No. 08-964
In The Supreme Court of the United States
BERNARD L. BILSKI AND RAND A. WARSAW,
Petitioners,
v.
JOHN J. DOLL, ACTING UNDER SECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY AND ACTING
DIRECTOR, PATENT AND TRADEMARK OFFICE,
Respondent.
ON WRIT OF CERTIORARI TO THE UNITED STATES
COURT OF APPEALS FOR THE FEDERAL CIRCUIT
BRIEF OF AMICUS CURIAE MEDTRONIC, INC.
IN SUPPORT OF NEITHER PARTY
Lawrence M. Sung
Michael J. Jaro
Counsel of Record
Noreen C. Johnson
Jeff E. Schwartz
Girma Wolde-Michael
Dewey & LeBoeuf, LLP
Medtronic, Inc.
1101 New York
710 Medtronic
Avenue, NW
Parkway, NE
Washington DC 20005
Minneapolis MN 55432
(202) 346-8000
Attorneys for Amicus Curiae
LEGAL PRINTERS LLC, Washington DC ! 202-747-2400 ! legalprinters.com
i
QUESTIONS PRESENTED
1. Whether the Court of Appeals for the Federal
Circuit erred by holding that a “process” must be
tied to a particular machine or apparatus, or
transform a particular article into a different state
or thing (“machine-or-transformation” test), to be
eligible for patenting under 35 U.S.C. § 101, despite
this Court’s precedent declining to limit the broad
statutory grant of patent eligibility for “any” new
and useful process beyond excluding patents for
“laws of nature, physical phenomena, and abstract
ideas.”
2. Whether the Federal Circuit’s “machine-or-
transformation” test for patent eligibility, which
effectively forecloses meaningful patent protection to
many business methods, contradicts the clear
Congressional intent that patents protect “method[s]
of doing or conducting business.” 35 U.S.C. § 273.
ii
TABLE OF CONTENTS
QUESTIONS PRESENTED ....................................... i
TABLE OF CONTENTS ............................................ ii
TABLE OF AUTHORITIES ..................................... iv
INTEREST OF THE AMICUS CURIAE .................. 1
SUMMARY OF THE ARGUMENT........................... 1
ARGUMENT .............................................................. 2
I. The Experience of Amicus Curiae Medtronic,
Inc., as a Global Leader in Medical Technology
Innovation Suggests that the Court of Appeals’
Revision of Section 101 of the Patent Act to
Require a Machine or Transformation Will
Jeopardize Progress Across Diverse Industries. ... 2
II. Examples of Significant Medical Advances
that a Machine-Or-Transformation Requirement
Would Render Patent Ineligible............................. 5
A. Patient Diagnosis............................................ 7
B. Monitoring and Medical Data Management.. 9
C. Personalized Medicine .................................. 11
III. Section 101 Should Be Inclusive, Rather
Than Exclusive...................................................... 12
iii
IV. Section 101 Should Invite the Patenting of
All Inventions that Result from Human
Ingenuity and Manipulation. ............................... 15
V. A Machine-Or-Transformation Requirement
Would Harm the Public by Deterring Prompt
and Open Disclosure of Medical Breakthroughs
and by Discouraging Investment in Medical
Innovation. ............................................................ 19
CONCLUSION......................................................... 21
iv
TABLE OF AUTHORITIES
Cases
Classen Immunotherapies, Inc. v. Biogen Idec,
304 Fed. Appx. 866, 2008 WL 5273107
(Fed. Cir. 2008) (non-precedential) ...................... 15
Diamond v. Chakrabarty, 447 U.S. 303 (1980)....... 17
Diamond v. Diehr, 450 U.S. 175 (1981)................... 14
Gottschalk v. Benson, 409 U.S. 63 (1972).......... 14, 17
In re Alappat, 33 F.3d 1526 (Fed. Cir. 1994)
(en banc) ................................................................ 14
In re Bilski, 545 F.3d 943 (Fed. Cir. 2008)
(en banc) ............................................................ 3, 17
In re Comiskey, 499 F.3d 1365 (Fed. Cir. 2007)...... 14
Lab. Corp. v. Metabolite, 548 U.S. 124 (2006)... 15, 16
Parker v. Flook, 437 U.S. 584 (1978)....................... 14
Prometheus Labs., Inc. v. Mayo Collaborative
Servs., No. 2008-1403 (Fed. Cir. 2009)................. 15
State St. Bank & Trust Co. v. Signature Fin.
