By Kevin E. Noonan —
The Supreme Court rendered its opinion in Association for Molecular
Pathology v. Myriad Genetics, Inc. ("the Myriad
case"), and in many ways it was anticlimactic: the Court adopted the
Department of Justice's position (thankfully, sans "magic microscope") by deciding that cDNA was patent
eligible but genomic DNA (and fragments thereof including oligonucleotides) was
not. While the biotechnology industry
avoided a categorical ban on patenting DNA (which was the goal of the ACLU) or,
worse, on "products of nature" no matter how altered, the Court's
carefully focused opinion contains enough worrisome dicta to permit plaintiffs
to declare victory even though the Court expressly disclaimed any decision on
genetic diagnostic methods (which, after all, was the purported basis for the
litigation in the first place).
The claims at issue are the following
(remembering that claims, not inventions, are the basis for determining
compliance with the patent statute):
1. An isolated DNA coding
for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set
forth in SEQ ID NO:2.
5. An isolated DNA having at least
15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least
15 nucleotides of the DNA of claim 2.
7. An isolated DNA selected from the
group consisting of:
(a) a DNA having
the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide
position 4056;
(b) a DNA having
the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at
nucleotide position 5385;
(c) a DNA having
the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide
position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ
ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.
U.S. Patent No. 5,747,282;
1. An isolated DNA molecule
coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid
sequence encoding the amino acid sequence set forth in SEQ ID NO:2.
6. An isolated DNA molecule coding
for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein
said mutated form of the BRCA2 polypeptide is associated with susceptibility to
cancer.
7. The isolated DNA molecule of
claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set
forth in SEQ ID NO:1.
U.S. Patent No. 5,837,492
(recombinant vector and transformed recombinant cell claims are not named);
1. An isolated DNA
comprising an altered BRCA1 DNA having at least one of the alterations set
forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a
deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ.
ID. NO:1.
U.S. Patent No. 5,693,473
(nucleic acid probe claims are not recited in the complaint).
The Court's unanimous opinion by Justice Thomas,
with a concurring opinion by Justice Scalia, began with a recitation of the "facts"
as established below; while important this portion of the opinion raises as
many issues as it purports to resolve and will be addressed below. More
important to the issue before the Court (and the answer to the Question
Presented, "Are human genes patentable?") is the legal rationale
Justice Thomas sets forth based on these facts. The Court in a footnote also puts the standing issue to bed, stating
that the only plaintiff found by the Federal Circuit to have standing, Dr.
Harry Ostrer, "has alleged sufficient facts 'under all the circumstances,
[to] show that there is a substantial controversy, between parties having
adverse legal interests, of sufficient immediacy and reality to warrant the issuance
of a declaratory judgment'" under the Court's MedImmune v. Genentech decision.
The opinion begins in the canonical way,
reciting the Constitutional basis of the patent grant, Congress' decision to
define patent eligibility broadly, and the Court's imposition of limitations on
this breadth (wherein laws of nature, natural phenomena and abstract ideas are
excluded). The opinion then provides the
rationale for these exceptions, relying heavily on its recent opinion in Mayo v. Prometheus. These include that such "basic tools of
scientific and technological work" should "lie beyond the domain of
patent protection" because if they did not, "there would be
considerable danger that the grant of patents would 'tie up' the use of such
tools and thereby 'inhibit future innovation premised upon them.'" In so basing its decision on this principle
in this case, the Court ignores the extensive evidence that, with regard to the
BRCA genes and Myriad's patents, there has not been such a tying up of isolated
BRCA DNA (including evidence of more than 10,000 scientific research reports in
peer-reviewed journals regarding research on BRCA). The Court's apprehension of a "tying up"
problem does not exist in this case, regardless of whether it is ever a
realistic deleterious outcome of patenting.
The Court is careful to ensure that its decision
is not interpreted as being a categorical ban on "naturally occurring
things," reminding us that "all inventions at some level embody, use,
reflect, rest upon, or apply laws of nature, natural phenomena, or abstract
ideas," and "too broad an interpretation of this exclusionary principle
could eviscerate patent law," a concept also taken from its Mayo decision. The decision solidifies
the Court's precept that patenting must achieve a "balance" between too
little patenting or too much patenting, either of which the Court believes can
harm innovation and thus not "promote the Progress . . . of the useful Arts."
