Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 34
` Entered: October 6, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`TEVA PHARMACEUTICALS USA, INC.
`and FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`ELI LILLY & COMPANY
`Patent Owner.
`____________
`
`Case IPR2016-01341
`Patent 7,772,209 B2
`____________
`
`
`Before MICHAEL P. TIERNEY, JACQUELINE WRIGHT BONILLA, and
`TINA E. HULSE, Administrative Patent Judges.
`
`TIERNEY, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
` Paper No. 34
` Entered: October 6, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`TEVA PHARMACEUTICALS USA, INC.
`and FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`ELI LILLY & COMPANY
`Patent Owner.
`____________
`
`Case IPR2016-01341
`Patent 7,772,209 B2
`____________
`
`
`Before MICHAEL P. TIERNEY, JACQUELINE WRIGHT BONILLA, and
`TINA E. HULSE, Administrative Patent Judges.
`
`TIERNEY, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`I.
`INTRODUCTION
`Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC
`
`(collectively, “Petitioner” or “Teva”), filed a Petition requesting an inter
`partes review of claims 1–22 of U.S. Patent 7,772,209 B2 (Ex. 1001, “the
`’209 patent”). Paper 2 (“Pet.”). Concurrent with the filing of the Petition,
`Petitioner filed a Motion for Joinder seeking to join the current proceeding
`to IPR2016-00237.1 Motion for Joinder, Paper 3. Patent Owner and
`Petitioner filed a Joint Notice of Stipulation Concerning Joinder that states,
`among other things, that Patent Owner waives its right to file a Preliminary
`Response to the Petition. Paper 8. We have jurisdiction under 35 U.S.C.
`§ 314.
`To institute an inter partes review, we must determine that the
`
`information presented in the Petition shows “a reasonable likelihood that the
`petitioner would prevail with respect to at least 1 of the claims challenged in
`the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, upon
`considering the Petition, we conclude that the information presented in the
`Petition establishes a reasonable likelihood that Petitioner will prevail in
`challenging claims 1–22 of the ’209 patent. We authorize an inter partes
`review to be instituted as to those claims. Our Decision to Institute in this
`proceeding is consistent with our institution of inter partes review in
`IPR2016-00237. IPR2016-00237, Paper 13 (“’237 Inst. Dec.”).
`
`Additionally, all parties have stipulated that, subject to our approval,
`Teva shall join the proceeding with Neptune designated as Lead Petitioner
`and that Teva will act as a silent understudy and will not file any papers or
`
`
`1 Neptune Generics, LLC (“Neptune”) v. Eli Lilly & Company (“Patent
`Owner”), IPR2016-00237.
`
`2
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`exhibits in the Joined Proceeding, except pro hac vice motions and
`administrative filings. Paper 8, 2–3. For the reasons provided below, we
`grant Teva’s Motion for Joinder and exercise our discretion to join Teva and
`the present proceeding to the IPR2016-00237 proceeding.
`
`Our factual findings and conclusions at this stage of the proceeding are
`based on the evidentiary record developed thus far. This decision to institute
`trial is not a final decision as to the patentability of claims for which inter
`partes review is instituted. Our final decision will be based on the full
`record developed during trial.
`
`
`A. Related Proceedings
`The ’209 patent is the subject of litigation in the Southern District of
`Indiana, including Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Case
`No. 1:10-cv-1376. Pet. 3–4.
`The ’209 patent also has been challenged in the following instituted
`inter partes reviews IPR2016-00237 and IPR2016-00240 by Neptune, and in
`IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to
`join the instituted reviews. Specifically, in addition to the current case,
`IPR2016-01190 (Apotex) and IPR2016-01335 (Wockhardt) seek to join
`IPR2016-00237.2 Also, IPR2016-01191 (Apotex), IPR2016-01337
`(Wockhardt) and IPR2016-01343 (Teva) seek to join IPR2016-00240.3
`
`
`2 Apotex’s request to join was granted. IPR2016-00237, Paper 31.
`3 Apotex’s request to join was granted. IPR2016-00240, Paper 33.