Group, 149 F.3d 1368 (Fed. Cir. 1998)................. 14
Statutes
35 U.S.C. § 101 ..........................................1, 15, 18, 19
INTEREST OF THE AMICUS CURIAE1
With the consent of the parties, this brief is filed by
Amicus Curiae, Medtronic, Inc., which is a global
leader in medical technology innovation. Amicus
Curiae engages in the research and development,
design, and manufacturing of medical products for
use in the diagnosis, monitoring, and treatment of
various diseases. Amicus Curiae’s business
operations include the medical technologies of
Cardiac Rhythm Disease Management, Spinal and
Biologics, CardioVascular, Neuromodulation,
Diabetes, Surgical Technologies, and Emergency
Response Systems. Medtronic has no financial
interest in the outcome of this case. Medtronic seeks
an application of the patent laws in a manner that
most effectively promotes innovation and most
accurately reflects the intent of Congress.
SUMMARY OF THE ARGUMENT
The requirement that a process must be tied to a
particular machine or apparatus, or must transform
a particular article into a different state or thing to
be eligible for patenting under 35 U.S.C. § 101 would
1 Pursuant to Supreme Court Rule 37, no counsel for any party
authored this brief in whole or in part, and no person or entity
other than Amicus Curiae made a monetary contribution to the
preparation or submission of the brief. Counsel of record for all
parties were notified prior to filing and have consented to this
filing. Letters of consent have been filed with the Clerk of the
Court.
2
adversely affect medical technology innovation. The
machine-or-transformation requirement would
preclude the patenting of significant advances in
medical research and development, diagnosis,
prevention, and treatment. Without the full range of
incentives of patent exclusivity, medical innovation
will suffer the loss of investment and a retreat into
secrecy, the very harms the patent laws were
enacted to guard against. Moreover, impeding the
patenting of medical breakthroughs jeopardizes
public health goals, including affordable universal
access, by deterring the invention and public
disclosure of competitive medical technology. The
machine-or-transformation requirement is therefore
inappropriate and should be discarded.
ARGUMENT
I. The Experience of Amicus Curiae Medtronic,
Inc., as a Global Leader in Medical Technology
Innovation Suggests that the Court of Appeals’
Revision of Section 101 of the Patent Act to
Require a Machine or Transformation Will
Jeopardize Progress Across Diverse Industries.
Ingenuity has many faces, and innovation takes
many shapes. These simple truths, however, were
ignored by the Court of Appeals when it decided the
case now before this Court by fashioning a broad,
limiting test with questionable application across
different technologies. Indeed, this Court’s review of
3
the Court of Appeals’ judgment in In re Bilski, 545
F.3d 943 (Fed. Cir. 2008) (en banc), involves the
significant revision of a patent law standard that has
far reaching implications beyond the parties or any
one particular industry. While much public attention
has focused on the implications for financial services
and computer software companies, the consequences,
unintended or otherwise, for medical technology and
health care have been understated. In this regard,
Amicus Curiae seeks to better inform the impact of a
change in patent eligible subject matter that Bilski
represents.
The benefits of a robust patent system where Section
101 of Title 35 of the U.S. Code has earned the
healthy reputation for inclusion, rather than
exclusion, are reflected in the story of Amicus
Curiae. Founded over a half century ago, Amicus
Curiae began as a medical equipment repair shop.
The company’s first product, inspired by a musical
metronome, was nothing short of a life changing
therapy – a wearable, battery-powered cardiac
pacemaker. This innovation was the foundation for
dozens more therapies of Amicus Curiae, which used
its electrical stimulation expertise to improve the
lives of millions of people.
