IN THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF OHIO 

EASTERN DIVISION 

ROXANE LABORATORIES, INC., 

 Plaintiff, 

vs. Civil Action 2:12-cv-312 

 Judge Watson 

 Magistrate Judge King 

ABBOTT LABORATORIES, 

 Defendant. 

OPINION AND ORDER 

 This matter is before the Court on Plaintiff’s Motion to Modify 

the Joint Claim Construction Statement (“Plaintiff’s Motion”), Doc. 

No. 77, on defendants’ response, Defendants’ Opposition to Plaintiff’s 

Motion to Modify the Joint Claim Construction Statement (“Defendants’ 

Response”), Doc. No. 85, and on plaintiff’s reply, Roxane’s Reply in 

Support of its Motion to Modify the Joint Claim Construction Statement

(“Plaintiff’s Reply”), Doc. No. 86. For the reasons that follow, 

Plaintiff’s Motion is GRANTED. 

I. Background 

 This is a patent infringement action in which plaintiff Roxane 

Laboratories, Inc., seeks a declaration of noninfringement of patents 

currently held by defendant AbbVie Inc., relating to the drug Norvir®. 

Amended Complaint, Doc. No. 56, ¶¶ 1, 11-15. The Court set December 

19, 2012 as the date by which the parties were to file a joint claim 

construction statement. Preliminary Pretrial Order, Doc. No. 29, p. 

3. The parties met that deadline. Joint Claim Construction and 

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Prehearing Statement, Doc. No. 65. The parties were to have completed 

claim construction discovery by February 4, 2013; opening claim 

construction briefs were due by February 19, 2013 and responsive claim 

construction briefs were due by March 21, 2013. Preliminary Pretrial 

Order, p. 3. 

 The Joint Claim Construction Statement identifies two disputed 

claim terms: “substantially pure” and “amorphous ritonavir.” Appendix 

B to Joint Claim Construction Statement, Doc. No. 66. Plaintiff 

proposes that “amorphous ritonavir” be construed as “the physical form 

of ritonavir characterized by lack of defined crystal structure and 

three-dimensional long-range structure.” Id. at p. 14. Defendants 

propose that the term be construed as “the solid physical form of 

ritonavir characterized by lack of crystal structure.” Id. 

After the Joint Claim Construction Statement was filed, the 

parties attempted, through a series of letters, to further narrow the 

claim construction disputes. On January 3, 2013, defendants suggested 

that the phrases lack of “defined crystal structure” and “threedimensional long-range structure” were synonymous. Plaintiff’s 

Motion, Exhibit A. Plaintiff rejected that suggestion on January 9, 

2013, Plaintiff’s Motion, Exhibit B, and, on February 13, 2013, 

proposed the following alternative construction: “the solid physical 

form of ritonavir (i.e., the form of ritonavir having a glass 

transition as shown in Figure 10 of the ‘359 patent) that is also 

characterized by the lack of crystal structure (i.e., as shown in 

Figure 3 of the ‘359 patent).” Plaintiff’s Motion, Exhibit C. 

Defendants rejected that proposal on February 15, 2013, and suggested 

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that the parties proceed with claim construction briefing using the 

definitions provided in the Joint Claim Construction Statement. 

Plaintiff’s Motion, Exhibit D. Plaintiff declined that suggestion and 

informed defendants that it intended “to present its compromise 

construction of ‘amorphous ritonavir’ to the Court in its claim 

construction briefing so as to narrow the remaining issues in 

dispute.” Plaintiff’s Motion, Exhibit E. Defendants again requested 

that plaintiff abide by the definitions provided in the Joint Claim 

Construction Statement. Plaintiff’s Motion, Exhibit F. plaintiff 

refused. Plaintiff’s Motion, Exhibit G. After the Court conferred with 

counsel for all parties on February 19, 2013, the Court directed 

plaintiff to file a motion to modify the joint claim construction 

statement. Amended Order, Doc. No. 74. The Court also suspended the 

dates for filing opening claim construction briefs and responsive 

claim construction briefs pending resolution of that issue. Id. 

Plaintiff’s motion to amend the Joint Claim Construction 

Statement is intended “to clarify its original construction.” 

Plaintiff’s Motion, pp. 5-6. Specifically, plaintiff seeks to amend 

its construction of “amorphous ritonavir” to be “the solid physical 

form of ritonavir (i.e., the form of ritonavir having a glass 

transition as shown in Figure 10 of the ‘359 patent) that is also 

characterized by the lack of crystal structure (i.e., as shown in 

Figure 3 of the ‘359 patent)”. See id. at pp. 5-6, Exhibit C. 

 Defendants oppose any such modification, arguing that plaintiff 

has failed to show good cause to modify the scheduling order and that 

defendants would be prejudiced by the proposed amendment. 

