Amicus Curiae Brief — Impression Prods., Inc. v. Lexmark Int'l, Inc., 136 S. Ct. 2501 (2016) (No. 15-1189)
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FILED
FEB 23 2097
—--—-. A ae
ETE COURT te
IN THE “— _
Supreme Court of the Anited States
_— —_—— —
No. 15-1189
_
_
IMPRESSION PRODUCTS, INC.,
Petitioner,
Vv.
LEXMARK INTERNATIONAL, INC.,
Respondent.
On Writ of Certiorari to the
United States Court of Appeals
for the Federal Circuit
BRIEF FOR MEDTRONIC PLC AND
BIOMET HOLDINGS, INC.
AS AMICI CURIAE SUPPORTING RESPONDENT
PAIK SABER KATHLEEN A. DALEY
MEDTRONIC PLC Counsel of Record
710 Medtronic Parkway J. DEREK MCCORQUINDALE
Minneapolis, MN “5432 FINNEGAN, HENDERSON,
FARABOW, GARRETT &
AMY LYDON DUNNER, LLP
MEDTRONIC PLC
: 901 New York Ave., NW
60 Middletown Ave. ,
North Haven, CT 06473 Washington, DC 20001
: (202) 408-4000
JOSEPH TOPMILLER kathleen.daley@finnegan.com
ZIMMER BIOMET
345 East Main Street
Warsaw, IN 46580
Counsel for Amici Curiae
February 23, 2017
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WiILSON-EPEesS PRINTING Co., INC. — (202) 789-0096 — WASHINGTON, D. C. 20002
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TABLE OF CONTENTS
TABLE OF AUTHORITIES.........................0....4.
INTEREST OF AMICI CURIAE ............ iebinsiasoiea
SUMMARY OF ARGUMENT .................00000......
THE AVAILABILITY OF PATENT REMEDIES
TO ENFORCE SINGLE-USE RESTRICTIONS
ON MEDICAL DEVICES’ BENEFITS
PATIENTS AND HELPS TO PROTECT THE
ORIGINAL MANUFACTURER’S REPUTA-
TION AND GOODWILL ..................... mailaienlartasanabs
A. Increasing Unauthorized Repro-
B.
C.
cessing of Single-Use Medical Devices
Could Risk Patient Harm....................
The Original Manufacturer’s Reputa-
tion and Goodwill Are Compromised
When an Unauthorized Reprocessor
Reprocesses and Resells a Single-Use
ree itcnninsisacisatnbiniasnccbeabscnstnenetincasaniiciiiiss
The Enforceability of Single-Use
Restrictions on Medical Devices Has
Not Destroyed the Reprocessing Indus-
try and Is Good for the Healthcare
EERSTE Eee eho ace
CONCLUSION .................... laa deng alphas ieledaatateda
(i)
12
16
19
‘i
TABLE OF AUTHORITIES
CASES Page(s)
B. Braun Medical, Inc. v.
Abbott Laboratories,
124 F.3d 1419 (Fed. Cir. 1997)................. 16
Dawson Chemical Co. v.
Rohm & Haas Co.,
ee 15
Lexmark International, Inc. v.
Impression Products, Inc.,
816 F.3d 721 (Fed. Cir. 2016)
(en banc), cert. granted,
gg 5 aT 15, 16
Mallinckrodt, Inc. v. Medipart, Inc..,
976 F.2d 700 (Fed. Cir. 1992)................... 12, 16
Monsanto Co. v. McFarling,
302 F.3d 1291 (Fed. Cir. 2002),
cert. denied, 537 U.S. 1232 (2003)............ 16
Princo Corp. v. International
Trade Commission,
616 F.3d 1318 (Fed. Cir. 2010) (en banc)... 16
STATUTES
EE TRAE anne Omer ocee 18
ib ciasticcnsossinsciincciousbscneiinettiitedes 12
REGULATIONS
is anccicerensiaedtnamenintainanines
i ncnsastbensceninanutchncedineaies
is nccxscscscuncctidnnieunvatioinninone
Be gE etsccicirwnerinsevescimvectsesersnaienbe
on ®& @
TABLE OF AUTHORITIES—Continued
Page(s)
Bic inriencnscenhesenninsenesecmesennes 8
Bee er ee FE rccceccccsscesevesescessccnesess 3
ESE a Oe 14
IED cs vsnscnsscccmncnssnonsonsnnentopseoses 3,9
i ssgcatomenepnnanundoinenin 9
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RULES
Supreme Court Rule 37.6....................:000000 1
OTHER AUTHORITIES
A.W. van Drongelen & A.C.P. de Bruijn,
Dutch Nat'l Inst. for Pub. Health & the
Env’'t, Reprocessing of Medical Devices
Eucomed, White Paper on the Reuse of
Single Use Devices 12 (2009) (Eucomed
White Paper) <tinyurl.com/eucomed
TT i cnsconnsetndiincdeionimiedasndiuanitiotienes 6,17
FDA Freedom of Information Annual
IT ictinescsintsieanitcaitinghicenpeielicamentens 10
FDA, Compliance with Section 301 of the
Medical Device User Fee and Moderniza-
tion Action of 2002—as amended, <tiny
url. com/f4jt7OWw>. ....cececcceccecsecsseseecsesesereeee 12
iv
TABLE OF AUTHORITIES—Continued
Page(s)
FDA, Deciding When to Submit a 510(k) for
a Change to an Existing Device: Draft
Guidance for Industry and Food and
Drug Administration Staff (2016)............