Over the years, Amicus Curiae adapted additional
technologies for the human body, including radio
frequency therapies, mechanical devices, drug and
biologic delivery devices, and diagnostic tools. Today,
4
the technologies of Amicus Curiae are used to treat
more than 30 types of chronic diseases affecting
many areas of the body. Since its humble beginnings
in Minnesota, Amicus Curiae has grown into a
multinational company that uses technology to
transform the way debilitating, chronic diseases are
treated.
Amicus Curiae thus implements a diverse group of
technologies with a focus on the need to provide
precise clinical interventions as well as progressively
decentralized health care delivery systems tailored
to specific patient needs. Specifically, Amicus
Curiae’s current and future product platforms
integrate a hybrid of technologies, such as
electromechanical, electrical, communication
systems, biotechnology, drugs, and information
systems, with the objective to identify patient risk
and deliver appropriate therapy by continuously
monitoring physiological parameters of a patient or
indices of a disease state.
In this highly integrated medical product
environment, physiological data or health
information, which generally relate to “natural laws
or principles” based on correlations, comparisons,
and deductions, are being used to inform and
manage therapy delivery and treatment. Amicus
Curiae invests heavily in the innovative use,
integration, and implementation of these
physiological data and relies on the patent system to
5
advance innovation and deliver on Amicus Curiae’s
long-standing mission to alleviate pain, restore
health and extend life.
Most importantly, the public has been a direct
beneficiary of the medical advances made possible by
Amicus Curiae and others because a robust patent
system has provided the incentive to innovate and
invest in medical technology. The lives of countless
patients, as well as those of their families and
communities, have been touched by medical
inventions such as rapid diagnostic tests and
minimally invasive surgical procedures.
II. Examples of Significant Medical Advances
that a Machine-Or-Transformation
Requirement Would Render Patent Ineligible.
In an attempt to better inform this Court’s
understanding of the various medical technologies
that may be affected by upholding the Bilski revision
to patent eligibility, Amicus Curiae respectfully
submits a series of examples drawn from composite
experiences of Amicus Curiae as a global leader in
medical technology innovation research and
development on human conditions, disease states,
and therapies relating to the heart, brain, spine,
bladder, stomach, blood vessels, and more. These
illustrations, which include Patient Diagnosis,
Monitoring and Medical Data Management, and
Personalized Medicine, reflect the extraordinary
6
breadth of technology in this industry sector and
foreshadow the importance of recognizing the grave
potential consequences, unintended or otherwise, of
Bilski for medical technology and health care.
In particular, the examples highlight the problem of
setting a limiting standard for patent eligibility that
applies across diverse fields of technology to
encourage inventors to elect the rights and
obligations of the patent system. The machine-or-
transformation requirement presents a poor fit for
those fields that depend on the generation of
predictive models from a comparison of individual
sample information against a database of previously
gathered information. Some have disparaged certain
methodologies in this regard as the mere correlation
of natural phenomena. However, while the bare
observation and act of correlation per se may not be
patent eligible, precisely how a specific correlation is
achieved should be.
In the context of medical technology, the proper
evaluation and effective treatment of patients
depend upon complex correlations assessed over
prescribed times. This, in turn, relies upon the
generation of predictive models from a comparison of
an individual patient’s signs and symptoms against
a database of studied human wellness parameters,
which contain patterns of diagnosis, chosen
treatment, and outcome. These efforts are far from
trivial.
7
A. Patient Diagnosis
As applied to medical technology, the Bilski
machine-or-transformation revision to Section 101
essentially precludes the patenting of patient
diagnosis. Under the Bilski test, a method of
diagnosis unaccompanied by a medical device or
treatment step would be patent ineligible. However,
the development of a diagnostic test almost always
precedes the ability to treat the disease and is often
a distinct research enterprise separated by years, if
not decades.
Indeed, the Patent Office has begun to require
patent applicants for medical diagnostics inventions,
who seek to overcome rejections under Section 101 in
the wake of Bilski, to recite treatment steps. And
moreover, the Patent Office has been inconsistent in
administering whether the additional recitation of
treatment steps will suffice. In any event, this
misapprehends the nature of medical diagnostics
development, with the effect being an increasing use
of Section 101 ineligibility as a dispositive ground for
denial of patent grant.
