Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 1 of 32 PageID #: 9406
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`UNITED STATES DISTRICT COURT
`DISTRICT OF DELAWARE
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`SANOFI-AVENTIS U.S. LLC and
`SANOFI-AVENTIS DEUTSCHLAND
`GMBH,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`C.A. No. 14-113-RGA-MPT
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`PRE-TRIAL ORDER EXHIBIT 3
`ELI LILLY’S STATEMENT OF CONTESTED FACTS
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 2 of 32 PageID #: 9407
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`C.
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`D.
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`The Asserted Formulation Patents ...................................................................................... 1
`A.
`Specifications of the Asserted Formulation Patents .............................................. 1
`B.
`Asserted Claims of the Formulation Patents .......................................................... 2
`Noninfringement of the Asserted Formulation Patents ...................................................... 3
`A.
`Sanofi’s Vial and Cartridge Formulations ............................................................. 3
`B.
`Lilly’s NDA Product Does Not Meet the “At Least One Chemical Entity”
`of the Claimed Pharmaceutical Formulation Limitation ....................................... 5
`Sanofi Has Failed to Prove that Lilly’s NDA Product is a Pharmaceutical
`Formulation Comprising
` .......................... 6
`Sanofi Has Failed to Prove that the Lilly NDA Product is a Pharmaceutical
`Formulation Comprising
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`..................................................................................................... 7
`Sanofi Has Failed to Prove that Lilly’s NDA Product is a Pharmaceutical
`Formulation Comprising
` ........... 9
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`Sanofi’s Prior Allegations Regarding
`from the Drug Substance............................................................................ 9
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`E.
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`F.
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`G.
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`III.
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`
` ............................................... 10
` ........ 11
`H.
`The Asserted Device Patents ............................................................................................ 14
`A.
`Asserted Claims of the Device Patents ................................................................ 14
`IV. Noninfringement of the Asserted Device Patents ............................................................. 16
`A.
`Sanofi Has Failed to Prove that Lilly’s
` Uses A Drive
`Sleeve That is Releasably Connected to a Dose Dial Sleeve............................... 16
`Sanofi Has Failed to Prove that Lilly’s
` Uses A
`“Tubular” Clutch .................................................................................................. 16
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`B.
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`- i -
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 3 of 32 PageID #: 9408
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`TABLE OF CONTENTS
`(continued)
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`Page
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`C.
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`B.
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`B.
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`V.
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`VI.
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` Uses a Clutch
`Sanofi Has Failed to Prove that Lilly’s
`Mechanism “Located Between” the Dose Dial Sleeve and the Drive
`Sleeve ................................................................................................................... 17
`The Asserted Formulation Patents Are Invalid for Lack of Written Description ............. 18
`A.
`The Specifications of the ʼ652 and ʼ930 Patents Do Not Support Claims
`So Broad as to Cover
`
` .................................................................... 18
`The Specifications Do Not Support Claims Covering All “Esters and
`Ethers of Polyhydric Alcohols” ........................................................................... 19
`The Asserted Device Patents Are Invalid for Obviousness .............................................. 20
`A.
`The Asserted Claims are Invalid in Light of the Prior Art, Including
`Steenfeldt-Jensen and Møller ............................................................................... 20
`The Alleged Commercial Success of Lantus® Does Not Demonstrate
`Nonobviousness of the Asserted Claims of the Asserted Device Patents ........... 23
`Other Secondary Considerations.......................................................................... 26
`C.
`VII. The Asserted Device Patents Are Unenforceable Based on Prosecution Laches ............. 27
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`- ii -
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 4 of 32 PageID #: 9409
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`Pursuant to Local Rule 16.3(c)(4), Defendant Eli Lilly and Company (“Lilly”) submits
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`the following statement of the issues of fact that remain to be litigated. This statement is not
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`exhaustive, and is based on Lilly’s current understanding of the arguments Plaintiffs Sanofi-
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`Aventis U.S. LLC and Sanofi-Aventis Deutschland GmbH (collectively, “Sanofi”) are likely to
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`make at trial, based on the pleadings, discovery, and expert reports to date. To the extent Sanofi
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`introduces different or additional facts or alleged facts in support of any claim or defense it
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`asserts in this case, Lilly reserves the right to contest such facts or alleged facts, and to present
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`any and all rebuttal evidence in response.
