Thursday, May 30, 2019

CAFC reverses DNJ in Nuvo vs. Dr. Reddy's

The outcome of Nuvo vs. Dr. Reddy's:

For the reasons stated above, we reverse the district
court’s [D NJ] determination that the asserted claims of the ’907
and ’285 patents are not invalid for lack of an adequate
written description. Those claims are invalid. We dismiss
as moot Nuvo’s cross-appeal challenging the district court’s
grant of summary judgment of noninfringement to Dr.
Reddy’s with respect to its second ANDA product and the
now-invalidated ’907 patent claims.

Of written description:

Whether a claim satisfies the written description requirement is a question of fact. Allergan, Inc. v. Sandoz
Inc., 796 F.3d 1293, 1308 (Fed. Cir. 2015). Therefore, on
appeal from a bench trial, we review a written description
determination for clear error. Id. “Under the clear error
standard, the court’s findings will not be overturned in the
absence of a ‘definite and firm conviction’ that a mistake
has been made.” Scanner Techs. Corp. v. ICOS Vision Sys.
Corp. N.V., 528 F.3d 1365, 1374 (Fed. Cir. 2008) (quoting
Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 1366
(Fed. Cir. 2008)).
Our analysis begins and ends with the “efficacy” written description issue.


The Generics argue that the district court clearly erred
when it concluded that the claimed effectiveness of uncoated PPI in the ’907 and ’285 patents is supported by adequate written description. Their argument is
straightforward. The ’907 and ’285 patents claim uncoated
PPI effective to raise the gastric pH to at least 3.5, the district court found upon Nuvo’s insistence as part of its obviousness analysis that ordinarily skilled artisans would not
have expected uncoated PPIs to be effective, and nothing in
the specification would teach a person of ordinary skill in
the art otherwise.

DNJ's problem:

But its analysis does not support its conclusion. The district court, after finding that the specification
lacks “information regarding the efficacy of uncoated
PPIs,” said it was enough that the specification described
the immediate release of uncoated PPI and the potential
disadvantages of enteric-coated PPI formulations. J.A. 82–
83. But that disclosure it pointed to in no way provides
support for the claimed efficacy of uncoated PPI. Even if
the district court thought that it was enough that the patents taught how to make and use drug formulations containing uncoated PPI, it flatly rejected Nuvo’s argument
“that the efficacy of uncoated PPIs need not be described
because it is ‘necessarily inherent’ in a formulation.” J.A.
83. Nevertheless, because we review the district court’s decision for clear error, we will scour the record created below
for evidence supporting the district court’s written description finding.


In sum, the parties appear to have assumed before the
district court that the claims require a therapeutically effective amount of uncoated PPI that can raise the gastric
pH to at least 3.5. We see no reason to change course on
appeal. Because the parties’ assumption at the trial court
is a fair reading of the claim language, we will proceed as
everyone did before the district court and search the specification for written description support for the efficacy of
uncoated PPI.

Of details

We have expressly rejected the “argument that the
written description requirement . . . is necessarily met as a
matter of law because the claim language appears in ipsis
verbis in the specification.” Enzo Biochem, Inc. v. Gen–
Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). We explained that “[t]he appearance of mere indistinct words in
a specification or a claim, even an original claim, does not
necessarily satisfy” § 112, ¶ 1 because it may not both put
others on notice of the scope of the claimed invention and
demonstrate possession of that invention. Id. at 968–69.
It is true that our case law does not require experimental data demonstrating effectiveness. Allergan, 796
F.3d at 1309; see also In re ’318 Patent Infringement Litig.,
583 F.3d 1317, 1324 (Fed. Cir. 2009) (“Typically, patent applications claiming new methods of treatment are supported by test results. But it is clear that testing need not
be conducted by the inventor.”). It also does not require
theory or explanation of how or why a claimed composition
will be effective. Allergan, 796 F.3d at 1308–09. Moreover,
we have repeatedly stated that the invention does not actually have to be reduced to practice. Univ. of Rochester v.
G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004).
Nevertheless, as the Generics point out and Nuvo cannot reasonably dispute, the record evidence demonstrates
that a person of ordinary skill in the art would not have
known or understood that uncoated PPI is effective.


