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exceptions to patentable subject matter are interpreted narrowly.
not seldom at the expense of all that is reasonable.<br>
<br>
-------- Original Message --------
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<th align="RIGHT" nowrap="nowrap" valign="BASELINE">Subject: </th>
<td>[The IPKat] Excluded Subject Matter American Style - <i>Association
of Molecu...</i></td>
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<th align="RIGHT" nowrap="nowrap" valign="BASELINE">Date: </th>
<td>Wed, 3 Aug 2011 11:50:04 -0700 (PDT)</td>
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<th align="RIGHT" nowrap="nowrap" valign="BASELINE">From: </th>
<td>Matt <a class="moz-txt-link-rfc2396E" href="mailto:matt.ipkat@gmail.com"><matt.ipkat@gmail.com></a></td>
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<th align="RIGHT" nowrap="nowrap" valign="BASELINE">Reply-To:
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<td><a class="moz-txt-link-abbreviated" href="mailto:matt.ipkat@gmail.com">matt.ipkat@gmail.com</a></td>
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<th align="RIGHT" nowrap="nowrap" valign="BASELINE">To: </th>
<td><a class="moz-txt-link-abbreviated" href="mailto:ipkat_readers@googlegroups.com">ipkat_readers@googlegroups.com</a></td>
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<br>
<br>
<img moz-do-not-send="true"
src="http://4.bp.blogspot.com/-ClwKHuoD-5I/TjmXNrey7_I/AAAAAAAAATo/P8HeZO8HgLQ/s320/pond.jpg"
style="float:right; margin:0 0 10px 10px;cursor:pointer;
cursor:hand;width: 320px; height: 240px;" alt=""
id="BLOGGER_PHOTO_ID_5636702669896871922" border="0">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 <i>The Association of Molecular Pathology & Ors v The USPTO
and Myriad Genetics Inc</i>, __ F.3d __ (available <a
moz-do-not-send="true"
href="http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf">here</a>)
(CAFC, 2011).<br>
<br>
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”.<br>
<br>
<b>Background</b><br>
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.<br>
<br>
<span class="Apple-style-span" style="color: rgb(0, 0, 238);
-webkit-text-decorations-in-effect: underline; "><img
moz-do-not-send="true"
src="http://1.bp.blogspot.com/-BZ0MERBNRXM/TjmW_uC7CjI/AAAAAAAAATY/pGpdPBx8HZo/s200/dna.gif"
alt="" id="BLOGGER_PHOTO_ID_5636702430067100210" style="float:
left; margin-top: 0px; margin-right: 10px; margin-bottom: 10px;
margin-left: 0px; cursor: pointer; width: 200px; height: 160px;
" border="0"></span>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 <i>MedImmune v Genentech</i>, 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.<br>
<br>
<b>Patentable Subject-Matter</b><br>
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.”<br>
<br>
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.<br>
<br>
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.<br>
<br>
<img moz-do-not-send="true"
src="http://3.bp.blogspot.com/-8QTC3gO4BKQ/TjmW0OkDWkI/AAAAAAAAATQ/wwZHqDq6WeI/s320/Myriad.gif"
alt="" id="BLOGGER_PHOTO_ID_5636702232637561410" style="float:
right; margin-top: 0px; margin-right: 0px; margin-bottom: 10px;
margin-left: 10px; cursor: pointer; width: 275px; height: 213px; "
border="0">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.”<br>
<br>
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:<br>
<blockquote>“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.”</blockquote>
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.<br>
<blockquote>“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.”</blockquote>
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”<br>
<br>
Circuit Judge Moore, concurring in part, noted that<br>
<blockquote>“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.”</blockquote>
Nevertheless:<br>
<blockquote>“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.”</blockquote>
<div>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. </div>
<br>
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.<br>
<br>
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.”<br>
<br>
Nevertheless, as <a moz-do-not-send="true"
href="http://www.patentlyo.com/patent/2011/07/federal-circuit-isolated-human-dna-molecules-are-patentable.html">numerous</a>
<a moz-do-not-send="true"
href="http://www.pharmapatentsblog.com/federal-circuit-decisions/federal-circuit-decides-myriad-oks-isolated-dna-claims/">commentators</a>
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.
<br>
<br>
--<br>
Posted By Matt to <a moz-do-not-send="true"
href="http://ipkitten.blogspot.com/2011/08/excluded-subject-matter-american-style.html">The
IPKat</a> on 8/03/2011 04:01:00 PM
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