
<http://www.pharmapatentsblog.com/federal-circuit-decisions/federal-circuit-decides-myriad-oks-isolated-dna-claims/> 
who have been quicker off the mark than this Kat in digesting this 
judgment have noted, whilst diluted somewhat Myriad’s patents remain 
strong and the plaintiffs are likely to seek an en banc rehearing in the 
CAFC or file a writ of certiorari with the Supreme Court.

--
Posted By Matt to The IPKat 
<http://ipkitten.blogspot.com/2011/08/excluded-subject-matter-american-style.html> 
on 8/03/2011 04:01:00 PM --
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