FDA, Deciding When to Submit a 510(k) for
a Change to an Existing Device: Guidance
for Industry and Food and Drug
Administration Staff (1997) .....................
FDA, Medical Device User Fee and
Modernization Act of 2002, Validation
Data in Premarket Notification Submis-
sions (510(k)s) for Reprocessed Single-
Use Medical Devices (2006) ......................
FDA, Medical Devices; Guidance on Label-
ing of Reprocessed Single Use Devices;
Request for Comments and Information
(2001), < tinyurl.com/zsdh3rd> ................
FDA, Reprocessing Medical Devices in
Health Care Settings: Validation Methods
and Labeling (2015) .............ccccccccccesereeeeeee
Health Canada, Recalls & alerts: LigaSure
Blunt Tip Laparascopic and Impact Open
Sealer / Divider (Dec. 13, 2016), <tinyurl.
com/strykerligasurerecall>.......................
Katrin Roth et al., Specific Hygiene Issues
Relating to Reprocessing and Reuse of
Single-Use Devices for Laparoscopic
Surgery, 16 Surgical Endoscopy 1091
14
15
Vv
TABLE OF AUTHORITIES—Continued
Page(s)
Michelle R. Tinkham, Reprocessing of
Single-Use Devices: Do the Benefits Out-
weigh the Potential Dangers?, 5 Periop-
erative Nursing Clinics 377 (2010) ..........
Philip Jacobs et al., Economic Analysis
of Reprocessing Single-Use Medical
Devices: A Systematic Literature Review,
29 Infection Control and Hospital
Epidemiology 297 (2008) .................:c0c0e.
U.K. Meds. and Healthcare Prods. Reg.
Agency, Single-Use Medical Devices:
Implications and Consequences of Reuse
7 (2013), <tinyurl.com/gwnznv8>.............
Zvi Fireman, Biopsy Forceps: Reusable or
Disposable?, 21 J. Gastroenterology &
Hepatology 1089 (2006) ....................0.0.....
11, 13
17
11
INTEREST OF AMICI CURIAE
Amicus Medtronic PLC is the world’s largest medi-
cal technology company.’ With over 85,000 employees,
Medtronic is transforming healthcare worldwide,
improving outcomes, expanding access, and enhancing
value. Medtronic is a leading innovator in the medical-
device industry and capitalizes on the intellectual
property it generates. Medtronic owns over 15,000
issued patents in the United States and files over a
thousand original patent applications annually.
Amicus Zimmer Biomet Holdings, Inc. is a medical
technology company that, through its subsidiaries,
designs, manufactures, and markets innovative ortho-
pedic and other musculoskeletal devices for surgeons
around the world. Zimmer Biomet has been a driving
force in the musculoskeletal healthcare industry for
nearly 90 years and sells its products in 100 countries
worldwide. Like Medtronic, Zimmer Biomet holds and
practices a significant number of patents in the United
States, and that number grows every year.
The first question presented in this case is whether
a patentee may invoke patent law to enforce restric-
tions on the use or resale of a patented article after an
authorized conditional sale (with post-sale restric-
tions) of the article in the United States. As leaders in
the medical-device industry, amici Medtronic and
Zimmer Biomet file this brief to explain how the
! Pursuant to Rule 37.6, amici affirm that no counsel for a
party authored this brief in whole or in part, no such counsel or a
party made a monetary contribution to fund its preparation or
submission, and no person other than amici or its counsel made
such a monetary contribution. Respondent Lexmark Interna-
tional, Inc., filed a letter of blanket consent to amici. Petitioner
Impressions Products, Inc., granted consent on February 22, 2017
by electronic mail, a copy of which is submitted herewith.
