Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-19-01270/USCOURTS-ca13-19-01270-0/pdf.json

Parties Involved:
Celltrion, Inc.
Appellee
Genentech, Inc.
Appellant
Andrei Iancu
Intervenor

Document Text:

NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________

GENENTECH, INC.,

Appellant

v.

ANDREI IANCU, UNDER SECRETARY OF 

COMMERCE FOR INTELLECTUAL PROPERTY 

AND DIRECTOR OF THE UNITED STATES 

PATENT AND TRADEMARK OFFICE,

Intervenor

______________________

2019-1263, 2019-1267

______________________

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. 

IPR2017-00731, IPR2017-01121, IPR2017-02063.

--------------------------------------------------

GENENTECH, INC.,

Appellant

v.

ANDREI IANCU, UNDER SECRETARY OF 

COMMERCE FOR INTELLECTUAL PROPERTY 

AND DIRECTOR OF THE UNITED STATES 

PATENT AND TRADEMARK OFFICE,

Intervenor

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2 GENENTECH, INC. v. IANCU

______________________

2019-1265, 2019-1270

______________________

Appeals from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. IPR2017-

00737, IPR2017-01122, IPR2017-01960.

______________________

Decided: March 26, 2020

______________________

ROBERT J. GUNTHER, JR., Wilmer Cutler Pickering Hale 

and Dorr LLP, New York, NY, for appellant. Also represented by ANDREW J. DANFORD, Boston, MA; THOMAS 

GREGORY SPRANKLING, Palo Alto, CA; THOMAS SAUNDERS, 

Washington, DC; NORA Q.E. PASSAMANECK, Denver, CO; 

ADAM R. BRAUSA, DARALYN JEANNINE DURIE, Durie Tangri 

LLP, San Francisco, CA.

 SARAH E. CRAVEN, Office of the Solicitor, United States 

Patent and Trademark Office, Alexandria, VA, for intervenor. Also represented by THOMAS W. KRAUSE, FARHEENA 

YASMEEN RASHEED, MAUREEN DONOVAN QUELER. 

 ______________________

Before LOURIE, MOORE, and WALLACH, Circuit Judges.

MOORE, Circuit Judge.

Genentech, Inc. appeals from the final written decisions of the Patent Trial and Appeal Board collectively 

holding unpatentable claims 1–14 of U.S. Patent No. 

7,846,441 and claims 1–17 of U.S. Patent No. 7,892,549.1 

1 Hospira, Inc., Samsung Bioepis Co., Ltd., Celltrion, 

Inc., and Pfizer, Inc. collectively made up the named 

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GENENTECH, INC. v. IANCU 3

In the final written decisions, the Board construed the 

claim terms “an amount effective to extend the time to disease progression in the human patient” and “an effective 

amount” to be in comparison to no treatment. Genentech 

appeals, arguing that the Board’s claim constructions were 

erroneous and that under its proposed claim construction 

the claims would not have been obvious. Genentech also 

appeals the Board’s denial of its motion to amend in 

IPR2017-00731. We have jurisdiction under 28 U.S.C 

§ 1295(a)(4)(A).

For the reasons discussed below, we affirm the Board’s 

decisions. The Board correctly construed the terms “an 

amount effective to extend the time to disease progression 

in the human patient” and “an effective amount.” Genentech does not challenge the Board’s obviousness conclusion 

under the Board’s constructions. We also hold that the 

Board did not abuse its discretion in entering partial adverse judgment on Ground 1 in IPR2017-00731 or in denying Genentech’s motion to amend. 

I. The ’441 and ’549 Patents

The ’441 and ’549 patents share a specification and are 

directed to treatment of disorders characterized by overexpression of the erbB2 gene, which encodes the ErbB2 protein. There is a correlation between individuals who 

overexpress the erbB2 gene (also known as her2) and 

breast cancer. ’441 patent at 1:10–27. The ’441 patent’s 

claims recite methods of treating cancer patients who overexpress erbB2 by administering a combination of an antiErbB2 antibody and a taxoid, in the absence of an anthracycline derivative. Relevant to these appeals, each independent claim of the ’441 patent contains the limitation 

petitioners in the inter partes reviews. Following the 

Board’s final written decisions, those parties dropped out 

and the Director intervened. 

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that the combination treatment be “in an amount effective 

to extend the time to disease progression in said human 

patient, without increase in overall severe adverse events.” 