are not rewarded for mere searches, but are intended to
compensate their successful completion. Ariad, 598 F.3d
at 1353. That is why the written description requirement
incentivizes “actual invention,” id., and thus “[a] ‘mere
wish or plan’ for obtaining the claimed invention is not adequate written description,” Centocor, 636 F.3d at 1348
(quoting Regents of the Univ. of Cal. v. Eli Lilly & Co., 119
F.3d 1559, 1566 (Fed. Cir. 1997)).
In light of the fact that the specification provides nothing more than the mere claim that uncoated PPI might
work, even though persons of ordinary skill in the art
would not have thought it would work, the specification is
fatally flawed. It does not demonstrate that the inventor
possessed more than a mere wish or hope that uncoated
PPI would work, and thus it does not demonstrate that he
actually invented what he claimed: an amount of uncoated
PPI that is effective to raise the gastric pH to at least 3.5.
That conclusion is confirmed by the inventor’s, Dr.
Plachetka’s, own testimony at trial during which he admitted that he only had a “general concept of coordinated delivery with acid inhibition” using uncoated PPI at the time
he filed his first patent application. J.A. 9942, 10000–01.
Although Dr. Plachetka said he thought he “put a rationale
in [the specification] as to why [uncoated PPI] would work,”
he did not identify any particular part of the specification
supporting that understanding. J.A. 9997. And his only
support in the specification for “a rationale explaining why
[he] thought the uncoated PPI would be effective for
treating gastric related injury” was that, in its “entire context,” he explained “why the coordinated delivery system
would be of benefit for patients.” Id. Although inventor
testimony cannot establish written description support
where none exists in the four corners of the specification, it
illuminates the absence of critical description in this case.

Of the difference between "written description" and enablement:

Teaching how to make and use an invention does not
necessarily satisfy the written description requirement.
We have recognized that the enablement requirement,
which requires the specification to teach those skilled in
the art how to make and use the claimed invention without
undue experimentation, is separate and distinct from the
written description requirement. Ariad, 598 F.3d at 1343–
51. And the fact that an invention may be enabled does not
mean it is adequately described, and vice versa. Univ. of
Rochester, 358 F.3d at 921–22. That is because “[t]he purpose of the written description requirement is broader than
to merely explain how to ‘make and use’ [the invention].”
Id. at 920. The focus of the written description requirement is instead on whether the specification notifies the
public about the boundaries and scope of the claimed invention and shows that the inventor possessed all the aspects of the claimed invention. Id. at 926.

Cokebusters prevails on "sham declaration" issue at CAFC

As a first matter related to Quest v. CokeBusters, the concept of
cokebusting refers to carbon ("coke") in a furnace, not the drug "coke."

The judgment of District Judge Sue Robinson was affirmed in part but was
reversed on the matter of sham declarations.

As to sham declarations/affidavits:

The Third Circuit “review[s] a district court’s decision
to exclude materials under the sham affidavit doctrine for
abuse of discretion.” Daubert v. NRA Grp., LLC, 861 F.3d
382, 389 (3d Cir. 2017). Under the Third Circuit’s sham
affidavit doctrine, “a party may not create a material issue
of fact to defeat summary judgment by filing an affidavit
disputing his or her own sworn testimony without demonstrating a plausible explanation for the conflict.” Baer v.
Chase, 392 F.3d 609, 624 (3d Cir. 2004). The Third Circuit
has explained its approach in applying the sham affidavit
doctrine as a “flexible” one, “giving due regard to the ‘surrounding circumstances’”:

Of the De Lorenzo declaration:

Second, De Lorenzo did not simply contradict his earlier testimony. He submitted a detailed declaration in
which he explained why his deposition testimony was incorrect. In the declaration, he stated that the source code
shows that the composite bend indicator function was still
under development as of July 8, 2004, and was not available for use until after the Norco Sale because the source
code shows that the most recent comment line for the composite bend indicator function is dated July 8, 2004 (i.e.,
after the Norco Sale). He further explained that he was
only given a portion of the source code during his deposition
and was not given the page with the July 8, 2004, date. He
stated that had he seen the July 8, 2004, comment during
his deposition, he would have known that the source code
was not commercially available on August 28, 2002.
De Lorenzo thus offered a plausible explanation for
why he misspoke at his deposition, and Cokebusters does
not dispute that De Lorenzo was not given access to the full
source code during his deposition. Nor does Cokebusters
dispute that the source code contains the July 8, 2004, modification date.


In summary, it was error for the district court to disregard the declarations of De Lorenzo and Bondurant, even
applying the deferential standard of review, particularly
since Cokebusters has the burden to show by clear and
convincing evidence that the Norco Sale satisfied all of the
limitations of claims 30 and 40.12 The district court could
not disregard the De Lorenzo and Bondurant declarations,
and there is a genuine issue of material fact as to whether
the Norco Sale satisfied the limitations of claims 30 and 40.
Accordingly, we reverse the judgment as to claims 30 and
40 and remand for a trial.