The criticality to the health care system of achieving
diagnostic correlation for predictive patient modeling
notwithstanding, this type of correlation is what
serves as the foundation for further research and
development. Without the incentive to find such
correlations due to the absence of patent exclusivity,
8
many avenues of medical treatment may remain
underdeveloped or altogether unexplored.
The patent claims to diagnostic methodologies,
which have been patentable under Section 101
because they yield a useful, concrete, and tangible
result, would fail under the Bilski machine-or-
transformation test. There is no preemption of a
fundamental principle when a correlation is of
defined scope, typically associated with a particular
condition or disease state. For example, imagine a
method of determining the risk of Sudden Cardiac
Death (SCD) involving the identification of one or
more single nucleotide polymorphisms in a patient.
This insight could enable a health care provider to
take active measures to successfully prevent or treat
a life threatening condition before the occurrence of
any adverse event.
Consider also the ability to treat children born with
a pulmonary artery malfunction using a method of
intelligent scheduling of required multiple surgeries
as the children grow. This protocol would ensure
that the necessary sizes and types of implantable
medical devices are provided at the exact times
needed to minimize the number of dangerous,
painful, and sometimes disfiguring procedures.
But patent claims to such innovations may be
susceptible to Bilski patent ineligibility although
they do not preempt a fundamental principle or
9
equate with an insignificant extra-solution activity.
To the contrary, these inventions improve the
quality of health care delivered and patient
outcomes through earlier diagnosis, less invasive
treatment options, and reductions in hospital stays
and rehabilitation times. These important medical
innovations would be undermined if this Court were
to uphold the Bilski machine-or-transformation test.
B. Monitoring and Medical Data Management
The dependable and accurate relay of patient data is
an essential component of life saving treatment.
There are numerous applications for patient data
management that span the spectrum of chronic to
acute care. In one instance, a methodology has been
developed to communicate information of the
physiological state of a patient who has experienced
an emergency medical event to a patient treatment
center to enable the receiving facility to prepare for
the patient’s arrival. One application of this
methodology could be routing event data from a field
device, such as an external defibrillator, to a
computer server for information distribution
throughout various hospital displays.
Another patient data management system transfers
cardiac information to assist doctors in making a
decision on whether to bring the patient to a clinic or
otherwise monitor long term trends, therapy, and
cardiac events. Specifically, the system is a patient
10
management tool that builds upon ideas relating to
continuous monitoring of physiological variances or
indicators, which are used to monitor a cardiac
patient remotely and tailor therapy and health care
as appropriate. Thus, the system is dependent upon
correlations, extrapolations, and deductions based on
the detection or monitoring of natural phenomena.
In most of these types of patient management
systems, the process of diagnosis, monitoring, or
even therapy delivery may not be tied to a machine
or apparatus or transform a particular article into a
different state or matter. Generally, the major aspect
of the operation may be comparative, correlative,
iterative, and deductive, rather than transformative.
Although certain embodiments of this technology can
be captured through patent claims that include
specific device elements (and thus pass muster
under the Bilski machine-or-transformation test), if
patent protection to the methodology itself were
unavailable, the initial concept may not have
resulted in further development to achieve actual
application. The business of innovation often
depends on the initial formulation of a system that
only later finds integration with real world devices.
To deny patent eligibility for such methodologies
would impede this innovation.
11
C. Personalized Medicine
The field of personalized medicine and
pharmacogenomics is rapidly gaining traction in the
medical technology space. The ability to correlate a
patient’s genomic profile and gene expression with
drug adverse event data can enable health care
providers to maximize the probability of a desired
treatment outcome and minimize the risk of harmful
side effects. The recognition and understanding of
the relationships between certain genetic mutations
and the occurrence of common diseases to develop
treatments tailored to an individual patient is the
exciting potential this medical technology presents.
However, the labor and cost intensity of these
correlations are discouraging without the incentive
of patent exclusivity.
