By Kevin E. Noonan —

There is a great cultural divide that has been
illuminated by the Myriad case (AMP v. Myriad Genetics), between
producers of technology and its consumers, governments and non-government
organizations such as patient groups who are goal-driven to reduce present
costs (especially in healthcare) regardless of future disadvantages, and the
more general schism between those who understand science and technology and
those who don't.  There is also the
problem of bright, educated, ambitious, and motivated graduates of America's
best colleges and universities who have the natural propensity of their class
and age to think they have better answers than their elders who have actually tackled
the problems of investment and commercialization.  This becomes a problem, of course, when many
of these folks go into government, resulting in the Justice Department's "magic
microscope" as but one example.

Another consequence is that briefs for both sides
of the "gene patenting" question repeat the same arguments based on
the same policy rationales to come to the same conclusions.  The AIPLA's amicus brief in the Myriad case
illustrates the issue.  The brief sets
forth the following propositions:

I. MYRIAD'S CLAIMED DNA MOLECULES ARE NOT PRODUCTS OF
NATURE
    A. Human DNA Is Complex in Both Structure and Function
    B. Myriad Claims Isolated DNA Molecules, Not Found in Humans,
That Can Perform New Functions
II. THE FEDERAL CIRCUIT APPLIED THE CORRECT TEST
    A. Patent Eligibility of Isolated DNA Molecules, Which Are
Compositions of Matter, Must Be Analyzed Under the Applicable Precedents
    B. Prometheus
Applies to
Method Claims, Not to the Isolated DNA Molecule Claims at Issue Here
    C. Myriad's Claims May Not Be Patentable, But That Does Not Make
Them Patent-Ineligible Under Section 101
III. PATENT PREEMPTION DOES NOT PRECLUDE THE PATENTABILITY OF
THE CLAIMED SUBJECT MATTER
    A. The Importance of Broad Patent Eligibility
    B. The Experimental Use Exception Allows For Some Uses of the
Claimed DNA Molecules
IV. CONGRESS HAS RECOGNIZED THE PATENT ELIGIBILITY OF ISOLATED DNA
MOLECULES
    A. Moral and Ethical Considerations Are for Congress, Not the
Courts

There is not an incorrect statement of the law in any of this,
nor the science.  (There are a few
aspects that bear closer scrutiny, as set forth below.)  But it is true that the science of DNA does
not resemble either the pointedly incorrect analogies set forth by the
petitioners (DNA as a kidney, or a leaf, or a mineral) or the equally inapt
analogies by courts (such as the distinctions between a tree and a baseball bat
or a statue and a piece of marble).  Ignoring the facts makes it easy to misapply the law; indeed, the old
aphorism may need to be updated to read "Bad analogies make bad law."  The distinctions set forth in Section I of
the AIPLA's brief are not news to anyone who understands the scientific basis
of isolated DNA.  But generalist lawyers
and judges can be understood (if not forgiven) to have believed that the ways
scientists have tried to explain DNA (as a library or a book or a code or
software) are in fact what DNA actually is.  "A gene is but a chemical compound, albeit a complex one" is
the proper measure of what is encompassed in claims to isolated DNA, and the
conflation of the patent-eligible molecule for the patent-ineligible sequence
has made it easier for petitioners to convince some judges and the public that
patents for human genes are a bad idea.

Nor is the brief incorrect on the law, setting forth the "applicable
precedents" of Chakrabarty, Funk Bros., and J.E.M. Ag Supply to support the proposition that isolated human DNA
satisfies the requirements for the "hand of man" and new utilities of
isolated natural products.  Unfortunately, the matter is before the Court because the patent
eligibility of isolated human DNA has not been decided before, despite the 30
years and thousands of patents in this area.  And the brief is also correct that the principles enunciated in Benson, Flook, Diehr, Bilski, and Mayo do not directly apply, as those were method claims embodying
laws of nature, not composition or manufacture claims directed to isolated "products
of nature."  The brief goes somewhat
astray in making this argument categorically, i.e., based on the statutory
category of invention rather than, for example, on the differences in scope of
the two types of claims.  This is nicely
illustrated by the Myriad claims at issue, which are limited to DNA molecules
that encode a specific amino acid sequence.  Unlike the broad reach of claims to a "law of nature," Myriad's
claims are extremely narrow.  Think:  if a putatively infringing DNA molecule
encodes a protein that differs by even a single amino acid, that DNA molecule
does not literally infringe.  This point
is even sharper when it is recognized that the one amino acid difference could
be a valine to isoleucine change, which is equivalent to the addition or
subtraction of a single methylene group – (-CH₂-) –  in a protein molecule comprising
60,000-100,000 atoms.  Never has so small
a change had so large an effect on claim scope, and yet the AIPLA misses the
opportunity to inform the Court that petitioners' claims about the scope of
preemption occasioned by permitting isolated human DNA to be patented are
grossly exaggerated.  Also in this
section of the brief the AIPLA appears to agree that Myriad's claims may not
even be patentable, a curious position for a brief in favor of patent
eligibility.  Mayo showed clearly that
the Court believes that its Section 101 jurisprudence is "well established"
and a better vehicle for preventing patenting of claims that should not be
patented — why give them a reason to think that Myriad's claims might not be
worth the effort?