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Specifically, defendants argue that the proposed amendment “add[s] 

new, unwarranted claim limitations” based on evidence that “has been 

available through the public record,” and it deprives defendants of 

the opportunity to “develop the evidence and arguments necessary for 

the claim construction briefing.” Defendants’ Response, pp. 2-3, 6-7. 

Defendants also argue that the grant of the requested modification 

would deprive them “of the opportunity to consider and present expert 

testimony on the new construction.” Id. at p. 6. Alternatively, 

defendants ask, should the modification be permitted, that they be 

granted at least sixty (60) days to conduct additional discovery, 

including expert discovery, prior to the filing of opening claim 

construction briefs. Id. at pp. 6-7. 

II. Discussion 

Plaintiff first argues that it has the unqualified right to amend 

the Joint Claim Construction Statement. Plaintiff’s Motion, p. 3 

(“[Plaintiff] is not aware of any requirement that a party seek leave 

of the Court to amend its proposed constructions. . . . The absence 

of a provision requiring [] leave to propose a modified construction 

for purposes of compromise creates a presumption that there is no such 

requirement.”). Alternatively, plaintiff cites to Pat.L.R. 103.7, 

“Amendment to Contentions,” for the proposition that amendment is 

permissible if there is “no undue prejudice to the parties and the 

party seeking amendment acts in good faith.” Id. at p. 4. 

In the case presently before the Court, the parties filed a Rule 

26(f) report, Doc. No. 25, the Court held a preliminary pretrial 

conference at which all parties were represented, and the Court issued 

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a Rule 16 scheduling order that, inter alia, set a date for the filing 

of a joint claim construction statement. Preliminary Pretrial Order, 

Doc. No. 29, p. 3. The Local Patent Rules do not usurp either the 

Federal Rules of Civil Procedure or the local rules of this Court that 

are not inconsistent with the Local Patent Rules. See Pat.L.R. 101.2 

(“The Local Civil Rules of this Court shall also apply to these 

actions, except to the extent that they are inconsistent with these 

Local Patent Rules.”); RFR Indus., Inc. v. Century Steps, Inc., 477 

F.3d 1348, 1351 (Fed. Cir. 2007) (citing Biodex Corp. v. Loredan 

Biomedical, Inc., 946 F.2d 850, 857-58 (Fed. Cir. 1991) (“[O]ur 

practice has been to defer to regional circuit law when the precise 

issue involves an interpretation of the Federal Rules of Civil 

Procedure or the local rules of the district court.”); Connective 

Tissue Imagineering, LLC v. Mitts, C 07-00058 WHA, 2007 WL 2348741 

(N.D. Cal. Aug. 14, 2007) (applying Rule 16(b) to a motion for leave 

to amend the joint claim construction statement). The date for filing 

a joint claim construction statement was established in a Rule 16 

scheduling order; a motion for leave to amend a joint claim 

construction statement must therefore comply with Fed. R. Civ. P. 16. 

Rule 16(b) of the Federal Rules of Civil Procedure requires the 

Court, in each civil action not exempt from that rule, to issue a 

scheduling order. Fed. R. Civ. P. 16(b). “A schedule may be modified 

only for good cause and with the judge’s consent.” Fed. R. Civ. P. 

16(b)(4). “‘The primary measure of Rule 16’s ‘good cause’ standard is 

the moving party's diligence in attempting to meet the case management 

order’s requirements.’” Inge v. Rock Fin. Corp., 281 F.3d 613, 625 

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(6th Cir. 2002) (quoting Bradford v. DANA Corp., 249 F.3d 807, 809 

(8th Cir. 2001)). “A district court should also consider possible 

prejudice to the party opposing the modification.” Andretti v. Borla 

Performance Indus., Inc., 426 F.3d 824, 830 (6th Cir. 2005) (citing 

Inge, 281 F.3d at 625). The focus is, however, “primarily upon the 

diligence of the movant; the absence of prejudice to the opposing 

party is not equivalent to a showing of good cause.” Ortiz v. Karnes, 

2:06-cv-562, 2010 WL 2991501, at *1 (S.D. Ohio July 26, 2010) (citing 

Tschantz v. McCann, 160 F.R.D. 568, 571 (N.D. Ind. 1995)). Whether to 

modify a pretrial schedule pursuant to Rule 16(b) falls within the 

district court’s discretion. Leary v. Daeschner, 349 F.3d 888, 909 

(6th Cir. 2003). 