Claim 1 is representative:

1. A method for the treatment of a human patient 

with a malignant progressing tumor or cancer 

characterized by overexpression of ErbB2 receptor, 

comprising administering a combination of an intact antibody which binds to epitope 4D5 within 

the ErbB2 extracellular domain sequence and a 

taxoid, in the absence of an anthracycline derivative, to the human patient in an amount effective to 

extend the time to disease progression in said human patient, without increase in overall severe adverse events.

’441 patent at 33:46–54 (emphasis added). 

The ’549 patent’s claims recite methods of treating 

breast cancer by administering a combination of an antiErbB2 antibody, a taxoid, and either a “further growth inhibitory agent” or a “further therapeutic agent.” Independent claims 1 and 16 each contain the limitation that the 

combination be “in an amount effective to extend the time 

to disease progression in the human patient.” Independent 

claim 5 differs from claims 1 and 16 by simply reciting “administering an effective amount of [the] combination.” The 

parties treat the “amount effective” in claims 1 and 16 the 

same as “an effective amount” in claim 5. Independent 

claims 1 and 5 of the ’549 patent recite: 

1. A method for the treatment of a human patient 

with breast cancer that overexpresses ErbB2 receptor, comprising administering a combination of 

an antibody that binds ErbB2, a taxoid, and a further growth inhibitory agent to the human patient 

in an amount effective to extend the time to disease 

progression in the human patient, wherein the 

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GENENTECH, INC. v. IANCU 5

antibody binds to epitope 4D5 within the ErbB2 extracellular domain sequence.

5. A method for the treatment of a human patient 

with breast cancer characterized by overexpression 

of ErbB2 receptor, comprising administering an effective amount of a combination of an anti-ErbB2 

antibody which binds epitope 4D5 within the 

ErbB2 extracellular domain sequence, a taxoid, 

and a further therapeutic agent, to the human patient.

’549 patent at 33:38–45 and 54–59 (emphases added). 

Petitioners filed six petitions collectively requesting inter partes review of all of the claims of the ’441 and ’549 

patents. The Board instituted all of the inter partes reviews and construed the terms “an amount effective to extend the time to disease progression in [the/said] human 

patient” and “an effective amount” to mean in comparison 

to a patient who received no treatment. See, e.g., No. 19-

1263, J.A. 12383. The Board maintained those constructions in its final written decisions and ultimately held the 

claims of the ’441 and ’549 patents would have been obvious. See, e.g., id. at J.A. 47, 86. Genentech challenges the 

Board’s constructions on appeal.

II. Claim Construction

When based solely on intrinsic evidence, as here, we 

review the Board’s claim construction de novo. Teva 

Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 

(2015). The prosecution history “is often of critical significance in determining the meaning of the claims” because it 

“contains the complete record of all the proceedings before 

the Patent and Trademark Office, including any express 

representations made by the applicant regarding the scope 

of the claims.” Vitronics Corp. v. Conceptronic, Inc., 90 

F.3d 1576, 1582 (Fed. Cir. 1996). During prosecution, 

“[a]pplicants can define (lexicography), explain, or disavow 

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claim scope.” Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 

F.3d 1335, 1343 (Fed. Cir. 2015). “A statement made during prosecution of related patents may be properly considered in construing a term common to those patents.” Id. 

“The public notice function of a patent and its prosecution 

history requires that a patentee be held to what he declares 

during the prosecution of his patent.” Springs Window 

Fashions LP v. Novo Indus., L.P., 323 F.3d 989, 995 (Fed.

Cir. 2003). 

The claims and specifications of the ’441 and ’549 patents do not clearly define what comparison is required by 

the disputed claim terms. The examiner recognized as 

much during prosecution of the ’441 patent, rejecting as indefinite the claim term “extend the time to disease progression.” The examiner found the term to be a relative term 

undefined by the claim, without “a standard for ascertaining the requisite degree,” and that “one of ordinary skill 

would not be reasonably apprised of the scope of the invention.” No. 19-1263, J.A. 2050–51. The examiner inquired:

Specifically, it is never set forth what the extension 

of time to disease progress is relative to, for example, is the extension of time to disease progress relative to untreated patients? Patients who received 

antibody or taxoid alone? Patients who received 

antibody and an anthracycline?

Id. at J.A. 2051. Genentech responded:

[T]he expressions “extend the time to disease progression” and “response rate” are clear from the 

specification (see, in particular, page 15, lines 15-

17; and pages 42-43) and would be readily understood by a skilled oncologist. Clearly, the combination of an anti-ErbB2 antibody and a taxoid is 

administered in an amount effective to extend the 

time to disease progression relative to an untreated 

patient.

