By Kevin E. Noonan —

Several weeks ago, U.S. District Court Judge Robert
W. Sweet denied the U.S. Patent and Trademark Office's motion to dismiss the
ACLU-sponsored lawsuit aiming for a human gene patenting ban (see "BRCA Patent Suit to Continue in Southern District of New York").  Just before Christmas, the Office
filed another motion with the District Court, for judgment on the pleadings (as well as
opposition to Plaintiffs' summary judgment motion).

The brief, by Preet Bharara, U.S. Attorney for the
Southern District of New York and Ross E. Morrison, Assistant U.S. Attorney, is
broadly based on jurisprudential principles of avoiding a constitutional issue
when possible, citing Allstate Ins. Co. v. Serio, 261 F.3d 143, 149-150 (2d Cir. 2001), and Spector Motor Serv. Inc. v. McLaughlin, 323 U.S. 101 (1944) ("'If
there is one doctrine more deeply rooted than any other in the process of
constitutional adjudication, it is that we ought not to pass on questions of
constitutionality . . . unless such adjudication is unavoidable.'")

Accordingly, the brief argues, Plaintiffs' remedy is to prevail against the other
defendants on the grounds that the patents-in-suit are invalid.  The Office asserts that the Patent Act
gives plaintiffs' a statutory basis for challenging the patents-in-suit, on the
grounds that the claims do not recite patent-eligible subject matter under § 101.  Thus, the brief argues, should the District Court find that the Myriad patents were improperly granted under 35 U.S.C. § 101
(as being subject matter not eligible for patenting), there will be no need to
address the constitutional aspects of the patent-eligibility issue.  Moreover, the Office contends it cannot
be haled into court for granting a patent in contravention of the Patent Act,
citing Syntex (USA), Inc. v. U.S. Patent
and Trademark Office, 882 F.2d 1570, 1572-1574 (Fed. Cir. 1989).

The office then argues that for the District Court to reach the constitutional issues
raised in the complaint, it must first decide that the Patent Office properly applied the relevant provisions
of the Patent Act, and thus that the Patent Act itself, not just the Office's
implementation of it, is unconstitutional.  With that, the brief turns to the substantive
constitutional questions raised in the lawsuit, identifying two:

1.  That granting gene
patents are contrary to Article I, section 8, clause 8 (termed "the IP
Clause" in the brief); and

2.  That
granting gene patents violates the First Amendment.

With regard to the IP Clause argument, the brief points
out plaintiffs' unfamiliarity with, or ignorance of, the meaning of the
Constitutional language reciting the copyright and patent clause.  Plaintiffs allege in their summary
judgment brief that the claims "impede rather than promote the progress of
science."  But the language of
the Constitution that mentions "science" does not refer to patents
but rather to copyrights, since in the 18th Century the term "science"
was associated with "learning or knowledge," and what we think of as
technology (what is eligible for patenting) was termed "the Useful Arts."  Thus, the brief contends that allegations
that the Patent Act does not promote "science" are "not relevant"
to the patent system, citing Graham v. John Deere Co., 383 U.S. 1, 5 (1966) (the brief also cites Eldred v. Ashcroft, 537 U.S. 186, 192-92
(2003), which concerned a challenge to revisions to the Copyright Act).

The Office also argues that it is "far from clear"
that the preamble to the IP Clause limits the power of Congress in establishing
the patent laws.  The brief cites
the Eldred case for this proposition,
as well as the Supreme Court's Second Amendment decision (District of Columbia v. Heller, 128 S. Ct. 2783, 2789 (2008)), where
the Court held that, outside a "clarifying function, a prefatory clause
does not limit or expand the scope of the operative clause" in the Second
Amendment.

Continuing, the brief further argues that there are
limits to the extent of review the District Court can give to the
constitutional question even if it were to reach it, saying it is well
established that "Congress has the power to establish a patent system as
it [sees] fit."  This is
essentially an argument for deference, the brief citing in support Graham as well as Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141
(1989).  While this power of
Congress may not be "absolute," the brief contends that at most
Congress' implementation of the IP Clause is subject to rational basis review,
again citing Eldred:  "[u]nder
that standard," the brief asserts, "courts 'accord great deference to
Congress's policy determinations,' and judicial review 'is limited to whether
Congress's actions were 'a rational exercise in the legislative authority
conferred by the [Patent] Clause,'" citing Figueroa v. United States, 466 F.3d 1023 (Fed. Cir. 2006).