`
`3
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt)
`and IPR2016-01340 (Teva) seek to join IPR2016-00318. 4
`
`
`B. The ’209 Patent
`The ’209 patent claims priority benefit of a series of applications, the
`earliest of which was filed on June 30, 2000. Ex. 1001, 1:2–10.
`“As cancer cells actively proliferate, they require large quantities of
`DNA and RNA.” Declaration of W. Archie Bleyer, Ex. 1025 ¶ 67.
`Antifolates are a well-studied class of antineoplastic agents that inhibit one
`or several key folate-requiring enzymes of the thymidine and purine
`biosynthetic pathways. Ex. 1001, 1:19–20, 1:36–41. As antifolates interfere
`with DNA and RNA synthesis, antifolates are used as chemotherapeutic
`drugs to treat certain types of cancer. Ex. 1025 ¶ 67.
`A limitation on the use of antifolate drugs is “that the cytotoxic
`activity and subsequent effectiveness of antifolates may be associated with
`substantial toxicity for some patients.” Ex. 1001, 1:62–64. Homocysteine
`levels have been shown to be a predictor of cytotoxic events related to the
`use of certain antifolate enzyme inhibitors. Id. at 2:16–26. The ’209 patent
`states that folic acid has been shown to lower homocysteine levels. Id.
`Additionally, the patent states that it was known in the art to treat and
`prevent cardiovascular disease with a combination of folic acid and vitamin
`B12. Id. at 2:50–54.
`The ’209 patent describes “[a] method of administering an antifolate
`to a mammal in need thereof.” Ex. 1001, abstract. The method is said to
`
`
`4 Apotex et al.’s request to join was granted. IPR2016-00318, Paper 37.
`
`4
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`improve the therapeutic utility of antifolate drugs by administering a
`methylmalonic acid (“MMA”) lowering agent, such as vitamin B12, to the
`host undergoing treatment. Id. at 2:37–46. The ’209 patent also states that a
`combination of a MMA lowering agent, such as B12, and folic acid
`“synergistically reduces the toxic events associated with the administration
`of antifolate drugs.” Id. at 2:47–50.
`The term antifolate is said to encompass chemical compounds that
`inhibit at least one key folate-requiring enzyme of the thymidine or purine
`biosynthetic pathways. Id. at 4:28–34. Pemetrexed disodium is the most
`preferred antifolate for the ’209 patent. Id. at 4:28–43. Pemetrexed is also
`referred to in the art as a “multitargeted antifolate” (“MTA”). Ex. 1022,
`129, Abstract 620P.
`
`C. Illustrative Claims
`The ’209 patent contains twenty-two claims, all of which are
`challenged by Petitioner. Independent claim 1 is directed to a method for
`administering pemetrexed disodium to a patient in need thereof, where folic
`acid and a MMA lowering agent, such as B12, is administered, followed by
`administering an effective amount of the pemetrexed disodium. Independent
`claim 12 is written in a Jepson claim format, where the preamble defines the
`admitted prior art as administering pemetrexed disodium to a patient in need
`of a chemotherapeutic treatment. Independent claim 12 further recites
`specific dosage amounts of folic acid and vitamin B12 that are administered
`to the patient prior to the first administration of the pemetrexed disodium.
`Dependent claim 2 requires the MMA lowering agent of claim 1 to be
`vitamin B12 and the remaining dependent claims recite various dosages of
`
`5
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`folic acid and B12, and times for administering folic acid. Certain claims
`also require the administration of cisplatin to the patient.
`Claims 1 and 12 are illustrative of the challenged claims and are
`reproduced below:
`
`1. A method for administering pemetrexed disodium to a patient
`in need thereof comprising administering an effective amount
`of folic acid and an effective amount of a methylmalonic acid
`lowering agent followed by administering an effective
`amount of pemetrexed disodium, wherein
`the methylmalonic acid lowering agent is selected from
`the group consisting of vitamin B12, hydroxycobalamin,
`cyano-10-chlorocobalamin,
`aquocobalamin
`perchlorate,
`aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin,
`cyanocobalamin, or chlorocobalamin.
