Tuesday, May 14, 2019

Novartis prevails at CAFC

The outcome:

West-Ward Pharmaceuticals International Ltd (“WestWard”)1 appeals
the decision of the United States District
Court for the District of Delaware holding that claims 1–3
of U.S. Patent No. 8,410,131 would not have been obvious
in view of the prior art. We conclude that the district court
did not err in its nonobviousness determination and affirm.

Of the impact of clinical trials on expectation of success:

In addition, the district court determined that the asserted prior art
would not have provided a person of ordinary skill in the art with a reasonable expectation of
success in using everolimus to treat advanced RCC. Id. It
noted Dr. Cho’s admission that a person of skill in the art
would not have reasonably expected a drug to work based
only on phase I clinical trial results, or on the fact that a
drug had entered phase II clinical trials. Id.
The district
court explained that the temsirolimus phase I data disclosed in
Hutchinson had diminished weight because it resulted from small sample sizes
and because phase I clinical
trials are designed to determine safety, not efficacy. Id. It
further noted that everolimus and temsirolimus differed in
pharmacological properties relevant to treatment. These
differences, along with the high failure rate of cancer drugs
in phase II and III clinical trials, and the fact that the molecular
pathways of advanced RCC were not fully understood, all diminished the relevance of the temsirolimus
data. Based on these facts, the district court found that
West-Ward failed to establish by clear and convincing evidence that
a person of skill in the art would have reasonably expected everolimus to effectively treat advanced RCC.

Of the error of the district court:

A party seeking to invalidate a patent based on obviousness must prove “by clear and convincing evidence that
a skilled artisan would have been motivated to combine the
teachings of the prior art references to achieve the claimed
invention, and that the skilled artisan would have had a
reasonable expectation of success in doing so.” Procter &
Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994
(Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1361 (Fed. Cir. 2007)). “The presence or absence
of a motivation to combine references in an obviousness determination is a pure question of fact.” PAR Pharm., Inc.
v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014)
(quoting Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286,
1289 (Fed. Cir. 2006)). “The presence or absence of a reasonable expectation of success is also a question of fact.”
We hold that the district court erred in its analysis of
whether there was a motivation to combine.
However, we
discern no clear error in the district court’s finding that a
person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC
as of February 2001. We thus agree with the district
court’s ultimate determination that the challenged claims
would not have been obvious. We address both prongs of
the obviousness inquiry below.


Yet, the district court
continued its analysis and found that West-Ward “failed to
prove by clear and convincing evidence that a POSA would
have been motivated to select everolimus.” Id. The district
court erred in applying this heightened standard. “[O]ur
case law does not require that a particular combination
must be the preferred, or the most desirable, combination
described in the prior art in order to provide motivation for
the current invention.”
In re Fulton, 391 F.3d 1195, 1200
(Fed. Cir. 2004); see also Bayer Healthcare Pharm., Inc. v.
Watson Pharm., Inc., 713 F.3d 1369, 1376 (Fed. Cir. 2013).
It is thus improper to require West-Ward to prove that a
person of ordinary skill would have selected everolimus
over other prior art treatment methods.


The district court, however, appeared to apply or conflate the standard
for these types of cases by requiring clear and convincing evidence that a person of
ordinary skill “would have been motivated to select everolimus.”
Decision, 287 F. Supp. 3d at 516 (emphasis added).
To the extent the district court required a showing that a
person of ordinary skill would have selected everolimus
over other prior art compounds, it erred.
The proper inquiry is whether a person of ordinary skill would have been
motivated to modify the prior art disclosing use of temsirolimus to treat advanced
RCC with the prior art disclosing
everolimus. This question was answered affirmatively
when the district court found that a person of ordinary skill
“would have been motivated to pursue everolimus as one of
several potential treatment options for advanced solid tumors, including advanced RCC.” Id.

Appellants lose in BTG v. Amneal: the epitome of a decision that must be sustained upon review for substantial evidence.

