[Ip-health] KEI letter to Senator Coons regarding injunction provisions in STRONGER Patents Act

James Love james.love at keionline.org
Wed Sep 11 07:56:53 PDT 2019


September 11, 2019

The Honorable Senator Christopher Coons
218 Russell Senate Office Building
Washington, DC 20510

Dear Senator Coons:

Knowledge Ecology International (KEI) is a public interest group based in
Washington, DC. KEI focuses on policies relating to the production and
management of and access to knowledge goods. This includes policies
regarding patents, as well as the affordability and pricing of medical
inventions, among other topics. More about KEI’s work is available here:

We are concerned that the STRONGER Patents Act and other proposals by
Senator Coons would change current U.S. law regarding the granting of
injunctions, effectively overturning the standard now established by the
U.S. Supreme Court in eBay v. MercExchange. As you know, that standard
requires a patent holder to prove:

that it has suffered an irreparable injury;
that the law does not provide other adequate ways to compensate it;
that considering the balance of hardships between the plaintiff and
defendant, an injunction is warranted; and
that the public interest would not be harmed by a permanent injunction.

If enacted, the STRONGER Patents Act would create a presumption of
irreparable injury and inadequacy of the remedies available, two of the
four factors that a court must consider when a party seeks an injunction,
according to the 2006 Supreme Court opinion in  eBay v. MercExchange.

The current statute on injunctions as a remedy for patent infringement is
found in Section 283 of title 35, which is one 38-word sentence:

§283. Injunction
The several courts having jurisdiction of cases under this title may grant
injunctions in accordance with the principles of equity to prevent the
violation of any right secured by patent, on such terms as the court deems

The STRONGER Patents Act seeks to add the following language to §283:

(b) Injunction.—Upon a finding by a court of infringement of a patent not
proven invalid or unenforceable, the court shall presume that—
(1) further infringement of the patent would cause irreparable injury; and
(2) remedies available at law are inadequate to compensate for that injury.
This is an attempt to make such injunctions more automatic, even when the
party seeking the injunction provides no evidence to support such claims,
and the contrary is readily apparent.

While unpopular with some patent holders (particularly those who do not
themselves make or provide goods or services), the eBay standard for
injunctions has had a very important procompetitive impact in many cases,
while providing income to inventors though reasonable royalty payments.

In the healthcare arena, there are several cases where permanent
injunctions were denied for medical devices or diagnostic tests. KEI has
researched some of these cases, and we have published a list of examples
available here: https://www.keionline.org/us-injunction-medical.

In these cases, including the ones described below, the courts have
examined the facts and found that a reasonable royalty was a more equitable
remedy than an injunction.

In our view, it is very important that a federal judge has the discretion
to deny a request for an injunction when the injunction would have a
harmful impact on the public’s health, particularly in cases involving
complex medical technologies, where a single patent claim can be asserted
to take an important medical product off the market, denying patients
access and/or driving up the prices.

It is our view that the current statutory standard is appropriate,and
should not be modified, particularly concerning the two factors that the
STRONGER Patents Act seeks to modify, which will be particularly harmful
changes to the law.

These are a few of the cases involving medical devices and diagnostic tests:

Jan K. Voda, M.d., V Cordis Corporation, Case: 5:03-cv-01512-L, September
5, 2006. Cordis manufactures an angioplasty guide catheter.

“plaintiff has failed to demonstrate either irreparable injury or that
monetary damages are inadequate, the court denies his request for a
permanent injunction.”

Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, January 17, 2008. Abbott
manufactured a device for genotyping hepatitis C virus, which, among other
things, is used to ensure blood banks do not sell blood infected with the
hepatitis C virus. From the opinion:

“We remand to the district court to delineate the terms of the compulsory
license, such as conditioning the future sales of the infringing products
on payment of the running royalty, the 5-10 Euros per genotyping assay kit.”

Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., No.
CV-03-0597-PHX-MHM, March 31, 2009. Medical technology: prosthetic vascular

“The Court is satisfied that a fair and full amount of compensatory money
damages, when combined with a progressive compulsory license, will
adequately compensate Plaintiffs’ injuries, such that the harsh and
extraordinary remedy of injunction–with its potentially devastating public
health consequences—can be avoided.

. . . the values of the Patent Act and the protections that it offers to
the patentee are sometimes outweighed by the Court’s equitable concern for
the greater public good, particularly in the realm of vascular surgery and
other potentially life saving technologies. The Court therefore declines to
enjoin Gore from the continued production and sales of its Counterpart
Products, finding that Plaintiffs’ remedy at law provides adequate
compensation under the meaning of the Patent Act, particularly when viewed
in light of the public interest served by Gore’s continued infringement—for
which Plaintiffs are to receive a compulsory license.”

