Chid S. Iyer
`T 202.775.7542
`ciyer@sughrue.com
`
`
`
`
`
`2100 Pennsylvania Avenue, NW
`Washington, DC 20037-3213
`T 202.293.7060
`F 202.293.7860
`
`www.sughrue.com
`
`
`
`January 14, 2013
`
`
`VIA FACSIMILE, USPS EXPRESS MAIL and CONFIRMATION BY USPS CERTIFIED
`MAIL WITH RETURN RECEIPT
`
`
`Legal Department
`Eli Lilly and Co. Inc.
`Lilly Corporate Center
`Indianapolis, IA 46285
`
`Phone: 1 (317) 276-2000
`Facsimile: 1 (775) 832-8501
`
`
`
`Re: Notice of Paragraph IV Certification of Non-infringement and/or
`Invalidity of the claims of U.S. Patent No. 7,772,209 Pursuant to 21
`C.F.R. § 314.95 Concerning Amendment to ANDA No. 203485 for
`Pemetrexed Disodium for Injection, 1000 mg/vial
`
`To Whom It May Concern::
`
`
`Pursuant to 21 C.F.R. § 314.95 and 21 U.S.C. § 355(j)(2)(B)(ii)(I) (i.e., section
`505(j)(2)(B)(ii) of the Federal Food, Drug and Cosmetic Act (“Act”)), Accord Healthcare Inc.,
`USA ( “Accord”) hereby provides notice to Eli Lilly & Co. that it has submitted to the U.S. Food
`and Drug Administration (“FDA”), and the FDA has received, an amendment to Accord’s
`Abbreviated New Drug Application (“ANDA”)No. 203485.
`
`Specifically, Accord has submitted an amendment to ANDA No. 203485 under 21 U.S.C.
`§ 355(j)(2)(A)(vii)(IV) seeking approval to engage in the commercial manufacture, use, and/or
`sale of Pemetrexed Disodium for Injection, 1000 mg/vial, on the basis that the claims of U.S.
`Patent No. 7,772,209 are invalid. In accordance with 21 U.S.C. § 355(j)(2)(B)(iv)(II) and 21
`C.F.R. §§ 314.95(c)(6)(i)-(ii), Accord notes that the factual and legal bases for this paragraph IV
`certification and the statement that the U.S. Patent No. 7,772,209 is invalid and/or the valid
`claims will not be infringed by Accord’s Pemetrexed Disodium for Injection, 1000 mg/vial are
`the same as those forth in the Notice Letter sent by Accord to Lilly on December 8, 2011.
`
`Since the 1000 mg/vial dosage is not a dosage listed in the Orange Book, we provide this
`notice as a matter of courtesy only. Accord reserves the right to allege the same, similar,
`different or new theories of non-infringement and/or invalidity and nothing in this or its
`
`
`
`Washington, DC ~ Tokyo ~ Silicon Valley ~ San Diego
`
`

`
`January 14, 2013
`Pages 2
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`December 8, 2011 Notice Letters shall be construed as to limit Accord’s rights to make any
`allegation in this or any subsequent litigation regarding any issue.
`
`
`Pursuant to 21 C.F.R. § 314.95(c)(7), Accord identifies the following name and address
`of an agent in the United States authorized to accept service of process in connection with
`ANDA no. 203485 and any amendment thereto for the applicant:
`
`Chid S. Iyer
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave, N.W
`Washington, DC 20037-3213
`Phone: 202-293-7060
`Fax: 202-293-7860
`ciyer@sughrue.com
`
`Furthermore, in accordance with 21 U.S.C. § 355(j)(5)(C)(i)(III), as amended by Title XI
`
`of the Medicare Prescription Drug, Improvement and Modernization Act, Pub. L. No. 108-173,
`117 Stat. 2066 (2003), this notice letter also includes, and Accord hereby extends, an “Offer of
`Confidential Access to Application” to Lilly under the specific restrictions set forth below in this
`letter.
`
`OFFER OF CONFIDENTIAL ACCESS TO APPLICATION
`
`Pursuant to 21 U.S.C. § 355(j)(5)(C), as amended by Title XI of the Medicare
`Prescription Drug, Improvement and Modernization Act, Pub. L. No. 108-173, 117 Stat. 2066
`(2003), this notice letter includes an Offer of Confidential Access to Application. As required by
`§ 355(j)(5)(C)(i)(III), and pursuant to certain restrictions described below, Accord offers to
`provide Lilly with confidential access to certain information from its amendment to ANDA No.
`203485 for the sole and exclusive purpose of determining whether an infringement action
`referred to in § 355(j)(5)(B)(iii) can be brought.
`
`Section 355(j)(5)(C)(i)(III) allows Accord to impose restrictions “as to persons entitled
`to access, and on the use and disposition of any information accessed, as would apply had a
`protective order been entered for the purpose of protecting trade secrets and other confidential
`business information”. That provision also grants Accord the right to redact its ANDA in
`response to a request for Confidential Access under this offer.
`
`As permitted by statute, Accord imposes the following terms and restrictions on its Offer
`of Confidential Access:
`
`Accord will permit confidential access to certain information from its proprietary ANDA
`(1)
`No. 203485 and any amendment thereto to attorneys from one (1) outside law firm representing
`Lilly provided, however, that such attorneys do not engage, formally or informally, in
`
`

