UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

NOT FOR PUBLICATION

 .

:

SHIRE LLC, et al., : Civil Action No. 11-3781 (SRC)(CLW)

: (Consolidated)

Plaintiff, :

:

v. : OPINION

:

AMNEAL PHARMACEUTICALS, LLC, :

et al., :

:

Defendant. :

 :

WALDOR, UNITED STATES MAGISTRATE JUDGE

Pending before this Court are cross motions by the parties to strike expert opinions 

associated with the claim construction proceeding in the above captioned matter. Plaintiff Shire 

LLC and Shire Development Inc. (collectively “Shire” or “Pl.”) move to strike defendants’ 

experts’ claim construction opinions. (Docket Entry No. 244; “Pl.’s Motion”). Second, 

Defendants Actavis Elizabeth LLC and Actavis, Inc., Amneal Pharmaceuticals, LLC, Johnson 

Matthey Inc. and Johnson Matthey Pharmaceutical Materials, Mylan Pharmaceuticals Inc. and 

Mylan Inc., Roxane Laboratories, Inc., and Sandoz Inc. (collectively “Defendants” or “Defs”)

move to strike portions of Shire’s expert’s claim construction opinion. (Docket Entry No. 269; 

“Defs’ Motion”). 

Opposition to Shire’s Motion was filed on February 12, 2013. (Docket Entry No. 261; 

“Opp. to Pl. Motion”). Shire filed a reply thereto on February 26, 2013. (Docket Entry No. 277; 

“Pl. Reply”). Opposition to Defendants’ Motion was filed by Shire on March 11, 2013. (Docket 

Entry No. 281; “Opp. to Defs’ Motion”). Defendants’ filed a reply thereto on March 18, 2013. 

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(Docket Entry No. 287; “Defs’ Reply”). At the request of the Defendants, the 

Court will address both motions simultaneously. (See Docket Entry No. 279). The Court decides 

both motions without oral argument pursuant to FED. R. CIV. P. 78. For the reasons set forth 

below, Shire’s Motion is GRANTED in part and DENIED in part. Defendants’ Motion is 

GRANTED. 

I. Background

Shire commenced these Hatch-Waxman patent infringement actions against a number of 

Defendants including Amneal, Actavis, Roxane, Sandoz, Maylan, Watson, and Johnson Matthey, 

alleging infringement of a number of patents related to lisdexamfetamine dimesylate, a drug 

developed to treat Attention Deficit Hyperactivity Disorder and marketed under the brand name 

Vyvanse®. To date, expert discovery has concluded and the parties’ responding Markman briefs 

have been submitted. (Opp. to Pl. Motion at 3). Shire moves to strike Dr. Ron Bihovsky’s and 

Dr. Mark Sacchetti’s opinions for several reasons articulated below. (Pl.’s Motion at 2). Also, 

Shire moves to strike Dr. William Jusko’s opinion as untimely or in the alternative seeks leave to 

file a reply brief and declaration. (Id.) 

On July 2, 2012, the Court entered a modified pretrial scheduling order which set dates 

for, among other things, the exchange of preliminary proposed claim constructions and extrinsic 

evidence and Markman submissions. (Docket Entry No. 111; “Scheduling Order”). The 

Scheduling Order in this case mirrored the required disclosures of L. Pat. R. 4 with modifications 

to the respective due dates of expert disclosures. (Id.). Further, the Scheduling Order allowed 

the parties to identify all rebuttal expert witnesses as a supplement to the Joint Claim 

Construction & Prehearing Statement after the filing of opening Markman briefs, and prior to the 

completion of Markman expert discovery. (Id.). 

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II. Legal Standard

The Local Patent Rules “exist to further the goal of full, timely discovery and provide all 

parties with adequate notice and information with which to litigate their cases.” Voxpath RS, 

LLC v. LG Elecs. U.S.A., Inc., No. 12-952, 2012 WL 5818143, at *3 (D.N.J. Nov. 14, 2012) 

(internal quotations marks omitted). Specifically, Local Patent Rule 4 governs claim 

construction proceedings. See L. Pat. R. 4. Pursuant to this rule and its subsections, the parties 

are required to exchange a list of claim terms which each “party contends should be construed by 

the Court, and identify any claim term which that party contends should be governed by 35 

U.S.C. § 112(6).” L. Pat. R. 4.1(a)–(b).

After exchanging claim term lists, the parties are required to exchange “Preliminary 

Claim Constructions” which list each claim identified for claim construction and all intrinsic and 

extrinsic evidence supporting the Preliminary Claim Constructions. L. Pat. R. 4.2(a)–(b). 

Extrinsic evidence includes expert witness testimony. L. Pat. R. 4.2(b). Under Rule 4.2, parties 

identifying expert witness testimony should “provide a description of the substance of that 

witness’ proposed testimony that includes a listing of any opinions to be rendered in connection 

with claim construction.” Id. After exchanging Preliminary Claim Constructions, the parties are 

required to identify and exchange all intrinsic and extrinsic evidence they “intend[] to rely upon 

to oppose any other party’s proposed construction.” L. Pat. R. 4.2(c). 

Pursuant to Local Patent Rule 4.3, the parties are then required to “complete and file a 

Joint Claim Construction & Prehearing Statement.” L. Pat. R. 4.3(a). The statement must 

include, inter alia, the term constructions the parties agree on, “[e]ach parties proposed 

construction of each disputed term,” the identification of all intrinsic and any extrinsic evidence 

“known to the party on which it intends to rely either to support its proposed construction or to 

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oppose any other party’s proposed construction,” and the identity of and a summary of the 

testimony for each expert witness whose “opinion [is] to be offered related to claim 

construction.” L. Pat. R. 4.3(a)–(b), (e). After the Joint Claim Construction & Pre-hearing

Statement are filed “all expert testimony should be known, or at least discernible, and there is no 

obvious basis for holding back or reserving additional expert testimony.” Warner Chilcott Labs. 

Ir. Ltd. v. Impax Labs., Inc., Nos. 08-6304, 09-0228, 09-0468, 09-1233, 09-2073, 2010 WL 

339034, at *3 (D.N.J. Jan. 22, 2010).

Courts in this district have held that a Joint Claim Construction & Pre-hearing Statement 

that only sets forth the names of a party’s proposed expert witnesses and describes their 

testimony as “concerning . . . the interpretation of the disputed terms by a person of ordinary skill 

in the art and or/ordinary meaning of the disputed terms” was insufficient to meet the 

requirements of L. Pat. R 4.3(e) and ordered that the party amend its Joint Claim Construction & 

Pre-hearing Statement to comply with the rule or otherwise “face possible adverse consequences 

including the risk of being precluded from relying on experts in the Markman proceedings.” 

APP Pharms., LLC v. Ameridose, LLC, No. 10-4109, 2011 WL 6325975, *1–2 (D.N.J. Dec. 6, 

2011).

After filing the Joint Claim Construction & Pre-hearing Statements, the parties’ opening 

Markman briefs are to be filed. L. Pat. R. 4.5(a). The opening Markman briefs are required to 

include “any evidence supporting claim construction, including experts’ certifications or 

declarations.” Id. Expert discovery from those experts submitting certifications or declarations 

with opening Markman briefs concludes within 30 days of the opening Markman brief 

submissions, unless a scheduling order provides otherwise. L. Pat. R. 4.5(b). The parties are 

then required to “file and serve responding Markman briefs and any evidence supporting claim 

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construction including any responding experts’ certifications or declarations.” L. Pat. R. 4.5(c). 

