UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ACCORD HEALTHCARE, INC., USA,
`Petitioner
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`
`
`Case IPR2013-00356
`U.S. Patent No. 7,772,209
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER ELI LILLY AND COMPANY’S
`PRELIMINARY RESPONSE TO PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 7,772,209 UNDER 35 U.S.C. §§ 311-319
`AND 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ACCORD HEALTHCARE, INC., USA,
`Petitioner
`
`v.
`
`ELI LILLY & COMPANY,
`Patent Owner.
`
`
`Case IPR2013-00356
`U.S. Patent No. 7,772,209
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER ELI LILLY AND COMPANY’S
`PRELIMINARY RESPONSE TO PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 7,772,209 UNDER 35 U.S.C. §§ 311-319
`AND 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`BACKGROUND ....................................................................................................... 3
`
`I.
`
`II.
`
`ALIMTA® and the ’209 Patent ........................................................................ 3
`
`The District Court Litigations .......................................................................... 4
`
`ARGUMENT ............................................................................................................. 8
`
`I.
`
`Accord’s Petition Is Time-Barred Under 35 U.S.C. § 315(b). ........................ 9
`
`A.
`
`B.
`
`C.
`
`Section 315(b) Unambiguously Forecloses Accord’s Petition. ................... 9
`
`The Board Has Held That § 315(b) Does Not Allow for Successive One-
`Year Filing Periods. ....................................................................................10
`
`Accord’s Assertion That the Two Civil Actions Involve “entirely different
`products” Does Not Excuse Accord from Missing Its One-Year Filing
`Deadline. .....................................................................................................14
`
`II.
`
`Accord’s Interpretation Would Have Far-Reaching Consequences in Hatch-
`Waxman Litigation. .......................................................................................17
`
`CONCLUSION ........................................................................................................19
`
`
`
`
`
`
`
`
`
`Accord Healthcare, Inc., USA’s (“Accord’s”) petition to institute inter
`
`partes review (“IPR”) of U.S. Patent No. 7,772,209 (“the ’209 patent”) should be
`
`denied because it is untimely. Under 35 U.S.C. § 315(b), a defendant has one year
`
`after being served with a complaint for infringement of a patent to petition for an
`
`IPR of that patent, or else “[a]n inter partes review may not be instituted.”
`
`§ 315(b) (emphasis added). Patent Owner Eli Lilly and Company (“Lilly”) sued
`
`Accord for infringement of the ’209 patent well over one year before Accord filed
`
`its petition: Lilly served Accord with a complaint alleging infringement of the
`
`’209 patent on January 23, 2012, but Accord did not file its petition until June 14,
`
`2013. That should end the matter; the plain language of the statute requires that
`
`Accord’s petition be denied.
`
`Accord asserts that it can nevertheless initiate an IPR because Lilly served it
`
`with a second complaint less than a year before the filing of Accord’s IPR petition.
`
`See Corrected Petition for Inter Partes Review at 3 & n.1, Accord Healthcare, Inc.,
`
`USA v. Eli Lilly & Co., IPR2013-00356 (P.T.A.B. June 26, 2013) (hereinafter,
`
`“Pet.”). Accord is wrong. The plain language of § 315(b) does not open a one-
`
`year window for requesting an IPR each time a party is served with a complaint.
`
`Rather, it imposes a one-year limit on when an accused infringer can petition for an
`
`IPR, starting from when that party is first served with a complaint alleging
`
`infringement of the patent. Because more than one year has elapsed since January
`
`
`
`
`
`
`
`23, 2012—the date Lilly served Accord with a complaint for infringement of the
`
`’209 patent—Accord is barred from petitioning for an IPR of that patent,
`
`regardless of whether Lilly later filed and served an additional complaint for
`
`infringement of the same patent.
`
`Indeed, the Board has squarely rejected Accord’s reading of the statute.
`
`The Board recently held that “the filing of a later lawsuit [does not] render[] the
`
`service of a complaint in an earlier lawsuit to be a nullity” for purposes of
`
`determining whether the one-year window for filing an IPR petition has closed.
