ME1 12886830v.1

John E. Flaherty

Partner 

T. 973.639.7903 

F. 973.297.3971 

jflaherty@mccarter.com

McCarter & English, LLP 

Four Gateway Center 

100 Mulberry Street 

Newark, NJ 07102-4056 

T. 973.622.4444 

F. 973.624.7070 

www.mccarter.com 

BOSTON

HARTFORD 

NEW YORK 

NEWARK 

PHILADELPHIA 

STAMFORD 

WILMINGTON 

January 25, 2012 

VIA ECF 

Honorable Tonianne J. Bongiovanni, U.S.M.J 

U.S. District Court for the District of New Jersey 

Clarkson S. Fisher Building & U.S. Courthouse 

402 East State Street 

Room 6052 

Trenton, New Jersey 08608 

Re: AstraZeneca AB, et al. v. Hanmi USA, Inc., et al. 

Civil Action No. 11-cv-00760 (JAP)(TJB) 

Dear Judge Bongiovanni: 

We, along with Fitzpatrick Cella Harper & Scinto, represent Plaintiffs in this matter 

and submit this letter in reply to Hanmi’s January 20, 2012 letter (D.I. 188) opposing 

AstraZeneca’s January 13, 2012 motion (D.I. 182) (“Motion”) to strike Hanmi’s 

improperly amended December 9, 2011 invalidity contentions (D.I. 179.10). 

Hanmi’s claim that its amended contentions add only “about six pages of text [to] 

Hanmi’s original detailed set of contentions” (D.I. 188 at 2, emphasis in original) is 

only half the story. In addition to those six pages, its amended contentions 

incorporated a remarkably broad “kitchen sink” catchall suggesting that counsel 

divine amended contentions from: “all of Hanmi’s record positions since the time of 

serving its initial contentions on May 25, 2011, including summary judgment briefing 

and supporting evidence, and Markman briefing and supporting evidence, including 

reply and response briefing expected to conclude over the course of the next 

month.” (D.I. 179.10 at 3). As explained in AstraZeneca’s Motion (at 1-2), Hanmi’s 

amended contentions therefore incorporate hundreds of pages of briefing, new 

expert opinions and documentary evidence (purportedly including those not yet 

briefed at the time), and set forth new invalidity contentions not previously disclosed 

in its initial contentions. (For example, Hanmi can point to only a single sentence in 

its original contentions, which simply identifies its esomeprazole strontium product, 

in support of its assertion that it had properly provided AstraZeneca with notice of a 

defense of lack of written description based on hydrates (D.I. 188 at 3) while 

Hanmi’s summary judgment motion no. 4 at pages 7-11 (D.I. 116) relies upon Exh. 

Nos. 22, 26-28 to the Declaration of Renita S. Rathinam (D.I. 112.13, 112.17-

112.19) as well as an expert declaration of Wayne K. Genck, Ph.D. at ¶¶ 79-89 (D.I. 

108)). 

As explained below, Hanmi’s contention amendments directed at claims other than 

3, 5 and 10 of the ’504 patent were inappropriate, were not ordered by the Court 

and therefore violate Local Patent Rule 3.7 and should be stricken. 

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AstraZeneca’s addition of ’504 patent claims 3, 5 and 10 does not justify 

Hanmi’s amendments pertaining to other claims 

Hanmi asserts that its contentions pertaining to other claims “required adjustment in 

view of the new claims.” (D.I. 188 at 3). But, claims 3, 5 and 10 were always part of 

the ’504 patent, and Hanmi had no trouble providing 144 pages of noninfringement 

and invalidity contentions before claims 3, 5 and 10 were asserted by AstraZeneca. 

And, claims 3, 5, and 10 have never been part of the ’192 patent. Hanmi has never 

explained how addressing claims 3, 5 and 10 of the ’504 patent now “requires” the 

incorporation of hundreds of additional pages of arguments and evidence relating to 

other claims of the ’504 and ’192 patents. 

The Court’s order permitting the addition of ’504 patent claims 3, 5 and 10 did 

not permit Hanmi’s amendments pertaining to other claims 

Hanmi justifies its amendments by stating that when the Court granted 

AstraZeneca’s motion to add claims 3, 5 and 10 to the case, the Court also granted 

Hanmi the right to amend its contentions with regard to the other claims that were 

already in the litigation. However, the parties previously agreed that the Court’s 

order did not permit Hanmi’s amendment to be broader than addressing claims 3, 5, 

and 10 when they negotiated the Court-ordered schedule governing the exchange 

of amended contentions. Pursuant to the November 14, 2011 Court Order (D.I. 

139), AstraZeneca proposed a schedule for the parties to “address claims 3, 5 and 

10 of the ’504 patent.” Hanmi responded by revising the proposed order to 

purportedly broaden it to “addres[s] the assertion of claims 3, 5, and 10.” 