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GENENTECH, INC. v. IANCU 7

Id. at J.A. 2082.

The Board determined that Genentech’s response to 

the examiner was an express choice, which defined the 

claim term and led to the issuance of the ’441 patent. Id. 

at J.A. 46. Genentech argues that the Board erred in its 

reliance on this exchange by using it “to override the meaning evident from the specification.” The specification does 

not, however, expressly define the disputed terms. And 

Genentech did not view this choice as inconsistent with the 

specification during prosecution. Instead, Genentech interpreted its own claim language, based on its own specification’s disclosure, as referring to a comparison to 

untreated patients. The examiner even provided Genentech with the very alternative option (“taxoid alone”) for 

which Genentech now advocates. Genentech expressly rejected this comparator during prosecution and instead 

clearly stated that it was effectiveness relative to an untreated patient. Genentech provided an unequivocal, direct response to the examiner’s inquiry—that the term 

“extend the time to disease progression” was compared to 

an untreated patient. Genentech’s comparator choice during prosecution of the ’441 patent applies equally to the 

same claim term that appears in the ’549 patent, which 

shares a specification and is in the same patent family. 

Given this relationship between the patents, the Board 

construed the relevant terms consistently in all six inter 

partes reviews. We see no error in the Board’s constructions. 

The Board’s construction of the term “extend the time 

to disease progression” as requiring comparison to an untreated patient is consistent with the claims, specifications, 

and prosecution histories of the ’441 and ’549 patents. The 

claims do not themselves provide an explicit comparator. 

And the specifications discuss several drugs and drug combinations that may be viable comparators, including a taxoid, anthracycline/cyclophosphamide treatment, and 

chemotherapy. The specifications do not select any one of 

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8 GENENTECH, INC. v. IANCU

these as the comparator, nor do they preclude comparison 

to an untreated patient. We do not agree with Genentech

that the Board’s construction is inconsistent with the claim 

language prohibiting an “increase in overall severe adverse 

events.” As discussed, Genentech is bound by the comparator choice it made during prosecution. Moreover, Genentech amended the claims to add the “severe adverse events” 

limitation after its statement that effectiveness is determined by comparison to untreated patients. 

In light of Genentech’s prosecution statements, we determine that the terms “in an amount effective to extend 

the time to disease progression in the human patient” and 

“an effective amount” are properly construed as measured 

relative to an untreated patient. Genentech does not challenge the Board’s unpatentability determinations under 

these constructions. We therefore affirm the unpatentability of claims 1–14 of the ’441 patent and claims 1–17 of the 

’549 patent. 

III. Genentech’s Motion to Amend

In IPR2017-00731, the petitioner challenged all fourteen claims of the ’441 patent under two alternative 

grounds: Ground 1 as the claims would have been obvious 

over Baselga ’972 and Baselga ’94,3 and Ground 2 as the 

claims would have been obvious over Baselga ’964 and 

2 Baselga et al., HER2 Overexpression and 

Paclitaxel Sensitivity in Breast Cancer: Therapeutic Implications, 11(3) (Suppl. 2) ONCOLOGY 43–48 (1997).

3 Baselga et al., Anti-HER2 Humanized Monoclonal 

Antibody (MAb) Alone and in Combination with Chemotherapy Against Human Breast Carcinoma Xenografts, 13 

PROC. AM. SOC. CLIN. ONCOL. 63 (Abstract 53) (1994).

4 Baselga et al., Phase II Study of Weekly Intravenous Recombinant Humanized Anti-p185HER2 Monoclonal Antibody in Patients with HER2/neu-Overexpressing 

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GENENTECH, INC. v. IANCU 9

Baselga ’94. The Board originally denied institution on 

Ground 1 because Genentech antedated Baselga ’97, and it 

denied institution on Ground 2 based on its determination 

that petitioner had not shown a reasonable likelihood that 

it would prevail. Petitioner requested a rehearing on the 

Board’s institution decision after which the Board instituted inter partes review on Ground 2. The Board continued to decline institution on Ground 1. Genentech then 

filed its first contingent motion to amend its claims under 

35 U.S.C. § 316(d)(1). 

After the Supreme Court’s decision in SAS Inst., Inc. v. 