The
brief's section on preemption is where questions are raised about the focus of
the brief and its potential vel non
for persuasiveness.  First, rather than
addressing the argument, the brief takes the position that "broad patent
eligibility" is necessary, thereby to a degree conceding to petitioners
the point that these claims broadly preempt use of human genes for
research.  The brief then posits the
existence of an "experimental use exception" for basic research that,
frankly, does not exist.  While there are
some 19th Century district court cases that support the proposition,
for most, the Federal Circuit's decision in Madey v. Duke Univ., 307 F.3d 1351, 1361-62 (Fed. Cir. 2002), foreclosed any
such broad protection against patent infringement liability for university
research.  This is because the Federal Circuit recognized that university research was not for "philosophical experiments" or "gratifying a
philosophical taste, or curiosity, or for mere amusement."  The brief correctly identifies the "safe
harbor" provisions of the Hatch-Waxman Act, codified under 35 U.S.C. §
271(e)(1), but while broadly interpreted by the Supreme Court (Medtronic v. Eli Lilly & Co., Merck v. Integra) this is of limited
usefulness for most inventions including isolated human DNA.  And the brief's citation of In
re Rosuvastatin Calcium Patent Litig., __
F.3d___,
2012 WL 6217356, at *12 (Fed. Cir. Dec. 14, 2012), misses the mark because while "patenting does not deprive the
public of the right to experiment with and improve upon the patented subject
matter" and "[i]t is not necessary to wait for the patent to expire before
the knowledge contained in the patent can be touched," the case does not
stand for the proposition that a three-judge panel of the Court sua sponte created a research exception
sufficient to protect university research on isolated, patented human DNA.  (It is somewhat amusing that one of the
citations set forth in the brief to support the existence of a experimental use
exception is L.C.
Bruzzone, The
Research Exemption: A Proposal, 21 AIPLA Q.J. 52 (1993), which is, on its face, a proposal.)  The better argument, of course, is that there
has never been patent infringement
litigation against basic research, even by Myriad:  indeed, more than 10,000 research papers have
been published since the BRCA gene patents were granted.  This statistic is much more persuasive than
an argument that bolsters the proposition that basic science research is at
risk of patent infringement liability but for the tenuous existence of a
experimental use/research exemption.

Finally,
as has been discussed in previous posts, it is a waste of paper to argue to
this Court deference to Congress on such matters, particularly when it is
inaction, rather than affirmative action, that is the basis for the argument.

Oral
argument is set for April 15th, and Patent Docs will be posting on
additional amicus briefs in the interim and oral argument in due course.

By
Kevin E. Noonan —

Myriad
Genetics filed its responsive  brief with the Supreme Court last Thursday in AMP v. Myriad Genetics ("the Myriad case").  It is a certainly a serviceable brief that
makes the patent law arguments that need to be made and cites at least some of
the precedent that should be cited.  But
reading the brief leaves nothing so much as the impression that Myriad has
squandered its opportunity to submit a brief the Supreme Court would listen to.

The
brief begins by expanding on the Question Presented by Petitioners (and for
which certiorari was granted, i.e., "Are human genes patentable")
to the following:

Did the Federal Circuit correctly apply 35 U.S.C. § 101 to conclude that these
particular molecules are "product[s] of human ingenuity 'having a
distinctive name, character [and] use,'" particularly where the general
legal rule followed by courts for 30 years has been to allow such patent
claims, where the U.S. Patent and Trademark Office ("USPTO") has
issued similar patents since at least 1982 and confirmed in the 2001 Utility
Guidelines that such isolated molecules are patent-eligible as human-made
inventions under § 101, where investors and technology companies have placed
significant reliance in these settled property rights over the last 30 years,
where the alternative dividing line is indefensible under law or science, and
where the challenged claims do not preempt or preclude the use of alternative
technologies to identify a patient's cancer predisposition?