AstraZeneca rejected that proposed revision and the parties agreed to submit the 

proposed order limiting Hanmi’s amended contentions to “addressing claims 3, 5 

and 10”. This is the language in the applicable order. See, Exhibit E 

(correspondence between parties from November 29, 2011 – November 30, 2011); 

D.I. 145 (December 1, 2011 Court Order). 

Hanmi points to language in the Court’s November 14, 2011 Memorandum Opinion 

suggesting that Hanmi would need to “invest additional resources in evaluating 

claims 3, 5 and 10 of the ’504 patent and that the inclusion of these claims in this 

matter will likely also require Hanmi to adjust [its] case strategy going forward.” (D.I. 

138 at 14). Hanmi interprets this comment to mean that the Court “ordered and 

permitted” Hanmi to supplement its contentions not only by adding contentions 

directed to the newly added claims 3, 5 and 10 but also by amending contentions 

directed to the originally asserted claims in both the ’504 patent and the ’192 patent. 

(D.I. 188 at 3, emphasis in original). Hanmi has not, and cannot, demonstrate that 

the statement directed at evaluating claims 3, 5 and 10 invited wholesale 

amendments of all its contentions, let alone amendment by catchall reference to any 

contention they have made or may make elsewhere in the case. 

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Hanmi should not be allowed to circumvent Local Patent Rule 3.7 simply by 

filing summary judgment motions 

From the outset, Hanmi has attempted to do an end-around the Local Patent Rules 

by pressing summary judgment motions. Hanmi asserts that its wholesale 

incorporation of summary judgment filings was “directed to conforming Hanmi’s 

contentions to the case record.” (D.I. 188 at 2). But such filings are not a substitute 

for the requirements of the local rules. Hanmi was clearly aware of the contentions 

it intended to raise and should have identified such contentions in its initial invalidity 

contentions. Hanmi cannot unilaterally amend its contentions by, inter alia, filing 

summary judgment motions, without first satisfying Local Patent Rule 3.7 which 

requires Hanmi to seek leave of the Court and demonstrate good cause to amend. 

Local Patent Rule 3.7 explicitly states that “[t]he duty to supplement discovery 

responses under Fed. R. Civ. P. 26(e) does not excuse the need to obtain leave of 

Court to amend contentions. . . .”1

 And, Hanmi’s suggestion that a party is not 

required to adhere to Local Patent Rule 3.7 if it files dispositive motions on new 

defenses, or amends pleadings to raise new defenses, has already been held 

improper by this Court.2 Opinion and Order in Hoffmann-La Roche Inc. v. Apotex 

Inc., CA No. 07-4417, D.I. 397 (D.N.J. Dec. 29, 2011). 

Hanmi also claims the local patent rules do not apply because AstraZeneca filed 

oppositions to Hanmi’s summary judgment motions. AstraZeneca did respond to 

each of Hanmi’s October 11, 2011 summary judgment motions. This does not 

provide any support for the position that our local rules for the orderly progression of 

patent cases do not apply. The fact remains that Hanmi never sought leave to 

amend its contentions so as to make its new positions part of this case and that 

when it tried to circumvent the rules to do so, it provided a non-specific catch-all 

incorporation by reference to contentions past, present and future. Hoffmann-La 

Roche, CA No. 07-4417, D.I. 397 (striking new contentions presented in an 

amended answer as required by F.R.C.P. 6(b)). 

 

1

See also, the Local Civil and Criminal Rules of the U.S. District Court for the D.N.J. (March 

18, 2011 Revisions) at 33 (“Report of the Local Patent Rules Committee: Explanatory Notes 

for the 2011 Amendments”) (“In an effort to avoid potential misunderstandings as to the 

scope of permitted amendments to obligations under the Local Patent Rules, the Committee 

sought to clarify that amendments apply to all filings with the Court or exchanges between 

the parties as may be required by the Local Patent Rules. The proposed rule also makes 

plain that any amendments require the approval of the Court, notwithstanding consent by the 

parties. See L. Pat. R. 3.7.”). 

2

 Hanmi incorrectly asserts that the Court already permitted Hanmi’s new contentions into 

the case. However, the Court never addressed whether Hanmi’s summary judgment 

motions contained new contentions that were properly in the case in setting a briefing 

schedule. 

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Conclusion 

Despite the clarity of Local Patent Rule 3.7, Hanmi never sought leave from the 

court to amend its contentions. AstraZeneca respectfully requests the Court strike 

Hanmi’s December 9, 2011 amended contentions to the extent they do not address 

the newly asserted claims 3, 5 and 10. 

Respectfully submitted, 

s/John E. Flaherty

John E. Flaherty 

cc: Hon. Joel A. Pisano, U.S.D.J. (via ECF) 

Counsel of record (via ECF) 

Enclosure 

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