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`I.
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`THE ASSERTED FORMULATION PATENTS
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`A.
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`1.
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`Specifications of the Asserted Formulation Patents
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`It is undisputed that the specifications of the ʼ652 and ʼ930 patents describe the
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`invention of the patents as being directed to “a pharmaceutical formulation”.
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`2.
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`The specifications of the ʼ652 and ʼ930 patents describe the invention of the
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`patents as being directed to “the addition” of non-ionic surfactants to “increase the stability” of
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`acidic insulin preparations.
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`3.
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`The specifications of the ʼ652 and ʼ930 patents describe the concentration of
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`surfactant present in the pharmaceutical composition to be 5-200 µg/mL.
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`4.
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`The specifications of the ʼ652 and ʼ930 patents do not describe
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` in the context of stabilizing protein or insulin formulations.
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`5.
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`The specifications of the ʼ652 and ʼ930 patents do not describe
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` in the context of stabilizing protein or insulin formulations.
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`6.
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`The specifications of the ʼ652 and ʼ930 patents do not describe
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` in the context of stabilizing protein or insulin formulations.
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`7.
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`The specifications of the ʼ652 and ʼ930 patents do not describe the use of
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`surfactant concentrations below 5 µg/mL as stabilizing protein or insulin formulations.
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`8.
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`The specifications of the ʼ652 and ʼ930 patents do not describe surfactant
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`concentrations below 1 µg/mL.
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`9.
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`The specifications of the ʼ652 and ʼ930 patents do not describe experimental
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`results with any non-ionic surfactant besides polysorbate 20 and polysorbate 80.
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`B.
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`10.
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`Asserted Claims of the Formulation Patents
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`It is undisputed that the asserted claims of the ʼ652 patent are all directed to a
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`“pharmaceutical formulation” comprising insulin glargine and either: (1) “at least one chemical
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`entity chosen from polysorbate 20 and polysorbate 80” or (2) “at least one chemical entity
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`chosen from polysorbate and poloxamers,” amongst other ingredients.
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`11.
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`It is undisputed that the asserted claims of the ʼ930 patent are all directed to a
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`“pharmaceutical formulation” comprising insulin glargine and “at least one chemical entity
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`chosen from esters and ethers of polyhydric alcohols”, amongst other ingredients.
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`12.
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`The asserted claims of the ʼ652 and ʼ930 patents all describe the addition of
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`certain non-ionic surfactants to a pharmaceutical formulation.
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`13.
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`The specifications of the ʼ652 and ʼ930 patents do not support claims asserted to
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`cover trace levels of polysorbates (including polysorbate 20 or 80), poloxamers, or esters or
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`ethers of polyhydric alcohols alleged to be
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`14.
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`The specifications of the ʼ652 and ʼ930 patents do not contain language to support
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`claims to trace levels of polysorbates (including polysorbate 20 or 80), poloxamers, or esters or
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`ethers of polyhydric alcohols that do not provide a stabilizing effect.
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`15.
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`The specifications of the ʼ652 and ʼ930 patents do not contain language to support
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`claims to the use of every compound that constitutes an ester or ether of a polyhydric alcohol in a
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`pharmaceutical formulation of insulin glargine.
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`16.
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`The specifications of the ʼ652 and ʼ930 patents do not contain language to support
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`claims to the use of every compound that constitutes an ester or ether of a polyhydric alcohol as a
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`stabilizer for a pharmaceutical formulation of insulin glargine.
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`17.
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`A person of ordinary skill in the art would not consider
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`18.