The
brief then makes many of the points that have been made by Myriad and its amici throughout this litigation:  that the
scope of Section 101 of the Patent Act is broad, the Federal Circuit came to
the correct decision, the requirements in Diamond
v. Chakrabarty, 447 U.S. 303, 309 (1980), are controlling precedent and Myriad's claims satisfy these requirements,
and that the government's and Petitioner's arguments and interpretations of the
law are incorrect.  The brief emphasizes
the distinctions between isolated DNA and DNA as it exists in nature, and the
new utilities imparted upon isolated DNA as the result of its isolation.  Myriad distinguishes claims to isolated human
DNA from the unpatentable claims in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (properly
stating that Funk Bros. was a case about "invention," i.e., non-obviousness and not
patent-eligibility), and relies heavily on the Court's interpretation of the
scope of Section 101 in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (1996).  The brief makes the following analogy (among
many):

No one would doubt the patent-eligibility of a newly-created chemical
composition that, when applied in a laboratory to a person's blood or tissue
sample, could detect a mutation genetically predisposing her to a risk of
breast or ovarian cancer, thereby allowing her to take proactive measures to
prolong her life even before cancer actually strikes.  That is what Myriad's
patented molecules are — and they were never available to the world until Myriad's
scientists applied their inventive faculties to a previously undistinguished
mass of genetic matter in order to identify, define, and create the isolated
DNA molecules.

Myriad
argues that there are other provisions of the Patent Act that can properly
cabin claims to their proper scope, and that what Section 101 requires is "invention,"
drawing a parallel with analogous concepts in copyright law (specifically, "the
eligibility threshold of copyright law, which requires authorial 'originality' — defined
as a "minimal level of creativity."  Feist Pub., Inc. v. Rural Tel. Serv. Co., 499 U.S. 340, 358-59
(1991)).

And
the brief reminds the Court that the USPTO has been granting patents on
isolated DNA (and the Federal Circuit upholding them) since 1982 as an
application of the broad interpretation of patent eligibility enunciated by the
Court in Chakrabarty.  Myriad emphasizes efforts by the PTO to
ensure that the scope of claims granted on isolated DNA was appropriate, for
example, as having "specific, substantial and credible" utility,"
citing both the 1995 (Utility Examination Guidelines, 60 Fed. Reg. 36,263 (July
14, 1995)) and 2001 (Utility Guidelines. 66 Fed. Reg. 1092 (Jan. 5, 2001))
versions of the Office's Utility Guidelines.  In this regard, Myriad cites numerous precedent to support the statement
that "isolates or extracts of natural products may be patented";
examples include digitalis (U.S. Patent No. 1,898,199), rapamycin (U.S. Patent No. 3,929,992)
and (perhaps infelicitously) the HIV virus (U.S. Patent No. 5,135,864), among others.

Myriad's
response to the government's position is that it is inconsistent with the
government's previous position permitting patents on isolated DNA in "[o]ver
thirty years of precedent."  Myriad
criticizes the government for arguing that the "line" should be drawn
between cDNA (patent eligible) and "other isolated DNA molecules (not)."  The line has been drawn elsewhere under
established government (PTO) practice, and this "'established general
legal rule' — not to mention the enormous reliance interests and property rights
arising from that practice — is far more worthy of respect than the arbitrary
line now being offered as a mere litigating position by the United States"
says Myriad, citing Bowen v. Georgetown
Univ. Hosp., 488 U.S. 204, 212 (1988).

These
arguments are followed in the brief by an argument related to the "[c]ountless
companies and investors [that] have risked billions of dollars to research and develop
advances under this promise of stable patent protection," followed almost
immediately by a disquisition on the differences between isolated DNA and how
it exists in nature, and a brief history of "the little biotech company
that could" (i.e., Myriad) and
the benefits to human health that resulted from the availability of patent
protection (although it does not explain how claims to isolated, full-length
BRCA1 and BRCA2 genes are relevant to genetic diagnostic testing, then or
now).  The brief does Myriad a great
service in getting before the Court some of the facts regarding the credit
Myriad is amply due in providing genetic diagnostic testing for breast and
ovarian cancer and setting forth the reality (as opposed to Petitioners'
fantasies) regarding the true costs of the tests and the number of women for
whom Myriad's BRCA gene tests are available.  As has been noted by others, Myriad also informs the Court that its "gene
patents" have not impeded research, citing the evidence that "since
the patents issued, over 18,000 researchers have conducted studies on BRCA1/2
genes, published over 8,000 papers, and conducted over 130 clinical trials."