`
`Universal Remote Control, Inc. v. Universal Elecs., Inc., IPR2013-00168, slip op.
`
`at 4 (P.T.A.B. Aug. 26, 2013). The Board concluded that regardless of whether a
`
`petitioner was later sued again for infringement of a patent, an IPR of that patent
`
`“may not be instituted” if the petitioner was first served with a complaint for
`
`infringement of the patent more than a year before the IPR petition was filed. Id.
`
`at 5. That is precisely the case here.
`
`Because Accord was served with a complaint alleging infringement of the
`
`’209 patent more than a year before Accord filed its petition, the IPR it requests
`
`“may not be instituted,” and its petition should be denied.
`
`
`
`2
`
`
`
`
`
`I.
`
`BACKGROUND
`ALIMTA® and the ’209 Patent
`The ’209 patent is owned by Lilly and protects Lilly’s anti-cancer agent
`
`ALIMTA®. ALIMTA was the first drug ever approved by the Food and Drug
`
`Administration (“FDA”) for the treatment of patients with mesothelioma (the
`
`primary cancer caused by exposure to asbestos), and is also indicated for treating
`
`the most common types of lung cancer. See Ex. 2001, ALIMTA Prescribing
`
`Information (May 2013), at 2.
`
`The ’209 patent is directed to methods of administering the active ingredient
`
`in ALIMTA, a compound called pemetrexed disodium, in a way that significantly
`
`improves patient safety. Pemetrexed belongs to a class of compounds known as
`
`“antifolates.” Antifolates kill cancer cells by interfering with the use of certain
`
`nutrients (“folates”) that cells need to grow and divide. Those same mechanisms,
`
`however, also kill rapidly dividing normal cells, which can lead to severe and life-
`
`threatening side effects. Surprisingly, administering folic acid—a folate—and
`
`vitamin B12 prior to the administration of pemetrexed reduces the incidence of
`
`severe side effects but does not reduce the efficacy of pemetrexed against cancer
`
`cells. Although considered to be counterintuitive when the method was first
`
`developed, such pretreatment is now required by the FDA for all pemetrexed
`
`patients. ALIMTA’s product labeling includes mandatory instructions to pretreat
`
`
`
`3
`
`
`
`
`
`patients with folic acid and vitamin B12 according to a particular regimen. The
`
`’209 patent is directed to methods of administering pemetrexed comprising such
`
`pretreatment regimens.
`
`II. The District Court Litigations
`ALIMTA’s success has led several companies to file Abbreviated New Drug
`
`Applications (“ANDAs”) with the FDA seeking permission to sell generic versions
`
`of ALIMTA. Lilly is engaged in infringement litigation involving the ’209 patent
`
`with several such ANDA filers, including Accord, in the United States District
`
`Court for the Southern District of Indiana.
`
`A first action, which does not involve Accord, was tried to the Court in
`
`August 2013.1 In December 2011, while that first action was ongoing, Accord sent
`
`Lilly a “notice letter” informing Lilly that it had filed ANDA No. 203485 to obtain
`
`approval from the FDA to market generic versions of ALIMTA. See 21 U.S.C.
`
`§ 355(j)(2)(B). Under the Hatch-Waxman Act, a generic filer such as Accord who
`
`is seeking approval to sell a generic version of an approved drug prior to the
`
`
`1
`Post-trial briefing in that action will occur through the end of this year, after
`
`which the parties will be awaiting the Court’s decision. See Ex. 2002, Stipulation
`
`Regarding Post-Trial Briefing Schedule, Eli Lilly & Co. v. Teva Parenteral Meds.,
`
`Inc., APP Pharm., LLC, Teva Pharm. USA, Inc., Barr Labs, Inc., and Pliva
`
`Hrvatska d.o.o., No. 1:10-cv-01376 (S.D. Ind. Sept. 4, 2013), ECF No. 319.
