By Kevin E. Noonan —
The U.S. Supreme Court
will hear arguments in Association for Molecular Pathology
v. Myriad Genetics, Inc. on April 15th, and the parties and their different cadres of amici have submitted briefs of varying
degrees of helpfulness and coherence to the Court. In reviewing these briefs, and the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision that forms
the basis for re-review by the Federal Circuit (albeit with little having been
changed from that reconsideration), the question arises whether what is at
issue in this case is the extent to which Myriad's claims unduly preempt what
should be "free
to all men and reserved exclusively to none." Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,130 (1948).
The context for the
Court's decision is its own recognition that patent eligibility should be given
an expansive scope, as mandated by Congress under 35 U.S.C. § 101. The Court recognized Congress's intent
expressly in Diamond v. Chakrabarty, 447
U.S. 303, 309 (1980), quoting the famous aphorism from the legislative history
that statutory subject matter should "include anything under the sun that
is made by man," a sentiment sounding in Thomas Jefferson's vision that "ingenuity
should receive a liberal encouragement." 5 Writings of Thomas Jefferson
75-76 (Washington ed. 1871). The Court
has been parsimonious in setting forth
what is not patent-eligible: "laws of nature, physical phenomena,
and abstract ideas" have fallen outside the statutory scope, and the Court
has provided explicit examples of what should reside inside those excluded
categories ("a new mineral
discovered in the earth or a new plant found in the wild is not patentable
subject matter" and "[l]ikewise, Einstein could not patent his
celebrated law that E=mc2; nor could Newton have patented the law of
gravity." Chakrabarty,
447 U.S. at 309).
These concerns were of
primary importance in the Court's Mayo v
Prometheus decision, in which the claims (according to the Court) were
directed to a natural law relating to the proper therapeutic dosage of a drug
for treating Crohn's disease. In finding
the claim ineligible for patenting, the Court said that:
The
claims purport to apply natural laws describing the relationships between the
concentration in the blood of certain thiopurine metabolites and the likelihood
that the drug dosage will be ineffective or induce harmful side-effects. We
must determine whether the claimed processes have transformed these
unpatentable natural laws into patent eligible applications of those laws. We
conclude that they have not done so and that therefore the processes are not
patentable.
The deficiency in the claim was thus that it did no
more than "inform a relevant audience about certain laws of nature,"
and "any additional steps [recited in the claim] consist of well understood,
routine, conventional activity already engaged in by the scientific community." Accordingly, "those steps, when
viewed as a whole, add nothing significant beyond the sum of their parts taken
separately" and thus the claimed method was unpatentable.
These concerns frequently arise when the claims
produce nothing more than information ("inform a relevant audience about
certain laws of nature"); this deficiency can be seen to be in common with
Mayo and earlier cases involving the
limits of statutory subject matter. These include O'Reilly v. Morse,
claiming a method of transmitting information using electromagnetism (56 U.S.
62 (1853)); Benson v. Gottschalk, claiming
methods for converting binary-coded decimal (BCD) numerals into pure binary numerals on a general purpose digital computer using a particular algorithm (409 U.S. 63
(1972)); Parker v. Flook, claiming
methods for determining an alarm limit (437 U.S. 584 (1978)); and Bilski v. Kappos, claiming methods for
hedging commodity trading outcomes (130 S. Ct. 3218 (2010)). These decisions of the Court stand in
contrast with its decision in Diamond v. Diehr, where a method for curing rubber using an application of the
Arrhenius equation was deemed patent-eligible (450 U.S. 175 (1981)). The production of a tangible outcome, cured
rubber, distinguishes the patent-eligible claims in Diehr from the information produced in those methods deemed
patent-ineligible by the Court in Mayo,
Morse, Benson, Flook, and Bilski.
The distinction can also be drawn that in Diehr the claimed methods were
particularly drawn to a specific, tangible result (the cured rubber) and that
the claim did not preempt all uses of the Arrhenius equation. The Supreme Court has been wary of claims
that preempt all uses of a law of
nature, as it deemed them to be in Mayo, Benson, Flook, and Bilski; in Mayo, the Court warned that "upholding
the patents would risk disproportionately tying up the use of the underlying
natural laws, inhibiting their use in the making of further discoveries"
and would "threaten to inhibit the development of more refined treatment
recommendations (like that embodied in Mayo's test), that combine Prometheus'
correlations with later discovered features of metabolites, human physiology or
individual patient characteristics." These statements illustrate this Court's continuing concern voiced in Funk Brothers that laws of nature
should not be burdened with patent exclusivity.
Unlike the method claims in
Mayo,
Benson, Flook, and Bilski, Myriad's
composition of matter claims at issue in the Myriad case are not broadly preemptive in the same way. They are
both specific and particular and as such do not implicate the policy concerns
enunciated by the Court in those earlier cases where preemption rendered claims
patient-ineligible. Myriad's claims,
when considered as a whole are narrowly focused on isolated human DNA molecules
that encode a protein having a particular amino acid sequence. The consequences of this specificity narrow
the scope of these claims substantially. Taking claim 1 of Myriad's U.S. Patent No. 5,837,492 as an example:
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.
