United States District Court, D. Delaware
before me are the parties‘ motions in limine. By their
nature, these motions help streamline the trial. However, in
some cases, the context of trial is necessary to properly
evaluate the admissibility of evidence. With that in mind, I
would encourage the parties to assert objections at trial
regarding motions I have denied, if and when doing so becomes
in limine allow the court ''to exclude anticipated
prejudicial evidence before the evidence is actually
offered.'' Luce v. United States, 469 U.S.
38, 41 n.2 (1984). ''The purpose of an in limine
motion is to aid the trial process by enabling the Court to
rule in advance of trial on the relevance of certain
forecasted evidence, as to issues that are definitely set for
trial, without lengthy argument at, or interruption of, the
trial.'' Palmieri v. Defaria, 88 F.3d 136,
141 (2d Cir. 1996) (internal quotation mark omitted).
JHU Motions in Limine 1-9
Granted as to direct infringement, denied as to
reasonable royalties: “Defendants Should Be
Precluded From Injecting An Element of 'Harm' Into
Either Direct Infringement or Reasonable Royalty
moves to preclude Alcon ''from arguing or presenting
evidence to suggest that 'harm‘ is an element of
either direct infringement or reasonable royalty
damages'' because it is not an element for either.
(Doc. No. 348, at 1.) JHU argues that such evidence would be
irrelevant under Rule 402 and prejudicial and misleading
under Rule 403.
parties note that direct infringement (here, allegedly by the
surgeons using Alcon‘s instruments) is an element of
induced and contributory infringement, the claims at issue in
this case. (Doc. No. 348, at 2; Doc. No. 375, at 3.) JHU
provides the following example of Alcon‘s allegedly
improper arguments regarding lack of harm to JHU. This is
taken from Alcon‘s Statement of Issues of Fact, at
Exhibit 3 of the parties‘ pretrial order, under the
heading, ''Induced Infringement.''
Whether Alcon‘s affirmative actions after June 23,
2009-as opposed to other factors-actually caused the surgeons
to directly infringe each and every element of the '848
patent for each of the Accused Products; and
whether JHU has suffered any harm actionable by
damages as a consequence of the alleged infringement by
surgeons and/or Alcon, and whether such alleged
affirmative actions by Alcon has caused JHU any harm that is
actionable by damages; is immune from suit because such
activity was engaged in pursuant to research and development
efforts, and thus falls within the scope of the
''safe harbor'' provisions of 35 U.S.C.
§ 271(e)(1), see, e.g., Lilly, 496
U.S. 661 (affirming Federal Circuit that the safe harbor
applies when seeking pre-marketing approval for a medical
device); and/or whether such uses may support JHU‘s
damages claim against Alcon in view of 35 U.S.C. §
(Doc. No. 288-1, Ex. 3 at 4) (emphasis added).
argues that ''the direct infringement statute says
nothing about harm.'' (Doc. No. 348, at 3) (citing 35
U.S.C. § 271(a)). The statute reads:
Except as otherwise provided in this title, whoever without
authority makes, uses, offers to sell, or sells any patented
invention, within the United States or imports into the
United States any patented invention during the term of the
patent therefor, infringes the patent.
35 U.S.C. § 271(a).
responds that JHU opened the door to a discussion of
''harm.'' Justifying this argument, Alcon
points to a footnote in JHU‘s motion in limine, which
states that ''Alcon‘s willful infringement has
harmed JHU'' through lost licensing revenue. (Doc.
No. 375, at 1 (citing Doc. No. 348, at 3 n.2).)
appears to me that this footnote is merely an aside to
JHU‘s argument. Harm is not relevant to a determination
of direct infringement (an element of indirect infringement).