Judge Newman's dissent in Sony; did the CAFC issue an advisory opinion?

On an appeal to the CAFC of IPR2016-

Sony Corp. is the owner of U.S. Patent No. 6,097,676
(“the ’676 patent”). It appeals the Patent Trial and Appeal
Board’s (“Board’s”) final decision in IPR No. 2016-00834.
The Board found claims 5 and 8 of the ’676 patent unpatentable as obvious. We vacate and remand.

Judge Newman dissented:

The threshold question on appellate jurisdiction is
whether there is a live case or controversy sufficient to satisfy Article III. The only patent on appeal, U.S. Patent
No. 6,097,676, expired in August 2017; the IPR petitioner,
ARRIS, declines to defend its PTAB victory; and the parties
have settled the infringement suit in district court. There
is no interest, neither private interest nor public interest,
in the fate of this patent. There appears to be no consequence of either our appellate decision today or the
potential PTAB decision on the remand now ordered by the
court.1 This appeal fails the requirements of Article III.

“No principle is more fundamental to the judiciary’s
proper role in our system of government than the constitutional limitation
of federal-court jurisdiction to actual cases
or controversies.” Raines v. Byrd, 521 U.S. 811, 818 (1997)
(quoting Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26,
37 (1976)). Federal courts are limited to their constitutional authority, and
“[i]f a dispute is not a proper case or
controversy, the courts have no business deciding it, or expounding the law in the course of doing so.”
DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 341 (2006).

Footnote 1 of the dissent:

The PTO Director, intervening “to defend the
Board’s decision,” does not explain the agency’s interest in
further judicial and administrative proceedings on this patent
that expired 20 months ago and is now devoid of controversy. The panel majority’s description of the Director
as a party that “remain[s] adverse,” is not explained.

Creating a necessary record:

A necessary question is whether there remain any consequences of our appellate decision. As the party seeking
judicial review, “[i]t is the responsibility of [Sony] clearly to
allege facts demonstrating that [it] is a proper party to invoke judicial resolution of the dispute and the exercise of
the court’s remedial powers.” Renne v. Geary, 501 U.S. 312,
316 (1991) (internal quotation marks and citation omitted).
Here, appellant Sony must establish its continuing interest
“‘when it seeks review of an agency’s final action in a federal court,’ by creating a necessary record in this court, if
the record before the Board does not” so establish. JTEKT
Corp. v. GKN Auto. LTD., 898 F.3d 1217, 1220 (Fed. Cir.
2018) (quoting Phigenix, Inc. v. Immunogen, Inc., 845 F.3d
1168, 1172 (Fed. Cir. 2017)).


The record contains not even a remote suggestion of
possible future litigation or other potential actions by unidentified acquirers of this expired patent. The panel majority searches for a possible case-or-controversy, proposing
that there may be speculative or unspecified circumstances. Maj. Op. 5 n.1. However, “[w]e presume that federal courts lack jurisdiction unless the contrary appears
affirmatively from the record.” Renne, 501 U.S. at 316 (internal quotation marks omitted) (quoting Bender, 475 U.S.
at 546)). If such possibility indeed exists, it was Sony’s obligation to say so, for the “burden of establishing” that the
requirements of Article III are met is placed on “the party
seeking judicial review.” JTEKT, 898 F.3d at 1220;

Of advisory opinions:

On the record before us, both the court’s decision on
this appeal and our remand for further PTAB proceedings
are devoid of substance and consequence—they thus appear to be advisory. And “[a]s is well known the federal
courts established pursuant to Article III of the Constitution do not render advisory opinions.” United Pub. Workers
of Am. (C.I.O.) v. Mitchell, 330 U.S. 75, 89 (1947).

CAFC discusses issue preclusion in Papst

From within Papst:

The Supreme Court in B & B Hardware noted as a general matter that the Restatement standards allow for some
exceptions to issue preclusion even when the above-quoted
conditions are met. 135 S. Ct. at 1303, 1309−10. The Court
specifically recognized that “[i]ssue preclusion may be inapt if ‘the amount in controversy in the first action [was] so
small in relation to the amount in controversy in the second
that preclusion would be plainly unfair.” Id. at 1309 (quoting Restatement (Second) of Judgments § 28, cmt. j). The
Court added: “After all, ‘[f]ew . . . litigants would spend
$50,000 to defend a $5,000 claim.” Id. (quoting Wright &
Miller § 4423, at 612); see Kroeger v. U.S. Postal Service,
865 F.2d 235, 239−40 (Fed. Cir. 1988); Marciel v. Comm’r,
489 F.3d 1018, 1023 (9th Cir. 2007); United States v. Berman, 884 F.2d 916, 922 (6th Cir. 1989); Ferrell v. Pierce,
785 F.2d 1372, 1385 (7th Cir. 1986).