“Under the Rules, the Plaintiffs in a Hatch-Waxman case should not ordinarily first learn about 

an expert’s testimony in a responding Markman submission.” Warner Chilcott Labs. Ir. Ltd., 

2010 WL 339034 at *3.

Under the Federal Rules of Civil Procedure, unless otherwise specified by the court, an 

expert witness is required to prepare a written report containing, inter alia, “a complete statement 

of all opinions that the witness will express and the basis and reasons for them.” Fed. R. Civ. P. 

26(a)(2)(B)(i). Pursuant to FED. R. CIV. P. 37(c), “If a party fails to provide information or 

identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that 

information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the 

failure was substantially justified or is harmless. In addition to or instead of this sanction, the 

court, on motion and after giving an opportunity to be heard: may impose other appropriate 

sanctions.” FED. R. CIV. P. 37(c)(1)(C). The Court has the authority to exclude evidence if a 

party fails to follow the court’s scheduling order. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 

791 (3d Cir. 1994). 

To determine whether expert testimony should be struck, the Third Circuit considers a 

number of factors: “(1) the prejudice or surprise in fact of the party against whom the excluded 

witnesses would have testified, (2) the ability of that party to cure the prejudice, (3) the extent to 

which waiver of the rule against calling unlisted witnesses would disrupt the orderly and efficient 

trial of the case or of other cases in the court, and (4) bad faith or willfulness in failing to comply 

with the court's order.” Meyers v. Pennypack Woods Home Ownership Ass’n, 559 F.2d 894, 

904–05 (3d Cir. 1977). Additionally, the importance of the evidence to be excluded should also 

be considered. Reckitt Benkiser Inc. v. Tris Pharma, Inc., No. 09-3125, 2011 WL 6722707 at *6 

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(D.N.J. Dec. 21, 2011). Courts in this district have excluded testimony when the prejudice 

suffered could not be cured by the injured party. Reckitt, 2011 WL 6722707 at *7 (the court

found that the prejudice suffered could not be cured when a set trial date precluded a party from 

having enough time to sufficiently respond to the introduction of new expert evidence).

The Federal Circuit has held generally “that extrinsic evidence in the form of expert 

testimony can be useful to a court for a variety of purposes, such as to provide background on the 

technology at issue, to explain how an invention works, to ensure that the court’s understanding 

of the technical aspects of the patent is consistent with that of a person of skill in the art, or to 

establish that a particular term in the patent or the prior art has a particular meaning in the 

pertinent field.” Phillips v. AWH Corp., 415 F .3d 1303, 1318 (Fed. Cir. 2005). 

With regard to Markman hearings, the Federal Circuit has prioritized the importance of 

intrinsic evidence in a court’s claim construction evaluation. Phillips, 415 F.3d at 1314-1317. 

Moreover, the Federal Circuit has also stated that extrinsic evidence “is less significant than the 

intrinsic record in determining the legally operative meaning of claim language.” Id. (internal 

quotation marks omitted). Extrinsic evidence can be useful to the court regarding claim 

construction, but is generally less reliable than intrinsic evidence in determining claim 

construction for a number of reasons. Id. at 1318–19. First, extrinsic evidence is not created 

during patent prosecution and is distinct from the patent itself. Id. at 1318. Second, “extrinsic 

publications may not be written by or for skilled artisans and therefore may not reflect the 

understanding of a skilled artisan in the field of the patent.” Id. Third, and most relevant to the 

present case, “extrinsic evidence consisting of expert reports and testimony is generated at the 

time of and for the purpose of litigation and thus can suffer from bias that is not present in 

intrinsic evidence.” Id. Fourth, because each party has nearly an unlimited supply of potential 

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extrinsic evidence and “will naturally choose the pieces of extrinsic evidence most favorable to 

its cause, leaving the court with the considerable task of filtering the useful extrinsic evidence 

from the fluff.” Id. 

Specifically, with regard to expert testimony, the Federal Circuit has opined that expert 

testimony can be useful to provide technical background, explain the function of an invention, to 

establish the understanding of a person skilled in the art, or to establish a particular field’s 

definition of a term. Id. The Federal Circuit has also opined that “conclusory, unsupported 

assertions by experts as to the definition of a claim term are not useful to a court.” Id. 

“Similarly, a court should discount any expert testimony that is clearly at odds with the claim 

construction mandated by the claims themselves, the written description, and the prosecution 

history, in other words, with the written record of the patent.” Id. (internal quotation marks 

omitted). Nevertheless, the court retains discretion to admit and use extrinsic evidence. Id. at 

1319.

III. Discussion

On June 29, 2012, the court entered the Scheduling Order that required that the parties

exchange: proposed claim terms for constructions on or by August 24, 2012; preliminary claim 

constructions (and extrinsic evidence) on or by August 31, 2012 with the exception of defendants 

Mylan, Johnson Matthey and Watson; and identification of intrinsic and extrinsic evidence to 

oppose claim construction on or by September 7, 2012. This deadline was only to apply to 

Mylan, Johnson Matthey and Watson. Further, that the parties were to file the Joint Claim 

Construction & Prehearing Statement on or by September 14, 2012; file and serve opening 

Markman submissions on or by October 25, 2012; supplement their witness list in the Joint 

Claim Construction & Prehearing Statement to identify all rebuttal expert witnesses on or by 

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November 5, 2012; complete Markman expert discovery on or by December 7, 2012; file and 

serve responding Markman briefs on or by December 21, 2012. (See Scheduling Order at 2-3, ¶¶ 

7-10, 12-15). 

A. Shire’s Motion to Strike

Shire moves to strike portions of the Defendants’ responding claim construction brief and 

several attachments thereto. Specifically, Shire moves to strike: (1) the redlined portions of 

Defendants’ Responsive Markman Brief (Docket Entry No. 219, Ex. A; “Defs’ Resp. Claim

Brief”); Dr. Bihovsky’s declaration (Docket Entry No. 191-18; “Bihovsky Decl.”); Dr. 

Sacchetti’s declaration (Docket Entry No. 191-21; “Sacchetti Decl.”); Dr. Jusko’s declaration 

(Docket Entry No. 191-14; “Jusko Decl.”); Dr. Jusko’s rebuttal declaration (Docket Entry No. 

214-9; “Jusko Rebuttal Decl.”); Dr. Bihovsky’s deposition transcript (Docket Entry No. 214-14; 

“Bihovsky Tr.”); Dr. Sacchetti’s deposition transcript (Docket Entry No. 214-16; “Sacchetti 

Tr.”); Dr. Jusko’s deposition transcript (Docket Entry No. 214-15; “Jusko Tr.”). In light of the 

Pennypack and Reckitt factors noted above, this Court will address each item sought to be 

excluded from consideration in the court’s claim construction hearing, in turn below.

On September 14, 2012, the parties submitted the Joint Claim Construction & Prehearing 

Statement – including Defendants’ listed experts and evidentiary support for proposed claim 

construction. (Docket Entry No. 157-8, “JCC&PS”). On October 25, 2012, outside the 

requirements of the Local Patent Rules and the Scheduling Order, Defendants submitted, with its 

opening claim construction brief, a letter indicating that they have attached the declarations of 

Dr. Bihovsky, Dr. Sacchetti and Dr. Jusko in order to “provide Shire with an opportunity to 

consider and address the testimony of Defendants’ experts in Shire’s responsive brief.” (Docket 

Entry No. 192; “Defs’ Letter”). These expert declarations were filed as an attachment to 

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Defendants’ opening claims construction brief despite the fact the due date for responsive expert 

disclosure was November 5, 2012. (Scheduling Order at 2, ¶13). On November 5, 2012, the 

Defendants submitted their supplemental Joint Claim Construction & Prehearing Statement

rebuttal expert disclosure, wherein Defendants identify Dr. Bihovsky, Dr. Jusko and Dr. 