`
`12. An
`for administering pemetrexed
`improved method
`disodium to a patient in need of chemotherapeutic treatment,
`wherein the improvement comprises:
`a) administration of between about 350 μg and about 1000
`μg of folic acid prior to the first administration of pemetrexed
`disodium;
`b) administration of about 500 μg to about 1500 μg of
`vitamin B12, prior to the first administration of pemetrexed
`disodium; and
`c) administration of pemetrexed disodium.
`
`
`D. Prior Art Relied Upon
`
`In the ground challenging the claims, Petitioner relies on the
`following prior art:
`Niyikiza et al., MTA (LY231514): Relationship of vitamin metabolite
`profile, drug exposure, and other patient characteristics to toxicity,
`Annals of Oncology, Vol. 9, Suppl. 4, 1998, Abstract 609P, pg.
`126 (“Niyikiza”) (Ex. 1008)
`
`
`
`6
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`U.S. Patent No. 5,217,974 (“the ’974 Patent”) (Ex. 1009)
`
`European Patent Application No. 0,595,005 A1 (“EP 005”) (Ex.
`1010)
`
`Petitioner contends that the challenged claims are unpatentable under
`35 U.S.C. § 103 based on the following ground (Pet. 27–53):
`
`
`
`7
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`
`
`References
`
`Basis Claims challenged
`
`Niyikiza in view of the
`’974 Patent, and further in
`view of EP 005
`
`§ 103
`
`1–22
`
`
`
`
`II. ANALYSIS
`
`A.
`Claim Interpretation
`Petitioner identifies several claim terms in the challenged claims and
`provides definitions for those terms. Pet. 13–16. Patent Owner did not take
`a position on claim construction at this time.
`We determine that it is unnecessary to construe explicitly the claim
`terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem.
`Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be
`construed ‘to the extent necessary to resolve the controversy.’” (quoting
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999))).
`
`
`Section 103 Obviousness Challenge
`B.
`Petitioner raises one challenge based on 35 U.S.C. § 103. Generally,
`Petitioner contends that the challenged claims merely require administering
`a specific antifolate cancer drug, which was known to elevate a patient’s
`homocysteine levels, with compounds known to decrease homocysteine
`levels, folic acid and vitamin B12. Pet. 17–22.
`
`Petitioner relies upon Niyikiza as teaching one of ordinary skill
`in the art that MTA has activity in a variety of tumors and that
`
`8
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`toxicities resulting from treatment with MTA appear to be predictable
`from pretreatment homocysteine levels. Id. at 25–26 (citing Ex. 1008,
`126–27). Petitioner explains that it was known in the art that
`homocysteine could be reduced by two pathways, including
`remethylation by methionine synthase, which requires folate as a
`methyl donor and vitamin B12 as a cofactor for the remethylation
`reaction. Id. at 19. Petitioner states that the ’974 Patent teaches that
`the toxic effects of antifolate agents can be significantly reduced by
`pretreatment of a patient with folic acid. Id. at 29–33. Further,
`Petitioner relies upon EP 005 for its teaching that 1000 µg of folic
`acid and 500 µg of vitamin B12 are preferred daily dosage amounts.
`Id. at 44–45; Ex. 1025 ¶¶ 136–139. As noted above, Patent Owner
`waived filing a Preliminary Response.
`In Neptune IPR2016-00237, we instituted inter partes review on the
`same ground, same evidence, and same claims. We incorporate our analysis
`from our institution decision in IPR2016-00237. ’237 Inst. Dec. 11–19. For
`the same reasons, we determine that Petitioner has demonstrated a
`reasonable likelihood that it will prevail with respect to its challenge to
`claims 1–22 of the ’209 patent.
`
`C. Motion for Joinder
`Teva seeks to join the present proceeding with IPR2016-00237.
`Paper 3. Teva contends that joinder is appropriate as it will promote the
`efficient determination of patentability of the ’209 patent without prejudice
`to prior Petitioners (Neptune) or Patent Owner. Id. at 1. Teva states that the
`present Petition raises the same ground of unpatentability over the same
`prior art as those instituted by the Board in the IPR2016-00237. Id. at 3.
