United States District Court, D. Delaware
C R BARD INC. ET AL, PLAINTIFF,
ANGIODYNAMICS INC., DEFENDANT.
MEMORANDUM AND ORDER
F. Bataillon, Senior United States District Judge.
matter is before the Court following plaintiff's
presentation of its case at trial. At the end of
plaintiff's case, the Court listened to motions and
arguments from the parties. The Court determined that
plaintiff C.R. Bard Inc. (hereinafter “Bard”) had
not presented sufficient evidence regarding its claims and,
therefore, issued a judgment as a matter of law pursuant to
Fed.R.Civ.P. 50(a) at the close of plaintiff's case. The
Court made some findings on the record but also told counsel
it would follow up with a written memorandum and order and a
judgment. Prior to the filing of this Court's memorandum
and order, the plaintiff filed an appeal of the rulings this
Court made at the close of the plaintiff's case in chief
for infringement. With this memorandum and order, the Court
enters judgment, and any deadline for appeal of the
Court's rulings shall be calculated from this date.
filed its original application on April 25, 2006; it's
‘417 patent on July 2, 2013; it's ‘460 patent
on October 1, 2013; and its ‘478 patent, the method
patent, on August 12, 2014. D.I. 192, See Exs.
The United States Patent Office permitted Bard to patent its
“means of identification” concept, and it also
issued Bard's method patent. At issue in this
infringement action is a port which is a power injection
port, with an identifiable feature by x-ray, and an
identifiable feature that is separate for the device.
Inc. (hereinafter “Angio”) filed with the Food
and Drug Administration (hereinafter “FDA”) in
August of 2006 and used Bard as a predicate device. Angio
received approval from the FDA. First approval included a
round port with a sticker and a hospital wrist band, and
there were no indicators that the port was power injectable.
However, there was a problem identifying the type of port
after insertion. Thereafter, Angio developed the scalloped
shape device and it is radiographic.
case has lingered in the district court since 2015. The
parties have hotly disputed discovery, legal issues, two
claims construction orders and multiple motions for summary
judgment. In the interim, administrative hearings and appeals
were taken including a decision in the Federal Circuit. Bard
contends the infringing products include a scallop shape
and/or a radiopaque CT marking and extraneous identification
as a matter of law is appropriate if “the court finds
that a reasonable jury would not have a legally sufficient
evidentiary basis to find for [a] party” on an issue.
Fed.R.Civ.P. 50(a)(1). “Entry of judgment as a matter of
law is a ‘sparingly' invoked remedy, granted only
if, viewing the evidence in the light most favorable to the
nonmovant and giving it the advantage of every fair and
reasonable inference, there is insufficient evidence from
which a jury reasonably could find liability.”
Marra v. Phila. Hous. Auth., 497 F.3d 286, 300 (3d
Cir. 2007) (citation omitted).
District Court in DiSalvio stated:
JMOL, pursuant to Federal Rule of Civil Procedure 50, is
appropriate only where, as a matter of law, there is not by
sufficient evidence to allow a reasonable juror to arrive at
a contrary verdict. See Link v. Mercedes-Benz, 788
F.2d 918, 921 (3d Cir.1986). In making the determination to
grant JMOL, the court must find that as a matter of law,
“the record is critically deficient of the minimum
quantity of evidence from which the jury might reasonably
afford relief.” Simone v. Golden Nugget Hotel &
Casino, 844 F.2d 1031, 1034 (3d Cir.1988). The party
opposing JMOL is entitled to the benefit of all reasonable
inferences that can be drawn from the evidence in order to
determine whether there is any rational basis for the
verdict. See Bhaya v. Westinghouse Elec.
Co., 832 F.2d 258, 259 (3d Cir.1987). JMOL is only
appropriate when there is no evidence or reasonable inference
that can be drawn supporting the verdict. See SCNO Barge
Lines, Inc. v. Anderson Clayton & Co., 745 F.2d
1188, 1192-93 (8th Cir.1984).
DiSalvio v. Lower Merion Sch. Dist., CIV.A. 00-5463,
2002 WL 734343, at *1 (E.D. Pa. Apr. 25, 2002). JMOL is
appropriate when “a party has been fully heard on an
issue and there is no legally sufficient evidentiary basis
for a reasonable jury to find for that party on that
issue.” Fed.R.Civ.P. 50(a)(1) (2002). Hence, a grant of
JMOL on an issue is improper if a reasonable jury could find
for the nonmoving party on that issue. Doyle v. Crain
Indus., Inc., 49 Fed.Appx. 920, 922 (Fed. Cir. 2002).
close of plaintiff's case, Angio moved for judgment as a
matter of law of non-infringement on three separate grounds
pursuant to Fed. R. Civ. P 50(a). For the purpose of its
ruling, the Court considers the evidence presented during the
plaintiff's case in chief and the evidence produced in
the context of the multiple motions for summary judgment
filed by both parties. Throughout the exhausting motion practice
for this case, the Court gave the plaintiff the benefit of
the doubt, relying on the weight of evidence that may be
provided by the plaintiff's expert witness. After the
plaintiff presented its evidence about its alleged invention
and infringement, the Court finds the defendant's
position is correct as a matter of law. Fundamentally, after
listening to the evidence presented to the jury and
considering the evidence for the previous motions for summary
judgment, the Court finds this patent is about labeling, not
invention and not technology. Praxair Distrib., Inc. v.