Papst has not asserted inadequate representation or an impaired opportunity to litigate in the IPRs involving the ’144 patent and the ’746
patent. See Soverain Software LLC v. Victoria’s Secret Direct Brand Mgt., LLC, 778 F.3d 1311, 1315−16 (Fed. Cir.
2015) (discussing such grounds for denying preclusive effect). Nor has Papst presented, let alone supported, any
allegation of a legally significant disparity in incentives between the present IPR and the two other Aytac-based IPRs
at issue. Papst is in no position now to say that the litigation costs in those other two IPRs were not worth incurring.
After all, Papst litigated all the way through to final written decisions—rather than, for example, disclaim the challenged patent claims in the ’144 patent and the ’746 patent
IPRs before the Board reached final written decisions.
Papst then litigated all the way up to the eve of oral argument in this court. Such pursuit through nearly all of the
available process undermines any assertion of relevantly
low incentives in the IPRs involving Aytac and the ’144 patent and ’746 patent.
More generally, given the heavy burdens that Papst
placed on its adversaries, the Board, and this court by waiting so long to abandon defense of the ’144 patent and ’746
patent claims, Papst’s course of action leaves it without a
meaningful basis to argue for systemic efficiencies as a possible reason for an exception to issue preclusion. Papst also
has no basis to argue that it tried unsuccessfully to secure
an agreement, from Samsung or other petitioners (in this
IPR or others),

Of substantial evidence:

We also confirm that Papst’s challenges fail
on the merits, even apart from issue preclusion.
We review the Board’s factual findings in an inter
partes review for substantial evidence and its legal conclusions de novo. See Arendi S.A.R.L. v. Apple, Inc., 832 F.3d
1355, 1360 (Fed. Cir. 2016). Substantial evidence means
“such relevant evidence as a reasonable mind might accept
as adequate to support a conclusion.” In re Mouttet, 686
F.3d 1322, 1331 (Fed. Cir. 2012). As to claim construction,
the Board saw no difference relevant to the issues here between identifying the best construction and identifying the
broadest reasonable construction, and the parties have
identified no difference either. See 37 C.F.R. § 42.100(b).

CAFC addresses licensing, standing, and FRCP 19 in Lone Star; appellant wins

The outcome:

Lone Star Silicon Innovations LLC (“Lone Star”) sued
Appellees1 for infringing various patents.2 The district
court concluded that Lone Star does not own these patents
and therefore lacks the ability to assert them. In re Lone
Star Silicon Innovations LLC, No. 3:17-cv-03980-WHA,
2018 WL 500258, at *1 (N.D. Cal. Jan. 20, 2018). We agree
with the district court that Lone Star cannot assert these
patents on its own. But the district court should not have
dismissed this case without considering whether Advanced
Micro Devices, Inc. (“AMD”), the relevant patentee, should
have been joined. Its failure to address this issue was legally
erroneous in view of Federal Rule of Civil Procedure
19 and our case law. We therefore vacate the district court’s
dismissal and remand for further proceedings consistent
with this opinion.

Lone Star's problem:

The asserted patents were originally assigned to AMD,
which later executed an agreement purporting to transfer
“all right, title and interest” in the patents to Lone Star.
The transfer agreement, however, imposes several limits
on Lone Star. For example, Lone Star agreed to only assert
the covered patents against “Unlicensed Third Party Entit[ies]”
specifically listed in the agreement. J.A. 2025; J.A.
2032. New entities can only be added if Lone Star and
The asserted patents were originally assigned to AMD,
which later executed an agreement purporting to transfer
“all right, title and interest” in the patents to Lone Star.
The transfer agreement, however, imposes several limits
on Lone Star. For example, Lone Star agreed to only assert
the covered patents against “Unlicensed Third Party Entit[ies]” specifically
listed in the agreement. J.A. 2025; J.A.
2032. New entities can only be added if Lone Star and

As to standing,

Appellees argue that, because Lone Star is not a patentee and
never explicitly alleged that it was an exclusive
licensee, it lacks standing to bring suit. We disagree.