`
`
`
`4
`
`
`
`
`
`expiration of a patent covering that drug or its use must send written notice to the
`
`patent owner that it has filed for approval to do so. The filing of an ANDA
`
`seeking approval to sell a generic drug prior to the expiration of a relevant patent is
`
`an act of patent infringement. 35 U.S.C. § 271(e).
`
`In response to Accord’s notice letter, on January 20, 2012, Lilly sued Accord
`
`in the United States District Court for the Southern District of Indiana, alleging
`
`that Accord’s proposed generic pemetrexed products would infringe the ’209
`
`patent. See Ex. 2003, Compl., Eli Lilly & Co. v. Accord Healthcare, Inc., USA,
`
`No. 1:12-cv-00086 (S.D. Ind. Jan. 20, 2012), ECF No. 1. The action was assigned
`
`docket number 1:12-cv-00086 (“the ’086 action”). Lilly served Accord with the
`
`summons and complaint on January 23, 2012. See Ex. 2004, Return of Service, Eli
`
`Lilly & Co. v. Accord Healthcare, Inc., USA, No. 1:12-cv-00086 (S.D. Ind. Feb. 6,
`
`2012), ECF No. 7 (declaring that Accord was served on January 23, 2012). A
`
`subsequent action against Apotex Inc. and Apotex Corp.—two arms of yet another
`
`company seeking approval for a generic version of ALIMTA—was consolidated
`
`with the ’086 action, and a bench trial is scheduled for July 2014.
`
`In the one-year period from the date Lilly served Accord with a summons
`
`and complaint in the ’086 action for infringement of the ’209 patent—i.e., by
`
`January 23, 2013—Accord did not file a petition for IPR of the ’209 patent.
`
`
`
`5
`
`
`
`
`
`On January 14, 2013, Accord mailed Lilly a second notice letter stating that
`
`Accord had submitted an amendment to its ANDA. Accord’s original ANDA
`
`sought permission to sell a generic pemetrexed product in two amounts—100 mg
`
`and 500 mg per vial—which match the two amounts in which ALIMTA is sold.
`
`The amendment added a third amount, 1000 mg per vial, to these two original
`
`amounts. Notably, pemetrexed is reconstituted into an intravenous solution and
`
`administered in a hospital or clinic setting at a dosage tailored to each individual
`
`patient. The dosage of pemetrexed administered to a patient thus does not depend
`
`on the amount of pemetrexed per vial. Ex. 2001, ALIMTA Prescribing
`
`Information, at 4. Because Accord sent Lilly a second notice letter, Lilly brought a
`
`second action against Accord under the Hatch-Waxman framework. Ex. 1000,
`
`Compl., Eli Lilly & Co. v. Accord Healthcare, Inc. USA, No. 1:13-cv-0335 (S.D.
`
`Ind. Feb. 28, 2013), ECF No. 1. That second action was filed on February 28,
`
`2013, and the complaint was served on March 7, 2013; the new action was
`
`assigned docket number 1:13-cv-00335 (“the ’335 action”).
`
`On May 30, 2013, Lilly filed a motion to consolidate the ’335 action with
`
`the ’086 action because “the two cases present common questions of fact and law.”
`
`Ex. 2005, Pl. Eli Lilly & Co.’s Mot. to Consolidate, Eli Lilly & Co. v. Accord
`
`Healthcare, Inc., USA, No. 1:12-cv-00086, at 3 (S.D. Ind. May 30, 2013), ECF No.
`
`62. As Lilly explained to the District Court, Accord’s 1000 mg/vial product was
`
`
`
`6
`
`
`
`
`
`simply “a generic version of ALIMTA® in a larger vial” than Accord’s earlier 100
`
`mg/vial and 500 mg/vial generic pemetrexed disodium products, and “[t]he only
`
`expected difference in subject matter between the two cases is the size of the vial
`
`in which the proposed ANDA product is to be sold.” Id. at 2-3. Lilly’s motion
`
`was granted on June 24, 2013, the ’335 action was consolidated into the ’086
`
`action and administratively closed, and Lilly’s infringement claims regarding all
`
`three of Accord’s proposed vial sizes are being litigated together in the ’086 action.
