Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01476/USCOURTS-ca13-14-01476-0/pdf.json

Parties Involved:
Apotex Corp.
Appellee
Apotex Inc.
Appellee
G.D. Searle LLC
Appellant
Lupin Pharmaceuticals, Inc.
Appellee
Mylan Pharmaceuticals Inc.
Appellee
Pfizer Asia Pacific Pte. Ltd.
Appellant
Teva Pharmaceuticals USA, Inc.
Appellee
Watson Laboratories, Inc.
Not party

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

G.D. SEARLE LLC, PFIZER ASIA PACIFIC PTE. 

LTD.,

Plaintiffs-Appellants

v.

LUPIN PHARMACEUTICALS, INC.,

Defendant-Appellee

TEVA PHARMACEUTICALS USA, INC.,

Defendant-Appellee

MYLAN PHARMACEUTICALS INC.,

Defendant-Appellee

WATSON LABORATORIES, INC.,

Defendant

APOTEX INC., APOTEX CORP.,

Defendants-Appellee

______________________ 

2014-1476

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 2:13-cv-00121-AWALRL, Judge Arenda L. Wright Allen.

______________________ 

Decided: June 23, 2015

______________________ 

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2 G.D. SEARLE LLC v. LUPIN PHARMACEUTICALS, INC. 

KANNON K. SHANMUGAM, Williams & Connolly LLP, 

Washington, DC, argued for plaintiffs-appellants. Also 

represented by ALLISON B. JONES, DAVID M. KRINSKY,

CHRISTOPHER ALAN SUAREZ; AARON STIEFEL, SOUMITRA 

DEKA, DANIEL REISNER, JEFFREY T. MARTIN, DANIEL 

DINAPOLI, Kaye Scholer LLP, New York, NY.

BETH D. JACOB, Kelley Drye & Warren, LLP, New 

York, NY, argued for defendant-appellee Lupin Pharmaceuticals, Inc. Also represented by CLIFFORD KATZ; 

DOUGLASS C. HOCHSTETLER, Chicago, IL.

HENRY C. DINGER, Goodwin Procter LLP, Boston, MA, 

argued for defendant-appellee Teva Pharmaceuticals 

USA, Inc. Also represented by KEITH A. ZULLOW, DAVID 

M. HASHMALL, New York, NY; WILLIAM M. JAY, Washington, DC. 

DOUGLAS H. CARSTEN, Wilson, Sonsini, Goodrich & 

Rosati, PC, San Diego, CA, argued for defendant-appellee 

Mylan Pharmaceuticals Inc. Also represented by PETER 

SOO KANG; NANCY L. ZHANG, Palo Alto, CA.

STEPHEN AUTEN, Taft, Stettinius & Hollister, LLP, 

Chicago, IL, argued for defendants-appellees Apotex Inc., 

Apotex Corp. Also represented by IAN SCOTT, RICHARD T.

RUZICH; RICHARD HOOPER OTTINGER, Vandeventer Black 

LLP, Norfolk, VA.

______________________ 

Before PROST, Chief Judge, BRYSON and HUGHES,

Circuit Judges. 

BRYSON, Circuit Judge. 

G.D. Searle LLC and Pfizer Asia Pacific Pte. Ltd. (collectively, “Pfizer”) appeal from a final judgment entered 

by the United States District Court for the Eastern District of Virginia. The court invalidated the relevant 

claims of Pfizer’s reissued U.S. Patent No. RE44,048 (“the 

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G.D. SEARLE LLC v. LUPIN PHARMACEUTICALS, INC. 3

RE ’048 patent”) for obviousness-type double patenting. 

We affirm.

I

The doctrine of obviousness-type double patenting is

intended to prevent the extension of the term of a patent 

by prohibiting the issuance of the claims of a second 

patent that are not patentably distinct from the claims of 

the first patent. Eli Lilly & Co. v. Teva Parenteral Meds., 

Inc., 689 F.3d 1368, 1376 (Fed. Cir. 2012). The doublepatenting issue in this case turns on whether Pfizer is 

entitled to invoke section 121 of the Patent Act, 35 U.S.C. 