The Constitution of the United States vests judicial
power in the federal courts. U.S. Const. art. III, § 1.
That power may only be exercised to resolve “Cases” or
“Controversies.” Id. art. III, § 2. “The doctrine of constitutional standing serves to identify which disputes fall within
these broad categories and therefore may be resolved by a
federal court.” WiAV Sols. LLC v. Motorola, Inc., 631 F.3d
1257, 1264 (Fed. Cir. 2010). A party must establish standing, i.e. show that its case or controversy is amenable to
resolution by a federal court, by demonstrating that it suffers an injury which can be fairly traced to the defendant
and likely redressed by a favorable judgment. Lujan v.
Defs. of Wildlife, 504 U.S. 555, 560–61 (1992). At the pleading stage, “general factual allegations . . . may suffice” to
satisfy these requirements. Id. at 561.

We have recognized that those who possess “exclusionary rights” in a patent suffer an injury when their rights
are infringed. See, e.g., WiAV, 631 F.3d at 1264–65 (“[A]
party holding one or more of those exclusionary rights—
such as an exclusive licensee—suffers a legally cognizable
injury when an unauthorized party encroaches upon those
rights and therefore has standing to sue.”).

The key point

Although Lone Star cleared this constitutional threshold, the district court concluded that it lacked standing to
proceed without AMD. But treating AMD’s absence as
implicating Lone Star’s standing confuses the requirements of Article III—which establish when a plaintiff may
invoke the judicial power—and the requirements of § 281—
which establish when a party may obtain relief under the
patent laws. The district court’s mistake, repeated by the
parties on appeal, is understandable. Indeed, we have often treated “statutory standing,” i.e. whether a party can
sue under a statute such as § 281, as jurisdictional. See
AsymmetRx, 582 F.3d at 1318 (‘The issue of AsymmetRx’s
standing to bring suit without Harvard joining as a plaintiff was not raised by either party or by the district court.
However, an appellate court must satisfy itself that it has
standing and jurisdiction whether or not the parties have
raised them.”).
But the Supreme Court has recently clarified that socalled “statutory standing” defects do not implicate a
court’s subject-matter jurisdiction:


Where intervening Supreme Court precedent makes clear that our earlier decisions
mischaracterized the effects of § 281, we are bound to
follow that precedent rather than our own prior panel decisions. Cf. Troy v. Samson Mfg. Corp.,
758 F.3d 1322, 1326
(Fed. Cir. 2014) (“It is established that a later panel can
recognize that the court’s earlier decision has been implicitly overruled as inconsistent with
intervening Supreme
Court authority.”). We therefore firmly bring ourselves
into accord with Lexmark and our sister circuits by concluding that whether a party possesses all substantial
rights in a patent does not implicate standing or subject matter jurisdiction.6

As to Rule 19:

Lone Star argues that, because it has standing, even if
it lacks all substantial rights in the patents, it should be
given an opportunity to join AMD as a necessary party before this case is dismissed. We agree.
This result is compelled by Federal Rule of Civil Procedure 19 and our case


The rule of Independent Wireless, as incorporated into
Rule 19, provides a clear command. A necessary party who
is subject to service of process and whose joinder will not
otherwise destroy a court’s subject-matter jurisdiction
“must be joined.” Fed. R. Civ. P. 19(a)(1). The rule extends
its command directly to courts. See Fed. R. Civ. P. 19(a)(2)
(“If a person has not been joined as required, the court must
order that the person be made a party.” (emphasis added)).

Patent attorney named defendant in Zirvi et al v. Flatley et al,, 2018cv07003 (SD NY)

As noted by GenomeWeb in December 2018, the plaintiffs in the 2018 case in the Southern District of New York — Monib Zirvi of Weill Cornell Medicine; Matthew Lubin, now an internist but previously director of medical genetics at Strang Cancer Prevention Center; and Maria Kempe of Lund University, amended their complaint to include patent attorney Robin Silva as a defendant.

GenomeWeb stated of the patent angle:

The suit accuses Illumina of submitting patent applications that appropriated the plaintiffs' zip code sequence technology. The term zip code was changed and references to Barany's patent application were left out, the suit alleges.

The amended suit also added two counts, one specifically targeted at Silva, alleging that she intended to deceive the US Patent and Trademark Office in filing patent applications for Illumina.


The presiding judge is John G Koeltl,

Pending as of May 6, 2019 are Defendants' Motions to Dismiss the Second Amended Complaint.


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.