Plaintiff argues, for the first time in its reply brief, that it 

established good cause to modify the scheduling order because “it 

immediately sought to amend its construction of ‘amorphous ritonavir’ 

as soon as the dispute between the parties crystallized.” Plaintiff’s 

Reply, p. 1. See also id. at p. 2 (“[Plaintiff notified defendants] 

of its intention to pursue its compromise construction on the same day 

that it became aware of the dispute.”). Plaintiff also argues that it 

“could not have brought up this dispute any earlier” because the 

parties were not aware “that the dispute existed” or that “further 

construction” was necessary until the parties met and conferred after 

the Joint Claim Construction Statement had been filed. Id. at p. 2. 

The issue presently before the Court is not whether the parties 

disputed plaintiff’s current proposed construction prior to the 

deadline for filing a joint claim construction statement; had there 

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been no dispute, the term would certainly have been included in the 

appendix of ”Agreed Terms” attached to the Joint Claim Construction 

Statement. See Joint Claim Construction Statement, p. 6. Yet, 

plaintiff has provided no explanation whatsoever why it did not 

present its new construction earlier. 

Plaintiff argues that “the very need for [] further construction 

was not evident until after the parties engaged in their meet and 

confer in January and February 2013.” Plaintiff’s Reply, p. 2 n.2. 

Plaintiff does not, however, explain why “further construction” was 

necessary and why it was not evident that further construction was 

necessary until one day prior to the deadline for filing opening claim 

construction briefs. The Figures in United States Patent No. 

7,148,359 referred to in plaintiff’s new construction, see Plaintiff’s 

Motion, pp. 5-6, Exhibit C, were available to plaintiff prior to the 

filing of the Joint Claim Construction Statement and prior to the 

parties’ exchange of proposed claim terms and phrases for 

construction. See Plaintiff’s Reply, p. 6. In fact, plaintiff cited 

to these Figures as intrinsic evidence in support of its construction 

in the Joint Claim Construction Statement. See Appendix B to Joint 

Claim Construction Statement, p. 14. Given plaintiff’s prior 

knowledge of the information upon which it now relies, the Court sees 

no reason, and plaintiff has provided no explanation, why plaintiff’s 

new construction could not have been asserted in the Joint Claim 

Construction Statement. 

Under the circumstances, plaintiff has failed to show good cause 

for modifying the scheduling order to permit an amendment to the Joint 

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Claim Construction Statement. Nevertheless, because claim 

construction is a question of law to be determined by the Court, see 

Markman v. Westview Instruments, Inc., 517 U.S. 370, 384 (1996), and 

because plaintiff’s amended construction might assist the Court in 

making that determination, the Court will permit plaintiff to file an 

amended Joint Claim Construction Statement to amend its construction 

of the term “amorphous ritonavir.” In so deciding, the Court also 

concludes that any prejudice otherwise accruing to defendants can be 

ameliorated. The parties have not yet filed opening claim construction 

briefs, a claim construction hearing has not yet been scheduled, and 

defendants will be permitted to pursue discovery and to prepare expert 

testimony on the new construction. Finally, plaintiff does not object 

to the withdrawal by defendants of their original three 

interrogatories directed to plaintiff’s original construction of term 

“amorphous ritonavir.” See Plaintiff’s Reply, p. 6 n.4. 

Plaintiff’s Motion to Modify the Joint Claim Construction 

Statement, Doc. No. 77, is therefore GRANTED. Plaintiff is ORDERED to 

file an amended joint claim construction statement no later than March 

25, 2013. The amended statement may modify only plaintiff’s 

construction of the term “amorphous ritonavir.” 

The Preliminary Pretrial Order, Doc. No. 29, is amended as 

follows: 

CLAIM CONSTRUCTION PROCEEDINGS: 

All claim construction discovery must be completed no later than 

May 31, 2013. Opening claim construction briefs, see Pat.L.R. 

105.4(b), must be filed by June 15, 2013; responsive claim 

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construction briefs, see id., must be filed no later than July 15, 

2013. The matter will be available for a claim construction hearing, 

to be held by Judge Watson, in July or August 2013. 

DISCOVERY AND EXPERTS:

All fact discovery must be completed within 45 days after the 

Court’s ruling on claim construction, but in no event later than 

August 30, 2013. 

The reports of primary experts on issues on which each party 

bears the burden of proof must be produced within 45 days after the 

Court’s ruling on claim construction, but in no event later than 

August 30, 2013. The reports of primary experts on issues on which 

the opposing party bears the burden of proof must be produced within 

45 days thereafter. The reports of rebuttal experts must be produced 

within 30 days thereafter. The reports shall conform to the 

requirements of Fed. R. Civ. P. 26(a)(2)(B) or (C), as appropriate. 

Depositions of experts must commence within 14 days after the 

production of rebuttal expert reports and must be completed within 60 

days of the commencement of the deposition period. 

If any date herein falls on a weekend or holiday, the next 

business date will control. 

March 28, 2013 s/Norah McCann King_______ 

 Norah McCann King 

 United States Magistrate Judge 

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