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`A person of ordinary skill in the art would not consider the trace amount of a
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`substance as asserted by Sanofi to be
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` to be part of a pharmaceutical formulation.
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`19.
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`II.
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`NONINFRINGEMENT OF THE ASSERTED FORMULATION PATENTS
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`A.
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`20.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 7 of 32 PageID #: 9412
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`21.
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`It is undisputed that Sanofi markets insulin glargine drug products under the trade
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`name Lantus®, that Lantus® was approved by the FDA in April 2000, that Sanofi began selling
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`Lantus® in the United States in May 2001.
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`22.
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`It is undisputed that the original Lantus® formulation was sold in 10 mL vials and
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`consisted of “100 IU (3.6378 mg) insulin glargine, 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol
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`85%, and water for injection,” with pH to be adjusted by addition of aqueous solutions of
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`hydrochloric acid and sodium hydroxide.
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`23.
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`24.
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`It is undisputed that Sanofi filed provisional application No. 60/409,338, from
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`which both the ʼ652 and ʼ930 patents claim priority, on September 9, 2002.
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`25.
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`It is undisputed that Sanofi received FDA approval to modify the marketed Lantus
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`10 mL vial presentation to include polysorbate 20 as a stabilizer in on March 15, 2005.
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`26.
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`It is undisputed that Sanofi has also sold Lantus® in 3 mL cartridges since at least
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`2005.
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`27.
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`The cartridge version of Lantus® contains the formulation approved by the FDA
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`in April 2000, which is the same formulation as the original Lantus® vials. Neither polysorbate
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`20, nor any other non-ionic surfactant, is listed as an ingredient of the Lantus® cartridge
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`formulation.
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`28.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 8 of 32 PageID #: 9413
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`29.
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`.
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`30.
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`Sanofi has taken the position that its 3 mL cartridge form of Lantus is not covered
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`by the ʼ652 and ʼ930 patents. It is undisputed that the ʼ652 and ʼ930 patents are not listed in the
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`Orange Book for the 3 mL cartridge form of Lantus®.
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`B.
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`Lilly’s NDA Product Does Not Meet the “At Least One Chemical Entity” of
`the Claimed Pharmaceutical Formulation Limitation
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`31.
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`Lilly submitted NDA No. 205-692 seeking FDA approval to market an insulin
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`glargine formulation in 3 mL cartridges. Lilly’s NDA defines the drug product that Lilly may
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`sell after it receives FDA approval.
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`32.
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`33.
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`The ingredients of Lilly’s proposed product are listed in its NDA.
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`34.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 9 of 32 PageID #: 9414
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`35.
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`C.
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`Sanofi Has Failed to Prove that Lilly’s NDA Product is a Pharmaceutical
`Formulation Comprising
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`36.
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`It is undisputed that the
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`37.
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`It is undisputed that the
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`38.
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`39.
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`40.
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`41.
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`Sanofi alleges Lilly’s NDA product contains
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 10 of 32 PageID #:
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`Sanofi Has Failed to Prove that the Lilly NDA Product is a Pharmaceutical
`Formulation Comprising
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`42.
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`Sanofi has also failed to show that
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`43.
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`44.
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`Literature indicates
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`45.
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`D.
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`46.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 11 of 32 PageID #:
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`47.
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`48.
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`49.
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`50.
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`51.
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`52.
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`53.
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`Literature indicates that
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`54.
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`Sanofi has failed to prove that
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`55.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 12 of 32 PageID #:
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`57.
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`Sanofi did not list the vial formulation patents in the Orange Book for Sanofi’s
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`Lantus cartridge product.
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`58.
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`Sanofi did not produce any testing of Lilly’s NDA product with regard to its
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`allegation of infringement based on
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`59.
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`E.
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`Sanofi Has Failed to Prove that Lilly’s NDA Product is a Pharmaceutical
`Formulation Comprising the Claimed Substances Based
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`60.
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`Sanofi alleges in the parties’ joint pretrial order (Exhibit 2) that
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`61.