Turning to Myriad's claims, the Court terms its Diamond
v. Chakrabarty decision as being
"central" to the inquiry of whether claims to isolated DNA are
patent-eligible. Comparing Myriad's
claims to this standard the Court opines that "Myriad did not create
anything" (the limitations of this statement are discussed below). The Court then announces that "[g]roundbreaking,
innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry";
the only saving grace in this statement is the qualifier "by itself,"
which prevents the sentence from being interpreted to mean that "[g]roundbreaking,
innovative, or even brilliant discovery" per se would categorically be outside the scope of patenting (an
interpretation that, inter alia,
would be contrary to the express language of the statute). Support for this statement is, not
surprisingly, Funk Bros. Seed Co. v. Kalo Inoculant Co., which the opinion describes as a case involving claims
to a "mixture of naturally occurring strains of bacteria that helped
leguminous plants take nitrogen from the air and fix it in the soil." The basis for the Court's decision that these
claims were unpatentable is that "the composition was not patent eligible
because the patent holder did not alter the bacteria in any way," and the
Court analogizes the "discovery" that certain bacteria could be
combined with Myriad's "discovery" of the "location of the BRCA1
and BRCA2 genes in the chromosomes." This analysis ignores several distinctions between these inventions,
including (as set forth in the opinion) that the existence of the bacteria in Funk Bros. was known, and that the bacteria had
been isolated and used by farmers to "inoculate" their crops to
improve the level of nitrogen fixation in the soil. In the words of the Court's Mayo decision, the bacteria were "well-known,
established and conventional," in contrast with the BRCA genes isolated by
Myriad into a composition of matter "having a distinctive name, character
[and] use."
Part of the problem, however, is the
specification of the '282 patent and the way it can be (and has been)
misinterpreted; the Court calls out portions of the specification that it reads
as being an assertion by Myriad that its invention was the identification of
the location of the BRCA genes and the association of mutations with increased
breast cancer risk. The Court interprets
this disclosure as "simply detail[ing] the 'iterative process' of
discovery by which Myriad narrowed the possible locations for the gene
sequences that it sought," and then ascribes to Myriad an attempt to "import
these extensive research efforts into the §101 patent-eligibility inquiry"
(finding these efforts to be unavailing). The Court also does not credit isolation of the BRCA genes as being
anything more than cleaving chemical bonds of the BRCA gene from the other
portions of the chromosome. In a portion
of the opinion that seemingly fails to recognize how the chemical compound that
is an isolated DNA molecule is claimed in English words, the opinion states
that "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." It is unlikely that the
Court is implying that the claim should have used chemical structures to identify
the isolated DNA or that such a representation would have satisfied the 101
inquiry. But by the plain meaning of the
language in this sentence of the opinion, the Court ignores the well-recognized
convention that a claim to "an isolated DNA
coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence
set forth in SEQ ID NO:2" is understood to be a representation of the
chemical composition that depends on the chemical changes that differentiate
the isolated DNA from the DNA as it exists in the chromosome. The opinion also
prompts the conclusion that the ACLU's position that "DNA is information"
was successful, despite the fact that DNA sequence information is not patented. This conclusion is reinforced by the next
sentence in the opinion, that:
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 (such as claims 1 and 2 of the '282
patent) 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.
The Justices have passed through the looking
glass to have come to these conclusions based on the evidence presented by
Myriad and its amici.
The Court dealt easily and summarily with the
policy question of whether calling into question thousands of patents granted
by the U.S. Patent and Trademark Office would deny the Executive the deference it
deserves as a co-equal branch of the Federal government. While this is not surprising from a Court
where one Justice believes the PTO is "patent-happy," the position
taken by the Obama administration's Justice Department "weigh[ed] against
deferring to the PTO's determination" that isolated DNA claims encompassing
genomic DNA were eligible for patenting. Insofar as reliance interests are relevant, the Court directs Myriad to
Congress in a footnote.
The Court came to the same conclusion of
patent-ineligibility for claims to oligonucleotides, despite their synthetic
nature and based on the identity of the sequence of these (albeit single-stranded) molecules with the corresponding sequence in chromosomal DNA. On the other hand, the Court found that
claims to cDNA "do[] not present the same obstacles to patentability as
naturally occurring, isolated DNA segments," based on the "creation"
by man of a "non-naturally occurring" DNA molecule. The Court rejected the sequence-based
objections argued by Petitioners, stating that while "[t]he nucleotide
sequence of cDNA is dictated by nature, not by the lab technician," "the
lab technician unquestionably creates something new when cDNA is made." The only exception would be for "very
short series (sic) of DNA [having] no
intervening introns to remove when creating cDNA" which "may be
indistinguishable from natural DNA." In another footnote, the Court rejects the argument that the existence
of pseudogenes (reverse transcription copies of genes reintroduced into human
chromosomes) requires cDNA to be treated as a natural product like genomic DNA,
saying that "[t]he possibility that an unusual and rare phenomenon might randomly create a molecule similar
to one created synthetically through human ingenuity does not render a
composition of matter nonpatentable" (emphasis
in opinion).