Turning
to Petitioner's arguments, the brief catalogs the many ways that Plaintiffs
have mischaracterized the evidence and the law in making their arguments.  This starts, according to Myriad, with
focusing on the similarities between isolated and naturally occurring human DNA,
because there will always be such similarities with any naturally occurring
product.  What is relevant, according to
Myriad, are the differences, because it is in the differences that will be
illustrated "whether a claimed composition is ''a product of human
ingenuity 'having a distinctive name, character and use'' from a
natural product," citing Chakrabarty.  The brief uses an analogy plucked from the
opinion below to make this point:

A patent-eligible baseball bat, though shaped and formed by human hands, will
share the characteristics of the wood embedded in the tree from which the bat
was formed.  But the fact that the bat shares the properties of natural wood
does not make the resulting, human-made product ineligible for patenting.

And
the brief addresses in this regard Petitioner's "information content"
argument, i.e., that Myriad's claims
are unpatentable because the sequence of the isolated DNA and the DNA as it
exists in nature are identical, pointing out that that to be useful the
sequence of the DNA:

[I]n combination with the inventors' scientific work
and ingenuity in characterizing and defining the molecule's starting and end
points, the severing of covalent bonds, and the removal of the specific defined
molecule from other materials in its native environment to create new
functionality as a probe or primer.  Only because of the addition of human
invention do these molecules exist to help patients chart their own course of
medical treatments.

(In a short
section, the brief also addresses the 1st and 14th
amendment arguments with regard to the absence of any threat to a woman's
access to information regarding her health.)  Perhaps the most apt application
of these principles comes in the brief's argument that, assessed as Petitioner
would have patent eligibility assessed, Chakrabarty's bacterium would not have
been sufficiently different from naturally occurring Pseudomonas bacteria to be eligible for patenting.

Myriad
also has "its day in court" by taking the opportunity to illustrate
the fanciful nature of the litigation, citing quotes from lawyers representing
the ACLU and the Public Patent Foundation (PubPat) that they were just looking
to "sue somebody" over patents to isolated DNA and that the goal was
to "rend[er] invalid patents on many other genes . . . .  We just had to
pick one case as our case."  However
tempting, this portion of the argument, and indeed the entire first section of
the brief, is devoted to Myriad's failed attempt below to convince the lower court
that the one plaintiff found by the Federal Circuit to have standing (Dr. Harry
Ostrer) in fact does not, either by virtue of a lack of "immediacy"
in the threat to his activities posed by Myriad's 1998 letter offering a
license to Myriad's patents to his then employer, NYU, or by virtue of his move
from NYU to Montefiore Hospital at the Albert Einstein College of Medicine
(which had never received a "cease and desist" or license offer
letter).  This portion of the brief goes
over the same ground trod extensively below, and one that the Court dismissed sub silentio by not including it as a
basis for granting certiorari (albeit as
part of Petitioners' Questions Presented that the Federal Circuit had been
overly exclusive in finding a lack of standing among the various
Plaintiffs).  If only by emphasizing this
argument by primacy of placement Myriad seems to have made a misjudgment on why
the Court granted cert. and what it
was interested in deciding.

Even
ignoring this strange choice in presenting the order of its arguments, the real
problem with the brief is that it seems tone deaf to the tenor of this Supreme
Court.  Its emphasis on deference — to
the USPTO or earlier precedent, including especially the Federal Circuit's
decision below — ignores frank and explicit statements and signals from this
Court that deference is not on its menu.  The
brief seemingly ignores the difference between the Chakrabarty Court's understanding of its role as a coequal branch:

Our task, rather, is the narrow one of determining what Congress meant by the
words it used in the statute; once that is done our powers are exhausted.  Congress is free to amend §101 so as to exclude from patent protection
organisms produced by genetic engineering.  Compare 42 U.S.C. §2181, exempting
from patent protection inventions "useful solely in the utilization of
special nuclear material or atomic energy in an atomic weapon."  Or it may
choose to craft a statute specifically designed for such living things.  But,
until Congress takes such action, this Court must construe the language of §101
as it is.

Diamond v. Chakrabarty.

And
this Court's:

[W]e must recognize the role of Congress in crafting more finely tailored
rules where necessary.  Cf. 35 U.S.C. §§161–164 (special rules for plant
patents).  We need not determine here whether, from a policy perspective,
increased protection for discoveries of diagnostic laws of nature is desirable.

(i.e., if Congress does not agree with us
they can "craft[] more finely tailored rules").  (Indeed, some
members of the Court indicated recently at oral argument in Shelby County v. Holder that the Court need not defer to a 98-0
vote in the Senate reauthorizing the Section 5 of the Voting Rights Act.)