Iancu, 138 S. Ct. 1348 (2018), the Board modified its institution decision to include institution on Ground 1. Genentech then sought to amend its claims again, arguing that it 

had a statutory right to do so under § 316(d)(1). Meanwhile, petitioner sought an adverse judgment on Ground 1, 

which the Board granted. The Board rejected Genentech’s 

argument that it had a statutory right to amend and

treated the motion as an additional motion to amend under 

§ 316(d)(2). Pursuant to 37 C.F.R. § 42.121(c), the Board

required Genentech to make a good cause showing before 

the Board considered the second motion to amend. No. 19-

1263, J.A. 13211. Having found that Genentech failed to 

establish good cause, the Board denied the second motion 

to amend. 

The Board alternatively held that, even if good cause 

existed, Petitioner’s request for adverse judgment as to 

Ground 1 under 37 CFR § 42.73(b) mooted the issue. No. 

19-1263, J.A. 21-22. The Board determined that 37 C.F.R. 

§ 42.73(a) and (b) permit partial adverse judgment as to a

single ground—in this case Ground 1. The Board referred 

to the “Frequently Asked Questions about SAS Implications” issued by the PTO, which states that, in order to 

Metastatic Breast Cancer, 14 J. CLIN. ONCOL. 737–44 

(1996).

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10 GENENTECH, INC. v. IANCU

limit the scope of the proceeding in the event the parties 

cannot agree to waive additional claims, “[t]he Petitioner 

can request adverse judgment on claims and/or grounds at 

any time.” The Board went on to explain that, under 37 

CFR § 42.5(b), it was permitted to waive any requirement 

that adverse judgment under § 42.73(b) is available only 

for disposition of all issues—“The Board may waive or suspend a requirement of parts 1, 41, and 42 and may place 

conditions on the waiver or suspension.”

Genentech argues that the Board erroneously granted

Petitioner’s request for partial adverse judgment because 

37 CFR § 42.73(a) defines a judgment as “dispos[ing] of all 

issues that were, or by motion reasonably could have been, 

raised and decided.” We need not reach whether the Board 

may grant partial adverse judgment under 37 CFR 

§ 42.73(a), however, because 37 CFR § 42.5(b) gives the 

Board discretion to “waive or suspend a requirement of 

part[] . . . 42.” The Board exercised that discretion here to 

waive any requirement of § 42.73(a) that could be read to 

preclude partial adverse judgment. The Supreme Court in 

SAS stated that “Congress chose to structure a process in 

which it’s the petitioner, not the Director, who gets to define the contours of the proceeding.” 138 S. Ct. at 1355. 

Here, the petitioner sought to “simplify the issues to be addressed in the final written decision” by requesting a partial adverse judgment with respect to Ground 1. No. 19-

1263, J.A. 13406. Genentech has identified no prejudice 

from the partial adverse judgment aside from purportedly 

losing its chance at a second motion to amend. The Board 

did not abuse its discretion when it waived any potential 

requirements precluding partial adverse judgment and we 

see no error in the Board’s treatment thereof. 

The grant of partial adverse judgment on Ground 1 returned the petition to a single ground, Ground 2, for which 

Genentech had already filed one motion to amend. Thus, 

the Board properly treated Genentech’s second motion to 

amend as one which required a showing of good cause. See

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GENENTECH, INC. v. IANCU 11

35 U.S.C. § 316(d)(2) and 37 C.F.R. § 42.121(c). We review 

the Board’s application of its own procedural rules, such as 

whether good cause exists for an additional motion to 

amend under 37 C.F.R. § 42.121(c), for abuse of discretion. 

See Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267, 1271 

(Fed. Cir. 2017). “The Board abuses its discretion if the 

decision: (1) is clearly unreasonable, arbitrary, or fanciful; 

(2) is based on an erroneous conclusion of law; (3) rests on 

clearly erroneous fact findings; or (4) involves a record that 

contains no evidence on which the Board could rationally 

base its decision.” Id. at 1272. Genentech’s second motion 

to amend was directed to Ground 1 concerns and Ground 1 

was no longer part of the inter partes review following the 

Board’s grant of partial adverse judgment. We see no 

abuse of discretion in the Board’s denial of Genentech’s second motion to amend for lack of good cause. 

CONCLUSION

We conclude that the Board did not abuse its discretion 

in entering partial adverse judgment on Ground 1 in 

IPR2017-00731 or in denying Genentech’s second motion to 

amend. We further conclude that the Board correctly construed the terms “in an amount effective to extend the time 

to disease progression in the human patient” and “an effective amount” in the ’441 and ’549 patents to be in comparison to an untreated patient. Genentech does not challenge 

the Board’s unpatentability determinations under these 

constructions. We therefore affirm the Board’s decisions.

AFFIRMED

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