The Court in its recent patent decisions has
been careful to craft them to the issue at hand and to avoid broad,
precedential decisions that could implicate future technology in unpredictable
ways. Justice Thomas's opinion does that
here, in the final section of the opinion:
First, there are no method claims
before this Court. Had Myriad created an innovative method of manipulating
genes while searching for the BRCA1 and BRCA2 genes, it could possibly have
sought a method patent.
[Second], this case does not involve patents on
new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson
aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and
BRCA2] sequences, Myriad was in an excellent position to claim applications of
that knowledge. Many of its unchallenged claims are limited to such
applications."
Nor do we consider the patentability of
DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we
express no opinion about the application of §101 to such endeavors.
And the Court set forth succinctly its only
holding:
We merely hold that genes
and the information they encode are not patent eligible under §101 simply
because they have been isolated from the
surrounding genetic material.
There are some troubling aspects to the decision,
not the least of which is the failure of the Court to recognize what in fact
was claimed. The Court's opinion begins
with the assertion that Myriad "discovered the precise location and
sequence of two human genes, mutations of which can substantially increase the
risks of breast and ovarian cancer. Myriad obtained a number of patents based
upon its discovery." The Court also
opines that:
It is undisputed that Myriad did not
create or alter any of the genetic information encoded in the BRCA1 and
BRCA2 genes. The location and order of the nucleotides existed in
nature before Myriad found them. Nor did Myriad create or alter the genetic
structure of DNA. Instead, Myriad's principal contribution was uncovering the
precise location and genetic sequence of the BRCA1 and BRCA2 genes within
chromosomes 17 and 13. The question is whether this renders the genes
patentable.
Of course, that is not how the claims at issue
read nor how those claims would be construed in an infringement action. This failure is significant because it
influences the Court's appreciation of the scope of Myriad's claims and their
preclusive effects. Indeed, the
information disclosed by Myriad, including the chromosomal location of the BRCA
genes, their genetic sequence, and the residues that when mutated enable an
increased risk of developing breast and ovarian cancer do not fall within
the scope of the claims and using this information does not infringe the
composition of matter claims at issue. Accordingly, the Court from the outset approaches the question of
whether these claims do not promote the progress of the useful arts from a
false premise, which colors and distorts the remainder of the decision.
The Court also goes astray in stating that "isolation
is necessary to conduct genetic testing" when discussing the preclusive
effect vel non of Myriad's isolated
DNA claims. Petitioners labored mightily
to conflate the effects of the genetic diagnostic method claims they challenged
and the isolated DNA claims, and they were clearly successful in convincing the
Court that these claims could be asserted against competitors practicing Myriad's
claimed methods. That was not the case
when the patents were filed and was even less the case after Myriad disclosed
the positions of the diagnostic mutations in its patent specification. Once these positions were known, isolation was
no longer necessary.
It is important to recognize what this opinion
does not do: it does not establish a categorical "product of nature"
preclusion and thus should not be interpreted as mandating that other products
of nature (such as those identified by Judge Moore in her concurring opinion)
are categorically unpatentable. Those
cases are to come (and those inventions will be the subject of future
posts). Despite the glaring scientific
and technological weaknesses of the Court's opinion, it does not (fortunately)
invalidate thousands of existing patents or sufficiently upset the "settled
expectations" of the biotechnology community. But the opinion is another data point on a
trend of the Court imposing its opinion of what is patent eligible on grounds
that come perilously close to "we know it when we see it," a standard
that works even less well for patenting than it did a generation ago for
pornography.
Finally, Justice Scalia's concurrence is
remarkable for its intellectual humility and honesty; the Justice refuses to
join the portions of the opinion "going into fine details of molecular
biology," the Justice stating that he is "unable to affirm those details
on my own knowledge or even my own belief." Would that the remainder of the Court had
come to this realization.
Last week, The
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