As an example, the identification of genetic markers
arguably would suffer inactivity or delay due to
concerns over collaboration, material transfer, and
licensing, in the absence of the defined intellectual
property rights that patents provide. The Bilski
machine-or-transformation test, if upheld as the sole
test for patent eligibility under Section 101 as
espoused by the Court of Appeals, would not easily
resolve questions about personalized medicine
inventions where a machine element or
transformation event seems inapposite. Like the
jurisprudence relating to the patent law doctrine of
equivalents, where this Court recognized that the
12
function-way-result test might be inapplicable to
certain technologies, the Bilski standard is similarly
unaccommodating to certain technologies that exist
today as well as those yet to come.
III. Section 101 Should Be Inclusive, Rather
Than Exclusive.
Section 101 is the principal invitation of the patent
laws to would-be innovators everywhere to bring
forward the products of their inventive efforts. Using
Section 101 in a gate keeping role projects a
disenfranchising image of a system established, in
the words of President Abraham Lincoln, to add “the
fuel of interest to the fire of genius.” Without the
continued openness of Section 101, this essential
combustion that drives the engine of innovation may
become a thing of the past. With public health
priorities already taking center stage, we cannot
afford to deny the promise of medical advances that
have yet to be seen by restricting patent eligible
subject matter under a machine-or-transformation
test.
Unlike the other conditions for patentability set
forth under the patent statutes, namely novelty and
nonobviousness, Section 101 of Title 35 governs
patent eligible subject matter and utility, both of
which do not require a comparative assessment of
the claimed invention against the prior art. Without
such a measure, Section 101 is ill suited to execute a
13
gate keeper function because it is relatively
insensitive to the pace of innovation in a specific art.
Rather, Section 101 looks more holistically to
progress in the useful arts and best fulfills a role as
a static prescription, which embraces existing
technology, and more importantly, encourages the
ingenuity of technology yet to come. Accordingly,
attempting to refine Section 101 to strike a
normative balance today merely defers the debate
until a new technology of concern arrives. But the
true detriment of revising the patent eligibility
standard now would be the incalculable lost
opportunity from potential innovators discouraged
from invention and public disclosure.
Advances in medical technology would not be
immune from the effect of the machine-or-
transformation requirement set forth in Bilski.
Medical technology encompasses numerous products
and processes, including medical devices and
supporting software. Indeed, there are many aspects
of medical technology that would pass muster
nonetheless under the Bilski revision to patent
eligibility, but significant other aspects remain that
would be impeded. And even in those instances
where a device component or transformation step
may be incorporated into a patent claim, the
patentee may still suffer a reduced scope of rights
due to a greater likelihood of competitive design
around.
14
Medical technology can also involve the evaluation,
diagnosis, and treatment of patients. By way of
example, a method of patient assessment can relate
to predictive modeling by comparing the patient’s
signs and symptoms to a database of other patient
information to obtain the likelihood of a particular
condition and/or likely success of certain therapy if
applied to that patient. This medical treatment,
whether or not implemented through a general
purpose computer, yields a “useful, concrete and
tangible result.” See State St. Bank & Trust Co. v.
Signature Fin. Group, 149 F.3d 1368, 1373 (Fed. Cir.
1998) (citing In re Alappat, 33 F.3d 1526, 1544 (Fed.
Cir. 1994) (en banc)).
To be certain, such methodologies do not constitute
“laws of nature, natural phenomena, [or] abstract
ideas,” see Diamond v. Diehr, 450 U.S. 175, 185
(1981) (citing Parker v. Flook, 437 U.S. 584, 589
(1978), and Gottschalk v. Benson, 409 U.S. 63, 67
(1972)), and thus, in the Court of Appeals’ parlance
in Bilski, are not fundamental principles. Nor are
they prohibited mental steps. See Benson, 409 U.S.
at 67; In re Comiskey, 499 F.3d 1365, 1377 (Fed. Cir.
2007) (holding that “mental processes,” “processes of
human thinking,” and “systems that depend for their
operation on human intelligence alone” are not
patent-eligible subject matter under Benson).