Therefore, I will grant JHU‘s motion in limine and will
preclude Alcon from offering arguments or evidence of harm to
prove direct infringement. This ruling only relates to direct
infringement-if evidence of harm, or lack thereof, is
relevant in other contexts at trial, we will resolve any
objections at that time.
liable for infringement is responsible for the following
Upon finding for the claimant the court shall award the
claimant damages adequate to compensate for the infringement,
but in no event less than a reasonable royalty for the use
made of the invention by the infringer, together with the
interest and costs as fixed by the court.
35 U.S.C. § 284.
argues that ''reasonable royalty damages are
calculated based on the value of what was taken by
the infringer, not the damage suffered by the
patentee.'' (Doc. No. 348, at 4 (citing
AstraZeneca AB v. Apotex Corp., 782 F.3d 1324, 1334
(Fed. Cir. 2015); Warsaw Orthopedic, Inc. v. NuVasive,
Inc., 778 F.3d 1365, 1377 (Fed. Cir. 2015); Aqua
Shield v. Inter Pool Cover Team, 774 F.3d 766, 770 (Fed.
responds that JHU has put harm at issue by virtue of its own
reasonable royalties arguments that put Bausch and Lomb
(B&L) at the hypothetical negotiating table. (Doc. No.
375, at 1-2.)
JHU‘s reasonable royalty theory puts B&L at the
hypothetical negotiating table, and argues JHU must
compensate B&L for 1) converting B&L‘s
exclusive license to a non-exclusive one before granting
Alcon a license; and 2) the ''direct negative
financial impact (i.e., harm) B&L‘s
product sales suffer if JHU licensed Alcon.
(See Ex. 38, Am. Napper Rep. at 21, 45).
Alcon responds that as part of its defense to the
contributory infringement claim, it should be permitted to
''show that it committed no affirmative act designed
to cause JHU any infringement harm.'' (Id.
at 3-4.) This consideration is separate from the reasonable
royalties issue but nonetheless shows that harm may be
relevant to certain aspects of this case.
Alcon argues that ''JHU‘s inability to find any
activity beyond Alcon‘s mere product sales that has
harmed it or B&L-let alone caused a surgeon to indirectly
infringe-is relevant; and independently probative on the
question of the reasonableness of JHU‘s royalty
demands.'' (Id. at 4 (citing Golden
Blount, Inc. v. Robert H. Peterson Co., 438 F.3d 1354,
1372-73 (Fed. Cir. 2006); Eidos Display, LLC v. Chi Mei
Innolux Corp., No. 6:11-CV-002010JRG, 2018 WL 1156284,
at *9-10 (E.D. Tx. Mar. 5, 2018)).)
Alcon argues that JHU‘s actual harm, or lack thereof,
is relevant to indirect and willful infringement theories
that ''turn on Alcon‘s actual, specific intent
at the time of the alleged infringement.''
(Id.) ''If Alcon never harmed JHU, it is
entirely appropriate for a jury to expect that Alcon was not
seeking to willfully target JHU by acting like a
pirate.'' (Id. (citing Halo Elecs., Inc.
v. Pulse Elecs., Inc., 136 S.Ct. 1923, 1932 (2016)).)
Along the same lines, Alcon argues that harm factors into its
equitable estoppel defense because ''JHU‘s lack
of harm is why JHU was perfectly content to lie in wait for
over ten years (while Alcon invested hundreds of millions in
R&D efforts for its vitreoretinal product portfolio) and
delay filing suit.'' (Id.)
the above analysis, it would not be proper to exclude
evidence of harm as it relates to reasonable royalty at this
stage because it may be relevant to various considerations.
JHU may object to such evidence at trial if and when it
Granted in part and denied in part:
“Defendants Should Be Precluded From Introducing
Evidence or Arguments about the Morality or Ethics of
Patenting Surgical Methods and of Patenting Government-Funded
moves to preclude evidence and argument ''(1)
suggesting it is unethical to patent medical procedures, or
(2) suggesting that it is improper or immoral for a nonprofit
teaching hospital that receives some government research
funding to seek patent protection on its
inventions.'' (Doc. No. 348, at 5.)