Sacchetti as rebuttal expert witnesses. (Docket Entry No. 194; “JCC&PS Supp.”). Defendants

contend that these respective submissions provided timely notice of each rebuttal expert’s 

opinion. (Opp. to Pl. Motion at 3). 

Shire argues that the responsive expert declaration attached to Defendants’ opening claim 

construction brief were “woefully deficient, containing largely background information and 

conclusory supporting opinions.” (Pl.’s Motion at 3; see also Pl. Reply at 1, 6) (emphasis in the 

original). Hence, not only were the submissions inadequate to provide the requisite notice 

contemplated by the Local Patent Rules, they also impermissibly offered supporting opinions to

the Defendants’ claim construction. Moreover, when the Defendants submitted their responding 

claim construction brief, it improperly contained deposition testimony of Dr. Bihovsky, Dr. 

Jusko and Dr. Sacchetti in lieu of expert declarations and a responding declaration of Dr. Jusko,

containing withheld opinions. (Pl.’s Motion at 3).

Defendants’ Responsive Markman Brief

The Third Circuit enumerated several factors for the court to address when considering 

whether to strike expert testimony: “(1) the prejudice or surprise in fact of the party against 

whom the excluded witnesses would have testified, (2) the ability of that party to cure the 

prejudice, (3) the extent to which waiver of the rule against calling unlisted witnesses would 

disrupt the orderly and efficient trial of the case or of other cases in the court, and (4) bad faith or 

willfulness in failing to comply with the court's order.” Pennypack, 559 F.2d ay 904–05. 

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Additionally, the importance of the evidence to be excluded should also be considered. Reckitt, 

2011 WL 6722707 at *6 (D.N.J. Dec. 21, 2011).

Shire moves to strike several sections of Defendants’ Resp. Claim Brief. Shire raises

varying bases upon which this Court should exclude the expert testimony cited in Defendants’ 

brief. For ease of reference, the Court will refer to the page number of Defendants’ Resp. Claim 

Brief and the specific text sought to be struck.

Page One 

Shire moves to strike the section of Defendants’ Resp. Claim Brief that reads: “and offer 

then only in rebuttal to the extent that the Court entertains Shire’s irrelevant expert evidence” 

and the accompanying footnote “[a]lthough Defendants believe that expert evidence is 

unnecessary to construe the disputed claims, in the event the Court chooses to consider such 

evidence, Defendants submit the declaration of Dr. Jusko and the deposition transcripts of Drs. 

Sacchetti, Bihovsky, and Jusko (Exs. 1-3) in response to Shire’s expert declarations.” (Defs’ 

Resp. Claim Brief at 1). Because the Court has granted in part and denied in part, Shire’s Motion 

to strike, striking the above language is unnecessary. As such, Shire’s Motion to strike this 

provision is denied. 

Page Five

Shire moves to strike Defendants’ citation “Ex. 16 at 174:9-24” to Dr. Sacchetti’s 

deposition, wherein Dr. Sacchetti provides support for the Defendants’ definition of a person of 

ordinary skill in the art as a team of scientists. Defendants identified, in the supplement on 

rebuttal experts, that Dr. Sacchetti would provide rebuttal to “Dr. Chyall’s definition of a person 

of ordinary skill in the art” (JCC&PS Supp. at 12 ¶ 1). Defendants, however, failed to identify 

Dr. Sacchetti as an expert who would offer an opinion in support of Defendants’ construction. In 

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light of Defendants’ failure to notice Dr. Sacchetti as an expert who would support Defendants’ 

construction that a person of ordinary skill in the art “is made up of a team of scientists”, Shire

was not afforded an opportunity to fully respond to the basis for Dr. Sacchetti’s opinion. Thus, 

Defendants have prejudiced Shire’s ability to respond to Dr. Sacchetti’s offered construction and 

the basis thereto. Shire cannot cure this deficiency because briefing on claim construction is 

complete and the parties positions are fully developed. Due to the fact that the first time Shire

discovered Dr. Sacchetti’s opinion on the proper construction of a person of ordinary skill in the 

art was in Defendants’ responsive claim construction brief, the appropriate remedy is to strike 

this citation from Defendants’ Resp. Claim Brief. (See Infra pp. 12-13); See also Warner Chilcott 

Labs. Ir. Ltd., 2010 WL 339034 at *3. 

Page Eight

Shire moves to strike the phrase “The parties’ experts agree that” from the sentence “The 

parties’ experts agree that the term “L-lysine d-amphetamine” is not a scientifically accepted 

chemical name with a well-accepted meaning in the art, as the compound contains neither Llysine nor d-amphetamine, but rather what a POSA would refer to as an L-lysyl group covalently 

bound to d-amphetamine” because it reflects Dr. Bihovsky’s supporting expert opinion of the 

Defendants’ claim construction that was not previously disclosed. (Defs’ Resp. Claim Brief at 

8). Said otherwise, no expert, including Dr. Bihovsky was previously identified to provide an 

opinion on construction of the claim term “L-lysine-d-amphetamine”. (Pl.’s Motion at 4). 

Therefore, Shire moves to strike the above phrase and the citation to Dr. Bihovsky’s deposition

“Ex. 14 at 104:19-105:15”. 

Under the Local Patent Rules, “the Plaintiffs in a Hatch-Waxman case should not 

ordinarily first learn about an expert’s testimony in a responding Markman submission.” Warner 

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Chilcott Labs. Ir. Ltd., 2010 WL 339034 at *3. After a review of Defendants’ evidentiary 

support for proposed claim construction and Defendants’ supplement to the Joint Claim 

Construction & Prehearing Statement, it is apparent to this Court that Dr. Bihovsky was not 

identified as an expert who would offer an opinion on “L-lysine d-amphetamine” not being a

scientifically accepted chemical name with a well-accepted meaning in the art. (JCC&PS at 38-

55). As such, Defendants have failed to comply with Local Patent Rule 4 and now are 

“precluded from relying on [Dr. Bihovsky’s opinion, as noted immediately above,] in the 

Markman proceedings.” APP Pharms., LLC v. Ameridose, LLC, No. 10-4109, 2011 WL 

6325975, *1–2 (D.N.J. Dec. 6, 2011).

This result is necessary because Defendants did not provide adequate notice of their 

expert’s opinion in a timely manner.1 As a result, Shire has conducted expert depositions and 

submitted its claim construction briefs without knowing that Dr. Bihovsky would be opining on 

the term “L-lysine d-amphetamine”. Shire’s arguments are fully briefed in its claim construction 

briefs and permitting new submissions would be unduly prejudicial to Shire because it would 

grant the Defendants an opportunity to submit new Markman papers knowing full well the 

arguments and positions Shire would submit in its claim construction. This Court notes that the 

“simultaneous” submission requirement applied to claims construction briefing schedules is not 

without purpose. It is intended, in part, to have the parties submit their respective positions on 

disputed terms without the luxury of the opposing parties’ papers. Any other remedy besides 

 

1 Defendants have not provided the Court with any reason why the appropriate expert disclosures could not have 

been provided when due pursuant to the Scheduling Order. Moreover, Defendants did not seek leave to modify the 

claim construction briefing schedule to allow for supplementing supporting or responding expert disclosures. See

Astrazeneca AB v. Mutual Pharamaceutical Co., Inc., 278 F.Supp.2d 491, 509 (E.D.Pa., Aug. 21, 2003). Instead, 

Defendants submitted their Markman briefs, relying on the provided expert testimony and took the position that their 

expert disclosures were sufficient. 

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striking the relevant portions of Dr. Bihovsky’s report would disrupt this litigation.2 At a 

minimum, Shire would be required to depose Dr. Bihovsky and make supplemental submissions. 