2
availability of patent remedies to enforce single-use
restrictions on medical devices promotes patient safety
and helps original device makers protect their reputa-
tion and goodwill. Amici take no position on the second
question presented.
SUMMARY OF ARGUMENT
In the medical-device industry, devices come in two
forms—single-use and reusable. Many crucial medical
devices for today’s physicians are single-use devices.
They are designed and tested only for one use or
for use on a single patient during a single procedure,
and not for subsequent cleaning, resterilization, and
reuse. Although safe when used as recommended by
the manufacturer, single-use medical devices may
have complex structures that were not designed with
repeated cleaning, resterilization, and reprocessing
in mind. In addition, single-use medical devices may
include components that were not designed to with-
stand multiple uses.
This is in contrast to reusable medical devices,
sometimes called multi-use devices. Reusable medical
devices are specifically designed for repeated use.
Design choices relating to efficacy, durability, and ease
of cleaning, disinfection, and sterilization of various
components are selected with reprocessing in mind.
Manufacturers include cleaning instructions with
reusable medical devices that explain which repro-
cessing methods will allow the device to be reused
without degrading it. Once used, medical providers
may send their reusable medical devices to the
manufacturer or third-party reprocessing companies,
who clean, disinfect, and sterilize the devices accord-
ing to the manufacturer’s instructions.
3
Although single-use medical devices are not designed
for reprocessing, third-party reprocessing companies
with no relationship with the original manufacturer
nevertheless collect certain used single-use medical
devices, reprocess them, and sell them at a cost lower
than a new single-use device. The original manufac-
turers, however, need not provide the Food and Drug
Administration (FDA) with procedures for proper
resterilization and reuse since single-use medical
devices are not designed for reprocessing. As a result,
those third-party reprocessors may not have cleaning
instructions, complete design specifications, and other
guidance from the original manufacturer to determine
whether a single-use medical device, though not
designed for reuse, would be amenable to reprocessing.
And because single-use medical devices are contin-
ually being improved, third-party reprocessors face
additional problems when trying to reuse a medical
device designed for a single use. For example, manu-
facturers regularly make design changes, which run
the gamut from complete redesigns to minor reengi-
neering of internal components to changes in raw
materials or material suppliers. While FDA approval
or premarket clearance is required for significant
changes, minor changes instead require an internal
letter to the file or notification to the FDA after the
fact in a periodic report, depending on the device type.
See 21 C.F.R. §§ 807.81(a)(3), 814.39. As a result, third
parties, such as unauthorized reprocessors, may not
know all the design changes made to a single-use
medical device.
Even minor design changes may affect whether and
how a medical device may safely be reprocessed, and
this is especially true for a medical device that was
designed for only a single use, such as a surgical vessel
4
sealer, cardiac catheter, or optical trocar. In addition,
single-use restrictions are often used to ensure com-
patibility between the single-use device and associated
medical equipment. Therefore, a third-party reprocessor
who has reprocessed a single-use medical device
may be unaware of design changes that necessitate a
revised reprocessing regime or make reprocessing of
that single-use medical device even less feasible, or
that impact compatibility with other associated
medical equipment.
When there is a problem with a reprocessed single-
use medical device, the original manufacturer's
reputation is at stake because a reprocessed medical
device still retains the original manufacturer’s mark-
ings and trademarks even though the reprocessor adds
an additional mark to the device. As a result, when a
reprocessed medical device fails, that problem can be
wrongly associated with the original manufacturer in
the eye of the customer. Reprocessed medical devices
are frequently returned to the original manufacturer
despite it not having serviced, validated, or sold the
reprocessed devices that failed. This causes confusion
in the market as to the source of the reprocessed
medical device and tarnishes the original manufac-
turer’s goodwill.