Morality and Ethics
moves to exclude the 1995 American Medical Association
''Reports of Council on Ethical and Judicial
Affairs'' (AMA report). (Doc. No. 348, at 5; Doc. No.
359, Ex. 4.) The report includes a ''statement that
'the Council believes that it is unethical for physicians
to seek, secure or enforce patents on medical
procedures.‘'' (Doc. No. 348, at 5.) JHU argues
that such evidence should be precluded under Rules 402 and
403 and states that ''[a] viewpoint on the ethics of
surgical method patents expressed by an AMA subcommittee and
which is contrary to United States patent law expressly
allowing such claims is irrelevant to the issues that will be
tried to the jury.'' (Id. at 6.)
responds that the AMA report should be permitted to rebut
JHU‘s ''supposed pure motives; surgeon praise;
and adherence to its university mission.'' (Doc. No.
375, at 5.) It notes that after the 1995 AMA report, which
was critical of surgical method patents, ''Congress
precluded patentees from enforcing such patents at least
against surgeons.'' (Id. at 5 (citing 35
U.S.C. § 287(c)(1)).)
asserts that ''[b]oth the law and the 1995 AMA Report
confirm the anti-patent-enforcement culture by and amongst
surgeons.'' (Id. at 5-6.) Therefore, it
argues that it should be permitted to ''ask
JHU‘s physician experts whether they accept their
peers‘ ethical standard [as voiced within the AMA
report] . . . or whether their long-term friendships with Dr.
de Juan . . . trump those concerns.'' (Id.
Alcon ignores an important point. JHU is not a surgeon, and
the law does not protect JHU from surgical method
infringement claims. Therefore, Alcon‘s purported use
of the AMA report essentially attacks the right-mindedness of
the applicable law. With that, I will grant JHU‘s
motion to exclude the 1995 AMA report, to the extent it is
used to attack the philosophy and principle of patenting
surgical methods (as permitted by law).
notes a second instance when it may wish to use the AMA
report at trial.
Alcon expects Ms. Wyskiel will opine that JHU was harmed
because it ''can‘t maximize licensing
revenue'' and its partners expect to have patents to
protect ''the dollars that they put into developing
and marketing products.''
(Ex. 42, Wyskiel Tr. 126:7-127:2 (emphasis added); Ex. 40,
JHU Resp. to Interrog. 12 at 8-9). Alcon can rebut this with
the 1995 AMA Report, which differentiates between instrument
patents and surgical method patents; and states that the
former, not the latter, requires significant capital
(Id. at 7 (footnotes omitted).)
not preclude the AMA report from being used in this manner,
to rebut a statement. To summarize my conclusion on this
issue, Alcon is precluded from using the AMA report as it
relates to the principles, ethics, and related considerations
underlying whether surgical methods should be patented, but
it may use the report for other purposes, such as rebutting a
witness‘s factual statement.
seeks to exclude evidence and argument that JHU‘s
research is government funded. As an example of how this
issue may arise at trial, JHU notes the deposition of Christy
Wyskiel, senior advisor to the university‘s president.
(Doc. No. 348, at 5, 7.)
At Ms. Wyskiel‘s deposition, Alcon established that
some of JHU‘s research is government funded, and that
JHU patents some inventions developed through its research.
(Ex. 3 at 14:6-23.) Counsel then asked
''[w]ouldn‘t it be better for society if you
just allowed anyone to practice the results of JHU‘s
research instead of seeking a patent to exclude others from
practicing it?'' (Id. at 14:24-15:2.) While
that may be an interesting topic for a philosophical or
political discussion, it has nothing to do with the issues
the jury will be asked to decide. . . . There is no authority
for the proposition that, because the government provides
funding to JHU, Alcon is immunized from liability for its
willful infringement of JHU‘s patent.