`
`9
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`Teva represents that it is willing to agree to consolidated filings with
`Neptune and that joinder will not affect the pending schedule in IPR2016-
`00237. Id. at 6–8.
`The parties in the present proceeding and IPR2016-00237 filed a Joint
`Notice of Stipulation Concerning Joinder. Paper 8. The Joint Stipulation
`generally provides that Neptune and Patent Owner do not oppose the joinder
`of the present proceeding with IPR2016-00237. Id. at 2. Patent Owner
`waives its right to file a preliminary response in the present proceeding. Id.
`As long as Neptune is not terminated as a party, Neptune will be Lead
`Petitioner and will conduct all argument and examination of witnesses for
`that side, and will submit all substantive written submissions for that side.
`Id. at 2–3. The Joint Stipulation further provides that Teva will act as a
`silent understudy. Id. at 3. The Joint Stipulation also provides that the
`presence of Joined Petitioners shall not be a basis for alteration of the
`schedule or time allotted for cross-examination, redirect, or re-cross
`examination of any witness. Id. at 4.
`We hold that Petitioner has satisfied the requirements of 35 U.S.C.
`§ 315(c) and we grant Petitioner’s Motion for Joinder. We exercise our
`discretion and join the present inter partes review, IPR2016-01341, to
`IPR2016-00237 subject to the conditions set forth in the Joint Stipulation.
`
`IV. CONCLUSION
`For the foregoing reasons, we determine that the information
`presented in the Petition establishes that there is a reasonable likelihood that
`Petitioner would prevail in demonstrating unpatentability of claims 1–22.
`The Board has not yet made a final determination of the patentability of any
`of claims 1–22 of the ’209 patent. Additionally, for the foregoing reasons,
`
`10
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`we join the present proceeding with IPR2016-00237 subject to the
`conditions set forth in the Joint Stipulation.
`
`V. ORDER
`Accordingly, it is:
`Ordered that Teva’s Motion for Joinder is granted;
`Further Ordered that the instant proceeding is instituted, joined with
`IPR2016-00237, and terminated under 37 C.F.R. § 42.72, and all further
`filings in the joined proceeding shall be made only in IPR2016-00237;
`Further Ordered that trial is instituted on the grounds of
`unpatentability on which trial was instituted in IPR2016-00237 and that
`there is no change to the Scheduling Order in IPR2016-00237;
`Further Ordered that the parties shall abide by the Joint Stipulation;
`Further Ordered that the case caption in IPR2016-00237 shall be
`changed to reflect the joinder of Teva as a Petitioner in accordance with the
`attached example; and,
`Further Ordered that a copy of this Decision shall be entered into the
`file of IPR2016-00237.
`
`
`
`
`11
`
`
`
`IPR2016-01341
`Patent 7,772,209 B2
`For Petitioner NEPTUNE:
`Sarah E. Spires
`Parvathi Kota
`237Neptune@skiermontderby.com
`
`For Petitioner TEVA:
`Gary J. Speier
`gspeier@carlsoncaspers.com
`Mark D. Schuman
`mschuman@carlsoncaspers.com
`Cynthia Lambert Hardman
`chardman@goodwinprocter.com
`
`For Patent Owner:
`Dov P. Grossman
`dgrossman@wc.com
`David M. Krinsky
`dkrinsky@wc.com
`James P. Leeds
`leeds_james@lilly.com
`Adam L. Perlman
`aperlman@wc.com
`
`12
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP.,
`TEVA PHARMACEUTICALS USA, INC.,
`and FRESENIUS KABI USA, LLC,
`
`Petitioners,
`
`v.
`
`ELI LILLY & COMPANY
`Patent Owner.
`____________
`
`Case IPR2016-002371
`Patent 7,772,209 B2
`____________
`
`
`1 Cases IPR2016-01190 and IPR2016-01341 have been joined with the
`instant proceeding.
`
`
`
`
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