The
brief's reliance on deference to the PTO's decisions granting gene patents and
the rules it has implemented to do so (like the 2001 Utility Guidelines) lose
much of its force in view of the brief filed by the government, that these
practices were inconsistent with law and these patents should not have been
granted.  While the brief notes that the
PTO did not join the brief (and the unprecedented nature of this omission), the
Court is certain to be familiar with the concept of the "unified Executive"
and thus likely to come to the conclusion that the PTO is stubbornly resisting
its comeuppance in a hidebound application of incorrect law.  The brief might have more aptly noted that
it is this type of changing positions that is not due deference, as argued
recently in Par Pharmaceuticals' brief in FTC
v. Actavis:

"[W]hatever
deference you are entitled to is compromised by the fact that your predecessors
took a different position."  Transcript of Oral Argument at 44, Kiobel v.
Royal Dutch Petroleum, No.10-1491 (Oct. 1, 2012) (Roberts, C.J.)

Such
a citation might have given the Court pause regarding whether the government's
position was persuasive, but the opportunity to make that case was lost.

Similarly,
the brief focuses on applications of all the other sections of the Patent Act —
§§ 102,
103, 112 — in making its arguments, with the rationale that these sections are
more appropriate or more flexible or more nuanced in their application to the
question before the Court.  This type of
argument was made in Mayo, by the
government, and rejected:

The
Government does not necessarily believe that claims that (like the claims
before us) extend just minimally beyond a law of nature should receive patents.  But in its view, other statutory provisions — those that insist that a claimed
process be novel, 35 U. S. C. §102, that it not be "obvious in light of
prior art," §103, and that it be "full[y], clear[ly], concise[ly],
and exact[ly]" described, §112 — can perform this screening function.  In
particular, it argues that these claims likely fail for lack of novelty under
§102.

This
approach, however, would make the "law of nature" exception to §101
patentability a dead letter.  The approach is therefore not consistent with
prior law.

*  *  *

These
considerations lead us to decline the Government's invitation to substitute
§§102, 103, and 112 inquiries for the better
established inquiry under §101.

(emphasis
added).

The
fact is that the Supreme Court doesn't consider patent questions like you or I,
and patent lawyers would do well to recognize and adapt to that fact.  This brief does not, and its persuasive punch
before the Court is likely much reduced as a consequence.

Finally,
the Court should have put to bed any comprehension that the "settled
expectations" or "economic investment" arguments, such as the
brief's argument that "[c]ountless companies and investors have risked
billions of dollars to research and develop advances under this promise of
stable patent protection," will have much traction, in finding more persuasive the arguments of
consumers rather than producers of technology and rejecting the position of
respondent and amici like the
Biotechnology Industry Organization in Mayo:

Patent protection is, after all, a two-edged sword.  On the one hand, the
promise of exclusive rights provides monetary incentives that lead to creation,
invention, and discovery.  On the other hand, that very exclusivity can impede
the flow of information that might permit, indeed spur, invention, by, for
example, raising the price of using the patented ideas once created, requiring
potential users to conduct costly and time-consuming searches of existing
patents and pending patent applications, and requiring the negotiation of
complex licensing arrangements.  At the same time, patent law's general rules
must govern inventive activity in many different fields of human endeavor, with
the result that the practical effects of rules that reflect a general effort to
balance these considerations may differ from one field to another.

The
ACLU and PubPat have prevailed — at the District Court and the court of public
opinion — by making this case about everything but patent law.  While in a different time it might have been sufficient to emphasize patent law in this argument, that time has passed
(at least for now).  The Court has
evinced a concern that its decisions now may inhibit future progress (a salient
concern, in view of the Constitutional imperative that patents and patent law "promote
the progress"), as noted in Bilski v.
Kappos:

It is important to emphasize that the Court today is not
commenting on the patentability of any particular invention, let alone holding
that any of the above-mentioned technologies from the Information Age should or
should not receive patent protection.  This Age puts the possibility of
innovation in the hands of more people and raises new difficulties for the
patent law.  With ever more people trying to innovate and thus seeking patent
protections for their inventions, the patent law faces a great challenge in
striking the balance between protecting inventors and not granting monopolies
over procedures that others would discover by independent, creative application
of general principles.  Nothing in this opinion should be read to take a
position on where that balance ought to be struck.

Emphasizing
the negative consequences on progress and innovation of a decision in the ACLU's
favor would have provided the Court with greater motivation to pause before
taking a broad, sweeping and unnecessary position on where the balance should
be struck on patenting isolated human DNA.  Myriad's brief gives the Court no basis for doing so.