(Id. at 8.)
responds that evidence of JHU‘s funding is relevant to
damages in this case because JHU ''seeks to boost its
royalty by approximately $50 million based in part on the
premise that it is a not-for-profit institution, Alcon did
not help fund JHU‘s research, and B&L would be
given a far lower royalty rate given the value of its early
stage funding support of JHU‘s MADLAB (about $1.5
million total over several years).'' (Doc. No. 375,
at 7-8.) These potential arguments by JHU, Alcon argues, make
it relevant that ''JHU receives over $1 billion in
research funding annually (including federal funds) . . .
dwarfing the contribution B&L made years ago.''
(Id. at 8.) JHU argues that this evidence of
government funding undermines JHU‘s ''poverty
pleas.'' (Id. at 8.)
their arguments on this motion, the parties address at least
two distinct purposes of evidence of federal funding. To the
extent that evidence of federal funding addresses a
''philosophical or political discussion'' of
whether surgical methods should be patented, it is not
permitted. However, at this time, I will not exclude such
evidence as it relates to damages.
Denied: “Defendants Retained Expert, Dr.
Donald D'Amico, Should Be Precluded From Testifying about
the Prior Art Beyond the Disclosure of Paragraph 98 of His
moves to limit Dr. Donald D‘Amico‘s expert
testimony regarding prior art ''to the discussion of
the two references found in paragraph 98 of his
report.'' (Doc. No. 348, at 12.) Paragraph 98 reads
This claim covers a method for providing access within an eye
using an entry alignment device without pulling back the
conjunctiva. This fairly describes the invention as described
in the specification, prosecution history, and as
distinguished from the prior art methods. Entry alignment
devices (e.g., cannulas) were known to provide access within
an eye (see, e.g., Machemer 1985), and procedures that did
not require pulling back the conjunctiva were known (see,
e.g., '363 patent). However, I am not aware of an
explicit description of providing access within an eye using
an entry alignment device without pulling back the
conjunctiva. Therefore, Claim 38 appears to address the
differences between the explicit disclosures in the prior art
and the claimed method.
(Doc. No. 224, Ex. 24 ¶ 98.)
argues that limiting Dr. D‘Amico‘s prior art
testimony to the confines of this paragraph is appropriate
because he is a ''vitreoretinal surgeon''
retained by Alcon to opine on ''infringement and
aspects of damages . . . [including] opinions about the
smallest saleable patent practicing unit
('SSPPU‘).'' (Doc. No. 348, at 9.) Whereas,
Alcon retained a different expert, Dr. Stanley Chang, to
opine on invalidity. (Id.)
also seeks to exclude the information stated in paragraph
of Dr. D‘Amico‘s report. Importantly, as JHU
points out, Judge Fallon‘s Report & Recommendation
(Doc. No. 294), which I adopted in its entirety (Doc. No.
339), explicitly excludes paragraph 106. (Doc. No. 294, at
23.) Judge Fallon‘s opinion stated: ''The
court‘s recommendation therefore excludes Dr.
D‘Amico‘s opinion on the ultimate invalidity
issue at paragraph 106 of his expert report and his
corresponding deposition testimony, but does not extend to
Dr. D‘Amico‘s opinion on the smallest salable
unit for purposes of the infringement analysis.''
motion, JHU seemingly seeks to both confirm Judge
Fallon‘s ruling regarding paragraph 106 and to narrow
the terms of that ruling, by limiting it to paragraph 98. In
JHU‘s own words, it requests that I interpret Judge
Fallon‘s ruling to mean that Dr. D‘Amico cannot
''stray beyond the discussion found in paragraph 98
of his report, block-quoted above, which is a subset of Dr.
D‘Amico‘s infringement analysis and has nothing
to do with validity.'' (Doc. No. 348, at 10.) JHU
argues that if Dr. D‘Amico offered testimony regarding
prior art beyond the scope of paragraph 98, ''[s]uch
testimony would go beyond the scope of Dr.