Furthermore, as discussed previously, the relatively low importance of extrinsic evidence such as 

expert opinions in a claim construction hearing supports the decision to strike Dr. Bihovsky’s 

opinion on “L-lysine d-amphetamine”. Phillips, 415 F.3d at 1317.3

Page Thirteen 

Shire moves to strike the sentence “[t]his position ignores generation of other active 

metabolites. Ex. 14 at 88:8-89:2 and 110:2-12; Ex. 15 at. 142:5- 143:24[.]” and citation to Dr. 

Bihovsky’s and Dr. Jusko’s deposition transcript. Defendants rely on Dr. Bihovsky’s opinion to 

respond to Shire’s construction that “amphetamine” should be limited to “d-amphetamine”. 

(Defs’ Resp. Claim Brief at 13). Shire’s Motion to strike is silent on any specific objection to 

Defendants’ experts’ response to Shire’s construction of the term “amphetamine”. Instead, this 

Court is left to presume that Shire’s objection is based on form rather than substance. That is, 

Shire objects to Defendants’ providing support for its responding expert opinions in the form of 

deposition testimony instead of a declaration. Courts in this district have made clear that the 

purpose of the Local Patent Rules is to “further the goal of full, timely discovery and provide all 

parties with adequate notice and information with which to litigate their case”. APP Pharms., 

LLC, 2011 WL 6325975, *1 (D.N.J. Dec. 6, 2011). 

Defendants’ supplemental Joint Claim Construction & Prehearing Statement gave notice 

that Dr. Bihovsky would provide rebuttal testimony to Shire’s position that the claim term 

 

2 The operative case management schedule and its pending proposed amendments set a final pretrial conference date 

that dangerously abuts the expiration of the thirty (30) month stay. Any supplemental briefing would inevitably 

delay and likely implicate the expiration of the stay. This could result in a need for emergent relief, accompanied by 

extensive motion practice. 

3 Defendants will not be unduly prejudiced by this exclusion because the merits of claim construction hearings turn 

largely on intrinsic evidence. The informational purposes of expert testimony in claim construction hearings rarely 

impact a court’s ruling. Moreover, any prejudice that may belie Defendants is of their own making. 

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“amphetamine” should be constructed differently and that it is not necessary to narrow the 

breadth of the claim term. (See JCC&PS Supp. at 2-3, ¶ 2). Moreover, as an attachment to their 

opening claim construction brief and prior to the due date for the supplemental rebuttal expert 

disclosure, Defendants’ attached Dr. Bihovsky’s proposed rebuttal declaration giving Shire 

notice that he would rebut Shire’s construction of the claim term “amphetamine” and his 

reasoning. (Bihovsky Decl. at 3-4, ¶ 10-11). Defendants’ disclosure satisfies the requirements 

contemplated by the Local Patent Rules. Shire had sufficient notice of Dr. Bihovsky’s rebuttal 

opinion and the basis for that opinion. As such, Shire’s Motion to strike Dr. Bihovsky’s expert 

opinion and the portion of Defendants’ responsive claim construction brief that relies on said 

opinion is denied. 

Dr. Jusko, however, was not identified as an expert who would offer an opinion on the 

proper construction of the claim term “amphetamine”. Dr. Bihovsky is the only expert listed 

under “amphetamine” in the Joint Claim Construction & Prehearing Statement. (See JCC&PS at 

34). Therefore, the citation to Dr. Jusko’s deposition “Ex. 15 at 142:5- 143:24” cannot be 

offered in support to Defendants’ response to Shire’s “amphetamine” construction. See Warner 

Chilcott Labs. Ir. Ltd., 2010 WL 339034 at *3. Defendants should remove the citation to Dr. 

Jusko’s deposition. For the reasons stated earlier, under the Pennypack analysis, Shire’s Motion 

to strike this portion of the Defendants’ Resp. Claim Brief is granted. (See Supra pp. 12-13). 

Page Eighteen

Shire moves to strike three citations to Dr. Sacchetti’s deposition that are intended to 

support their position that “the explicit language of the patent [] include[s] Figure 77 without 

reference to Table 73”. The specific citations are as follows: (1) “Ex. 16 at 141:22-25” in the 

first bullet point; (2) “Ex. 16 at 149:6-18” in the second bullet point; and (3) “Ex. 16 at 129:13-

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130:8” in the third bullet point. (Defs’ Resp. Claim Brief at 18). Defendants identified that Dr. 

Sacchetti would “provide supporting or rebuttal testimony, including that a person of ordinary 

skill in the art would understand the term “X-ray powder diffraction pattern substantially as 

shown in FIG. 77” to mean having the same peak locations ±0.1 or 0.2 20 with the same peak 

heights ± 20% as appear in FIG. 77” in both the Joint Claim Construction & Prehearing 

Statement as well as it’s supplement on rebuttal experts. (See JCC&PS at 78-79, JCC&PS Supp. 

at 12).4 Here, Defendant used Dr. Sacchetti’s testimony in response to Shire’s construction that 

imported language that required that “the XRPD pattern contain peaks that ‘are substantially 

based on Table 73.’” (Defs’ Resp. Claim Brief at 17-18).

Defendants’ rebuttal expert disclosure responds by offering a competing construction of 

the disputed claim term. Responding experts, however, must appropriately tailor their opinion 

within the scope of the opening claim construction expert’s opinion. That is, a rebuttal expert 

must only respond to the opposing party’s offered construction and the provided basis for that 

construction. Responding experts cannot oppose a construction by simply offering one of their 

own. Likewise, an appropriate expert disclosure for a rebuttal expert must identify an expert and 

set forth the basis for their responding opinion. It is insufficient for an expert disclosure of a

rebuttal expert to simply adopt the construction offered by the responding party in their opening 

claim construction brief. Instead, the rebuttal expert must provide the scientific disagreement 

with the offered construction. While an exhaustive list of a rebuttal expert’s bases of 

disagreement is unnecessary, the disclosure made here is clearly insufficient to satisfy 

Defendants’ obligations under the Local Patent Rules. For the reasons stated earlier, under the 

 

4

In Dr. Sacchetti’s Decl., Defendants provided the basis for his rebuttal testimony. (See Sacchetti Decl. at 4-6, ¶¶ 

19-27). Defendants are entitled to use Dr. Sacchetti’s opinion only to rebut the claim construction offered by Shire 

and its experts. 

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Pennypack analysis, Shire’s Motion to strike this portion of the Defendants’ Resp. Claim Brief is 

granted. (See Supra pp. 12-13). 

Page Twenty

Shire seeks to strike the Defendants’ citation to Dr. Sacchetti’s deposition that again 

objects to Shire’s construction of the term “X-ray powder diffraction pattern substantially as 

shown in FIG. 77.” Said construction imported language which required that “the XRPD pattern 

contain peaks that ‘are substantially based on Table 73.’” (Defs’ Resp. Claim Brief at 17-18).

The specific language Shire seeks to strike is: (1) “Ex. 16 at 149:6-18.”; (2) “Moreover, the 

XRPD subject matter recited in the disputed claim term is Figure 77 not Table 73. Ex. 16 at 

129:13-130:8.”; and (3) “It is another way of saying the same thing. Ex. 16 at 156:13-25.” Here,

and unlike the reasons stated immediately above, Defendants’ properly disclose the basis upon 

which Dr. Sacchetti would be offering a rebuttal to Shire’s construction. (See Sacchetti Decl. at 

4-6, ¶¶ 19-27; see also Supra at 15, n. 4). The statements Shire seeks to strike here are clearly in 

rebuttal to Shire’s “characterization of peak locations” and its construction of the term “X-ray 

powder diffraction pattern substantially as shown in FIG. 77”. (Defs’ Resp. Claim Brief at 20). 

The request to strike these sections of Defendants’ Resp. Claim Brief is denied. 