From the decision of the CAFC:

Appellants appeal the PTAB’s Final Written Decisions
and the District Court’s Final Judgment. We consolidated
the appeals. We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a)(1) and 1295(a)(4)(A) (2012). We affirm the
PTAB’s Final Written Decision in Wockhardt. Because our
affirmance renders the remaining issues on appeal moot,
we dismiss the appeals of Amerigen, Mylan, and BTG.

Footnote 2 states:

When a party challenging the actions taken by an
agency in separate appeals and “the decision [in one case]
resolves the substantive issues appealed” in the other
cases, the other cases are moot. See Dep’t of Commerce v.
U.S. House of Representatives, 525 U.S. 316, 344 (1999)
(explaining that by “affirm[ing] the judgment of the District
Court . . . this decision also resolves the substantive issues
presented by” the other companion case and, therefore, the
“appeal in that case is therefore dismissed”); see also Synopsys, Inc. v. Lee,
812 F.3d 1076, 1077 (Fed. Cir. 2016) (dismissing an appeal
of a district court opinion as “moot”
because “[o]ur decision in the companion [PTAB appeal] resolves
all of the substantive issues presented in this [district court appeal];
nothing remains to be decided” and
“this [district court appeal] no longer presents a ‘sufficient
prospect that the decision will have an impact on the parties’” (citation omitted)).

Of the meaning of the word "or":

The specification states that a “therapeutic agent” may
be either “an anti-cancer agent or a steroid.” Id. col. 10
ll. 54–55 (emphasis added). As such, the use of “or” in
between “anti-cancer agent” and “steroid” suggests that a
steroid is not necessarily the same thing as an anti-cancer
agent. See Housey Pharm., Inc. v. Astrazeneca UK Ltd.,
366 F.3d 1348, 1353–54 (Fed. Cir. 2004) (explaining the
claim term “inhibitor or activator of a protein” was “not limited”
to the narrow meaning because “the specification and
prosecution history affirmatively demonstrate that [the
appellant] intended the broader meaning”). Importantly,
the specification identifies prednisone as a glucocorticoid,
see ’438 patent col. 3 ll. 9–11 (“[A] glucocorticoid includ[es],
but [is] not limited to, hydrocortisone, prednisone[,] or dexamethasone”),
and glucocorticoid as a steroid, see id. col. 5
ll. 9–11 (explaining that “one therapeutic agent, such as an
anti-cancer agent or steroid, particularly [is] a glucocorticoid”).
Prednisone is similarly listed as an example of an
antibiotic agent. See id. col. 9 ll. 30–44 (“Suitable antibiotic
agents . . . [include] prednisone.”). The specification states
that antibiotic agents are one example of anti-cancer
agents. Id. col. 7 l. 46 (providing that “anti-cancer agent[s]
include . . . antibiotic agents”). Therefore, the specification
explains that prednisone may be used as both a steroid and
an anti-cancer agent.

Of "substantial evidence":

“We review the PTAB’s factual findings for substantial
evidence and its legal conclusions de novo.” Redline Detection, LLC
v. Star Envirotech, Inc., 811 F.3d 435, 449 (Fed.
Cir. 2015) (citation omitted). Substantial evidence “is such
relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”
In re NuVasive, Inc., 842
F.3d 1376, 1380 (Fed. Cir. 2016) (internal quotation marks
and citations omitted). “If two inconsistent conclusions
may reasonably be drawn from the evidence in record, the
PTAB’s decision to favor one conclusion over the other is
the epitome of a decision that must be sustained upon review for substantial evidence.”
Elbit Sys. of Am., LLC v.
Thales Visionix, Inc., 881 F.3d 1354, 1356 (Fed. Cir. 2018)
(internal quotation marks, brackets, and citation omitted).