`
`See Ex. 2006, Order Granting Pl.’s Mot. to Consolidate, Eli Lilly & Co. v. Accord
`
`Healthcare, Inc., USA, No. 1:12-cv-00086 (S.D. Ind. June 24, 2013), ECF No. 65;
`
`see also Ex. 2007, Report on the Filing or Determination of an Action Regarding a
`
`Patent or Trademark, Eli Lilly & Co. v. Accord Healthcare, Inc., USA, No. 1:13-
`
`cv-00335 (S.D. Ind. July 1, 2013), ECF No. 29 (notice informing the Director of
`
`the PTO of the Court’s decision to consolidate the two actions).2
`
`Just prior to the Court’s consolidation order, on June 14, 2013, Accord filed
`
`its IPR petition—over a year and four months after being served with a complaint
`
`for infringement of the ’209 patent.3
`
`2
`Consolidation did not alter the schedule for the ’086 action, which is
`
`currently in fact discovery and remains set for trial in July 2014.
`
`3
`
`On June 26, 2013, Accord filed its corrected petition for inter partes review
`
`to address defects in its application.
`
`
`
`7
`
`
`
`
`
`ARGUMENT
`
`The plain language of 35 U.S.C. § 315(b) grants a defendant a single, one-
`
`year period following service of a complaint for patent infringement to file an IPR
`
`petition challenging the patent. As the Board has recently confirmed, the one-year
`
`time limit imposed by § 315(b) is unaffected by the filing of any later complaint.
`
`Moreover, that interpretation is consistent with the legislative history and is
`
`reinforced by important policy concerns. Because Accord missed its one-year
`
`statutory deadline, its IPR petition is untimely under § 315(b) and should be
`
`denied.
`
`Lilly’s arguments herein are limited to the untimeliness of Accord’s petition,
`
`a threshold procedural defect that precludes the initiation of an IPR. However,
`
`Lilly also disagrees with Accord’s allegations on the merits, contends that all
`
`claims of the ’209 patent are valid and should be maintained, and reserves the right
`
`to present additional evidence and arguments should the Board grant Accord’s
`
`petition and institute an IPR. See generally Athena Automation Ltd. v. Husky
`
`Injection Molding Sys. Ltd., IPR2013-00290, slip op. (P.T.A.B. Sept. 3, 2013).4
`
`
`4
`If an IPR is instituted, Lilly intends to demonstrate, among other things, that
`
`the art (including some of the very art Accord cites) taught away from pretreatment
`
`with folic acid and vitamin B12, and indeed that vitamin B12 pretreatment (a
`
`
`
`8
`
`
`
`
`
`I.
`
`Accord’s Petition Is Time-Barred Under 35 U.S.C. § 315(b).
`Section 315(b) Unambiguously Forecloses Accord’s Petition.
`A.
`Inter partes review is a creation of the America Invents Act. See Leahy-
`
`Smith America Invents Act, Pub. L. No. 112-29, § 6, 125 Stat. 284, 299-305
`
`(2011). Among other limitations on the filing of an IPR petition, the law sets forth
`
`a one-year period during which a defendant in patent infringement litigation may
`
`file a petition to institute an IPR of the patent at issue. In relevant part, § 315(b)
`
`states that the period begins the date that the defendant is served with a complaint
`
`alleging infringement of the patent, and ends exactly one year later:
`
`(b) Patent Owner’s Action.— An inter partes review may not be
`instituted if the petition requesting the proceeding is filed more than 1
`year after the date on which the petitioner . . . is served with a
`complaint alleging infringement of the patent.
`
`The Board has recognized that this plain language compels denial of an IPR
`
`petition whenever the one-year period beginning with service of a patent
`
`infringement complaint has elapsed. Universal Remote, slip op. at 5; see also
`
`Motorola Mobility LLC v. Arnouse, IPR2013-00010, 2013 WL 2023657, at *1
`
`(P.T.A.B. Jan. 30, 2013) (“[U]nder 35 U.S.C. § 315(b), a party may not file a
`
`petition for inter partes review if the party had been served with a complaint
`
`limitation of every claim) had never been used with any antifolate cancer treatment
`
`over the more than 50 years that such treatments have been in use.