Page Twenty-Eight

Shire moves to strike the citation “Jusko Rebuttal Dec. ¶ 27” to Dr. Jusko’s Rebuttal 

Decl. as it stands for the proposition that “[s]piking is not a term that is used with regard to 

pharmacokinetics[.]” and the following sentence “[t]he patents do not provide any guidance or 

examples as to what the patentees considered to be spiking. See Jusko Rebuttal Dec. ¶ 28.”

(Defs’ Resp. Claim Brief at 28). Shire fails to make specific reference in its motion to strike as 

to why these provisions should be excluded from Defendants’ Resp. Claim Brief. 

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Defendants noted in the Joint Claim Construction & Prehearing Statement that “Dr. 

William Jusko and/or another expert(s) may provide supporting or rebuttal testimony, including 

that a person of ordinary skill in the art would find the term “prevents spiking or increased blood 

serum concentrations compared to unbound amphetamine” to be unclear . . . .” (JCC&PS at 64). 

Further, Defendants provide a similar basis for Dr. Jusko’s responding opinion in the supplement 

disclosure of rebuttal experts. (JCC&PS Supp. at 8-10, ¶¶ 8, 10-11). Moreover, Defendants 

provided the basis for Dr. Jusko’s rebuttal opinion in his declaration. (See generally, Jusko Decl. 

at 4-8, ¶¶ 16-26).

A review of Dr. Jusko’s rebuttal declaration makes clear that the above statements are 

offered in response to Shire’s expert Dr. Sawchuk’s construction on the term “spiking”. (Jusko 

Rebuttal Dec. ¶¶ 27-28). Defendants made clear, in the Joint Claim Construction & Prehearing 

Statement as well as the supplement thereto, that Dr. Jusko would provide a responsive opinion 

that the use of term spiking was “unclear” in pharmacokinetics. Defendants clearly offer Dr.

Jusko’s opinion in response to Shire’s expert’s construction and use of the term “spiking”. As 

such, Defendants have complied with their obligations under Local Patent Rule 4. Shire Motion 

to strike these provisions is denied. 

Page Thirty

Shire moves to strike the following sections of Defendants’ Resp. Claim Brief that is 

offered in support of the construction of the term “Steady-state Serum Release Curve”: (1) “This 

is a classic example of irrelevant extrinsic evidence that should be ignored, especially here where 

the Wagner-Nelson deconvolution analysis that Dr. Sawchuk employed was faulty. Jusko 

Rebuttal Dec. ¶¶ 53-62”; (2) “see also Jusko Rebuttal Dec. ¶¶ 48-52”; and (3) “Such a profile 

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directly addresses serum concentration, the measurement reflected in a serum release curve. See 

Jusko Dec. ¶¶ 16, 24.” (Defs’ Resp. Claim Brief at 30).

Defendants provided the following rebuttal disclosure in the supplement to the Joint 

Claim Construction & Prehearing Statement: “Dr. Jusko will testify in rebuttal of Dr. Sawchuk’s 

opinion on how a person of ordinary skill in the art would understand the term “maintains a 

steady-state serum release curve.” (JCC&PS Supp. at 8, ¶ 5). Instead, a person of ordinary skill 

in the art would understand the term “maintains a steady-state serum release curve” to mean 

having a pharmacokinetic profile wherein the Cmin remains equivalent during consecutive 

dosing periods. See Joint Claim Construction Statement, Exhibit J; see also Jusko 10/25/12 

declaration ¶ 22-24.” (Id.). The Defendants’ disclosure can be divided into two parts. First, 

notice to Shire that Dr. Jusko will be offered to rebut Dr. Sawchuk’s construction of how a 

person of ordinary skill in the art would understand the term “maintains a steady-state serum 

release curve. Second, support for the Defendants’ proposed construction of the term “maintains 

a steady-state serum release curve”. 

The first part of Defendants’ rebuttal expert disclosure identifies that Dr. Jusko will 

oppose Dr. Sawchuk’s construction. Little else is provided as a basis for Dr. Jusko’s rebuttal of 

Dr. Sawchuk’s claim construction of the term “maintains a steady-state serum release curve”. 

Said otherwise, Defendants give notice that Dr. Jusko will rebut Dr. Sawchuk’s construction but 

fail to identify Dr. Jusko’s disagreement with Dr. Sawchuk’s construction. Instead, Dr. Jusko 

offers a virtually identical construction to that of the Defendants’ opening claim construction of 

the term.5 Defendants cannot simply offer Dr. Jusko’s construction as rebuttal to Shire’s expert’s 

 

5

 In Dr. Jusko’s Decl., Defendants offer the statement “Cmin (or the minimum concentration) is the lowest 

concentration of drug in the blood over a given time period. When Cmin values are substantially constant during a 

multiple drug dosing schedule, the drug plasma concentration time curve is said to have reached steady-state.” 

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construction on the term in dispute. Dr. Jusko’s construction of the term “maintains a steadystate serum release curve” should have been identified and reserved in Defendants’ opening 

claim construction brief. A responding claim construction expert cannot rebut another expert’s

opinion by simply offering their own construction. (See Supra p.15). A strained reading of Dr. 

Jusko’s Decl. provides basic background on the study of pharmacokinetics and little from which 

Shire could have discerned the basis for Dr. Jusko’s rebuttal testimony. (See Jusko Decl. at 4-8, 

¶¶ 14-25). 

In light of Defendants’ insufficient rebuttal expert disclosure, Shire was unable to discern 

the basis for Dr. Jusko’s disagreement with Dr. Sawchuk’s construction. For the reason stated 

above, the appropriate cure for insufficient expert disclosure at this stage of the litigation is 

striking the testimony. (See Supra pp. 12-13). The delay caused by curing the prejudice to Shire

outweighs the limited harm created by striking these portions of expert testimony. Shire’s 

Motion to strike the above portions of Defendants’ Resp. Claim Brief and citations thereto is 

granted. 

Page Thirty-One

Shire moves to strike the phrase “All the parties and experts agree that” and “Jusko 

Rebuttal Dec. ¶¶ 66-69, 71-73” from the sentence “All the parties and experts agree that for the 

‘561 and ‘936 patents, “bioavailability” has its ordinary and customary meaning of “extent of 

absorption.” Sawchuk Dec. ¶ 197; Jusko Rebuttal Dec. ¶¶ 66-69, 71-73.” (Defs’ Resp. Claim 

Brief at 31). Defendants seek to rely on the rebuttal declaration of Dr. Jusko to offer an opinion 

on the proper claim construction for “bioavailability” for the 561 and ‘936 patents. As noted 

earlier, no expert, including Dr. Jusko was previously identified to provide an opinion on the 

 

(Jusko Decl. at 7, ¶ 24). This is virtually the exact construction offered by Defendants’ opening claim construction 

brief. (See Defs’ Resp. Claim Brief at 29). 

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claim term “bioavailability”. Therefore, Shire moves to strike the above phrase and the citation 

to Dr. Jusko’s Rebuttal Decl. 

Under the Local Patent Rules and the Fed. R. Civ. P., “the Plaintiffs in a Hatch-Waxman 

case should not ordinarily first learn about an expert’s testimony in a responding Markman

submission.” Warner Chilcott Labs. Ir. Ltd., 2010 WL 339034 at *3. After a review of 

Defendants’ evidentiary support for proposed claim construction and Defendants’ supplement to 

the Joint Claim Construction & Prehearing Statement, it is apparent to this Court that Dr. Jusko

was not identified as an expert who was to offer an opinion on the term “bioavailability”. As 

such, the Defendants have failed to comply with Local Patent Rule 4 and now are “precluded 

from relying on [Dr. Jusko’s opinion, as noted immediately above,] in the Markman

proceedings.” APP Pharms., LLC, 2011 WL 6325975, *1–2 (D.N.J. Dec. 6, 2011).