However, under the machine-or-transformation
requirement of Bilski, it is unclear whether the
15
Patent Office and the federal courts would deny
patent protection on the grounds of ineligibility
under 35 U.S.C. § 101. The experiences of Amicus
Curiae in patent application examinations since
Bilski suggest the Patent Office has increasingly
relied on this ground of rejection.
IV. Section 101 Should Invite the Patenting of
All Inventions that Result from Human
Ingenuity and Manipulation.
As related to medical technology, the confusion
Bilski creates has resurrected the concern
contemplated by this Court briefly in Lab. Corp. v.
Metabolite, 548 U.S. 124 (2006) (“LabCorp”), and has
manifested in cases such as Classen
Immunotherapies, Inc. v. Biogen Idec, 304 Fed. Appx.
866, 2008 WL 5273107 (Fed. Cir. 2008) (non-
precedential), and Prometheus Labs., Inc. v. Mayo
Collaborative Servs., No. 2008-1403 (Fed. Cir. 2009)
(reviewing Civil No. 04cv1200 JAH (RBB), 2008 WL
878910, 86 U.S.P.Q.2d 1705 (S.D. Cal. Mar. 28,
2008)). Some have criticized patent claims to certain
medical diagnosis, for example, on the basis that
they seek patent coverage for the mere correlation of
natural phenomena. What constitutes mere
correlation is then a question open to reasonable
dispute.
In LabCorp, this Court dismissed the writ of
certiorari as improvidently granted. Justice Breyer,
16
joined by Justices Stevens and Souter, dissented
from the order. The dissent argued that the Court
should have taken the case in order to lend
necessary clarity to an important issue in patent
law. The patent claims at issue in LabCorp recited
“correlating an elevated level of total homocysteine
in [a sample of] body fluid with a deficiency of
cobalamin or folate.” In the dissenters’ view, a
natural correlation between two substances in the
body is a “natural phenomenon” that cannot be
patented. LabCorp, 548 U.S. at 135.
At least one member of the Court of Appeals has
recognized the potential havoc that the application of
the Bilski machine-or-transformation test may
create with medical technology innovation. In
dissent from the en banc opinion of the Court of
Appeals, Judge Rader states:
Before the invention featured in Lab
Corp., medical science lacked an
affordable, reliable, and fast means to
detect this debilitating condition.
Denial of patent protection for this
innovation – precisely because of its
elegance and simplicity (the chief aims
of all good science) – would undermine
and discourage future research for
diagnostic tools. Put another way, does
not Patent Law wish to encourage
researchers to find simple blood tests or
17
urine tests that predict and diagnose
breast cancers or immunodeficiency
diseases? In that context, this court
might profitably ask whether its
decisions incentivize research for cures
and other important technical
advances. Without such attention, this
court inadvertently advises investors
that they should divert their
unprotectable investments away from
discovery of “scientific relationships”
within the body that diagnose breast
cancer or Lou Gehrig’s disease or
Parkinson’s or whatever.
In re Bilski, 545 F.3d 943, 1014 (Fed. Cir. 2008) (en
banc) (Rader, J., dissenting). Amicus Curiae concurs
with these policy sentiments.
Furthermore, while “[p]henomena of nature, though
just discovered, mental processes, and abstract
intellectual concepts are . . . the basic tools of
scientific and technological work,” see Gottschalk v.
Benson, 409 U.S. 63, 67 (1972)), that does not mean
all methods, which originate from the invention or
discovery of a natural correlation, are similarly
patent ineligible. To hold otherwise would be a
departure from the wisdom of Diamond v.
Chakrabarty, 447 U.S. 303, 309 (1980), that
“anything under the sun that is made by man” is
patent eligible under 35 U.S.C.§ 101, which
18
implicitly recognized that human intervention could
take unpatentable subject matter into the realm of
patentability. In particular, the mere correlation of
natural phenomena mantra belies the reality that
much more often than not, the diagnosis of a patient,
and the subsequent treatment based on that
diagnosis, are not the products of mere observation
and simple correlation. In other words, although a
correlation step may be at the heart of the claimed
medical treatment, most procedures involve not only
the sophisticated appreciation that a correlation may
exist, but the studied determination to act based on
a perceived significance of that correlation. But these
complex methods may not necessarily involve a
machine or transforming an article into a different
state or thing.