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`Sanofi has never identified in any of its discovery responses, infringement
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`contentions, expert reports, or court filings any substance that it alleges constitutes infringement
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`62.
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`Sanofi does not identify
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` in the parties’ joint pretrial order.
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`F.
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`Sanofi’s Prior Allegations Regarding Introduction of
`from the Drug Substance
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`63.
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`In its infringement contentions and expert reports, Sanofi alleged that
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`patent claims, and that this substance was present in Lilly’s NDA product because it is an
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` within the scope of the ’930
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`64.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 13 of 32 PageID #:
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`65.
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`Sanofi’s expert, Dr. Randolph, has taken the position that unless it is shown that
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`66.
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`Dr. Randolph also testified that he could not opine as to whether all the
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` Sanofi did not produce documents to establish that it
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` in accordance with Dr. Randolph’s assertions.
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`67.
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`In the parties’ joint pretrial order, Sanofi does not assert that Lilly’s NDA Product
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`contains
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` or that this is a basis for an infringement contention. To the
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`extent Sanofi contends that Lilly’s NDA Product infringes because of the presence of
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`, the Asserted Claims of Sanofi’s
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`’930 patent would be invalid as anticipated by Sanofi’s own prior art Lantus formulation.
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`G.
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`68.
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`69.
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`70.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 14 of 32 PageID #:
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`71.
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`72.
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`73.
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`74.
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`H.
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`75.
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`76.
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`77.
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`Claimed substances were not identified
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`Sanofi Has Not Proven Infringement by Its Reliance on
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 15 of 32 PageID #:
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`78.
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` Dr. Nuckolls reports that
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 16 of 32 PageID #:
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`82.
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`83.
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`84.
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`85.
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`Prior to
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`86.
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`Dr. Nuckolls cannot demonstrate that the compound he asserts to be
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`87.
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`88.
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`Sanofi asserts for the first time in the parties’ pretrial order that Lilly’s NDA
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`product infringes the ’930 patent based on the presence of
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 17 of 32 PageID #:
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`Sanofi did not raise this theory of infringement in any of its previous discovery responses,
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`infringement contentions, expert reports, or court filings.
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`89.
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`Sanofi has failed to show that Lilly is seeking approval to sell a product
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`containing
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`90.
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`Sanofi has failed to show that Lilly’s NDA product as approved will contain
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`III. THE ASSERTED DEVICE PATENTS
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`A.
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`91.
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`Asserted Claims of the Device Patents
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`Sanofi alleges Lilly’s
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` infringes claims 1, 2, 4, 5, 6, 7, 8 and 10
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`of U.S. Patent No. 8,603,044 (“the ’044 patent”). Claims 2, 4, 5, 6, 7, 8 and 10 of the ʼ044 patent
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`depend from claim 1 of the ʼ044 patent either directly or through intervening dependent claims.
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`92.
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`Sanofi alleges Lilly’s
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` infringes claim 1 of U.S. Patent No.
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`8,679,069 (“the ’069 patent”). Claim 1 of the ʼ069 patent is an independent claim.
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`93.
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`Sanofi alleges Lilly’s
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` infringes claims 2 and 3 of U.S. Patent
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`No. 8,556,864 (“the ’864 Patent”). Claim 3 of the ʼ864 patent depends from claim 2 of the ʼ864
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`patent.
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`94.
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`The asserted claims of the ’044 and ’069 patents require, inter alia, a “housing
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`part for a medication dispensing apparatus” that includes a “drive sleeve” threadedly connected
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`with a piston rod and a “dose dial sleeve” threadedly connected to the housing, in which the dose
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 18 of 32 PageID #:
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`dial sleeve and the drive sleeve are “releasably connected.” The’044 and ’069 patent claims also
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`require a “tubular clutch.”
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`95.