`
`
`
`9
`
`
`
`
`
`alleging infringement more than one year previously.”). Cf. In re Swanson, 540
`
`F.3d 1368, 1376 (Fed. Cir. 2008) (explaining that statutory construction “‘begin[s],
`
`as always, with the language of the statute’”) (quoting Duncan v. Walker, 533 U.S.
`
`167, 172 (2001)).
`
`Accord’s IPR petition concedes that “[i]n January 2012, Patent Owner
`
`commenced a lawsuit for infringement of the ‘209 Patent.” Pet. 3 n.1. As the
`
`proof of service in the ’086 action indicates—and as Accord does not dispute—
`
`Accord was served with the complaint on January 23, 2012. Accord filed its IPR
`
`petition on June 14, 2013, well over a year after Accord was served. In such
`
`circumstances, where “the petition requesting the [IPR] proceeding is filed more
`
`than one year after the date on which the petitioner is served with a complaint
`
`alleging infringement of the patent,” the Board has held that “inter partes review
`
`cannot be instituted.” Universal Remote, slip op. at 5-6. Accord’s petition should
`
`therefore be denied.
`
`B.
`
`The Board Has Held That § 315(b) Does Not Allow for Successive
`One-Year Filing Periods.
`
`Accord urges the Board to accept its untimely petition, asserting that it was
`
`“filed less than one year after the date on which Accord was served with ‘a
`
`complaint.’” Pet. 3. Accord effectively asserts that “a complaint” in § 315(b)
`
`means “any complaint,” thus permitting successive one-year periods for filing an
`
`IPR petition. By Accord’s logic, the statutory one-year clock is reset each time a
`
`
`
`10
`
`
`
`
`
`defendant alters its infringing product in a way that results in the service of another
`
`complaint. The Board should reject this nonsensical interpretation.
`
`This is not a matter of first impression. In Universal Remote, the Board held
`
`that the plain language of § 315(b) permits only a single one-year filing period.
`
`Universal Remote, slip op. at 5-6. That case, like this one, involved the timeliness
`
`of an IPR petition filed more than one year after a first complaint, but within one
`
`year of a second complaint. Id. at 2-3. There, as here, the first complaint, second
`
`complaint, and IPR petition all involved the same patent. Id. The petitioner, like
`
`Accord, argued that its IPR petition was timely notwithstanding the earlier-served
`
`complaint because it was filed within one year of the second-filed complaint. The
`
`Board rejected the petitioner’s argument, holding that the petition was untimely
`
`under § 315(b) as it was not filed within the one-year period following the first
`
`complaint. Id. at 4-5 (“Service of a second complaint does not nullify the effect of
`
`a first served complaint for purposes of 35 U.S.C. 315(b)[.]”) (emphasis omitted).
`
`On the dispositive issue of timeliness under § 315(b), therefore, Universal
`
`Remote is indistinguishable from this case. Applying Universal Remote, the Board
`
`should hold that Accord’s IPR petition is untimely in view of the complaint served
`
`in the earlier ’086 action.5
`
`5
`In Universal Remote, the petitioner’s statutory filing period expired in 2002,
`
`such that the petitioner in effect had no opportunity to initiate an IPR. Here, the
`
`
`
`11
`
`
`
`
`
`The Board’s decision in Universal Remote rested on sound principles of
`
`statutory interpretation. Section 315(b) sets a one-year limit on the period for
`
`filing an IPR petition. The statute is unambiguous and states that an IPR “may
`
`not” be instituted if a certain condition is met—namely, the service of “a
`
`complaint” more than a year before the filing of the IPR petition. It does not
`
`provide additional filing periods whenever the defendant provokes service of
`
`another complaint. Universal Remote, slip op. at 2; see also Universal Elecs., Inc.