Footnote 11:

Because Appellants predicate their obviousness arguments upon
their assertion that the “PTAB’s erroneous
construction infected its analysis of obviousness,” Appellants’ Br. 35,
we need not separately address Appellants’
conditional invalidity arguments, see Knowles, 886 F.3d at
1373 n.3 (“Because we conclude that the PTAB did not err
in its construction of the disputed limitation, we need not
address the appellants’ conditional arguments as to the
PTAB’s unpatentability determinations.”(internal quotation marks and citation omitted)). However, for purposes
of this appeal, we address these arguments as an independent basis for affirming the PTAB’s findings.

Wednesday, May 08, 2019

Amgen loses at CAFC in filgrastim case

Sandoz prevailed against the appeal of Amgen at the CAFC:

Amgen Inc. and Amgen Manufacturing Ltd. (collectively, “Amgen”)
appeal from two decisions of the United
States District Court for the Northern District of California
in two patent infringement actions brought by Amgen under
the Biologics Price Competition and Innovation Act
(“BPCIA”), 42 U.S.C. § 262 (2012). The court construed
claims of U.S. Patents 6,162,427 (the “’427 patent”) and
8,940,878 (the “’878 patent”), Amgen Inc. v. Sandoz Inc.,
No. 14-CV-04741-RS, 2016 WL 4137563 (N.D. Cal. Aug. 4,
2016) (“Claim Construction Order”), and granted summary
judgment of noninfringement of claim 7 of the ’878 patent
by Sandoz’s filgrastim biosimilar and its proposed pegfilgrastim biosimilar,
Amgen Inc. v. Sandoz Inc., 295 F. Supp.
3d 1062, 1064 (N.D. Cal. 2017) (“Decision”). We conclude
that the district court correctly construed the claims and
granted summary judgment of noninfringement of claim 7.
The judgment of the district court is therefore affirmed.

The technical area:

Amgen created and commercialized two related biologic products,
filgrastim (marketed as Neupogen®) and
pegfilgrastim (marketed as Neulasta®), indicated for treating neutropenia,
a deficiency of white blood cells. Neutropenia often results from exposure to certain
chemotherapeutic regimens or radiation therapy during
cancer treatment. Filgrastim is a recombinant analog of
granulocyte-colony stimulating factor (“G-CSF”), a naturally-occurring
human glycoprotein that stimulates the
production of neutrophils and stem cells and their release
into the bloodstream.

A legal issue was "sequence of steps":

We reject this [Amgen's] argument for two reasons.

First, as in Mformation, the claim language logically requires that the process steps,
lettered (a) through (g), be performed in sequence.
For example, expressing the protein in a nonmammalian cell
(limitation (a)) obviously must occur before the step of lysing
that cell (limitation (b)). There is no
indication on the face of claim 7 that the washing and
eluting steps are any different. Second, washing and eluting
are consistently described in the specification as separate
steps performed by different solutions. See ’878 patent col.
10 ll. 44–46 (“After the separation matrix with which the
protein has associated has been washed, the protein of interest is eluted from the matrix using an appropriate solution.”), c

Saturday, May 04, 2019

Endo and Mallinckrodt prevail at CAFC in hydroxymorphinone case

Of interest:

The District Court, relying on intrinsic and extrinsic
evidence, determined that a PHOSITA would understand
the 14-hydroxymorphinone limitations stated in claims 1–
2 and 5 to mean “14-hydroxymorphinone hydrochloride,”
i.e., the “salt form” of 14-hydroxymorphinone. Endo, 2017
WL 3731001, at *14 (internal quotation marks omitted).
Actavis argues that this limitation requires no construction
because of “[t]he plain language of the claims, and the undisputed
chemical difference between 14-hydroxymorphinone [i.e., oxymorphone ABUK] and its
hydrochloride salt.” Appellants’ Br. 67. We disagree with

Judge Stoll dissented:

I respectfully dissent. The FDA set a regulatory requirement that ABUK content in oxymorphone products be
less than 0.001% (10 ppm). Mallinckrodt then claimed this
requirement in the ’779 patent. Not only does the FDA’s
mandate disclose every limitation of claim 1, but it is the
only prior art reference that discloses the 0.001% oxymorphone ABUK limitation.
Compare J.A. 2736, 2895,
with ’779 patent col. 37 ll. 58–59. Yet, the district court determined
that this mandate did not disclose “anything substantive relevant to obviousness.” Endo Pharm. Inc. v.
Actavis Inc., No. CV-14-1381, 2017 WL 3731001, at *7
(D. Del. Aug. 30, 2017) (“Decision”). It further erred by imposing a requirement that a reference must teach how to
solve a problem to provide a motivation to combine,
conflating enablement and reasonable expectation of success requirements with motivation. See id. at *12. Finally, the
district court applied an erroneously heightened standard
for reasonable expectation of success by requiring a “definitive solution” and proof of actual success. Id. at *9. The
majority would disregard a number of these errors as
harmless, affirming on the lack of a reasonable expectation
of success. Given the significance of the court’s errors, however, I cannot agree. While we owe deference to a district
court’s factual findings, such deference is not due where
the trial court applies the incorrect standard to arrive at
those findings. I would vacate the district court’s decision
and remand for a proper analysis under the correct legal


Whether a reference teaches how to achieve the claimed invention speaks
to enablement or reasonable expectation of success—entirely
separate inquiries from motivation to combine. “[O]ne
must have a motivation to combine accompanied by a reasonable expectation
of achieving what is claimed in the patent-at-issue.” Intelligent Bio-Sys., Inc. v. Illumina
Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (emphasis added).
Motivation to combine refers to “a reason
that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007). A reasonable expectation of success, on the other hand,
addresses whether a person of ordinary skill in the art would have understood that the
proposed combination or modification would have been reasonably likely to be successful.
See, e.g., UCB, Inc. v. Accord Healthcare, Inc., 890 F.3d 1313, 1325–26 (Fed. Cir.

Wednesday, May 01, 2019

The CAFC contemplates the intersection of the ITC and the FDA/FDCA

From the decision

After Amarin filed its complaint, the FDA submitted a
letter urging the Commission not to institute an investigation and instead to dismiss Amarin’s complaint. J.A. 627–
37. In the FDA’s view, the FDCA prohibits private enforcement actions, including unfair trade practice claims that
seek to enforce the FDCA. J.A. 630. The FDA contended
that the FDCA precludes any claim that would “require[]
the Commission to directly apply, enforce, or interpret the
FDCA.” J.A. 631. The FDA further contended that the
Commission should decline to institute an investigation
based on principles of comity to the FDA. J.A. 629.

On October 27, 2017, the Commission issued its decision declining to institute an investigation and dismissing
the complaint. J.A. 1–3. The Commission reasoned that
Amarin’s allegations are precluded by the FDCA. Id.; see
also POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102,
109 (2014) (“Private parties may not bring [FDCA] enforcement suits.” (citing 21 U.S.C. § 337)).

Stanford University loses appeal of attorneys fees case

The outcome of the CAFC decision:

Nevertheless, we see no abuse of discretion in the district court’s
determination of exceptionality based on plaintiffs’
inadequate pre-suit investigation of infringement

The patents at issue:

Stanford owns U.S. Patent Nos. 5,891,459, 6,117,872,
6,646,006, and 7,452,916, which claim methods and compositions
involving the amino acids arginine and lysine, to be
ingested to enhance vascular function and physical performance.


Some months later, in February 2013, Stanford exclusively licensed
the four patents to ThermoLife. From
March 19, 2013, to December 11, 2013, ThermoLife filed a
total of eighty-one infringement suits, including suits
against Hi-Tech and Vital, in the Southern District of California.