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`The asserted claims of the ’864 patent require, inter alia, a “drive mechanism for
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`use in a drug delivery device” that includes a “drive sleeve” and a “dose dial sleeve” that is
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`threadedly connected to the housing, in which the dose dial sleeve and the drive sleeve are
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`“releasably connected.” The ’864 patent claims also require a “clutch mechanism located
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`between the dose dial sleeve and the drive sleeve.”
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`96.
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`The asserted patents describe the operation of the patented device in two phases:
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`dose setting and injection.
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`97.
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`During dose setting and injection phases, the patented device uses a releasable
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`connection between the drive sleeve and dose dial sleeve via a clutch located between the two
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`sleeves.
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`98. When setting a dose in the patented device, the user rotates the dose dial grip,
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`which is attached to the dose dial sleeve. The dose dial sleeve and drive sleeve are connected to
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`each other in this phase by the clutch sandwiched between the two sleeves. The dose dial sleeve
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`and the drive sleeve rotate together during dose setting, with the dose dial sleeve climbing the
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`thread of the housing and the drive sleeve climbing the thread of the piston rod at the same rate.
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`99. When injecting a dose with the patented device, the user depresses the injection
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`button, which disengages the clutch, and the drive sleeve and dose dial sleeve are thereby
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`disconnected from each other. With the drive sleeve and dose dial sleeve disconnected from
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`each other, the dose dial sleeve rotates freely back into the housing during injection, while the
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`drive sleeve is prevented from rotating and moves only axially, pushing the piston rod, which
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`rotates forward to deliver the dose.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 19 of 32 PageID #:
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`100. Lilly’s
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` does not infringe the asserted claims of the ʼ044, ʼ069,
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`or ’864 patents because
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` does not contain at least the following limitations
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`(1) “a drive sleeve releasably connected to the dose dial sleeve,” a (2) “tubular clutch,” and (3) a
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`“clutch mechanism located between the dose dial sleeve and the drive sleeve.”
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`IV. NONINFRINGEMENT OF THE ASSERTED DEVICE PATENTS
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` Uses A Drive
`Sanofi Has Failed to Prove that Lilly’s
`Sleeve That is Releasably Connected to a Dose Dial Sleeve
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`A.
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`101.
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`
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`102.
`
`It is undisputed that the Court construed the term “drive sleeve” to mean “[a]n
`
`essentially tubular component of essentially circular cross-section which is further releasably
`
`connected to the dose dial sleeve.” (Markman Opinion at 10.)
`
`103.
`
`It is undisputed that the Court construed the term “a drive sleeve releasably
`
`connected to the dose dial sleeve” to mean “[a] drive sleeve that is reversibly joined to the dose
`
`dial sleeve, which allows coupling and decoupling.” (Markman Opinion at 11-12.)
`
`104.
`
`It is undisputed that the patented device uses a releasable connection between the
`
`drive sleeve and the dose dial sleeve.
`
`105.
`
`
`
`
`
`
`
`B.
`
`Sanofi Has Failed to Prove that Lilly’s
`Clutch
`
` Uses A “Tubular”
`
`106. Sanofi has failed to show that the
`
` has a tubular clutch as
`
`claimed, as required by the asserted claims of the ’044 and ’069 patents.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 20 of 32 PageID #:
` 9425
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`107. The Court has construed “tubular” in the term “tubular clutch” to mean “a clutch
`
`having the shape of a hollow cylindrical structure.” (Markman Opinion at 13.)
`
`108.
`
`It is undisputed that the asserted patents describe the patented device as having a
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`“clutch means 60 [that] is generally cylindrical . . . .”
`
`109.
`
`110.
`
`
`
`
`
`
`
`
`
`C.
`
`® Uses a Clutch
`Sanofi Has Failed to Prove that Lilly’s
`Mechanism “Located Between” the Dose Dial Sleeve and the Drive Sleeve
`
`111. Sanofi has failed to show that the
`
` uses a clutch mechanism
`
`located between
`
`, as required by the asserted claims of the ’864 patent.
`
`112. The Court concluded that no construction was necessary for the term “located
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`between” and that it would have its “plain and ordinary meaning.” (Markman Opinion at 13-14.)