§ 121, as a defense against a claim of double patenting. 

That issue in turn depends on an interpretation of the 

prosecution history of the RE ’048 patent and U.S. Patent 

No. 5,760,068 (“the ’068 patent”), which is the original of 

the RE ’048 patent.

The ’068 patent can be traced back to an application 

filed with the Patent and Trademark Office (“PTO”) in 

1993. That application, Serial No. 08/160,594 (“the ’594 

application”), disclosed and claimed compounds, compositions, and methods of use regarding the treatment of pain 

and inflammation without the harmful side effects associated with certain traditional anti-inflammatory drugs. 

In an office action dated July 12, 1994, the patent examiner imposed a three-way restriction requirement on 

the ’594 application. The restriction requirement identified the compound, composition, and method-of-use claims 

as each directed to patentably distinct subject matter, and

it required Pfizer to elect only one of the three classes of 

claims. Pfizer elected to prosecute the compound claims 

in the ’594 application, which issued in November 1995 as 

U.S. Patent No. 5,466,823.

Pfizer prosecuted the composition claims that had 

been restricted out of the ’594 application in a divisional 

application filed in June 1995, Serial No. 08/457,059 (“the 

’059 application”). The ’059 application matured into U.S. 

Patent No. 5,563,165 (“the ’165 patent”) in October 1996.

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Pfizer did not file a divisional application to prosecute 

the restricted-out method-of-use claims of the ’594 application. Instead, prior to receiving the restriction requirement, it filed a continuation-in-part of the ’594 

application in April 1994, Serial No. 08/223,629 (“the ’629 

application”) that included new matter. The ’629 application contained all three classes of claims, i.e., compounds, 

compositions, and methods of use, including claims covering the new matter, and it issued as U.S. Patent No. 

5,521,207 in May 1996.

In November 1994, Pfizer filed International Patent 

Application No. PCT/US94/12720 (“the PCT ’720 application”), which was designated as a continuation-in-part of 

the ’629 application and as a continuation-in-part of the 

original ’594 application. The PCT ’720 application contained all three classes of claims, and it encompassed 

much of the subject matter in the method-of-use claims 

that had been restricted out of the ’594 application. 

The PCT ’720 application became a national stage application in the United States as U.S. Patent Application 

No. 08/648,113 (“the ’113 application”) in September 1996. 

During the prosecution of the ’113 application, the examiner issued a lack of unity rejection/restriction requirement in a telephone conference with the patentee. That 

restriction requirement again limited Pfizer to prosecuting only one of the three classes of claims—compounds, 

compositions, or methods of use. Pfizer elected to prosecute only method-of-use claims in the ’113 application, 

which matured into the ’068 patent in June 1998. The 

’068 patent describes itself as issuing from a continuationin-part of the ’629 application, which was a continuationin-part of the original ’594 application. 

In Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 

F.3d 1353 (Fed. Cir. 2008), which addressed a patent 

infringement action filed by Pfizer on the ’068 patent, we 

held the relevant claims of the ’068 patent invalid for 

obviousness-type double patenting in light of the earlier 

issued ’165 patent. In that case, Pfizer invoked the soCase: 14-1476 Document: 132-2 Page: 4 Filed: 06/23/2015
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called “safe harbor” provision of section 121, which in 

certain circumstances protects a patent that issues on a 

divisional application from invalidation based on a related 

patent that issued on an application as to which a restriction requirement was made, or on an application filed 

as a result of such a requirement. We held that even 

though both the ’165 patent and the ’068 patent traced 

their lineage back to the original ’594 application, the 

statutory safe harbor provision did not shield the ’068 

patent from the invalidating effect of the ’165 patent. 

That was because “the protection afforded by section 121 

to applications (or patents issued therefrom) filed as a 

result of a restriction requirement is limited to divisional 

applications,” id. at 1362, and the ’068 patent issued from 

a continuation-in-part, not a divisional application. 

Pfizer subsequently filed U.S. Patent Application No. 