`
`January 14, 2013
`Pages 3
`
`prosecution of patent applications related to Pemetrexed Disodium. Such information
`(hereinafter, “Confidential Accord Information”) shall be marked with the legend
`“CONFIDENTIAL”.
`
`The attorneys representing Lilly who have been permitted access under paragraph (1)
`(2)
`shall not disclose any Confidential Accord Information to any other person or entity, including
`Lilly employees, outside scientific consultants, and/or other outside counsel retained by Lilly,
`without the prior written consent of Accord’s counsel, SUGHRUE MION, PLLC.
`
`As provided by § 355(j)(5)(C)(i)(III), attorneys permitted access under paragraph (1)
`(3)
`shall make use of the Confidential Accord Information for the sole and exclusive purpose of
`determining whether an action referred to in § 355(j)(5)(B)(iii) can be brought and for no other
`purpose. In this regard, the attorneys permitted access under paragraph (1) shall be permitted to
`advise whether or not to bring suit alleging infringement of U.S. Patent No. 7,772,209.
`Moreover, the Confidential Accord Information shall not be used to prepare or prosecute any
`future or pending patent applications by Lilly, or in connection with any filing to, or
`communication with, the FDA relating to Accord’s ANDA No. 203485 and any amendment
`thereto. The attorneys permitted access under paragraph (1) agree to take all measures necessary
`to prevent unauthorized disclosure or use of the Confidential Accord Information, and that all
`Confidential Accord Information shall be kept confidential and not disclosed in any manner
`inconsistent with this Offer of Confidential Access. Attorneys permitted access under paragraph
`(1) further agree never to use Confidential Accord Information, directly or indirectly, in
`competition with Accord, nor will it allow any other person or entity to do so.
`
`The Confidential Accord Information disclosed is, and remains, the property of Accord.
`(4)
`By providing the Confidential Accord Information, Accord does not grant, implicitly, explicitly,
`or otherwise, to Lilly and/or attorneys permitted access under paragraph (1) any interest in or
`license for or to the Confidential Accord Information.
`
`Lilly and / or attorneys permitted access under paragraph (1) shall, within forty-five (45)
`(5)
`days from the date that it first receives the Confidential Accord Information, return to Accord’s
`counsel, SUGHRUE MION, PLLC, all Confidential Accord Information and any copies thereof.
`Lilly’s law firm shall return to SUGHRUE MION, PLLC, all Confidential Accord Information
`before any infringement suit is filed by Lilly, if suit is commenced before this 45-day period
`expires. Lilly and / or attorneys permitted access under paragraph (1) shall return to Accord’s
`counsel, SUGHRUE MION, PLLC, all Confidential Accord Information and any copies thereof,
`even if Lilly does not file suit against Accord within forty-five (45) days from the date that it first
`receives the Confidential Accord Information. In the event that Lilly opt to file suit, none of the
`information contained in or obtained from any Confidential Accord Information that Accord
`provides will be included in any publicly-available complaint or other pleading.
`
`

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`January 14, 2013
`Pages 4
`
`Nothing in this Offer of Confidential Access shall be construed as an admission by
`(6)
`Accord regarding the validity, enforceability, and/or infringement of any U.S. Patent. Further,
`nothing herein shall be construed as an agreement or admission by Accord with respect to the
`competency, relevance, or materiality of any such Confidential Accord Information, document,
`or thing. The fact that Accord provides Confidential Accord Information upon request of Lilly
`shall not be construed as an admission by Accord that such Confidential Accord Information is
`relevant to the disposition of any issue relating to any alleged infringement of the Lilly patent, or
`to the validity or enforceability of any such patent.
`
`The attorneys from Lilly and / or attorneys permitted access under paragraph (1) will
`(7)
`acknowledge in writing their receipt of a copy of these terms and restrictions prior to production
`of any Confidential Accord Information. Such written acknowledgement shall be provided to
`Accord’s counsel SUGHRUE MION, PLLC.
`
`(8)
`
`This Offer of Confidential Access shall be governed by the laws of the State of Maryland.
`
`Section 355(j)(5)(C)(i)(III) of the Act provides that any request for access that Lilly make
`
`under this Offer of Confidential Access “shall be considered acceptance of the offer of
`confidential access with the restrictions as to persons entitled to access, and on the use and
`disposition of any information accessed, contained in [this] offer of confidential access” and that
`the “restrictions and other terms of [this] offer of confidential access shall be considered terms of
`an enforceable contract.” Thus, to the extent that Lilly request access to Confidential Accord
`Information, it necessarily accepts the terms and restrictions outlined above. Written notice
`requesting access under this Offer of Confidential Access should be made to:
`
`Chid S. Iyer
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave, N.W
`Washington, DC 20037-3213
`Phone: 202-293-7060
`Fax: 202-293-7860
`ciyer@sughrue.com
`
`By providing this Offer of Confidential Access to Application, Accord has satisfied the
`
`condition set forth in 21 U.S.C. § 355(j)(5)(C)(i)(I)(cc) to bring a Declaratory Judgment action
`under 28 U.S.C. § 2201 et seq., pursuant to 21 U.S.C. § 355(j)(5)(C). As Lilly is no doubt
`aware, under controlling Federal Circuit precedent, a patent holder is required to conduct a
`reasonable pre-suit investigation before filing pleadings accusing a third party of patent
`infringement. If Lilly desires to conduct a pre-suit investigation to determine whether it would
`have a good faith factual and legal basis to ever bring a suit alleging infringement of any of the
`valid claims of U.S. Patent No. 7,772,209 against Accord, Lilly should accept Accord’s Offer of
`Confidential Access to its ANDA and review it at this time.
`
`

`
`January 14, 2013
`Pages 5
`
`
`
`Receipt of this notice begins the 45-day period provided in Section 505(j)(5)(B)(iii) of
`the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. The ANDA will
`be amended with a copy of the return receipt for this notice, as required by 21 C.F.R. §
`314.95(e).
`
` Very truly yours,
`
`
`
`
`
` Chid S. Iyer
`
`
`cc: Ellen E. Oberwetter, Esq. (via Email)