Again, this result is necessary because Defendants did not provide adequate notice of 

their expert’s opinion in a timely manner. (See Supra pp. 12-13). As a result, Shire has 

conducted expert depositions and submitted its claim construction briefs without knowing that 

Dr. Jusko would be opining on the term “bioavailability”. Shire’s arguments are fully briefed in 

its claim construction briefs and permitting new submissions would be unduly prejudicial to 

Shire because it would grant the Defendants’ an opportunity to submit new Markman papers 

knowing full well the arguments and positions Shire would submit in its claim construction. 

This Court again notes that the “simultaneous” submission requirement applied to claims 

construction briefing schedules is not without purpose. It is intended, in part, to have the parties 

submit their respective positions on disputed terms without the luxury of the opposing parties’ 

papers. Any other remedy besides striking the relevant portions of Dr. Jusko’s opinion would 

disrupt this litigation. (See Supra p. 15). At a minimum, Shire would be required to re-depose 

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Dr. Jusko and make supplemental submissions. Furthermore, as discussed earlier, the relatively 

low importance of extrinsic evidence such as expert opinions in a claim construction hearing 

supports the decision to strike Dr. Jusko’s opinion on “bioavailability”. Phillips, 415 F.3d at 

1314-1317.

Page Thirty-Two

Shire moves to strike the sentence “[t]he specifications of these 3 patents contain largely 

the same information with respect to this term. Jusko Rebuttal Dec. ¶¶ 66-78.” Defendants cite 

to Dr. Jusko’s Rebuttal Decl. for the proposition that the ‘735, ‘561 and ‘936 patents contain the 

same information with respect to their terms but Shire’s offered definition of “rate” inexplicably 

lacks homogeneity among the three patents. 

Again, Defendants’ attempt to rebut Shire’s claim construction by disagreeing and 

offering their own in the form of Dr. Jusko’s Rebuttal Decl. Defendants’ supplemental rebuttal 

expert disclosure states that “Dr. Jusko will testify in rebuttal of Dr. Sawchuk’s opinion as to 

how a person of ordinary skill in the art would understand the term “bioavailability.” Instead, the 

person of ordinary skill in the art would understand the term “bioavailability” to mean extent of 

absorption. See Joint Claim Construction Statement, Exhibit J; see also Jusko 10/25/12 

declaration ¶ 22.” (JCC&PS Supp. at 11, ¶ 15).6 For the reason stated above, Defendants’ 

cannot offer Dr. Jusko’s claim construction as it relates to “bioavailability” in his responding 

declaration. (See Supra p. 15). Therefore, Shire’s Motion to strike the above statements must be

granted. (See Supra pp. 12-13).

 

6 Dr. Jusko’s Decl. is similarly vacant of any discernible basis from which Shire could have gleaned Dr. Jusko’s 

rebuttal to Shire’s construction of the term “bioavailability”. (See Jusko Decl. at 4-8). 

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Page Thirty-Three

Shire moves to strike the citation “see also Jusko Rebuttal Dec. ¶¶ 81-84” because it 

supports that proposition that bioavailability “can be extent, and in fact it is extent.” (Defs’ 

Resp. Claim Brief at 33). Defendants again attempt to offer Dr. Jusko’s claim construction in the 

form of a rebuttal opinion. (See Supra p. 15). For the reason stated immediately above, Shire’s 

motion to strike Dr. Jusko’s support of Defendants’ construction of “bioavailability” is granted. 

(See Supra pp. 12-13).

Page Thirty-Seven

Shire moves to strike the section of Defendants’ Resp. Claim Brief that reads: “[t]hus, the 

phrase is insolubly ambiguous to a POSA because euphoria is commonly understood not to be 

tied to Cmax, but rather to the rate of increase of amphetamine in the blood. See Jusko Rebuttal 

Dec. ¶¶ 42-45.” (Pl. Motion at 4, n.7). Dr. Jusko was not previously identified to provide a 

supporting opinion on the claim term “amount insufficient to provide a Cmax which results in 

euphoria”. (Id.). Therefore, Shire moves to strike the citation to Dr. Jusko’s rebuttal declaration 

and the respective portion of Defendants’ Resp. Claim Brief. 

A review of the Joint Claim Construction & Prehearing Statement indicates that 

Defendants’ did not identify an expert that would offer an opinion with respect to this claim’s 

construction. (See JCC&PS at 32-33). For reasoning stated above, wherein this Court struck Dr. 

Bihovsky’s construction of the term “L-lysine d-amphetamine” from page eight of Defendants’ 

Resp. Claim Brief, the Court grants Shire’s Motion to strike with respect to the claim term 

“amount insufficient to provide a Cmax which results in euphoria”. (See Supra pp. 12-13).

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Page Thirty-Nine

Shire moves to strike the section on page thirty-nine of Defendants’ Resp. Claim Brief 

that reads “Release does not suddenly mean something different the second time it is used in this 

paragraph, or when used in the claims. Jusko Rebuttal Dec. ¶ 20. Nor should it, as a POSA 

would consider “limited” to modify the extent—not the rate—of release. Bihovsky Dec. ¶ 12; 

Ex. 14 at 170:24 -171:10; Jusko Rebuttal Dec. ¶¶ 19-24. Shire and its expert go to great lengths 

to read the word “rate” into the meaning of “release,” but no intrinsic evidence supports 

changing the plain and ordinary meaning of this term. See Jusko Rebuttal Dec. ¶¶ 19-24.”

Defendants’ identified that Dr. Jusko would provide testimony “in rebuttal of Dr. 

Sawchuk’s opinion on how a person of ordinary skill in the art would understand the term 

‘limited release of amphetamine.’ Instead, the person of ordinary skill in the art would 

understand the term “limited release of amphetamine” to mean less than all of the amphetamine 

is released from the prodrug following oral administration.” (JCC&PS Supp. at 7-8, ¶ 4).7 

Defendants’ rebuttal expert disclosure again responds by offering a competing construction of 

the disputed claim term. Responding experts, however, must appropriately tailor their opinion 

within the scope of the opening claim construction expert’s opinion. (See Supra p. 15). That is, 

a rebuttal expert must only respond to the opposing party’s offered construction and the provided 

basis for that construction. Responding experts cannot oppose a construction by simply offering 

one of their own. Likewise, an appropriate expert disclosure for a rebuttal expert must identify 

an expert and set forth the basis for their responding opinion. It is insufficient for an expert 

disclosure of a rebuttal expert to simply adopt the construction offered by the responding party in 

their opening claim construction brief. Instead, the rebuttal expert must provide the scientific 

 

7 Dr. Jusko’s Decl. is similarly vacant of any discernible basis from which Shire could have gleaned Dr. Jusko’s 

rebuttal to Shire’s construction of the term “limited release of amphetamine”. (See Jusko Decl. at 4-8).

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disagreement with the offered construction. While an exhaustive list of a rebuttal expert’s bases 

is unnecessary, the present disclosure is clearly insufficient to satisfy Defendants’ obligations 

under the Local Patent Rules. 

In addition to Dr. Jusko’s rebuttal opinion, the second sentence in the above paragraph 

relies on the testimony of Dr. Bihovsky, both through his declaration and citation to his 

transcript. Defendants’ rebuttal expert disclosure stated that “Dr. Bihovsky will testify in 

rebuttal to Shire’s construction of the term “limited release” to mean “limited rate of release” (D. 