The continued availability of patent remedies to
enforce single-use restrictions is important to original
manufacturers for guarding against these risks and
protecting their reputations. Because patent remedies
may deter unauthorized third-party reprocessing,
used single-use medical devices can be discarded as
intended or funneled back to their original manufac-
turer. Contract law alone cannot provide the same
incentives, because the manufacturer and reprocessor
ordinarily lack contractual privity. Removing the
5
protection that patent law provides to enforce clearly
conveyed, single-use restrictions on medical devices
would likely cause reprocessing of single-use medical
devices to increase, leading to more confusion in the
marketplace and potentially eroding the original
manufacturer’s reputation and goodwill.
Concern that the availability of patent remedies to
enforce single-use restrictions on medical devices will
end the reprocessing industry is overstated. Manufac-
turers have provided medical devices on the condition
they be limited to a single use for decades, and these
restrictions have been enforceable under the patent
laws for a quarter of a century. Yet during that time,
the market for reprocessing multi-use medical devices
has flourished. Allowing manufacturers to continue to
enforce single-use restrictions under the patent laws
incentivizes reprocessors to keep their efforts focused
on medical devices intended to be reusable.
While third-party reprocessors argue that repro-
cessing could provide a lower-cost alternative to
purchasing brand-new single-use medical devices, the
overall costs and benefits associated with reusable and
single-use medical devices are more complicated than
that. A market exists for both single-use and reusable
medical devices, and can adjust for the existence of
single-use restrictions by devaluing products that
have such restrictions. There is no reason to remove
available patent remedies for single-use medical devices
simply to achieve a perceived lower-cost alternative.
The market can already dictate those terms under the
current system. In other words, the market for single-
use and reusable medical devices is robust and
functioning without the need for this Court to inter-
vene and restructure the reprocessing industry, which
by its own account has been booming.
6
ARGUMENT
THE AVAILABILITY OF PATENT REMEDIES
TO ENFORCE SINGLE-USE RESTRICTIONS
ON MEDICAL DEVICES BENEFITS PATIENTS
AND HELPS ‘'* : PROTECT THE ORIGINAL
MANUFACTURER’S REPUTATION AND
GOODWILL
A. Increasing Unauthorized Reprocessing of
Single-Use Medical Devices Could Risk
Patient Harm
1. Some medical devices are specifically designed to
be reprocessed and reused. These are referred to as
reusable or multi-use devices. Medical providers and
hospitals often contract with third-party reprocessing
businesses to clean their reusable medical devices.
The development process for reusable medical
devices “often includes multiple redesigns and compro-
mises” related to “the functionality and dimensions” in
an effort to produce a device that “can be reprocessed,
where possible with automated processes.” Eucomed,
White Paper on the Reuse of Single Use Devices 12
(2009) (Eucomed White Paper), <tinyurl.com/eucomed
whitepaper>. The FDA notes that “[m]anufacturers of
reusable devices should consider device designs that
facilitate easy and effective cleaning, as well as any
necessary disinfection or sterilization by the users.”
FDA, Reprocessing Medical Devices in Health Care
Settings: Validation Methods and Labeling 4 (2015).
Manufacturers are cautioned that, “[f]rom the
earliest stages of device design and engineering, [they]
should consider alternative designs to facilitate effec-
tive reprocessing (e.g., replace features that are
challenging to reprocess with single-use parts; include
flush ports; specify and/or provide dedicated cleaning
7
accessories).” Jd. The manufacturer must also develop
cleaning instructions to accompany the reusable
medical device. Id. at 4-22. As a result, in order to
facilitate effective subsequent cleaning and resterili-
zation, the design process for reusable devices can be
complicated as well as time consuming and costly.
2. In contrast to reusable devices, a single-use
medical device is intended by the original manufac-
turer for one use or on a single patient during a single
medical procedure. The product packaging for a medi-
cal device will typically state whether the device is
designated for a single use, and the device itself may
carry a label to that effect too. Medical-device manu-
facturers are responsible for making that designation,
which depends primarily on whether the device was
designed and validated to be reprocessed for multiple
uses (i.e., the cleaning, disinfecting, and sterilizing of
a used device).
For single-use medical devices, because manufac-
turers need not focus on facilitating reprocessing, they
can develop complex devices that may not lend them-
selves to repeated use or easy cleaning after the initial
use. And the manufacturer need not develop a protocol
for cleaning and reprocessing a single-use medical
device, or provide dedicated cleaning accessories.