`
`v. Universal Remote Control, Inc., No. SACV 12-00329, 2013 WL 1876459, at *2
`
`(C.D. Cal. May 2, 2013) (“This one year limit [under § 315(b)] sets a ceiling on the
`
`PTO’s ability to commence inter partes review where there is ongoing
`
`litigation.”); Motorola Mobility, 2013 WL 2023657, at *4; Macauto U.S.A. v. Bos
`
`GmbH & KG, IPR2012-0004, slip op. at 16 (P.T.A.B. Jan. 24, 2013).
`
`The Board in Universal Remote also recognized that its interpretation of the
`
`statute is consistent with the legislative history underlying § 315(b). “It is well
`
`settled law that the plain and unambiguous meaning of the words used by Congress
`
`prevails in the absence of a clearly expressed legislative intent to the contrary.”
`
`argument for strictly enforcing the one-year time limit in § 315(b) is even stronger,
`
`as Accord had every opportunity to petition for an IPR after the Board began
`
`accepting IPR petitions on September 16, 2012, but before its statutory period
`
`ended on January 23, 2013.
`
`
`
`12
`
`
`
`
`
`Universal Remote, slip op. at 5 (quoting Hoechst Aktiengesellschaft v. Quigg, 917
`
`F.2d 522, 526 (Fed. Cir. 1990)). Accord, like the petitioner in Universal Remote,
`
`“has not pointed to any particular legislative history associated with 35 U.S.C.
`
`§ 315(b) which clearly expresses that the filing of a later lawsuit renders the
`
`service of a complaint in an earlier lawsuit to be a nullity.” Id. at 5. That is not
`
`surprising, for the legislative history demonstrates that lawmakers uniformly
`
`understood the IPR provision as containing “procedural safeguards to prevent a
`
`challenger from using the process to harass patent owners” and to help avoid
`
`“abusive serial challenges to patents”—both of which would be dangers if an
`
`accused infringer could reopen the window for filing an IPR by triggering the
`
`filing of a second infringement complaint. Ex. 2008, 157 Cong. Rec. S936, S952
`
`(daily ed. Feb. 28, 2011) (Statement of Sen. Grassley); see also Ex. 2009, Meeting
`
`of H. Comm. on the Judiciary, Tr. of Markup of H.R. 1249, at 72 (Apr. 14, 2011)
`
`(statement of Judiciary Committee Chairman Lamar Smith) (“The inter partes
`
`proceeding in H.R. 1249 has been carefully written to balance the need to
`
`encourage its use while at the same time preventing the serial harassment of patent
`
`holders.”); Ex. 2010, 157 Cong. Rec. S1360, S1374 (daily ed. Mar. 8, 2011)
`
`(Statement of Sen. Kyl) (recognizing “procedural limits on post-grant
`
`administrative proceedings that will prevent abuse of these proceedings for
`
`purposes of harassment or delay”).
`
`
`
`13
`
`
`
`
`
`For these reasons, § 315(b) precludes an IPR if more than one year has
`
`elapsed from when an accused infringer was served with a complaint for
`
`infringement, without regard to whether a second complaint has also been served.
`
`Even Accord concedes that Lilly served it with a complaint more than a year
`
`before Accord’s petition. Pet. 3 n.1. Only by advancing an interpretation
`
`antithetical to the plain language of § 315(b) and its legislative history can Accord
`
`assert that its petition is not time-barred.6
`
`C. Accord’s Assertion That the Two Civil Actions Involve “entirely
`different products” Does Not Excuse Accord from Missing Its
`One-Year Filing Deadline.
`
`Accord further asserts that although it failed to file an IPR petition within the
`
`statutory one-year period running from service of process in the ’086 action, its
`
`untimeliness should somehow be excused because the ’086 and ’335 actions
`
`“involve entirely different products and are based on different set[s] of facts.” Pet.
`
`3 n.1. Accord’s argument is wrong both as a matter of law and on the facts of this
`
`case.