Johnson & Johnson Vision Care, Inc., v. CIBA Vision Corp., 712 F. Supp. 2d
1285, April 27, 2010, involving extended-wear contact lenses.

. . . evidence convinces the Court that millions of innocent contact lens
wearers will suffer real adverse consequences if sale of ACUVUE OASYS is
enjoined. These are not just issues of comfort or cosmetics, as CIBA
argues, but rather deal with the more substantive concerns of proper vision
and eye care. There will also be significant disruption, confusion and cost
(estimated to be in the hundreds of millions of dollars) caused by ACUVUE
OASYS patients being abruptly told that the contact lens for which they
have been fitted and with which they are satisfied, is no longer available.
Choosing a new lens will at minimum require refitting and the new lens may
not prove as efficacious as the ACUVUE OASYS lens. Moreover, patients may
have to be refitted more than once until an appropriate lens is found. An
undefined number will not be able to be refitted appropriately at all.
CIBA’s answer that ‘‘they can just wear glasses’’ is no answer, in this
Court’s view.

The preponderance of the evidence convinces the Court that an injunction
will create consequential medical, practical and economic issues for large
numbers of ACUVUE OASYS users. The deleterious effects of the injunction on
the general public would simply be too great to permit. Thus, CIBA has
failed to carry its burden of proving that the public interest would not
disserved by the entry of a permanent injunction.

Edwards Lifesciences AG v. CoreValve, Inc., et al., No. C.A. 08-91-GMS,
February 7, 2011, a case involving a valve prosthesis that can be implanted
in the body without the need for surgical intervention, but rather through
the use of a catheter.

The object of the invention, and the key innovation upon which the parties
focused at trial, is to provide a valve prosthesis that can be implanted in
the body without the need for surgical intervention, but rather through use
of a catheter. With respect to cardiac valves, the invention thus permits a
valve to be implanted without the need for open heart surgery and the risks
that come with such surgery.

. . . CoreValve's infringement stems not from sales of the accused product,
all of which occurred outside the United States, but rather from the
manufacturing of the accused product in the United States. 13 Thus, Edwards
must establish that CoreValve's manufacturing operations in the United
States are continuing and will continue to cause irreparable harm if not
enjoined. Edwards, however, does not appear to dispute that CoreValve would
be able to move its remaining manufacturing operations to Mexico almost
immediately if the court enjoined it from continuing to manufacture its
products in the United States. . .

The court fails to see what hardship Edwards would suffer if CoreValve were
permitted to continue manufacturing its product in the United States, as
opposed to in Mexico, that could not be compensated through remedies at
law. The public interest would not be substantially advanced or harmed by
the issuance of an injunction, since Core Valve would be able to continue
manufacturing accused product abroad without seriously affecting the supply
of the product available to the public. Consequently, the court will deny
Edwards' motion for a permanent injunction.

Conceptus, Inc. v. Hologic, Inc., No. C 09-02280 WHA, January 9, 2012, a
case involving intrafallopian contraceptives.

Defendant Hologic owns and markets the infringing Adiana contraceptive
system. The Adiana system, like the Essure system, involves the minimally
invasive transcervical placement of a contraceptive device (referred to by
Hologic as a “matrix”) into a woman’s fallopian tubes. Combined with the
use of radiofrequency energy, the Adiana matrix — much like the Essure
system — is intended to produce intrafallopian occlusion, which either
prevents conception from occurring or blocks the passage of a fertilized
ovum to the uterus. Adiana received FDA approval in July 2009. This is a
two-product market: Essure and Adiana are the only two products available
for transcervical hysteroscopic sterilization.

The public interest would undoubtedly be harmed by an injunction. Enjoining
the sale of Adiana would leave only one product for transcervical
hysteroscopic sterilization. Public health has benefitted, and will
continue to benefit, from having a choice of products for transcervical
hysteroscopic sterilization. This is especially important because the
products are different. Removing Adiana from the market would have
eliminated an important alternative for patients.

Essure and Adiana are not interchangeable products and procedures. With
Essure, there is a risk of perforations because of its long corkscrew-like
tail. Evidence at trial also showed that some patients do not want Essure
because it is metallic. For example, Essure is not available to patients
who have nickel allergies. With Essure, there is a concern that the
trailing coils could interfere with certain types of endometrial ablation
procedures. There is also the possibility of pain after placement of Essure
coils (TX 137 at 9976–78).