12/205,319 (“the ’319 application”), seeking reissue of the 

’068 patent under 35 U.S.C. § 251.1 In the reissue decla1 At the relevant time, section 251 read as follows:

Whenever any patent is, through error without 

any deceptive intention, deemed wholly or partly 

inoperative or invalid, by reason of a defective 

specification or drawing, or by reason of the patentee claiming more or less than he had a right 

to claim in the patent, the Director shall, on the 

surrender of such patent and the payment of the 

fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for 

the unexpired part of the term of the original patent. 35 U.S.C. § 251(a).

The America Invents Act amended the statute by 

striking the words “without any deceptive intention.” 

Pub. L. No. 112-29, § 20, 125 Stat. 284, 333-34 (2011). The 

amendment took effect on September 16, 2012, after 

 

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ration, Pfizer asserted that it had erred in prosecuting the 

application leading up to the ’068 patent as a continuation-in-part, rather than as a divisional application, and 

that the error had resulted in invalidating the relevant 

claims of the ’068 patent for obviousness-type double 

patenting.

Pfizer sought to correct that alleged error by reissue. 

The preliminary amendment that accompanied the initial 

reissue declaration made the following changes to the ’068 

patent: (1) it deleted portions of the ’068 patent specification that were not present in the ’594 application; (2) it 

designated the ’113 application as a divisional of the ’594 

application and removed the priority claim to the ’629 

application; (3) it amended claim 1 to be a method claim 

using only the compounds originally disclosed in the ’594 

application; (4) it canceled claims 2-12, which were method claims using compounds that were not present in the 

’594 application; (5) it canceled claim 18 (reciting a method of preventing colorectal cancer), which was not found 

in the ’594 application; and (6) it added new method 

claims 19-23, which recited the use of the method disclosed in claim 1 to treat five specific types of inflammation-associated disorders. The preliminary amendment 

stated that those actions were taken to conform the ’068 

patent to a divisional of the ’594 application.

The examiner rejected the preliminary amendment, 

finding that the “error” identified in Pfizer’s reissue 

declaration was not correctable under section 251. Pfizer 

then filed a request for continuing examination and 

submitted an additional reissue declaration, in which it 

cited various technical errors relating to the claimed 

chemical structures that it wished to correct through the 

reissue. Those technical errors, according to Pfizer,

rendered the claims of the ’068 patent indefinite and were 

Pfizer had filed its reissue application on September 5, 

2008. “Deceptive intention” is not at issue in this case. 

 

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therefore eligible for correction by reissue under section 

251. 

The examiner found that the later-identified technical 

errors provided a proper basis for reissue under section 

251. Pfizer was allowed to correct those technical errors; 

it was also allowed to make additional changes, including 

designating the ’113 application from which the ’068 

patent issued as a divisional of the ’594 application and 

removing subject matter not present in the ’594 application. The PTO eventually allowed the claims of the ’319 

application, which issued as the RE ’048 patent on March 

5, 2013. 

On the day the RE ’048 patent issued, Pfizer filed the 

instant case against five generic drug manufacturers, 

alleging infringement of the RE ’048 patent. The generic 

manufacturers moved for summary judgment, and the 

district court granted the motion in part. The court found 

that the RE ’048 patent was not a valid reissue patent, 

because Pfizer’s asserted error of prosecuting a prior 

patent application as a continuation-in-part, rather than 

as a divisional, was not correctable by reissue under 

section 251. The court further found that the safe harbor 

provision of 35 U.S.C. § 121 did not apply to the RE ’048 

patent, and that the relevant claims of the RE ’048 patent 

were invalid for obviousness-type double patenting in 

light of the ’165 patent. A final judgment of invalidity 

was entered against Pfizer. This appeal followed. 

II

The parties present two principal issues on appeal: (1) 

whether 35 U.S.C. § 251 authorized the PTO to reissue 

the ’068 patent under the circumstances; and (2) assuming reissue was authorized, whether the safe harbor

provision of 35 U.S.C. § 121 applies to the RE ’048 patent

and protects it from invalidation based on the ’165 patent. 