`
`
`6
`Accord’s petition is also untimely under 37 C.F.R. § 42.101(b), the PTO’s
`
`regulation implementing § 315(b), which contains language that tracks the
`
`language of § 315(b) and forbids IPRs requested more than a year after the party is
`
`served with a complaint.
`
`
`
`14
`
`
`
`
`
`As a threshold matter, it makes no difference under § 315(b) whether a
`
`second complaint for patent infringement concerns the same product or a different
`
`product as an earlier complaint for infringement of the same patent. Either way,
`
`the one-year period under § 315(b) is not restarted upon service of the second
`
`complaint. The statute focuses on “the patent” asserted, not on what products are
`
`at issue—it unambiguously applies to any petitioner who has been “served with a
`
`complaint alleging infringement of the patent.” § 315(b) (emphasis added). And
`
`based on this language, the Board found in Universal Remote that the IPR petition
`
`was untimely even though the patentee had served a second complaint involving
`
`products “different from those” in an earlier-served complaint. See Ex. 2011,
`
`Preliminary Response of Patent Owner, Universal Remote Control, Inc. v.
`
`Universal Elecs., Inc., IPR2013-00168, at 3 n.1 (P.T.A.B. May 28, 2013); see also
`
`Universal Remote, slip op. at 4. Accord is simply wrong to assert that whether the
`
`earlier and later complaints concern “different products” is relevant.
`
`Even if it mattered under § 315(b) whether the second-filed infringement
`
`suit concerned a “different product,” however, Accord’s argument still fails on the
`
`facts of this case. The products at issue in the ’086 and ’335 actions are virtually
`
`identical. Each of Accord’s three accused products (100 mg/vial, 500 mg/vial, and
`
`1000 mg/vial) contain the same active ingredient, pemetrexed disodium, and have
`
`the same physical, chemical, and biological properties—the only difference is the
`
`
`
`15
`
`
`
`
`
`quantity of pemetrexed in each container. Even if Accord chooses to refer to them
`
`as separate “products,” or the FDA treats them as different “products” for purposes
`
`of regulatory approval, they are not different in any way that is meaningful to the
`
`’209 patent claims. The quantity of pemetrexed in each vial is not a limitation of
`
`any claim of the ’209 patent and does not affect any issue of infringement or
`
`validity.
`
`Indeed, Accord has conceded that the factual and legal questions regarding
`
`infringement and validity are identical for each ANDA product. Although Accord
`
`now states in its petition that the complaint involving its 100 mg/vial and 500
`
`mg/vial products and the complaint involving its 1000 mg/vial product “are based
`
`on different set[s] of facts,” Accord previously represented just the opposite in its
`
`correspondence with Lilly. As Accord stated in its January 14, 2013 notice
`
`letter—in which it was required to disclose the bases for its theories of invalidity
`
`and/or noninfringement of the ’209 patent, see 21 U.S.C. § 355(j)(2)(B)(iv)(II)—
`
`the 1000 mg/vial product rested on “the same” factual and legal bases as its 100
`
`mg/vial and 500 mg/vial products:
`
`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
`
`
`
`16
`
`
`
`
`
`8, 2011 [i.e., the notice letter involving Accord’s 100 mg/vial and 500
`mg/vial products].
`
`Ex. 2012, Letter from Chid S. Iyer to Eli Lilly & Co., at 1 (Jan. 14, 2013)
`
`(emphases added).7 Even Accord has therefore admitted that with respect to the
`
`’209 patent, its three accused products rest on the same factual and legal footing.
`
`Thus, not only is Accord legally incorrect that service of a second complaint
`
`involving a different product matters to the § 315(b) analysis, but by Accord’s own
`
`admission its argument lacks a factual basis as well.
`
`II. Accord’s Interpretation Would Have Far-Reaching Consequences in
`Hatch-Waxman Litigation.