Instead, the manufacturer can focus its design efforts
solely on optimizing the safety and effectiveness of the
device for the intended single use. As a result, single-
use medical devices are safe, “reliable,” “enable techni-
cally complex operations to be performed,” and may be
“easier to use” than their reusable counterparts. Zvi
Fireman, Biopsy Forceps: Reusable or Disposable?, 21
J. Gastroenterology & Hepatology 1089, 1090 (2006);
A.W. van Drongelen & A.C.P. de Bruijn, Dutch Nat’
Inst. for Pub. Health & the Env't, Reprocessing of
8
Medical Devices 9 (2008) (Dutch Report), <tinyurl.
com/dutchreprocessingreport>. Many surgeries “could
not be performed or would be considerably more
invasive and riskier” without the availability of single-
use medical devices. Dutch Report at 9.
Despite the differences between reusable and single-
use medical devices, third-party reprocessors collect
and clean certain used single-use devices and sell
them for reuse. These reprocessors must seek pre-
market clearance from the FDA in the form of a
“510(k)” premarket notification submission or a report
seeking premarket approval containing, among other
information, validation data to distribute reprocessed
single-use medical devices. The FDA considers such
reprocessors to be “manufacturers” of those cleared or
approved reprocessed devices, subject to the tradi-
tional regulatory framework applicable to medical-
device manufacturers, including the requirement to
register their facilities and list the devices they dis-
tribute with the FDA, 21 C.F.R. Part 807; properly
label the device, 21 C.F.R. Part 801; develop and
implement a quality system, 21 C.F.R. Part 820;
comply with medical-device reporting obligations, 21
C.F.R. Part 803; and report certain corrections and
removals of previously distributed devices to the FDA,
21 C.F.R. Part 806.
Even with the FDA regulating reprocessed single-
use medical devices, there could still be gaps in the
process that introduce risk because third-party repro-
cessors of single-use devices often do not have full
access to all design changes made by the original
manufacturer. Manufacturers are continually inno-
vating medical devices and regularly making design
changes, ranging from complete redesigns to the minor
reengineering of internal components, or changing
9
raw materials or material suppliers. In doing so, manu-
facturers must follow strict quality system regulation
requirements to evaluate planned changes (including
through appropriate testing), document those changes
in a design history file, and maintain that file for
future reference as well as FDA inspection. See 21
C.F.R. §§ 820.30, 820.180.
While significant changes require FDA clearance
through the premarket notification 510(k) process or
premarket approval, minor changes instead require an
internal letter to the file or submission to the FDA in
a periodic report. See FDA, Deciding When to Submit
a 510(k) for a Change to an Existing Device: Guidance
for Industry and Food and Drug Administration Staff
(1997); FDA, Deciding When to Submit a 510(k) for a
Change to an Existing Device: Draft Guidance for
Industry and Food and Drug Administration Staff
(2016); see also 21 C.F.R. § 814.39. Reprocessors may
thus be unaware of some design changes made to a
single-use medical device. For example, a manufac-
turer may change a component material or a surfacing
process that, while not impacting the device in a single
use context, may have different implications when
subject to repeated use or reprocessing techniques
such as sterilization. And because even a minor change
may affect whether and how a medical device may be
safely reprocessed, reprocessors cleared or approved to
reprocess a single-use medical device may be unaware
of all of the changes that could affect the reprocessing
regime.
Amici have faced this problem first-hand. In 2016,
Medtronic issued a routine software update for one
of its medical generators used to power single-use
surgical tools. After that update, certain older tools
became incompatible with the generator. But an
10
unauthorized third-party reprocessor, unaware of the
software update, continued to sell those older tools for
use with the generator and eventually was forced to
recall them. See Health Canada, Recalls & alerts:
LigaSure Blunt Tip Laparascopic and Impact Open
Sealer / Divider (Dec. 13, 2016), <tinyurl.com/stryker
ligasurerecall>. If that problem had been encountered
during a surgical procedure, complications could have
ensued, such as the surgeon being forced to wait for a
new vessel-sealing instrument while the patient was
on the surgical table and at risk for infection.
Even for design changes that require 510(k) clear-
ance or premarket approval by the manufacturer,
which are therefore publicly disclosed by the FDA,
unauthorized reprocessors typically will not have
access to detailed information about the change. The
FDA 510(k) Premarket Notification and PMA Data-
bases only show limited information relating to
changes made to devices cleared through the 510(k)
process or approved through a supplemental pre-
market approval. In order for the reprocessor to obtain
more information relating to the changes made, the
reprocessor must complete a full Freedom of Infor-
mation Act request, which may take months or years.
See FDA Freedom of Information Annual Report 2014.