Because we find that the safe harbor provision of section 

121 does not apply to the RE ’048 patent, even assuming 

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it was proper to grant the reissue patent under section 

251, we affirm the district court’s judgment. 

The safe harbor provision of section 121 provides as 

follows: 

A patent issuing on an application with respect to 

which a requirement for restriction under this 

section has been made, or on an application filed 

as a result of such a requirement, shall not be 

used as a reference either in the Patent and 

Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the 

divisional application is filed before the issuance 

of the patent on the other application.

We apply “a strict test” for application of section 121, 

“[g]iven the potential windfall [a] patent term extension 

could provide to a patentee.” Geneva Pharm., Inc. v. 

GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 

2003); see also Amgen Inc. v. F. Hoffman-La Roche Ltd., 

580 F.3d 1340, 1353 (Fed. Cir. 2009) (requiring “a strict 

application of the plain language of § 121”).

Pfizer contends that the RE ’048 patent is entitled to 

the protection of the safe harbor provision against invalidation by the ’165 patent. We disagree. 

A 

The safe harbor provision of section 121 protects a patent issuing on an application with respect to which a 

restriction requirement has been made, or on an application filed as a result of such a restriction requirement. 35 

U.S.C. § 121; Pfizer, 518 F.3d at 1360. It is undisputed 

that the reference ’165 patent issued on a divisional of the 

original ’594 application, which was filed as a result of the 

July 1994 restriction requirement. The challenged RE 

’048 patent, however, is not entitled to safe harbor protection, because it did not issue on either the ’594 application 

or a divisional of the ’594 application.

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The RE ’048 patent issued from the ’319 application, a 

reissue of the ’068 patent, which in turn issued from the 

’113 application. The ’113 application cannot be a divisional of the ’594 application, despite being designated as 

such in the reissue patent, because it contains new matter 

that was not present in the ’594 application. See PTO, 

Manual of Patent Examining Procedure § 201.06 (9th ed. 

2014) (“A later application for an independent or distinct 

invention, carved out of a pending application and disclosing and claiming only subject matter disclosed in the 

earlier or parent application, is known as a divisional 

application or ‘division.’”). Simply deleting that new 

matter from the reissue patent does not retroactively alter 

the nature of the ’113 application.

Moreover, when the ’113 application issued as the 

’068 patent in June 1998, Pfizer obtained patent protection for the new matter that was not present in the ’594 

application. For years thereafter, the public was not free 

to practice that new matter (e.g., the now cancelled claims 

2-12 and 18 of the ’068 patent) because of that patent 

protection. Pfizer cannot now identify the ’113 application as a divisional of the ’594 application (for purposes of 

section 121) and retroactively relinquish the new matter

in the ’113 application, after having enjoyed years of 

patent protection for it. See In re Harita, 847 F.2d 801, 

809 (Fed. Cir. 1988) (“In any given case, the [reissue] 

statute should be so applied to the facts that justice will 

be done both to the patentee and the public.”); see also In 

re Serenkin, 479 F.3d 1359, 1362 (Fed. Cir. 2007) (“[Section] 251 is based on fundamental principles of equity and 

fairness[.]”). Fairness to the public does not permit Pfizer 

to convert the ’113 application into a division of the original ’594 application, and thereby take advantage of the 

safe harbor provision, simply by designating it as a divisional application years after the fact. 

The ’113 application is a national stage application of 

the PCT ’720 application. The PCT ’720 application, like 

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tion. PCT ’720 identified itself as a continuation-in-part 

of the ’594 application and as a continuation-in-part of the 

’629 application; it added compound, composition, and 

method-of-use claims that were not contained in those 

applications. 

Pfizer does not assert that the PCT ’720 application 

can become a divisional application of the ’594 application 

for section 121 purposes simply by disregarding all matter 

not present in the original ’594 application, and for good 

reason. Pfizer obtained foreign patent protection based 

on the PCT ’720 application. Altering the scope of the 

PCT ’720 application could call into question the proper 

scope of those foreign patents. Thus, because the PCT 

’720 application contains matter not present in the original ’594 application, it cannot be a division of the ’594 

application.