`
`Adopting Accord’s interpretation of § 315(b) would lead to particularly
`
`pernicious consequences in the context of Hatch-Waxman litigation. In an
`
`ordinary patent infringement action, the patent owner generally controls when suit
`
`is filed, and a defendant typically lacks control over when it is sued. Thus, if a
`
`defendant has already been sued and then alters its infringing product or releases a
`
`trivially different one, this may or may not cause the patentee to file a new
`
`complaint.
`
`Hatch-Waxman litigation works differently. The statutory scheme is
`
`designed so that infringement and validity disputes are generally litigated before
`
`7
`Accord’s petition does not mention its previous directly contradictory
`
`representation, despite Accord’s obligations under 37 C.F.R. § 42.11.
`
`
`
`17
`
`
`
`
`
`the generic company has approval from the FDA and before it is selling its
`
`product. And the statutory scheme effectively allows the defendant to control
`
`when it is sued for infringement. That is because Hatch-Waxman infringement
`
`suits are generally triggered by the defendant sending the patent owner a notice
`
`letter. Once a defendant does so, the statute requires the patentee to “br[ing]” an
`
`“action . . . for infringement of the patent” within 45 days after receipt of a notice
`
`letter or else the ANDA may be immediately approved. 21 U.S.C.
`
`§ 355(j)(5)(B)(iii). The same is true when a Hatch-Waxman defendant amends its
`
`ANDA and sends an additional notice letter to the patent holder—under the
`
`statutory scheme, the patent owner is all but compelled to sue again.
`
`Under Accord’s reading of § 315(b), not only can a Hatch-Waxman
`
`defendant effectively control the filing of a second complaint, but in doing so, it
`
`can re-open at will the window for requesting an IPR of the very patent on which it
`
`has already been sued more than a year earlier. And it can do so simply by making
`
`a trivial change to its product, amending its ANDA, and serving a new notice
`
`letter. That is precisely the case here, where the difference between the old and
`
`new products is merely the amount of drug product per vial, which has no bearing
`
`on any issue in the infringement cases. Accord’s interpretation would thus create a
`
`loophole in the IPR statute for ANDA filers, who would have both an incentive
`
`and an ability to stagger their ANDA filings or subsequently amend their ANDAs
`
`
`
`18
`
`
`
`
`
`to exploit successive one-year periods for filing an IPR petition. The Board should
`
`not permit such opportunistic gaming of the IPR process.
`
`CONCLUSION
`
`Accord missed its statutory one-year period for filing an IPR petition under
`
`35 U.S.C. § 315(b). The Board should deny Accord’s petition as untimely and
`
`decline to institute an IPR of the ’209 patent.
`
`The Board is hereby authorized to charge any fees or costs associated with
`
`this submission and to credit any excess payments to Deposit Account No. 05-
`
`0840.
`
`Dated: September 19, 2013
`
`Respectfully submitted,
`
`/Andrew V. Trask/
`______________________________
`Andrew V. Trask
`Reg. No. 59,239
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`202-434-5098 (Telephone)
`202-824-4223 (Facsimile)
`atrask@wc.com
`
`Attorney for Patent Owner
` Eli Lilly and Company
`
`
`
`19
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Patent Owner Eli Lilly
`
`and Company’s Preliminary Response to Petition for Inter Partes Review of U.S.
`
`Patent No. 7,772,209 under 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80,
`
`42.100-.123 was served on September 19, 2013, by filing this document through
`
`the Patent Review Processing System as well as delivering a copy via electronic
`
`mail upon the following attorneys of record for the Petitioner:
`
`Chidambaram S. Iyer
`ciyer@sughrue.com
`accordipr@sughrue.com
`Sughrue Mion PLLC
`2100 Pennsylvania Ave, N.W.
`Washington, DC 20037
`
`Chandran B. Iyer
`cbiyer@sughrue.com
`accordipr@sughrue.com
`Sughrue Mion PLLC
`2100 Pennsylvania Ave, N.W.
`Washington, DC 20037
`
`
`Dated: September 19, 2013
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Andrew V. Trask/
`______________________________
`Andrew V. Trask
`Reg. No. 59,239
`
`20
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