Even when the unauthorized third-party reprocessor
eventually receives the 510(k) submission or report
seeking premarket approval, the 510(k) or premarket
approval report will typically be redacted to protect
the original manufacturer’s confidential commercial
and trade-secret information.
Reprocessors with no relationship to the original
manufacturer face additional hurdles when seeking to
reprocess a single-use medical device. They have little
insight into the design features and intent of the
11
medical-device manufacturer other than what is
available from physical inspection of the device and
the FDA 510(k) Premarket Notification and PMA
Databases. Medical-device manufacturers design their
single-use product with specifications, materials, and
validated manufacturing processes that provide a
reasonable assurance of the device’s safety and
effectiveness. Without that product-specific infor-
mation, these third-party reprocessors may be forced
to disassemble and reverse-engineer the device as best
they can to determine whether and how a given single-
use medical device can be reprocessed. Lacking the
manufacturer's design knowledge, a third-party repro-
cessor may fail to recognize all of the places where
debris and potential contaminants may collect on
the device. See Michelle R. Tinkham, Reprocessing of
Single-Use Devices: Do the Benefits Outweigh the
Potential Dangers?, 5 Perioperative Nursing Clinics
377, 379 (2010) (Tinkham) (“This information may be
difficult to acquire because many OEM [original
equipment manufacturer] companies claim that repro-
cessors do not have access to their proprietary product
specifications.”).
It has also been recognized that single-use medical
devices may have structural features that complicate
effective reprocessing. Those devices can be “more deli-
cate and physically complex than reusable devices.”
K. Roth et al., Specific Hygiene Issues Relating to
Reprocessing and Reuse of Single-Use Devices for
Laparoscopic Surgery, 16 Surgical Endoscopy 1091,
1091 (2002). Medical devices with sharp angles, hinges,
coils, or long or narrow cavities may create particular
challenges for reprocessing. See U.K. Meds. and
Healthcare Prods. Reg. Agency, Single-Use Medical
Devices: Implications and Consequences of Reuse 7
(2013), <tinyurl.com/gwnznv8>. These are just some of
12
the challenges to reprocessing a single-use medical
device so that it is safe and effective.
The original manufacturer, with its specific know!-
edge of the product, remains in the best position to
know the extent to which a single-use device is
amenable to reprocessing. Diluting or eliminating a
manufacturer's ability to enforce single-use restric-
tions could exacerbate the risks posed by third-party
reprocessing of single-use medical devices.
B. The Original Manufacturer’s Reputation
and Goodwill Are Compromised When an
Unauthorized Reprocessor Reprocesses
and Resells a Single-Use Device
When problems arise with reprocessed medical
devices, the reputation of the original manufacturer
may be injured despite not having designed the
product for multiple uses or reprocessing and not
having approved of the method of reprocessing. And
although reprocessors are required to place their own
mark on the reprocessed device, the reprocessed device
still retains the mark of the original manufacturer as
well, leading to confusion in the market and reputa-
tional injury. 21 U.S.C. § 352(u) (2012); FDA, Compliance
with Section 301 of the Medical Device User Fee
and Modernization Action of 2002—as amended, <tiny
url.com/ j4jt79w>. The Federal Circuit identified
similar facts underlying its Mallinckrodt decision
twenty-five years ago. Mallinckrodt, Inc. v. Medipart,
Inc., 976 F.2d 700, 702 (Fed. Cir. 1992) (after
unat thorized reprocessing by Medipart, the devices
were “shipped back to the hospitals,” but “still
bear[ing] the inscription ‘Single Use Only’ and the
trademarks ‘Mallinckrodt’ and ‘UltraVent”).
13
The confusion in the market as to the source of
reprocessed single-use medical devices is demon-
strated by the fact that if third-party reprocessed
devices fail during procedures, they are often returned
to the original manufacturer instead of to the unau-
thorized reprocessor that last serviced it. Such a
situation leaves the customer with the mistaken
impression that the failure is due to a problem with
the originally manufactured device when, in fact, the
problems may have arisen through reprocessing or
repeated use. This confusion inevitably harms the
goodwill that an original manufacturer has developed
over time and damages its reputation with customers.