`
`113. With respect to Sanofi’s proposed construction—“A clutch mechanism spatially
`
`positioned to engage with the dose dial sleeve and the drive sleeve”—the Court stated that
`
`Sanofi’s “‘spatially positioned’ language is vague and unhelpful to construction” and it did not
`
`adopt Sanofi’s proposed construction. (Id. at 14.)
`
`114. When describing the location of the clutch, the asserted ’864 patent states that the
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`clutch is located radially between the drive sleeve and the dose dial sleeve: “A clicker 50 and a
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`clutch 60 are disposed about the drive sleeve 30, between the drive sleeve 30 and a dose dial
`
`sleeve 70 . . . .”
`
`115. The asserted ’864 patent describes the clutch in the patented embodiment in
`
`relation to its physical location.
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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 21 of 32 PageID #:
` 9426
`
`
`116.
`
`
`
`
`
`V.
`
`THE ASSERTED FORMULATION PATENTS ARE INVALID FOR LACK OF
`WRITTEN DESCRIPTION
`
`A.
`
`The Specifications of the ʼ652 and ʼ930 Patents Do Not Support Claims So
`Broad as to Cover the Trace Amounts of Compounds Asserted by Sanofi as
`Constituting Infringement
`
`117. A person of ordinary skill in the art with respect to the asserted claims of the ʼ652
`
`and ʼ930 patents would have a Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a
`
`similar field, with a few years of experience in the development of pharmaceutical formulations,
`
`including protein formulations.
`
`118. The specifications of the ʼ652 and ʼ930 patents do not demonstrate to a person of
`
`ordinary skill in the art that Dr. Lill,
`
`
`
`, or Dr. Brunner-Schwarz, was in possession of an alleged invention covering trace
`
`amounts of a compound that is alleged to be a component of a non-ionic surfactant in an insulin
`
`glargine formulation.
`
`119. The specifications of the ʼ652 and ʼ930 patents define the alleged invention as
`
`being the use of a non-ionic surfactant in an insulin formulation. The specifications further
`
`disclose that the surfactant concentration range for the alleged invention is 5-200 µg/mL.
`
`Specifically, the specifications state, “The surfactants are present in a concentration of 5-200
`
`µg/mL, preferably of 5-120 µg/mL and particularly preferably of 20-75 µg/mL”.
`
`120. The lowest concentration discussed in the specifications of the ʼ652 and ʼ930
`
`patents is the use of “Insulin glargine + 0.001 mg/mL of polysorbate 20” and “Insulin glargine +
`
`0.001 mg/mL of polysorbate 80” in Example 3. 0.001 mg/mL is equivalent to 1 µg/mL.
`
`- 18 -
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 22 of 32 PageID #:
` 9427
`
`
`121. Example 3 in the specifications of the ʼ652 and ʼ930 patents does not contain any
`
`control. It does not and cannot show that 0.001 mg/mL (1 µg/mL or 1 ppm) of polysorbate has
`
`any stabilizing effect on an insulin glargine formulation.
`
`122.
`
`
`
`
`
`
`
`
`
`
`
`123. The specifications of the ʼ652 and ʼ930 patents indicate the invention is the
`
`addition of non-ionic surfactants to stabilize insulin formulations. The specification does not
`
`support claims so broad as to allegedly cover the trace amounts of substance which Sanofi
`
`contends constitutes infringement in this action. Claims of such broad scope fail the requirement
`
`of adequate written description.
`
`B.
`
`The Specifications Do Not Support Claims Covering All “Esters and Ethers
`of Polyhydric Alcohols”
`
`124. The specifications of the ʼ652 and ʼ930 patents would not have demonstrated to a
`
`person of ordinary skill in the art that Dr. Lill, or Dr. Brunner-Schwarz
`
`
`
`
`
`
`
`
`
`125. The specifications of the ʼ652 and ʼ930 patents do not describe the use of any
`
`non-ionic surfactant in stabilizing an insulin glargine formulation except for polysorbate 20 and
`
`polysorbate 80.