The scope of this claim should be understood by
these affirmatively recited limitations:
• an isolated DNA molecule that
• encodes a specifically-recited amino acid sequence.
Much of the discussion surrounding these claims in
the Federal Circuit's opinion and in Plaintiffs' and their amici's briefs to the Court focus on the requirement that the DNA
molecule is isolated. Neglected in this
discussion, and particularly relevant to the question of preemption and the
scope of Myriad's composition of matter claims, is the narrowness of the scope
of this claim and the consequences of this narrow scope on the preemption
issue. First, the only isolated (human)
DNA molecules falling within the scope of this claim are those that encode this
(and only this) particular amino acid
sequence encoding BRCA2, which in this case encompasses 3,418 amino acids
arrayed in a particular and specific order. An isolated human DNA comprising any
change in this encoded amino acid sequence is not exclusive to the patentee and
can be performed freely without literal infringement liability by anyone. (The availability of the
doctrine of equivalents for isolated human DNA claims is severely limited by
U.S. Patent and Trademark Office practice in interpreting the application of 35
U.S.C. § 112(a) to such claims, and by ensuing prosecution history
estoppel.)
The significance of this limitation in scope of
Myriad's claims can be understood by the following example. If the single change in the amino acid
sequence of the BRCA2 protein encoded by the claimed isolated human DNA is from
a valine (Val) residue to an isoleucine (Ile) residue, the number of atoms in
the protein would be increased by a mere 3 atoms (the difference in structure
between these two amino acids is a methylene group,-CH2-) out a
total of more than 60,000 atoms in
the protein. Yet, even such a molecule changed
to such a small degree would not literally infringe claim 1 of Myriad's
'492 patent. Similarly, insertions or
deletions of the sequence, mutations and sequence variants (naturally occurring
or man-made) do not fall within the scope of Myriad's claims to a specific, particular
isolated human DNA, due to this restricted scope. Properly construed, claims to isolated human
DNA are the antithesis of the type of broadly preemptive claims that have
concerned the Supreme Court in its earlier precedent, because by their nature such
claims do not "impede the flow of information that might permit, indeed
spur, invention" and thus do not call within the Court's proscriptions
based on these concerns.
Moreover,
such changes, insertions or deletions in the sequence, mutations and sequence
variants (naturally occurring or man-made) are independently patentable to
future researchers who describe such variants and satisfy the statutory
requirements embodied in 35 U.S.C § 112. (The
Federal Circuit has interpreted the disclosure requirements of 35 US.C. § 112 to require that claims
to isolated human DNA must disclose the specific sequence claimed (or provide a
biological deposit thereof). Regents of the University of California v.
Eli Lilly & Co.; Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.
(en banc). The U.S. Patent and Trademark Office has
implemented this interpretation of the statutory requirements (see
USPTO Written Description
Examination Guidelines, 66 Fed. Reg. 1092 (2001)). In fact,
disclosure of the predicted amino acid sequence encoded by the human BRCA2 gene
in Myriad's '492 patent, required as it is by 35 U.S.C. § 112(a) to provide "a
written description of the invention,
and of the manner and process of making and using it, in such full, clear,
concise, and exact terms as to enable any person skilled in the art to which it
pertains, or with which it is most nearly connected, to make and use the same,
and [] the best mode contemplated by the inventor or joint inventor of carrying
out the invention" provides the best starting point for work by future
inventors to identify or produce such changes, insertions or deletions of the
sequence, mutations and sequence variants (naturally occurring or man-made) and
patent them, independent of any restrictions that can be imposed by Myriad (or
any other patentee). Disclosure
as required by the Patent Act is "the quid
pro quo of the right to exclude." Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 484 (1974), and
Myriad's disclosure of the BRCA1 and BRCA2 gene sequence provides future
researchers with the ability to continue to research and make improvements, as
envisioned in Article I of the U.S. Constitution.
In
view of these distinctions, it should be evident that Myriad's claims to
isolated human DNA are different in both kind and effect than the claims the Court
has proscribed due to their capacity to unduly preempt future invention. Viewed in this light, and stripped of the
emotional and political implications generated by presenting the question of
whether human genes should be patent-eligible (a legal question) (as opposed to
whether isolated human DNA should be patented, a policy decision best left to
Congress), the real question before the Court is whether there are grounds
consistent with the issues and concerns motivating prior decisions that support
those who would have the Court apply a categorical rule that isolated human DNA
should be proscribed. The Court can
certainly decide that such policymaking falls within its purview, but only by
expanding the grounds is has previously applied for finding otherwise statutory
subject matter not to be eligible for patenting.
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