In Classen, the Court of Appeals affirmed the district
court’s summary judgment that Dr. Classen’s patent
claims were invalid under 35 U.S.C. § 101 because
the claims were neither tied to a particular machine
or apparatus, nor did they transform a particular
article into a different state or thing. The patent
claim at issue involved a method of determining
whether an immunization schedule affected the
incidence or severity of a chronic immune-mediated
disorder in a treatment group of mammals relative
to a control group of mammals. The Court of Appeals
offered no additional reasoning, its opinion being a
19
mere 69 words, twenty words shorter than the actual
patent claim.
In Prometheus, the Court of Appeals is presently
reviewing the district court’s summary judgment
that the claims of U.S. Patent No. 6,355,623 are
invalid under 35 U.S.C. § 101. The patent claim at
issue involved a method of optimizing therapeutic
efficacy for treatment of an immune mediated
gastrointestinal disorder by determining the level of
6-thioguanine. The district court analysis fell in
lockstep with this Court’s LabCorp dissent.
In any event, these cases reflect the tip of the iceberg
of possible judicial controversy over the patentability
of medical technology if the Bilski machine-or-
transformation standard is upheld. Moreover, in a
particularly crowded field of technology, such as
medical technology, the uncertainty over entitlement
to patent exclusivity can disqualify otherwise
innovative methods and their associated products
from access to commercial investment, market entry,
and/or post-market entry sustainability.
V. A Machine-Or-Transformation Requirement
Would Harm the Public by Deterring Prompt
and Open Disclosure of Medical
Breakthroughs and by Discouraging
Investment in Medical Innovation.
The oft cited purpose of the patent laws is to promote
the progress of the useful arts through the creation
20
of temporary exclusivity rights as an incentive for
the prompt, public disclosure of inventions because
the patent exclusivity facilitates innovative efforts
and encourages investment in such endeavors. These
principles apply with equal if not greater force in the
medical technology industry sector, where
commercial competition is intense. Beyond the
known beneficial effects today of an enfranchising
patent eligibility standard under Section 101,
perhaps a more essential consideration is the
maintenance of a Section 101 test that will continue
the promise of patent protection for innovations to
come.
The Court of Appeals decision in Bilski opens the
door to the use of Section 101 as an instrument for
determining precisely what innovation will be
acceptable. In Chakrabarty, this Court took the wise
approach of interpreting Section 101 as broadly
inclusive in favor of allowing the other statutory
conditions for patentability to more finely monitor
what inventions may be patented vis-à-vis the prior
art. A Section 101 that embraces inclusiveness
ensures continuing innovation in new as well as old
fields of technology. Tinkering with Section 101 in
hopes of crafting a standard generally applicable to
past, present, and future technologies, however well
intentioned, may bring unforeseeable consequences,
including the unfortunate chilling of future
innovation.
21
CONCLUSION
For the foregoing reasons, Amicus Curiae
respectfully submits that the Bilski machine-or-
transformation test has far reaching consequences
for enterprises outside the financial services and
computer software industry sectors that are critical
to this country’s public health goals and economic
well being. Indeed, for companies, like Amicus
Curiae, focused on medical technology innovation,
the prospect of a revised patent eligibility standard
that is less inclusive presents the grave concern that
the development of critical lifesaving medical
technology will be impeded.
Respectfully submitted,
Lawrence M. Sung
Michael J. Jaro
Counsel of Record
Noreen C. Johnson
Jeff E. Schwartz
Girma Wolde-Michael
Dewey & LeBoeuf LLP
Medtronic, Inc.
1101 New York
710 Medtronic
Avenue, NW
Parkway, NE
Washington DC 20005
Minneapolis MN 55432
(202) 346-8000
Counsel for Amicus Curiae
Medtronic, Inc.
Document Outline
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