D‘Amico‘s expert report in violation of
Fed.R.Civ.P. 26(a)(2), be unhelpful to the trier of fact
under FRE 702 because the testimony would be divorced from
the relevant law of invalidity, irrelevant under FRE 402 for
the same reason, and excludable under FRE 403 because any
probative value would be substantially outweighed by the
danger of unfair prejudice to JHU.'' (Id. at
confirms that ''Dr. D‘Amico will not opine on
the ultimate conclusion of invalidity.'' (Doc. No.
375, at 10.) However, Alcon argues that ''Dr.
D‘Amico should be permitted to testify about the
history of vitreoretinal surgery, the state of the art before
the patent was filed and the prior art references which
relate to those opinions, as disclosed in his
report.'' (Id.) These opinions, Alcon
argues, relate to reasonable royalty, because they shed light
on the smallest salable patent practicing unit, the
advantages of the patented property over old methods, and the
value of the patented invention over nonpatented
alternatives. (Id. (citing Georgia Pacific Corp.
v. U.S. Plywood Corp., 318 F.Supp. 1116, 1120 (S.D.N.Y.
1970) (listing reasonable royalty factors)).)
Alcon acknowledges that Dr. D‘Amico cannot testify
outside the bounds set forth by Judge Fallon, it points out
that Dr. D‘Amico‘s relevant testimony goes beyond
paragraph 98. Alcon cites paragraph 94 of Dr.
D‘Amico‘s expert report as an example:
I have been asked to determine what I understand is called
the ''smallest saleable patent-practicing unit,
'' which I understand is the product(s) sold by Alcon
that embodies the ''patented feature'' of the
Asserted Claims (I understand that no device is technically
claimed by the '848 patent-only methods). To do this, I
considered the language and scope of the Asserted Claims, the
specification, the prosecution history, the improvements the
Asserted Claims purportedly made over the prior art methods,
among other things. The smallest saleable patent-practicing
units, which embody the patented feature of allowing access
within an eye without pulling back the conjunctiva and
without using sutures to seal the wound, are Alcon‘s
(Doc. No. 224, Ex. 24 ¶ 94.)
deny JHU‘s motion in limine to limit Dr.
D‘Amico‘s prior art testimony to paragraph 98 of
his expert report. In general, I would hesitate to define
restricted testimony by a paragraph number rather than a
category of subject matter. And furthermore, I find that the
Judge Fallon‘s report sufficiently resolves this issue.
Judge Fallon very clearly stated that Dr. D‘Amico may
not testify regarding the ''ultimate conclusion of
invalidity'' but may testify regarding ''the
smallest salable unit for purposes of the infringement
analysis.'' (Doc. No. 294, at 23.) Beyond that,
objections should be made at trial.
Denied: “Defendants Should Be Precluded From
Presenting Evidence or Argument that JHU's Election to
Pursue Method Claims During Prosecution Prevents JHU From
Recovering a Reasonable Royalty”
motion, JHU seems to make two distinct requests for
exclusion-one general and one specific. In its general
request, JHU argues that Alcon should be precluded from
offering evidence or arguing that ''because
JHU‘s patent claims are directed to methods of use, JHU
cannot recover a reasonable royalty for Alcon‘s
indirect infringement.'' (Doc. No. 348, at 13.) In
other words, JHU argues that I should ''preclude
Alcon from contending that it cannot infringe method claims
because that argument is legally wrong and will mislead the
parties acknowledge, this issue has already been addressed by
Judge Fallon in her report. Judge Fallon found that Alcon did
not directly infringe but found that ''[i]t
is well-established that medical device and drug
manufacturers may be liable for inducing or contributing to a
medical practitioner‘s direct infringement of a
patented method.'' (Doc. No. 294, at 24-26, 28.)