The argument against Stanford and co-plaintiff ThermoLife:

Rhetoric aside, they [defendants] made two related arguments
for exceptionality that are relevant here.4 Their main argument
was that plaintiffs did not conduct an adequate
pre-suit investigation into infringement, an investigation
that would have revealed that the accused products did not
infringe claim 1 of the ’459 patent, the only claim Hi-Tech
and Vital specifically discussed. One premise of the argument
was that the accused products all contained less than
one gram of L-arginine (or its hydrochloride salt) per serving.5
The other premise was that plaintiffs’ own validity
expert made clear in his 2015 deposition testimony and2016 trial testimony
that studies published before these
suits were filed showed that amounts of L-arginine less
than one gram were ineffective to enhance nitric oxide production
(being too small an increase over the regular human intake of arginine). See J.A. 10456, 10461−63. Based
on those premises, Hi-Tech and Vital argued that plaintiffs
would have discovered that the accused products did not
infringe had they read the labels on the accused products
and conducted simple tests before suing. In their secondary argument,
Hi-Tech and Vital broadened their focus and
accused plaintiffs of filing many suits, without adequate investigation,
simply to try to extract nuisance-value settlements.

At the district court level

In April 2017, the district court issued its decision on
the motions for attorney’s fees. ThermoLife Int’l, LLC v.
Myogenix Corp., No. 13-cv-651, 2017 WL 1235766 (S.D.
Cal. Apr. 4, 2017) (Fees Op.). The court began by striking
the Woods declaration. The court explained that plaintiffs
could have presented the same information in their initial
opposition to the attorney’s fees motions, that the declaration went
beyond providing facts about their counsel’s prefiling investigation,
and that Hi-Tech and Vital had no opportunity to conduct discovery regarding
the new statements and arguments. Id. at *2–3.

A summary of the CAFC determination:

We conclude that the district court in this case acted
within its discretion in determining, on the limited arguments
plaintiffs made in response to the fee motions, that
plaintiffs did not conduct an adequate pre-suit investigation
into infringement by Hi-Tech and Vital. That determination would suffice to support the exceptional-case
determination. And we read the district court’s additional
discussion of plaintiffs’ filing of numerous suits on the patents
at issue here as itself ultimately resting on the same
lack of adequate pre-suit investigation, not simply on ThermoLife’s
limited product sales, the expiration dates of three
of the four patents, the number of suits filed, or the
amounts of the settlements. For those reasons, we affirm
the exceptional-case determination.

Monday, April 29, 2019

CAFC analyzes "skepticism" in Neptune Generics case

Neptune Generics loses to Lilly at the CAFC in pemetrexed disodium case:

Because the Board did not err in its obviousness analysis,
substantial evidence supports its underlying
fact findings, and subject matter eligibility is not properly
before the court in an appeal from an IPR decision, we affirm.

Of skepticism:

Evidence of industry skepticism is a question of fact
that weighs in favor of non-obviousness. WBIP, LLC v.
Kohler Co., 829 F.3d 1317, 1335 (Fed. Cir. 2016). The
Board found that evidence of skepticism of others, particularly the FDA,
supported a conclusion of nonobviousness.
J.A. 87. During Lilly’s clinical trials for pemetrexed, a
number of fatalities occurred. In response, Lilly recommended supplementation
with folic acid and vitamin B12.
The FDA responded that the “medical officer does not support
adding vitamins to the ongoing . . . trial.” J.A. 8748
(capitalization changed).


Petitioners argue that the Board legally erred in holding this evidence sufficient
to support a finding of skepticism because, despite the FDA’s concerns, it allowed the
trial to continue. It argues skepticism must be premised
on whether it is “technically infeasible,” “unworkable,” or
“impossible” that the claimed subject matter would work
for its intended purpose. Appellants’ Br. 51. This position
is not consistent with our caselaw, which recognizes a
range of third-party opinion that can constitute skepticism.
See, e.g., Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331,
1337 (Fed. Cir. 2015) (holding testimony that third parties
were “worried” or “surprised” was sufficient to establish
skepticism). The FDA’s concerns in this case fall well
within that range. While evidence that third parties
thought the invention was impossible might be entitled to
more weight, that does not mean the Board erred in giving
weight to the skepticism evidence here. Accordingly, the
Board did not err in finding that skepticism supported a
conclusion of nonobviousness.