Mallinckrodt Hosp. Prod. IP Ltd., 890 F.3d 1024, 1032
(Fed. Cir. 2018) (“Claim limitations directed to the
content of information and lacking a requisite functional
relationship are not entitled to patentable weight because
such information is not patent eligible subject matter under
35 U.S.C. § 101”). It is clear from the evidence,
or lack of evidence, that the labeling does not change the
port and labeling is old technology.
to Bard's disclosure of its power injectable port and
indicators, the FDA had issued warnings and reported patient
complications with vascular ports being used for power
injections. After the FDA warning the standard of medical
care required practitioners to identify ports capable of
power injection before beginning such procedures. The
plaintiff understood this news as an opportunity to create a
new market - the power injectable vascular port authorized as
a new medical device by the FDA. It tested its vascular ports
to determine whether they could withstand the pressure and
flow rate necessary for power injection. Bard's port,
along with others in the industry, were able to qualify for
power injection use without essential modification.
Bard's marketing team was also astute enough to
understand that labeling its vascular ports would give it a
competitive advantage. To that end, it decided to further
enhance its market share by obtaining a patent for its
labeling. It identified three means of labeling:
radiographic, extraneous, and otherwise. It also pursued a
method patent that outlined a procedure for identifying its
patented power injectable ports.
consideration of the evidence, the Court finds that the
“means of identification” patent claims were no
more than features that identified a power injectable port
device, externally and/or subcutaneously. The method claim
was no more than a recitation of the standards of medical
care required following the FDA warning.
accused devices use the same letters Bard uses to identify
its power injectable vascular ports, CT. The letters CT
are recognizable by the medical profession because most power
injection procedures are used to inject contrast material in
preparation for Computer Tomography Scans (commonly referred
to as CT Scans). The accused products etch the letters in
titanium ports and use radiopaque foil in plastic valves.
Both practices took Bard and the defendant, Angio, a matter
of months to test, manufacture and market.
in its initial attempt to identify its power injectable port,
created a scalloped shape. The testimony demonstrated that
the significance of this shape was not sufficiently clear to
users while the CT marking was unmistakably clear. After
seeking a legal opinion, Angio marketed a series of power
injectable ports that were marked with the letters CT.
Thereafter, Bard sued for infringement.
Angio contends that Dr. Timothy Clark's opinions relied
on incorrect law. Dr. Clark addressed the claim limitations,
but according to Angio, Dr. Clark did not address the
Court's claim construction. On cross-examination, Dr.
Clark admitted he did not rely on Judge Robinson's claim
construction regarding the term vascular access port or
access port. See Transcript, D.I. 445,
913:2-914:20. When an expert fails to apply the correct claim
construction, the testimony does not create triable issues of
fact. Weiner v. NEC Electronics, Inc., 102 F3rd 534,
542 (Fed. Cir. 1996) and Quest Licensing Corp v.
Bloomberg, 2017 Westlaw 239345 *3 (D. Del. 2017),
aff'd 726 Fed.Appx. 819 (D. Del. 2018). The Court agrees
that Dr. Clark did not clearly articulate that he followed
the claims constructions issued by the Court.
Angio moved for infringement of the ‘478 method patent
contending that Bard failed to offer sufficient evidence that
a single person or entity had performed all steps of the
claimed method. The Court agrees Bard did not show that Angio
took actions with respect to all steps of the claimed
methods. Bard failed to do so, and thus this claim fails.
Bard also contends that the reference should be
“entity” and not separate out physicians, and
hospital, and hospital staff, as they all constitute one
entity when determining if all the steps are made in
compliance with the law. Limelight Networks, Inc. v.
Akamai Tech, 572 U.S. 915, 921-23 (2014) (all the steps
claimed in the patent must be performed or attributable to
one person, or by a person who exercises all the control, and
all steps must be carried out). See Akamai
Tech., Inc. v. Limelight Networks, Inc., 797 F.3d 1020,
1022 (Fed. Cir. 2015) (“Where more than one actor is
involved in practicing the steps, a court must determine
whether the acts of one are attributable to the other such
that a single entity is responsible for the infringement. We
will hold an entity responsible for others' performance
of method steps in two sets of circumstances: (1) where that
entity directs or controls others' performance, and (2)
where the actors form a joint enterprise”). Dr. Clark,
argues Angio, did not introduce any evidence of infringement
by directing the actions of multiple actors. The Court agrees
and will also grant the JMOL motion of non-infringement of
the ‘478 Patent on this basis.
addition, the Court finds there is a failure of proof on the
method issue. Bard introduced some evidence regarding a
patient at University of Pennsylvania having issues related
to the ports. However, the evidence presented that a Smart
Port was implanted in that hospital and that the additional
required steps taken there is pure speculation. The Court
finds there is insufficient evidence, lack of relevant
evidence and lack of foundation for this testimony.
there is a failure of proof regarding Xcela's being a
vascular access for the structured power injection. No. one
testified in that regard. The only mention is the FDA's
indication for power injection, but even Dr. Clark admitted
the decision by the FDA was irrelevant to infringement. D.I.