Answering its own question in this regard, the
Office contends that there is no doubt that Congress had "a rational basis
to believe that a statutory scheme that established broad categories of subject
matter eligible for patenting . . . would promote innovation and research."  Further, whether the patents-in-suit
were properly granted does
not implicate the constitutionality of the Patent Act:  "[t]he fact that some patents
issued under the patent system can be argued not to 'promote progress' has no
bearing on the question of whether the system as a whole has a rational basis"
and is "simply not relevant," citing Eldred ("In sum, we find that the [Copyright Term Extension Act] is a
rational enactment; we are not at liberty to second-guess congressional
determinations and policy judgments of this order, however debatable or
arguably unwise they may be.")

The
proper question in this regard, the Office contends, is whether
permitting patents on compositions of matter and processes have a rational
relationship to "Congress's legitimate objectives under the IP Clause."  Here, the brief asserts, there are
"multiple plausible bases" upon which Congress could have enacted § 101.  These include that "[c]hoosing
broad categories of subject matter ensured that the Patent Act would not have
to be repeatedly amended to accommodate new and emerging technologies,"
citing Diamond v. Chakrabarty for
the proposition that the Supreme Court had "specifically found that broad
statutory categories fulfill the constitutional goal."  Even limiting the question to the gene
patents at issue, the brief argues that Congress had a rational basis for
permitting patenting in "a field of technology [that] can be expected to
stimulate investment, research and innovation within this area, all to the benefit
of the national economy," citing the House of Representative report on the
Hatch-Waxman Act.

The brief also cites numerous academic sources for
the proposition that biotechnology required intensive investment and thus
patent protection to promote such investment.  The brief then cites the benefits of disclosure as a
rational basis for patenting, because "other researchers learn what has
been patented, and therefore are able to focus their research dollars on areas
that have yet to be explored."  "Under rational basis
review, the task of performing the 'careful balance between the need to promote
innovation and the recognition that imitation and refinement through imitation
are both necessary to invention itself and the very lifeblood of a competitive
economy,' must be left to Congress," the Office asserts, citing Bonito
Boats, 489 U.S. at 146.

Finally, the brief reminds the District Court that Congress
had recently considered, and did not deign to pass, a bill prohibiting gene
patenting, asserting that this constitutes a suggestion "that courts
should tread lightly in this area."

Regarding the First Amendment argument, the brief
contends that the First Amendment does not provide a substantive limitation on
Congress' authority to enact patent laws.  Indeed, the Office argues that the Patent Act actually
supports the concerns motivating the First Amendment, since it "promote[s]
the dissemination of knowledge."  Citing Kewanee Oil Co. v. Bicron, 416 U.S. 470 (1974) for support, the
brief asserts that:

[T]he
Patent Act promotes free speech and general dissemination of information
because it grants a temporary exclusive right to an invention in exchange for
disclosure of information that might otherwise have remained secret.  By making
the information about the invention available, it creates the possibility for
stimulating further research in a related area as well as for one who wants to
practice the invention to seek a license.  If the information were
kept secret — potentially in perpetuity, depending on the nature of the
technology — no such opportunity would arise.

The brief then contends that patents are fully
compatible with free speech rights, noting that Congress enacted the first
Patent Act "in close proximity" to adoption of the First Amendment.  Indeed, the Office argues, the Framers did not seem to believe
there was any "tension" between the IP Clause and the First
Amendment, "given the proximity in time between the establishment of the
patent system and the ratification of the First Amendment."

The
Office also argues that any purported impact on free speech is not unique to
the patents-in-suit.  The brief mentions
in particular Morse's patent on the telegraph and Bell's patent on the
telephone as patents impacting "free" speech, specifically by
charging a fee for speech:  "[i]n each case, individuals wishing to use
these devices to communicate their thoughts or to gain access to new knowledge
could do so only subject to the rights of the patentholder."  In a footnote, the brief makes this
point more forcefully:

"Nothing
in the First Amendment requires that the exercise of First Amendment rights be
cost-free.  Those who wish to publish must pay for the equipment and labor (or
internet access) required for publication; indeed, even parade demonstrators
may be required to pay to exercise their First Amendment right to march,"
citing Cox v. New Hampshire, 312 U.S. 569, 576-77 (1941) and, more
generally, Eric Neisser, Charging for Free Speech: User Fees and Insurance
in the Marketplace of Ideas, 74 Geo. L.J. 257 (1985).