Because the RE ’048 patent identifies itself as descended from the ’113 application and the PCT ’720 

application, and because neither of those applications is a 

division of the original ’594 application, the section 121 

safe harbor does not apply to the RE ’048 patent. See 

Pfizer, 518 F.3d at 1362 (“We conclude that the protection 

afforded by section 121 to applications (or patents issued 

therefrom) filed as a result of a restriction requirement is 

limited to divisional applications.”); Amgen Inc. v. F. 

Hoffman-La Roche Ltd., 580 F.3d 1340, 1352-53 (Fed. Cir. 

2009) (same).2

2 Pfizer suggests that the reissue application itself 

(i.e., the ’319 application) may also be deemed a division 

of the ’594 application for purposes of section 121. See, 

e.g., Applicants’ Reply Br. 23-25. That position, however, 

is inconsistent with the record. The RE ’048 patent states 

that it is a reissue of the ’068 patent, which issued from 

the ’113 application, which in turn is designated as a 

divisional of the ’594 application. That characterization 

accords with Pfizer’s stated purpose for seeking reissue, 

 

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B 

Section 121 is inapplicable to the RE ’048 patent for a 

second reason as well: The RE ’048 patent (the challenged 

patent) and the ’165 patent (the reference patent) are not 

“derived from the same restriction requirement.” Pfizer, 

518 F.3d at 1360; see also Boehringer Ingelheim Int’l 

GmbH v. Barr Labs., Inc., 592 F.3d 1340, 1354 (Fed. Cir. 

2010) (section 121 protects “claims prosecuted in two or 

more applications having common lineage in a divisional 

chain”). 

When separate restriction requirements are imposed 

on separate applications and the record does not show 

that any of the various restriction requirements carried 

forward from one application to the next, the earlier 

restriction requirement cannot be viewed as having 

continued in effect with respect to the later-filed application. See Bristol-Myers Squibb Co. v. Pharmachemie B.V., 

361 F.3d 1343, 1349-50 (Fed. Cir. 2004). 

In 1994, the examiner imposed a three-way restriction 

requirement on the original ’594 application (the “1994 

restriction requirement”), prohibiting Pfizer from prosecuting all three classes of claims—compounds, compositions, and methods of use—in the same application. 

Pfizer elected to prosecute the compound claims in the

’594 application and separately prosecuted the composition claims in the ’059 application, a division of the ’594 

application. 

i.e., “so that the ’113 Application from which the ’068 

Patent issued qualifies as a divisional application in 

compliance with the recent Federal Circuit opinion.” The 

evidence thus shows that the reissue patent relies on its 

lineage from the ’113 application, and not from the ’319 

application, to satisfy the “divisional application” requirement of section 121.

 

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The ’059 application matured into the ’165 patent. It 

is undisputed that the ’165 patent is derived from the 

1994 restriction requirement. The RE ’048 patent, on the 

other hand, identifies itself as being descended from the 

’113 application and the PCT ’720 application. Both of 

those applications, as filed, contained three classes of 

claims: compounds, compositions, and methods of use. 

During the national stage prosecution of the ’113 application, and in an April 8, 1997, supplemental amendment, 

Pfizer noted that the examiner had issued “[a] lack of 

unity rejection/restriction requirement” during a telephone conference (the “1997 restriction requirement”). 

The 1997 restriction requirement again limited Pfizer to 

an election among the claimed compounds, compositions, 

and methods of use. Pfizer elected to prosecute only 

method-of-use claims in the ’113 application, which matured into the ’068 patent. Appellants’ Br. 5 (“After the 

examiner issued a restriction requirement, Pfizer amended the ’113 application to elect, with traverse, only the 

method-of-treatment claims.”).

The record thus shows that two separate restriction 

requirements affected the chain of applications involved 

in this case. The 1994 requirement, which was imposed 

on the original ’594 application, led to the ’165 patent. 