445, Transcript, 828:20-25. Bard provided no testing results
on Xcela. The Court will likewise grant JMOL on this issue.
is clear, one cannot obtain a patent that simply labels a
product, especially if the label is no more than alphabetic
letters. Each of the patent claims in this lawsuit rely on
the identification of alphabetic letters or words to identify
a device. Furthermore, the defendant cannot infringe a patent
by simply marking a product with letters that identify its
use, nor with a unique shape. This product is not covered by
a copyright or trademark protection for the letters
“CT”, nor a design patent covering the
product's shape. The defendant did not infringe the
Bard's patent because the patent does not prohibit
addition, the Court notes the following. There is no
contention that any of Angio's vascular ports
structurally infringe Bard's ports. Bard believes it can
prevent Angio from designing the shape of a port and
advertise it as unique for power injection. Bard does not
have a design patent. Furthermore, Angio cannot infringe a
patent by simply providing instructions for the use of its
Court concludes that the ‘478 method Patent recites
claims that are routine well understood and conventional
standards of care present before the claimed invention.
“Claim limitations directed to the content of
information and lacking a requisite functional relationship
are not entitled to patentable weight because such
information is not patent eligible subject matter under 35
U.S.C. § 101.” Praxair Distrib., 890 F.3d
at 1032. The Federal Circuit has generally found printed
matter falls outside the scope of § 101. See
AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064
(Fed. Cir. 2010); In re Marco Guldenaar Holding
B.V., 911 F.3d 1157, 1161 (Fed. Cir. 2018). See
Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253,
1258 (Fed. Cir. 2017) (“[W]e must ... ask whether the
claims are directed to an improvement to computer
functionality versus being directed to an abstract
idea” (internal quotations omitted)). The shape of the
power injectable ports is only protected by a design patent
or trademark. Bard has no claim. The extraneous
identification materials (I.D. bracelet, I.D. cards, key
chain tags, etc.) are not an intrinsic part of the vascular
access port and provide no structural function. Any claims under
the patent that rely on this claim are
unenforceable. The evidence supports that identifying
ports capable of power injection by means of the medical
record, patient history, product materials or radiograph was
routine, conventional and required by the standard of medical
care existing at the time of the alleged invention. The Court
agrees that this is ineligible patent subject matter. The
Court determines, as it stated on the record that it has no
“evidence in the record at all that this is not an
abstract idea or that all limitations that were outlined in
my order with respect to letters and instructions are even -
are even addressed. In fact, everything that you've done
has supported the problem that you have with the letters. All
you've done is identified your product. I just don't
see any evidence in the record that shows me that this patent
is eligible under any circumstance.” D.I. 446,
the Court agrees that Bard has power ports, but several
companies, likewise, have structurally non-infringing power
ports. Second, Bard has shown it has radiographic properties
suitable for power injection. Bard contends that the scallop
shape is an indicator of these claims. The Court disagrees.
The evidence demonstrates that doctors did not sufficiently
recognize scalloped shape as a power injectable port.
second alleged infringing feature under the ‘460 patent
are extrinsic indicators identifying the port as power
injectable. The evidence is clear that these extrinsic
indicators are merely printed material which includes a
bracelet and a key tab identifying the product as power
injectable. The Court finds these extrinsic indicators are in
fact printed material and unpatentable.
the ‘417 patent Bard contends the infringed extrinsic
indicators are the scallop shape, the radiopaque letters CT
and the device can be identified by palpation. The Court
finds the letters and shape are not eligible for patenting as
discussed herein. As to whether the shape gives rise to the
additional means of identification by palpation, Bard's
expert, Powers, admitted that Bard did not invent palpation,
as it was well known. D.I. 444, Transcript - Powers,
579:9-22. Essentially, the expert admitted that none of the
alleged infringing means of identification were new or
original. On redirect, Mr. Kelly Powers testified:
Q. Mr. Powers, did you invent radiographic letters?
A. I invented a radiographic identifier that was used in
combination with a port structure for power injection to
identify that is what it was.
Q. You didn't -- A. Letters being among a broad category
that does that in alphanumeric indicia.
Q. But you didn't invent radiographic letters; is that
A. Well, I -- I don't know. I guess I'm not claiming
that I invented it. If there are other examples, then I
didn't invent it.
D.I. 444, 156:16-157:3. Likewise on cross examination, Dr.
Q. Okay. So, we agree that there were no changes necessary to
the Vaxcel product, then, in order for it to be structured
for power injection?
Q. Okay. Same with Vortex, there were no changes necessary to
be made to the Vortex structure in order for it to be
structured for power injection?
A. Yes, the same Vortex port that remains on the market,
although without the FDA clearance to be marketed as power
Q. And we also agree that both Vortex and Vaxcel were
publicly available and sold and used more than one year
before the filing date of these patents?
A. Yes, though not as ports identified as being power
Q. You're aware that the Vortex ports were sold with
Q. And that labeling would have identified the port as a