point, I have nothing further to add. Judge Fallon thoroughly
articulated the claims that remain at issue in this case and
the law relevant to her analysis, and the parties must
on to JHU‘s more specific request, JHU moves under
Rules 402 and 403 to prohibit Alcon from making arguments and
introducing evidence related to a patent application that JHU
pursued separately from the ‘848 patent. (Doc. No. 348,
at 14, 16.) JHU filed this separate patent application, which
JHU refers to as the ''Divisional Application,
'' to cover surgical tools, but it later
''discontinued prosecution'' of the
argues that evidence of the Divisional Application is
relevant and would help the jury apportion damages because
JHU‘s expert measures damages by product sales
(i.e., sales of surgical tools)-and JHU never
obtained a patent on tools. (Doc. No. 375, at 14-15.)
''Evidence that JHU failed to secure claims for
instruments makes it more likely than not, and is highly
probative evidence, that at least some portion of
Alcon‘s instruments are attributable to
unpatented features the ‘848 patent
doesn‘t cover.'' (Id. at 15.)
Alcon argues that evidence of the Divisional Application may
be relevant on cross-examination of JHU‘s damages
expert, Brian Napper, if he incorrectly asserts that the
claims at issue ''directly cover both
methods and products.'' (Id. at 15.)
Evidence of the Divisional Application ''directly
rebuts his core assumption, and thus is a ripe topic for
cross-examination.'' (Id.) Further, JHU
argues, ''[e]ven assuming some infringement occurs,
because JHU lacks a product claim, it is not entitled to a
reasonable royalty on all product sales.''
(Id at 17 (citing Cardiac Pacemakers, Inc. v.
St. Jude Med., Inc., 576 F.3d 1348, 1358-59 (Fed. Cir.
the above discussion, I agree with Alcon that the Divisional
Application may be relevant to the discussion of damages and
helpful to a jury, and I will accordingly deny this motion in
Denied: “Defendants Should Be Precluded From
Making Any Arguments About the Importance of Alleged
Substantial Non-Infringing Uses”
seeks to preclude Alcon ''from making arguments or
eliciting testimony about the 'importance‘ of
alleged non-infringing uses of the accused products,
'' under Rules 402 and 403. (Doc. No. 348, at 17.)
to 35 U.S.C. § 271(c), which establishes liability for
contributory infringement, JHU must show that Alcon‘s
accused surgical tools are ''not a staple article or
commodity of commerce suitable for substantial noninfringing
use.'' In this motion in limine, JHU argues that the
''importance'' of a surgical tool‘s use
is irrelevant to, and could easily be confused with, the
legal standard-―substantial noninfringing
use.'' (Doc. No. 348, at 17-19.)
JHU takes issue with Alcon‘s characterization of
''vit-buckle'' eye surgery, which Alcon
argues is a ''substantial noninfringing
use.'' JHU argues:
During fact and expert discovery, JHU adduced evidence that
the accused products are used nearly exclusively to perform
the patented method. Alcon has attempted to rebut that
evidence by showing that the accused products have a
non-infringing use-an eye surgery referred to as a
''vit-buckle.'' Alcon‘s retained expert
opined that, because vit-buckle procedures are
''important '' when
used to treat retinal detachment patients, that use is a
substantial non-infringing use (D.I. 224 at Ex. 20, Aug. 22,
2017 Ryan Rpt. ¶ 71.)
(Doc. No. 348, at 17-18.)
JHU‘s argument that the surgery‘s
''importance'' is irrelevant, JHU seems to
define importance as the surgery‘s impact on an
individual patient. Importantly, in her summary judgment
opinion, Judge Fallon defined ''substantial
noninfringing use'' as
any use that is ''not unusual, far-fetched, illusory,
impractical, occasional, aberrant, or experimental.''
Vita-Mix Corp. v. Basic Holding, Inc., 581 F.3d
1317, 1327 (Fed. Cir. 2009). Relevant considerations in
assessing whether an asserted non-infringing use is
substantial include the frequency of the non-infringing use,
its practicality, the ...