The 1997 requirement, which was imposed on the ’113 

application, led to the ’068 patent and ultimately to the

RE ’048 patent. In order for section 121 to protect the RE 

’048 patent against the invalidating effect of the ’165 

patent, the 1994 restriction requirement must have 

“carried forward” from the ’594 application to the ’113 

application. Bristol-Myers, 361 F.3d at 1349. No such 

showing has been made, however. 

Pfizer admits that the ’113 application contains 

claims directed at “subject matter that was newly added

. . . and had not been disclosed in the . . . ’549 application[].” Appellants’ Br. 22. Thus, while the 1994 restriction requirement and the 1997 restriction 

requirement both limited Pfizer to an election among

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compounds, compositions, and methods of use, they did 

not apply to the same compounds, compositions, and 

methods of use. They are therefore not the same restriction requirement.

Furthermore, the record is devoid of any evidence 

showing that the examiner “reinstate[d] or even advert[ed] to” the 1994 restriction requirement when issuing 

the 1997 restriction requirement. Bristol-Myers, 361 F.3d 

at 1348-49. There is no evidence that the examiner made 

any reference to the 1994 restriction requirement at all 

during prosecution of the ’113 application. Without such 

evidence, the 1994 and the 1997 restriction requirements, 

although appearing similar, must be deemed to have been 

“separately imposed with respect to” the ’594 and the ’113 

applications. Id. at 1349. Because the ’165 patent and 

the RE ’048 patent are derived from two separately imposed restriction requirements, section 121 does not apply 

as between those two patents. 

Pfizer contends that the 1994 restriction requirement 

nonetheless should be deemed to have carried forward to 

the ’113 application because, “but for the [1994] restriction requirement” Pfizer could have pursued the 

claims contained in the RE ’048 patent in the original ’594 

application. Pfizer relies on the Boehringer case for the 

proposition that if the claims at issue would have been 

prosecuted in the original application but for the restriction requirement, they must be deemed to have been 

derived from that restriction requirement. Appellants’ 

Reply Br. 24. Boehringer, however, does not go that far.

The issue in Boehringer was whether section 121 applies to a patent that issues from an application that is a 

divisional of a divisional of the application upon which a 

restriction requirement was imposed. See Boehringer, 592 

F.3d at 1352. In Boehringer, a single restriction requirement was entered in the grandparent application. The

patentee then filed two successive divisionals to different 

combinations of the inventions identified in the restriction 

requirement. We held that section 121 applies to a diviCase: 14-1476 Document: 132-2 Page: 13 Filed: 06/23/2015
14 G.D. SEARLE LLC v. LUPIN PHARMACEUTICALS, INC. 

sional of a divisional of the grandparent application, so 

long as (1) the claims prosecuted in two or more applications share common lineage in the divisional chain; and 

(2) the lines of demarcation drawn by the examiner are 

preserved as between applications. Id. at 1354.

In Boehringer, common lineage was not at issue, because that case involved a single restriction requirement 

imposed only on the grandparent application. Here, by 

contrast, the record shows two separate restriction requirements, one of which led to the reference ’165 patent

and the other of which led to the challenged RE ’048

patent. This case requires us to answer the question 

whether the applications from which the two patents 

issued share “common lineage in the divisional chain”; in 

other words, we must determine whether the two patents

are derived from the same restriction requirement. 

Boehringer, 592 F.3d at 1354; Pfizer, 518 F.3d at 1360. 

As noted above, the 1994 and 1997 restriction requirements were not imposed on the same compound, 

composition, and method-of-use claims. No evidence 

shows that the PTO intended the 1994 restriction requirement to carry forward to the ’113 application. Thus, 

the record does not show that the 1994 and 1997 restriction requirements are one and the same, and the 

“common lineage” requirement of Boehringer is not satisfied. For that reason as well, we hold that the safe harbor 

provision of section 121 does not apply to protect the RE 

’048 patent from the use of the ’165 patent in the obviousness-type double patenting analysis.3

AFFIRMED

3 Because we conclude that the section 121 safe 

harbor provision does not apply to the RE ’048 patent, we 

need not address the question whether the RE ’048 patent 

was validly reissued under 35 U.S.C. § 251. 

 

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