E. No. 181 at 15-16; D. E. No. 181 Ex. 72 ¶¶ 117- 128) and that he disagrees with Shire’s 

construction because a POSITA would consider “limited” to refer to the extent of release, not the 

rate of release.” (JCC&PS Supp. at 6, ¶ 11). The statement “[n]or should it, as a POSA would

consider ‘limited’ to modify the extent—not the rate—of release[]” provides Dr. Bihovsky’s 

competing construction of the dispute term. Because Dr. Bihovsky was not previously identified 

as an expert offering a construction to the disputed claim term, Defendants cannot rely on his 

opinion to rebut Shire’s offered construction. (See Supra p. 15). Therefore, Shire’s Motion to 

strike the above statements is granted. (See Supra pp. 12-13).

Dr. Bihovsky’s, Dr. Sacchetti’s and Dr. Jusko Declaration

Shire moves to strike the declarations of Dr. Bihovsky, Dr. Sacchetti and Dr. Jusko that

were filed with Defendants’ opening brief on claim construction. In a letter filed on the same 

date, Defendants state that they:

“are forgoing inclusion of expert testimony in their opening brief 

because such extrinsic evidence is not necessary. However, 

Defendants anticipate relying on such expert testimony as part of 

their responding brief, in order to rebut Plaintiffs’ positions and 

anticipated expert positions. Therefore, in a good faith effort to 

provide Shire with an opportunity to consider and address the 

testimony of Defendants’ experts in Shire’s responsive brief, and 

even though not required by the Local Patent Rules, Mylan and JM 

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have submitted these declarations from their experts at this time.”

(Defs’ Letter at 1). 

Defendants are correct that submitting a declaration for a rebuttal expert with opening 

claim construction briefs is not required under the Local Patent Rules. As noted in their letter, 

Defendants do not rely on these declarations in their opening claim construction brief despite the 

fact that the declarations are titled as support for Defendants’ opening claim construction brief. 

(See cover page to Bihovsky Decl., Sacchetti Decl. and Jusko Decl.). 

While this premature rebuttal expert disclosure is unorthodox and leads to the confusion, 

the Court will construe it as an attachment to the supplemental rebuttal expert disclosure that was 

filed ten days later on November 5, 2012, pursuant to the Scheduling Order. In light of the 

above, Shire’s Motion to strike (1) Dr. Bihovsky’s declaration (Docket Entry No. 191-18; 

“Bihovsky Decl.”); (2) Dr. Sacchetti’s declaration (Docket Entry No. 191-21; “Sacchetti Decl.”); 

and (3) Dr. Jusko declaration (Docket Entry No. 191-14; “Jusko Decl.”) is granted. These filings

will not be considered with the opening claim construction brief. However, the Court will permit 

the declarations to serve as part of the supplemental rebuttal expert disclosures. 

Dr. Jusko’s Rebuttal Declaration

Shire moves to strike Dr. Jusko’s rebuttal declaration (Docket Entry No. 214-9) attached 

to Defendants’ responding claim construction brief. This Court denied the portion of Shire’s 

motion that seeks to strike Dr. Jusko’s rebuttal testimony under the claim term “spiking”. There, 

Defendants rely on Dr. Jusko’s rebuttal declaration to dispute Shire’s construction of “spiking” 

on the basis that the term is indefinite. (See Defs’ Resp. Claim Brief at 28). In light of the above, 

Shire’s Motion to strike Dr. Jusko’s rebuttal declaration is denied. 

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Dr. Bihovsky’s and Dr. Sacchetti’s Deposition Transcripts

Shire seeks to strike the entirety of Dr. Bihovsky’s (Docket Entry No. 214-14) and Dr. 

Sacchetti’s (Docket Entry No. 214-16) deposition transcripts. This Court declines Shire’s 

invitation to strike the depositions of Defendants’ experts because the opinions were not solely 

provided in a written declaration pursuant to FED. R. CIV. P. 26(a)(2)(B)(i). The decision to 

strike expert testimony in a patent case turns on notice. That is, a motion to strike expert 

testimony should be granted where the expert opinion in dispute was not known or discernible. 

See Warner Chilcott Labs. Ir. Ltd., 2010 WL 339034 at *3. To the extent an expert is relied 

upon in an opening or responding claim construction opinion, and their opinion and basis have 

been properly disclosed pursuant to Local Patent Rule 4, such opinions are permissible whether 

in the form of deposition testimony or declaration. Expert deposition testimony that was not 

properly disclosed, however, cannot be relied on in the form of declaration or citation to sworn 

deposition testimony.

This Court is unaware of any restriction on the use of expert deposition testimony in 

addition to a declaration. Nor does the Court look at the use of deposition as an improper 

attempt to avoid laying all cards on the table. To the contrary, during the deposition of an 

opposing expert, counsel can delve into the intricacies of an expert’s opinion.8 Such testimony is 

often useful to the Court in its analysis. Here, all portions of the expert testimony Defendants

cite, that was properly disclosed pursuant to the Local Patent Rules, can be relied on in 

Defendants’ Resp. Claim Brief. This Court believes that a draconian outcome would otherwise 

result if a party was required to provide an exhaustive disclosure of an entire expert’s opinion 

 

8 That is not to say that a deposing party opens the door to undisclosed expert opinion solely by the fact that the 

expert’s opinion is addressed during a deposition. The concept of permitting undisclosed expert testimony from a 

deposition is to prevent the injustice of the testimony being used as a shield by an opposing party but not a sword by 

the party it’s offered against, or vice versa. See Cephalon, Inc. v. Watson Pharms., Inc., 769 F. Supp. 2d 761, 772 n. 

13 (D. Del. 2011). This is not the case here. 

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and basis in the form of a declaration or face preclusion.9 A party should not be handcuffed to a 

rebuttal expert’s declaration where properly disclosed expert opinion through sworn deposition 

testimony better serves the court’s purpose. 

This Court denied the portion of Shire’s Motion that sought to strike Dr. Bihovsky’s and 

Dr. Sacchetti’s rebuttal testimony under the claim term “Amphetamine” and “X-ray powder 

diffraction pattern substantially as shown in FIG. 77”, respectively. There, Defendants rely on 

Dr. Bihovsky’s and Dr. Sacchetti’s sworn deposition testimony to dispute Shire’s construction. 

(See Defs’ Resp. Claim Brief at 13, 20). In light of the above, Shire’s Motion to strike Dr. 

Bihovsky’s and Dr. Sacchetti’s deposition transcript is denied.

Dr. Jusko Deposition Transcript

Shire moves to strike Dr. Jusko’s deposition transcript (Docket Entry No. 214-15), 

submitted in support of Defendants’ Resp. Claim Brief. Defendants only cite to Dr. Jusko’s 

deposition testimony one time in their brief. That citation is located under the “Amphetamine” 

claim construction section on page thirteen of Defendants’ Resp. Claim Brief. For the reason 

articulated above (See Supra pp. 13-14), Shire’s Motion to strike Dr. Jusko’s testimony on that 

point was granted. As such, Dr. Jusko’s deposition transcript offers no relevance to the claim 

construction proceeding and should be struck. 

B. Defendants’ Motion to Strike

Defendants move to strike portions of Shire’s opening and responding claim construction 

briefs and portions of two attachments thereto. Specifically, Defendants move to strike: (1) 

paragraphs 219-289 of Dr. Sawchuk’s opening declaration (Docket Entry No. 181-27, pgs. 79-

 

9

In order for an expert’s opinion in the form of sworn deposition testimony to be used in a claim construction 

hearing, the offering party must have properly disclosed the expert’s opinion pursuant to the Local Patent Rule 4. 

This includes a proper identification of the expert and sufficient detail of that expert’s opinion for the opposing party 

to discern the underlying basis of that expert’s reasoning. 

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101; “Sawchuk Decl.”); (2) paragraphs 428-482 of Dr. Sawchuk’s rebuttal declaration (Docket 

Entry No. 215-3, pgs. 70-99; “Sawchuk Rebuttal Decl.”); and the portion of Shire’s opening and 

responding claim construction briefs that rely on the excluded portions of Dr. Sawchuk’s 

declarations. 