On the other hand, Adiana is not a metallic coil but is a small foam
cylinder. It is not screwed into the fallopian tube. Instead, the fallopian
tube is “burned” slightly by radiofrequency energy. As the tube heals, the
healing tissue grows into the foam insert. . . . the precise mechanism of
action has important advantages over Essure, such as a non-metalic body, no
risk of perforation, and use of radiofrequency energy.

In this action, the public benefit of having two products with different
qualities in the transcervical hysteroscopic sterilization market militates
strongly against an injunction.

Tyco Healthcare Grp. L, et al., v. Ethicon Endo-Surgery, Inc.,
3:10-cv-00060-JBA, March 28, 2013, involving ultrasonic surgical devices.

The three patents at issue in this lawsuit are directed to ultrasonic
surgical devices, which employ ultrasonic energy to cut and coagulate
vessels in surgery. . . .

The devices at issue are commonly used in laparoscopic surgery in which
trocars are used to pierce a patient’s body and a narrow hollow tube, or
“cannula,” is used to provide a “working pathway” to the target surgical

. . . “remedies available at law, such a monetary damages,” are fully
adequate to compensate for Tyco’s injury.

The Court finds that the public interest prong cuts both ways, as there is
certainly an interest in “protecting the rights of patent owners,” see
Smith & Nephew, Inc. v. Synthes (U.S.A.), 466 F. Supp. 2d 978, 985 (W.D.
Tenn. 2006), as well as an important consideration that a permanent
injunction would pull many devices that are presently used in surgery off
the market.

Verinata Health, Inc., et al., v. Ariosa Diagnostics, Inc., et al., 329 F.
Supp. 3d 1070, July 19, 2018. This suit involves the Harmony test, a
non-invasive prenatal screening of fetal chromosomal abnormalities, sold by
Ariosa, a company acquired by Roche in 2014.

Defendant Ariosa is a molecular diagnostics company that researches,
evaluates, and develops non-invasive prenatal tests for chromosomal
abnormalities in a fetus. . .

This Court is unconvinced by Illumina’s argument that the harm resulting
from competing against Roche is not compensable by monetary damages.

Even when an injunction is granted, such as in the Braun/Terumo case below,
the court now can narrow the injunction in ways that protect competition,
and protect access to an important medical technology.

B. Braun Melsungen AG, et al., v. Terumo Med. Corp., et al., 778 F. Supp.
2d 506, April 21, 2011, involving intravenous catheters.

The Court finds that [the balance of hardships] factor weighs heavily in
favor of Terumo’s proposed injunctive relief, as opposed to Braun’s much
more expansive proposal. If the Court were to immediately and entirely
exclude Terumo’s Surshield from the market, medical professionals who are
currently using Terumo’s device would be required to stop doing so. In at
least some instances, this would result in medical professionals being
abruptly deprived of a device for which they have expressed a preference,
and have been specifically trained to use. (See, e.g., D.I. 385, Omiecinski
Decl., ¶¶ 10–11) Terumo’s reputation would also be harmed to a degree
disproportionate to the infringement found by the jury. What would appear
to many to be an urgent, “recall-like” decree from this Court is simply not
warranted under the circumstances presented here. (See id. ¶ 14)

. . .

The Court concludes that the public interest likewise favors entry of the
more limited injunctive relief proposed by Terumo, as opposed to the
injunction sought by Braun. The Court reaches this conclusion largely for
the reasons already described, primarily the impact of Braun’s requested
relief on medical professionals currently using Terumo’s Surshield, Again,
the Court does not minimize the importance of the competing considerations
relied on by Braun—including, especially, the public interest in strong and
consistent enforcement of patent rights. See Callaway, 585 F.Supp.2d at 622
(finding insufficient evidence “to counter the strong public policy
favoring the enforcement of patent rights recognized by the courts.”)
(internal quotation marks omitted). However, in the overall circumstances
presented here, particularly the public interest in access to competing
alternatives to safe medical devices, see, e.g., Cordis Corp. v. Boston
Scientific Corp., 2003 WL 22843072, at *6 (D.Del. Nov. 21, 2003) (denying
preliminary injunction in part due to “the obvious concern of depriving the
public of the best and safest medical devices by limiting competition”),
the public interest favors the more limited injunction proposed by Terumo.

James Love
Luis Gil Abinader
Knowledge Ecology International
1621 Connecticut Avenue, NW, Suite 500
Washington, DC 20009

James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>

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