Original manufacturers are also frequently asked to
investigate problems with their marked devices, only
to determine that the devices in question were repro-
cessed by third parties not authorized by the original
manufacturer. Oftentimes, a device failure is reported
to the original manufacturer, but it is difficult to
investigate since the reprocessed device has not been
returned and cannot be tracked down. As a result, it is
not always possible to properly link a patient injury to
a reprocessed device. See Tinkham at 379-80 (noting
that many original device manufacturers “have per-
formed testing of reprocessed versions of their products
and have found many issues,” and that “[djue to poor
tracking and reporting processes within [healthcare]
facilities, . . . some patient injuries may not be linked
to a reprocessed item”). This leaves the original device
manufacturer compromised because it cannot evalu-
ate whether the problem was attributable to its device
or a third-party reprocessor.
Also, in order to obtain clearance from the FDA, a
reprocessor has to show that the reprocessed single-
14
use device is “substantially equivalent” to the origi-
nally manufactured device or “any device of that type.”
FDA, Medical Device User Fee and Modernization Act
of 2002, Validation Data in Premarket Notification
Submissions (510(k)s) for Reprocessed Single-Use
Medical Devices 4, 9 (2006); 21 C.F.R. § 807.87. But a
reprocessed device that the FDA has determined to be
substantially equivalent to the original single-use
device may still not meet the full spectrum of the
original manufacturer’s requirements.
For example, a manufacturer may have a require-
ment that a knife or cutting edge have a particular
degree of sharpness. That sharpness could degrade
with reprocessing. And while the blade may still be
substantially equivalent to the original device, it
may not meet the manufacturer’s very high standard.
As another example, a manufacturer may provide a
specific nano-coating on the jaws of a single-use surgi-
cal instrument, which improves, but is not integral to,
the performance of the instrument. The nano-coating
cannot withstand reprocessing. As a result, when that
instrument is reprocessed, the improved performance
resulting from the nano-coating may not be main-
tained. Or, a manufacturer may have requirements
regarding the finish on a handle. That finish could
become blemished or discolored after reprocessing.
This may not be something that affects the safety and
effectiveness of a product but does impact the manu-
facturer’s brand and reputation for a certain quality
product. Thus, the reprocessed device, while cleared
by the FDA, may not perform in every respect as the
original manufacturer intended. This leads to further
problems for the original manufacturer since that
reprocessed device is being sold with its markings still
on the device.
15
The reputational harm resulting from this practice
led a trade group of many original manufacturers to
file a Citizen Petition with the FDA to stop it. The
trade group sought to have the FDA require third-
party reprocessors of single-use medical devices to
remove identifying marks of the original device manu-
facturer, including any references in the label. But the
FDA denied the request. See FDA, Medical Devices;
Guidance on Labeling of Reprocessed Single Use
Devices; Request for Comments and Information (2001),
<tinyurl.com/zsdh3rd>. So FDA regulations alone do
not eliminate the potential for market confusion based
on a third-party reprocessor’s actions.
Removing protections that a patent provides in
enforcing clearly conveyed single-use restrictions would
only increase these harms to an original device manu-
facturer’s reputation. If the “long-settled view [is] that
the essence of a patent grant is the right to exclude
others,” Dawson Chem. Co. v. Rohm & Haas Co., 448
U.S. 176, 215 (1980), then, as the Federal Circuit
noted, the ability to do so in order to safeguard a
company’s reputation is “hardly unrelated to the
interests protected by the patent law,” Lexmark Int'l,
Inc. v. Impression Prods., Inc., 816 F.3d 721, 752 (Fed.
Cir. 2016) (en banc), cert. granted, 137 S. Ct. 546
(2016). The Federal Circuit acknowledged this legiti-
mate concern facing original device manufacturers
and recognized the right to exclude in this context,
particularly because it touches on reliability and
patient safety. Id. (“A medical supplier in Mallinckrodt’s
position plausibly may have similar reason to believe
that reuse, when not under its own control, carries a
significant risk of poor or even medically harmful
performance, to the detriment of its customers and its
own reputation.”). FDA regulations lack the necessary
provisions to protect these reputational interests, and
16
contract law alone cannot provide relief because the
manufacturer and reprocessor ordinarily lack privity.
Single-use restrictions are critical to helping original
manufacturers prevent marketplace confusion and the
resulting damage to reputation.
C. The Enforceability of Single-Use Restric-
tions on Medical Devices Has Not Destroyed
the Reprocessing Industry and Is Good for
the Healthcare Industry
1. Various amici supporting petitioner, including the
Association of Medical Device Reprocessors Associa-
tion (AMDR), AMDR Br. 16-21, argue that the
availability of patent remedies to ‘enforce single-use
restrictions will spell the end of secondary markets for
used products. That has certainly not been the case
with medical devices.