Defendants’ take the position that wherein/whereby clauses are not typical claim terms 

but require the court to address them in a separate inquiry during claim construction. (Defs’ 

Reply ay 2). Moreover, if Shire intended to offer expert testimony to support its position on the 

wherein/whereby clauses, it should have properly disclosed those expert opinions according to 

the Local Patent Rules. (Id. at 2-3). In light of the Pennypack and Reckitt factors noted above, 

this Court will address each item sought to be excluded from consideration during the court’s 

claim construction hearing, in turn below.

Shire did not list any supporting or responding experts in exhibit H of the Joint Claim 

Construction & Prehearing Statement. (JCC&PS at 79-94, ¶¶ 60-75). However, in its own 

separate claims chart, submitted as exhibit D, for all wherein/whereby claim terms Shire 

provided the following disclosure: “See corresponding claim terms for term Nos. 1-130”. (See

Docket Entry No. 157-4, at 69 – 84, ¶¶ 131- 148; “Shire’s Expert Discl.”). 

Shire’s opposition to Defendants’ Motion offered a two stage expert disclosure process 

that differs from existing case law. See Warner Chilcott Labs. Ir. Ltd., 2010 WL 339034 at *3. 

Shire does not mention the preliminary claim construction and extrinsic evidence disclosures that 

occur pursuant to L. Pat. R. 4.2. Instead, Shire first mentions the latter disclosure, i.e., those that 

accompany the Joint Claim Construction & Prehearing Statement pursuant to L. Pat. R. 4.3. 

Shire states that the disclosure accompanying the pre-hearing statement should identify the 

expert and their general opinion. (Opp. to Defs’ Motion at 1). It is at this point that “all expert 

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testimony should be known, or at least discernible, and there is no obvious basis for holding back 

or ‘reserving’ additional expert testimony.” Warner Chilcott Labs. Ir. Ltd., 2010 WL 339034 at 

*3. 

Shire’s disclosure, as it relates to supportive and responsive expert testimony for the 

wherein/whereby clauses, is deficient. (See Shire’s Expert Discl. at 69 – 84, ¶¶ 131- 148). It 

fails to clearly identify which of Shire’s experts, Dr. Chyall or Dr. Sawchuk, would be providing 

an opinion for any of the wherein/whereby clauses. Further, there is no substantive support or 

rebuttal for Dr. Sawchuk’s opinion on the wherein/whereby clauses provided in any disclosure. 

Instead, Defendants are left to “correspond” the underlying claim terms associated with the 

wherein/whereby clauses, and from them, deduce which expert will opine and what the basis of 

that opinion will be from previous disclosures. (Id.). This disclosure is clearly deficient and fails 

to satisfy intent of the Local Patent Rules.

Shire argues that the underlying claims of the wherein/whereby clauses provide sufficient 

disclosure of its expert’s opinion. Wherein/whereby clauses, however, require their own 

analysis. See Minton v. Nat’l Ass’n of Sec. Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003). 

The construction of the underlying terms do not provide the basis to conclude if the 

wherein/whereby clauses are claim limitations. A court’s review a wherein/whereby clause 

typically requires evidence in addition to that used for the construction of underlying terms and, 

more importantly, can lead to extensive expert submissions. To the extent that a party intends to 

submit an expert report in support or in opposition to wherein/whereby clauses, that opinion 

must comply with the same expert disclosure rules as the underlying claim terms. 

 

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Shire’s Claim Construction Briefs

Defendants seek to strike the following phrases from Shire’s opening claim construction 

brief: 

“Notably, each of the “wherein”/“whereby” clauses of Terms 

131–145 and 148 contains at least one disputed claim term for 

which Defendants are offering a construction. (See Sawchuk ¶¶ 

219–289)” (Docket Entry No. 181 at 28; “Shire’s Opening Claim 

Br.”). 

In addition to striking the wherein/whereby phrase in Shire’s Opening Claim Brief, 

Defendants seek to strike the following sections of Shire’s Responding Claim Brief: 

“Shire provides opinions from Dr. Sawchuk that 

pharmacokinetics of d-amphetamine released from L-lysine-damphetamine could be affected by, for example, various 

formulations, physiological factors, physiochemical properties of a 

drug, dosage amount, and drug interactions.

(Sawchuk ¶¶ 431–452). For example, pharmacokinetics could be

affected by a formulation with an enzyme that hydrolyzes Llysine-d-amphetamine to release d-amphetamine. (Sawchuk ¶ 

441)[.]”; and

“Instead, Defendants make sweeping attorney argument as 

to all 16 wherein/whereby clauses based on a single out-of-context 

statement from the specifications. (Sawchuk ¶ 431).

Such generalizations are insufficient to meet Defendants’ burden 

and show that the claimed methods and compositions necessarily 

result in the limitations of these clauses every time. Shire’s expert 

Dr. Sawchuk, on the other hand, addresses how all 16 

wherein/whereby clauses are not inherent. (Sawchuk ¶¶ 453–

485).” (Docket Entry No. 215 at 29-30; “Shire’s Resp. Claim 

Br.”).

In light of the fact that Shire’s disclosures are deficient as it relates to the 

wherein/whereby phrases and all the above sentences sought to be struck are provided with the 

support of Dr. Sawchuk’s expert opinion with regard to the wherein/whereby phrases, they must 

be struck. For the reasons states above, applying a similar Pennypack analysis as in Shire’s 

Motion to strike, this result is necessary to further the goals of this litigation. (See Supra pp. 12-

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13). Defendants’ were clearly prejudiced by not having Dr. Sawchuk’s appropriate expert 

disclosure. That prejudice can only be cured by striking these portions of Shire’s opening and 

responding claim construction briefs because any other remedy would unduly delay this 

proceeding. Finally, in light of the limited benefits of extrinsic evidence such as expert 

testimony in claims construction hearings, the consideration of the importance of the struck 

expert testimony supports the conclusion to strike. Phillips, 415 F.3d at 1317. 

Dr. Sawchuk’s Opening and Rebuttal Declaration

Defendants seek to strike the following portions of Dr. Sawchuk’s opening and rebuttal 

declaration: (1) paragraphs 219-289 of Dr. Sawchuk’s opening declaration (Docket Entry No. 

181-27, pgs. 79-101; “Sawchuk Decl.”) and (2) paragraphs 428-482 of Dr. Sawchuk’s rebuttal 

declaration (Docket Entry No. 215-3, pgs. 70-99; “Sawchuk Rebuttal Decl.”). Immediately 

above, this Court struck all of the sections of Shire’s opening and responding claim construction 

briefs that relied on Dr. Sawchuk’s expert opinion of the wherein/whereby phrases. As such, the 

respective portions of Dr. Sawchuk’s opening and rebuttal declarations offer no relevance to the 

claim construction proceeding and should likewise be struck. Therefore, for the reason 

articulated above (See Supra pp. 26-27), Defendants’ Motion to strike the portions of Dr. 

Sawchuk’s Decl. and Rebuttal Decl. that relate to wherein/whereby clauses is granted. 

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IV. Conclusion

For the reason stated above, the undersigned hereby GRANTS in part and DENIES in 

part Shire’s Motion to strike. Defendants’ Motion to strike is GRANTED. The parties are to file 

their opening and responding claim construction briefs and appropriate attachments thereto, in 

conformity with this Opinion within ten (10) days. The parties need not furnish the Court with 

hard copies. An appropriate order reflecting the Court’s holdings herein shall accompany this 

Opinion. The Clerk of the Court is to terminate Docket Entry Nos. 244 and 269.

SO ORDERED

s/Cathy L. Waldor x 

Cathy L. Waldor, U.S.M.J.

Dated: May 7, 2013

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