Even
the portion of the statutes providing for remedies for infringement could, the
brief asserts, "be said to regulate speech and thus, according to
plaintiffs' theory, to violate the First Amendment."  Any "incidental limitation" of unfettered speech is just
"a temporary burden on the public that Congress has deemed necessary to
encourage invention and disclosure of inventions that inure to the public
benefit," the brief contends, and it characterizes such limitation as ones on conduct, not speech,
thus not implicating the First Amendment.  Making the point more strongly, the Office argues
that "[t]here
are few restrictions on action which could not be clothed by ingenious argument
in the garb of decreased data flow.  For example, the prohibition on
unauthorized entry into the White House diminishes the citizen's opportunities
to gather information he might find relevant to his opinion of the way the
country is being run, but that does not make entry into the White House a First
Amendment right.  The right to speak and publish does not carry with it the
unrestrained right to gather information," citing Zemel v. Rusk,
381 U.S. 1, 16-17 (1965).

The brief's conclusion is that:

[T]he
free-speech interests here — if any — are subordinate to the interest in a
working patent system that provides complete remedies to patentholders.  The
question is not whether any given patent might inhibit more speech than it
promotes, but rather whether in establishing a patent system that awarded such
a patent, Congress somehow violated the First Amendment.  Because Congress did not, plaintiffs'
First Amendment claim should be dismissed.

The Office then goes on the offensive in this
regard, stating that the Supreme Court has held the patent statutes to "promote
free speech interests," notably by Supreme Court decisions precluding information
and abstract ideas from being patent-eligible (citing Gottschalk v. Benson).  Using Eldred as an
illustration, the brief illustrates the infirmities of plaintiffs' First
Amendment case:  the plaintiffs in Eldred raised similar First Amendment
allegations against the 1998 Copyright Term Extension Act, and the Supreme
Court held that the Copyright Act and the First Amendment were compatible on
historical grounds (closeness in time of adoption).

The brief also rebuts the
argument that patenting genes is the same as patenting information, citing Amgen Inc. v. Chugai Pharmacutical Co. ("A gene is a
chemical compound"), and reminding the District Court that chemical compounds have
been patent-eligible subject matter since the first Patent Act.  "[P]laintiffs attempt to blur the line between genes, which
are chemical compounds, and genetic sequences, which are human-created
representations that identify one of the gene's properties:  the arrangement of
nucleic acids in the gene.  . . .  Plaintiffs fail to cite — nor is the USPTO
aware of — any case law supporting the notion that a chemical (or machine or
any other physical structure) that is capable of conveying information no
longer qualifies for patent protection based on the fact that it has
informational content."  This
distinction between chemistry and information is accommodated by the Office,
according to the brief, citing specifically the Utility Guidelines (wherein the
Office does not grant patents on the nucleotide sequence but on the chemical),
and that use of the sequence per se is not patent infringement.  Regarding Plaintiffs' argument that
genes can be represented by "a series of letters" and hence comprise
information, the brief also reminds the court that "[a]ll chemicals
can be described in letter and number format."

The brief provides a good example of the constitutional and
jurisprudential deficiencies in the Plaintiffs' arguments.  The risk, of course, is that Judge Sweet
will grant the Office's motion, thus removing any incentive for the Office to
weigh in on the substantive question raised in Plaintiffs' summary judgment
brief — that the patents on the BRCA1 and BRCA2 genes were improperly
granted.  No matter what decision
the parties receive from the Judge, the case will be appealed and eventually
reach a petition for certiorari.  At that point, it is likely that the Solicitor General will set out the
Administration's position on the patent-eligibility of isolated human DNA.  But it could be helpful to have the
Office's arguments before the case gets to that point.

For
information regarding this and other related topics, please see:

•
"Gene Patenting: Australian Potpourri," December 28, 2009
•
"Science Progress Article Examines Impact of Gene Patents on Research,"
December 21, 2009
•
"Gene Patenting Debate Continues – Round Three," December 17, 2009
•
"BRCA Patent Suit to Continue in Southern District of New York,"
November 2, 2009
•
"Empirical Research Fails to Support Gene Patenting Ban," October 22,
2009
•
"The Tragedy of a Bad Idea," August 25, 2009
•
"Gene Patenting Debate Continues – Round Two," August 4, 2009
•
"The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
•
"Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate,"
June 15, 2009
•
"Gene Patenting Debate Continues," June 9, 2009
•
"Association for Molecular Pathology v. U.S. Patent and Trademark Office,"
May 17, 2009
•
"Court Report: Special Edition," May 13, 2009
•
"BIO IP Policy Briefing," May 11, 2009
•
"Gene Patenting and the Wisdom of Judge Lourie," April 12, 2009
•
"The Effects of Intellectual Property Protection on Agricultural Research:
Patents Are Not The Problem," February 3, 2009
•
"Newsweek Joins the Anti-patent Bandwagon," January 26, 2009