In fact, the AMDR boasts that reprocessing medical
devices is a successful industry in the United States,
AMDR Br. 9-10, notwithstanding that the Federal
Circuit’s conditional-sale doctrine in patent cases has
been binding precedent dating back to Mallinckrodt.
It cannot be that the Mallinckrodt decision was simply
ignored all those years, as AMDR suggests, AMDR
Br. 5, 14; on the contrary, it was heavily cited and
frequently reaffirmed. E.g., Princo Corp. v. ITC, 616
F.3d 1318, 1328 (Fed. Cir. 2010) (en banc); Monsanto
Co. v. McFarling, 302 F.3d 1291, 1298 (Fed. Cir. 2002),
cert. denied, 537 U.S. 1232 (2003); B. Braun Med., Inc.
v. Abbott Labs., 124 F.3d 1419, 1426 (Fed. Cir. 1997).
So the Federal Circuit's recent Lexmark decision is not
likely to suddenly “erase medical device reprocessing,”
as the AMDR claims, AMDR Br. 3, because it merely
“reaffirm(s] the principles of [its] earlier decisions”
that have been the controlling law for decades. See
Lexmark, 816 F.3d at 726. The Mallinckrodt era
17
coincides with a period of growth for reprocessors. See
AMDR Br. 3, 9-10.
2. There is a good reason why reprocessors generally
have been able to thrive alongside the conditional-sale
doctrine: medical providers want at least some prod-
ucts they can reuse or resell. In other words, there is
market demand for both reusable and single-use
medical devices. That demand naturally drives original
manufacturers to supply reusable medical devices in
the first instance, in addition to single-use medical
devices. And that in turn opens the door for the repro-
cessing industry to service reusable medical devices.
What is more, the fact that medical providers desire
some reusable medical devices demonstrates that the
market places some value on reusability. Presumably,
then, the market adjusts to the existence of single-use
restrictions by devaluing products so restricted.
Indeed, that is exactly what happened with respond-
ent’s ink cartridges: the reusable version fetches a
price “roughly 20 percent” higher than the single-use
version. Pet. App. 10a. In the medical device space,
a similar phenomenon has been documented. See
Eucomed White Paper at 6 (“Multiple use devices
would normally command a significant premium over
single use devices . . . .”). The touted efficiency and
environmental benefits to reprocessing, moreover,
must be weighed against the considerable resources
consumed to make devices reusable. Compare id. at 7
(“[Alnalyses of the environmental impact of single use
devices should also consider the significant resources
(e.g. chemicals) needed and the energy consumed
during the refurbishment of devices.”), with AMDR Br.
3, 5. See also Philip Jacobs et al., Economic Analysis
of Reprocessing Single-Use Medical Devices: A System-
atic Literature Review, 29 Infection Control and Hospital
18
Epidemiology 297, 301 (2008) (surveying economic
literature to assess the costs and benefits of reusing
single-use medical devices and concluding that “[o]ur
review indicates that the cost-effectiveness of reusing
single-use medical devices is not established”).
Enforceable single-use restrictions ensure that both
single-use and reusable medicai devices are available
in the market. Absent patent remedies, contract law
and FDA regulations alone do not fully address all
potential harms created by unauthorized reprocessing
of single-use devices. Overturning the line of authority
subjecting unauthorized single-use reprocessors to
liability under 35 U.S.C. § 271 will undoubtedly increase
the frequency of such activities. The status quo per-
mitting enforceable single-use restrictions provides a
net social benefit. It provides ready access to afforda-
ble medical devices while minimizing risk to patient
safety. At the same time, it maintains the current
functioning market and incentivizes the reprocessing
industry to focus its efforts on those reusable devices
that are designed for reprocessing.
19
CONCLUSION
The judgment of the court of appeals should be
affirmed.
PAIK SABER
MEDTRONIC PLC
710 Medtronic Parkway
Minneapolis, MN 55432
AMY LYDON
MEDTRONIC PLC
60 Middletown Ave.
North Haven, CT 06473
JOSEPH TOPMILLER
ZIMMER BIOMET
345 East Main Street
Warsaw, IN 46580
Respectfully submitted,
901 New York Ave., NW
Washington, DC 20001
(202) 408-4000
kathleen.daley@finnegan.com
Counsel for Amici Curiae
February 23, 2017
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.