`
`- 19 -
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 23 of 32 PageID #:
` 9428
`
`
`126. Polysorbate 20 and polysorbate 80 are insufficient species to support Sanofi’s
`
`broad claims to all “esters and ethers of polyhydric alcohols.”
`
`127.
`
`128.
`
`
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`
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`
`
`
`
`
`
`
`
`
`
`129.
`
` The alleged inventors could not even testify competently about the full scope of
`
`esters and ethers of polyhydric alcohol in the context of an insulin glargine formulation.
`
`VI.
`
`THE ASSERTED DEVICE PATENTS ARE INVALID FOR OBVIOUSNESS
`
`A.
`
`The Asserted Claims are Invalid in Light of the Prior Art, Including
`Steenfeldt-Jensen and Møller
`
`130. Sanofi did not invent injector pens or their components. The prior art is crowded
`
`with injector pens.
`
`131. The operations of injector pen devices in the prior art involve mechanical
`
`components operating in a predictable fashion that function in expected ways.
`
`132. Steenfeldt-Jensen (U.S. Patent No. 6,004,297) discloses an injector pen that
`
`includes a dose dial sleeve and a drive sleeve.
`
`133. The Steenfeldt-Jensen dose dial sleeve surrounds at least a portion of hooks (34),
`
`and the upper portion of the injection button (dose dial grip) is disposed near a proximal end of
`
`the dose dial sleeve. (Steenfeldt-Jensen, 7:52-57, Figs. 6-10.)
`
`- 20 -
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 24 of 32 PageID #:
` 9429
`
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`134. Steenfeldt-Jensen discloses that, during dose dialing, the dose dial sleeve and
`
`drive sleeve rotate together along the thread of the housing and the thread of the piston rod,
`
`respectively.
`
`135. Steenfeldt-Jensen discloses that, during injection, the drive sleeve does not rotate
`
`but moves axially, and the dose dial sleeve rotates freely back to its original position.
`
`136. Steenfeldt-Jensen discloses that, during the dose dialing and injection phases, the
`
`drive sleeve and dose dial sleeve are rotationally coupled during dose dialing and rotationally
`
`uncoupled during dose injection.
`
`137. Steenfeldt-Jensen discloses that rotation of the injection button and drive sleeve is
`
`prevented during injection, with grooves (39) engaging with the clicker (protrusions (38)) inside
`
`the housing. (Id. at 8:13-30.)
`
`138.
`
`It is undisputed that Sanofi previously argued that Steenfeldt-Jensen discloses a
`
`clutch. (C.A. No. 07-306 (D.N.J.), D.I. 206 at 21 (“As shown in the claim charts, both
`
`embodiments of [Steenfeldt-Jensen] Figs. 6-10 and Figs. 11-13 disclose a device having a clutch,
`
`dose dial sleeve, and drive sleeve.”))
`
`139. Møller (U.S. Patent No. 7,241,278) discloses a tubular clutch that couples a dose
`
`dial sleeve and a drive sleeve during dose setting, allowing the two to rotate together as the dose
`
`is set, and that decouples the dose dial sleeve from the drive sleeve during injection, allowing the
`
`dose dial sleeve to rotate freely back to the zero position, while the drive sleeve is prevented
`
`from rotating and moves only axially to advance the piston rod.
`
`140. Møller’s tubular clutch location in between the dose dial sleeve and drive sleeve
`
`accomplishes this coupling/uncoupling.
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 25 of 32 PageID #:
` 9430
`
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`141. Møller discloses that, during injection, the drive sleeve is prevented from rotating
`
`and can only move axially because there is no longer enough axial space for the ring (125) and
`
`teeth (124) to move down and pass the teeth on the clutch.
`
`142. The modification of Steenfeldt-Jensen’s clutching function to use the tubular
`
`clutch structure of Møller is an obvious design choice. There are no differences between the
`
`combination of elements in the prior art and the subject matter of the Asserted Claims of the
`
`Asserted Device Patents.