As to a 101 challenge in an IPR:

We do not agree. Congress expressly limited the
scope of inter partes review to a subset of grounds that can
be raised under 35 U.S.C. §§ 102 & 103. 35 U.S.C. § 311(b)
(stating that in an “inter partes review,” a petitioner is
limited to only grounds that “could be raised under section
102 or 103”). The ground of patent eligibility arises under
§ 101. Accordingly, we may not address it on appeal of an

Sunday, April 21, 2019

Conciliation in Civil War era United States

Gerrit Smith was an abolitionist who financially supported the raid of John Brown on the arsenal at Harper's Ferry (then in Virginia).
Years later, in 1867, Smith financially supported the bond for Jefferson Davis.

Friday, April 19, 2019

CAFC tackles CBM issues in Trading Technologies

The CAFC noted:

Pursuant to § 18(a)(1)(E) of the AIA, the Board may
only institute CBM review for a patent that is a CBM patent.
A CBM patent is “a patent that claims a method or
corresponding apparatus for performing data processing or
other operations used in the practice, administration, or
management of a financial product or service, except that
the term does not include patents for technological inventions.”
Id. § 18(d)(1) (emphasis added). Pursuant to its authority under § 18(d)(2), the Patent and Trademark Office
(“PTO”) promulgated 37 C.F.R. § 42.301(b), which requires
the Board to consider the following on a case-by-case basis
in determining whether a patent is for a technological invention:
“whether the claimed subject matter as a whole
recites a technological feature that is novel and unobvious
over the prior art” and whether it “solves a technical problem using
a technical solution.” We review the Board’s reasoning “under the arbitrary and capricious standard and
its factual determinations under the substantial evidence
standard.” SightSound Techs., LLC v. Apple Inc., 809 F.3d
1307, 1315 (Fed. Cir. 2015).

The only issue of CBM eligibility that TT contests is
whether its patents are for technological inventions.

The issue

We agree with the Board that these claims are directed
to a covered business method and thus CBM review was
appropriate. These claims are directed to a financial trading method used by a computer. We see no technological
invention in this software method for trading. The claims
require receiving bid and offer information from an electronic exchange, displaying such information (“bid indicators” and “offer indicators”), and sending an order to the
electronic exchange based on a user input. The two claims
differ mainly in the way the user places the order (clicking
and dragging an “order icon” to a location on the price axis
versus selecting a point on the price axis). In each case, the
Board applied the considerations of § 42.301(b) and found
that the claims do not recite a technological feature that is
novel and unobvious over the prior art and do not solve a
technical problem with a technical solution for essentially
the same reasons.

TT argues the Board erred in applying the first consideration of § 42.301(b)
based on our decision in Versata Development Group Inc. v. SAP America, Inc., 793 F.3d 1306
(Fed. Cir. 2015). According to TT, Versata set aside the
novelty and nonobviousness language of the regulation,
leaving the definition of a technological invention as one
having a technological feature that solves a technical problem using a technical solution.
E.g., Appellant Br. 24–25,
No. 18-1063 (citing 793 F.3d at 1326). We need not decide
this issue because we agree with the Board
that the considered claims do not solve a technical problem using a technical solution.
See Apple, Inc. v. Ameranth, Inc., 842 F.3d
1229, 1240 (Fed. Cir. 2016) (“We need not address this argument regarding whether the first prong of 37 C.F.R.
§ 42.301(b) was met, as we affirm the Board’s determination on the second prong of the regulation . . . .”).

CAFC reverses D. Oregon on trademark issue

From the opinion by Judge Newman:

The district court held that Georgia Expo’s use of VersaTop’s trademarks
in advertising and brochures did not
violate the Trademark Act because Georgia Expo had not
“affixed” the VersaTop trademarks to goods that were “sold
or transported in commerce.” The court held that such “use
in commerce” was required for trademark infringement liability,
and therefore the relevant statutory provision concerning likelihood of confusion was not applicable.
Summary judgment of noninfringement in favor of Georgia
Expo was granted on this ground.
We conclude that the district court erred in law. On
the correct law, violation of the Trademark Act was established
on the admitted facts. We reverse the district court’s
judgment, and remand for appropriate further proceedings.