`
`143. The concepts of mechanically linking the injection button and the piston rod for
`
`operation of the device, transforming linear motion of a drive sleeve during injection to push a
`
`piston rod to deliver a dose, and using a clutch component to either engage or disengage a
`
`coupling of components during dose dialing or injecting, were established in the art of injector
`
`pens and mechanical devices more generally.
`
`144. Novo’s FlexPen was a dial-a-dose device, included a large, clear dose indicator
`
`window to help with accurate dose setting by the dose dial and allowed for dose correction by
`
`dialing forward and/or backward, had a dosing mechanism providing a mechanical advantage,
`
`and contained a clicker comprising flexible arms with tooth members and at least one spline.
`
`145. Burroughs incorporates “a clutching device for engaging and disengaging a
`
`generally cylindrical internally threaded nut” and a radial stop to prevent a user from dialing a
`
`too-high dose.
`
`146.
`
`It is undisputed that Sanofi previously admitted that there are a finite number of
`
`acceptable pen injector mechanisms in the crowded pen injector field. (Novo Nordisk A/S v.
`
`Sanofi Aventis U.S. LLC, 07-cv-03206 (D.N.J. Feb. 4, 2008) (Novo Litigation, D.I. 206 at 3)
`
`- 22 -
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 26 of 32 PageID #:
` 9431
`
`
`(“Not only are there a limited number of acceptable mechanisms to link the injection button to
`
`the piston rod, but these limited options are already disclosed in numerous patents.”)
`
`147. When there is a design need or market pressure to solve a problem and there are a
`
`finite number of identified, predictable solutions, a person of ordinary skill in the art has good
`
`reason to pursue the known options within his or her technical grasp.
`
`148. One of ordinary skill in the art may find it obvious to combine pieces of prior art
`
`to gain the commonly understood benefits such as decreased size, increased reliability, simplified
`
`operation, and reduced cost.
`
`149. A person of ordinary skill in the art with respect to the asserted claims of the ’864,
`
`’044, and ’069 patents would have a bachelor’s degree in Mechanical Engineering or equivalent
`
`and a minimum of four years’ experience with design of injector pens or other
`
`mechanical/electro-mechanical drug delivery devices.
`
`150. A person of skill in the art would draw on prior art teachings that disclosed both
`
`disposable and reusable devices.
`
`151. From the perspective of one of skill in the art, improving the Steenfeldt-Jensen
`
`clutching function using a clutch shaped like that in Møller would be simple and predictable, and
`
`would readily be seen as working for its intended purpose.
`
`B.
`
`The Alleged Commercial Success of Lantus® Does Not Demonstrate
`Nonobviousness of the Asserted Claims of the Asserted Device Patents
`
`152.
`
`In 1997, Sanofi was granted U.S. Patent No. 5,656,722, which covers insulin
`
`glargine, pharmaceutical compositions thereof, and the treatment of diabetes. Sanofi listed the
`
`’722 patent in the Orange Book as covering its Lantus® and Lantus® SoloSTAR® products. The
`
`’722 patent expired in August 2014, and had pediatric exclusivity extending its regulatory
`
`exclusivity to February 2015. The ’722 patent granted Sanofi exclusive rights with respect to
`
`- 23 -
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`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 27 of 32 PageID #:
` 9432
`
`
`insulin glargine formulations, including all the Lantus® products, from the time of their launch in
`
`May 2001 through expiration of the regulatory exclusivity in February 2015.
`
`
`
`153.
`
`
`
`154.
`
`155.
`
`156.
`
`157.
`
`158.
`
`159.
`
`
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`
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`
`
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`- 24 -
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-3 Filed 09/25/15 Page 28 of 32 PageID #:
` 9433
`
`
`
`
`
`
`160.
`
`161.
`
`162.
`
`
`
`163.
`
`164.
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`