Of relevance

The treatise McCarthy on Trademarks and Unfair
Competition explains that the “use in commerce” definition
in § 1127—
was clearly drafted to define the types of “use” that
are needed to qualify a mark for federal registration—not as a candidate for infringement. It defines the kinds of “use” needed to acquire
registerable trademark rights—not to infringe
4 McCarthy § 23:11.50 (5th ed. 2018) (footnote omitted); see
id. (“This statutory anachronism certainly was never intended to limit the scope of ‘uses’ that would constitute infringement.”).
In Hasbro, Inc. v. Sweetpea Entertainment, Inc.,
No. 13-3406, 2014 WL 12586021 (C.D. Cal. Feb. 25, 2014),
the district court again stated the distinction between infringing use and the “use in commerce” requirement for
federal registration:

Sweetpea’s statement of the law is incorrect. The
Ninth Circuit has explained that the definition of
“use in commerce” in Section 1127 “applies to the
required use a plaintiff must make in order to have
rights in a mark . . . .” Playboy Enterprises, Inc. v.
Netscape Commc’ns Corp., 354 F.3d 1020, 1024
n.11 (9th Cir. 2004). Section 1127 is not, however,
the legal standard for proving infringement.
Id. at *9 (omission in original).
Contrary to this precedent, the district court in this
case incorrectly applied the definition of “use in commerce”
that is included in the statute for purposes of trademark
registration. This definition does not apply to trademark
infringement. See Network Automation, 638 F.3d at 1144–
45; Playboy, 354 F.3d at 1024 n.11

Where will the statue of Confederate general Kirby Smith end up?

Back on 2 July 2017, IPBiz had a post titled CBS Sunday Morning on 2 July 2017: notable for what was not said which included text:

The Almanac feature, going back to July 2, 1864 (one year after Day 2 of Gettysburg) was of interest for what was NOT mentioned. The 1864 date was that of the authorization of the National Statuary Hall in what had been the place of the House of Representatives. Each state was authorized to submit statues of two important people from the state. Exemplars on the CBS show included Garfield and Edison from Ohio. Another inventor mentioned was Robert Fulton. Not mentioned was Florida's included inventor John Gorrie, and Florida's other person, Confederate General Edmund Kirby-Smith (of the Trans-Mississippi Department). Relevant to certain public debate about statues of prominent Confederates, one notes that Mississippi presented Jefferson Davis and Virginia did Robert E. Lee. South Carolina did John Calhoun and General Wade Hampton. One wonders the fate of these Southerners/Confederates in the National Statuary Hall if protests are made?

On 19 April 2019 (nearly two years later), the Orlando Sentinel ran a story titled 'Evil coup?' Confederate statue sparks political fight for control of Lake County Historical Society , which included the text

A statue of Confederate General Edmund Kirby Smith that has represented Florida for nearly a century in the U.S. Capitol is at the heart of an unlikely partisan political fight — for control of the Lake County Historical Society.

The normally low-profile society, which runs a free historical museum in Tavares, won the right last year to display the statue when the general’s bronzed likeness is evicted from National Statuary Hall to make room for a figure of African-American educator and civil-rights activist Mary McLeod Bethune. That could be as soon as next year.

But if the general is coming, he won’t arrive without a battle.

“He has no place here, no connection whatsoever to Lake County,” said Mae Hazelton of Eustis, who is among more than two dozen people who have applied to be voting members of the society in hopes of reversing a decision to bring the statue to Tavares.

Hazelton said the museum’s pursuit of a confederate statue is insulting to her and other African-Americans in Lake County, where notoriously racist Sheriff Willis McCall was elected to office seven times from 1944 to 1972.

Within the Sentinel piece: