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28 Reply: Patent Owners Surreply

Document IPR2019-00451, No. 28 Reply - Patent Owners Surreply (P.T.A.B. Mar. 10, 2020)
EX2031, 89:23-90:6. While Dr. Wermeling does not dispute that Neurelis’ formulation, Valtoco®, works to treat epileptic seizures, he nonetheless acknowledged that it behaves differently than other nasal formulations do when acute and ...
Nonetheless, Dr. Wermeling admits that Neurelis went a different route from other intranasal formulators and intentionally designed a slower absorbing intranasal formulation, completely counterintuitive to the need for a fast-absorbing ...
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No. 132 NOTICE by Mylan Inc., Mylan Pharmaceuticals Inc., Mylan, N.V. of Venue Decision by CAFC (Attachments: ...

Document Celgene Corporation v. Mylan Pharmaceuticals Inc. et al, 1:20-cv-00003, No. 132 (N.D.W.Va. Nov. 11, 2020)
The decision, attached as Exhibit A, affirms a decision by the District of New Jersey dismissing Mylan Pharmaceuticals Inc. and Mylan Inc. from Hatch- Waxman litigation in New Jersey, on the grounds that venue in New Jersey is improper as to those two entities.1 The Federal Circuit’s decision is pertinent to this Court’s prior decision (Dkt. No. 62) to deny Plaintiff’s motion to stay (Dkt. No. 51).
Shortly after this Court denied Plaintiff’s motion to stay these proceedings, the United States District Court for the District of New Jersey stayed proceedings in the parallel case pending there (the “New Jersey Suit”).
1 The Federal Circuit also reversed the decision below as to Mylan Laboratories Ltd. and remanded the case as to that entity, incorporated in India and not a party in this action, for further proceedings.
Pharm Inc., et al., Civil Action No. 2:19-cv-22231, ECF No. 47 (D.N.J.).2 In the New Jersey Suit, the district court stayed proceedings (including a ruling on the motion by the defendants to dismiss), expressly in order to obtain guidance from the Federal Circuit in the appeal that now has been resolved in the attached decision, finding that venue is improper as to Mylan Pharmaceuticals Inc. and Mylan Inc.
Respectfully submitted this 11th day of November 2020.
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75 Hearing Transcript: Hearing Transcript

Document IPR2017-01528, No. 75 Hearing Transcript - Hearing Transcript (P.T.A.B. Sep. 27, 2018)
I guess the question is, why were none of these submitted with the Petition? MR. CARSTEN: Why were -- JUDGE ANKENBRAND: Why did -- all of the recall documents, the MedWatch documents, the consumer complaints, none of those ...
There could be a number of other reasons -- for example, misuse, mishandling, microbial contamination -- and none of those would motivate a person of ordinary skill in the art to modify the formulation to add a surfactant.
DESAI: That's correct, but none of those drugs involve the same native aggregation mechanism that glargine 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 69 Case IPR2017-01526 (Patent 7,476,652) Case ...
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 81 Case IPR2017-01526 (Patent 7,476,652) Case IPR2017-01528 (Patent 7,713,930) And none of that information we had access to at the time we prepared that Petition.
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77 Hearing Transcript: Hearing Transcript

Document IPR2017-01526, No. 77 Hearing Transcript - Hearing Transcript (P.T.A.B. Sep. 27, 2018)
I guess the question is, why were none of these submitted with the Petition? MR. CARSTEN: Why were -- JUDGE ANKENBRAND: Why did -- all of the recall documents, the MedWatch documents, the consumer complaints, none of those ...
There could be a number of other reasons -- for example, misuse, mishandling, microbial contamination -- and none of those would motivate a person of ordinary skill in the art to modify the formulation to add a surfactant.
DESAI: That's correct, but none of those drugs involve the same native aggregation mechanism that glargine 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 69 Case IPR2017-01526 (Patent 7,476,652) Case ...
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 81 Case IPR2017-01526 (Patent 7,476,652) Case IPR2017-01528 (Patent 7,713,930) And none of that information we had access to at the time we prepared that Petition.
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73 Order Conduct of Proceeding: Authorizing Sur reply and Sur sur reply

Document IPR2017-01528, No. 73 Order Conduct of Proceeding - Authorizing Sur reply and Sur sur reply (P.T.A.B. Sep. 25, 2018)
In its motion, Patent Owner requested to strike, inter alia, Petitioner’s argument that “a [person of ordinary skill in the art] ‘would have understood the different storage requirements as suggesting a propensity for insulin glargine to aggregate.’” Paper 47, 2.
Specifically, Patent Owner argued that it was unable to respond with its own evidence as to the issues it raised in the motion to strike, including Petitioner’s in-use storage requirement argument.
After having considered Patent Owner’s due process assertion further, we were persuaded that additional briefing regarding the in-use storage requirement argument might be helpful in resolving the disputed issues in these proceedings.
Within one week, Patent Owner would file a six-page sur-reply limited to whether one of ordinary skill in the art would have understood the different storage requirements in the Lantus Label to suggest a propensity for insulin glargine to aggregate.
The parties agreed that they would work together with respect to scheduling and completing depositions in a timely manner in order to fit within the timeline they proposed.
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75 Order Conduct of Proceeding: Authorizing Sur reply and Sur sur reply

Document IPR2017-01526, No. 75 Order Conduct of Proceeding - Authorizing Sur reply and Sur sur reply (P.T.A.B. Sep. 25, 2018)
In its motion, Patent Owner requested to strike, inter alia, Petitioner’s argument that “a [person of ordinary skill in the art] ‘would have understood the different storage requirements as suggesting a propensity for insulin glargine to aggregate.’” Paper 47, 2.
Specifically, Patent Owner argued that it was unable to respond with its own evidence as to the issues it raised in the motion to strike, including Petitioner’s in-use storage requirement argument.
After having considered Patent Owner’s due process assertion further, we were persuaded that additional briefing regarding the in-use storage requirement argument might be helpful in resolving the disputed issues in these proceedings.
Within one week, Patent Owner would file a six-page sur-reply limited to whether one of ordinary skill in the art would have understood the different storage requirements in the Lantus Label to suggest a propensity for insulin glargine to aggregate.
The parties agreed that they would work together with respect to scheduling and completing depositions in a timely manner in order to fit within the timeline they proposed.
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98 Notice: Petitioners Mandatory Change of Information Notices

Document IPR2017-01528, No. 98 Notice - Petitioners Mandatory Change of Information Notices (P.T.A.B. Nov. 6, 2020)
Case IPR2017-01528 Patent No. 7,731,930 Pursuant to 37 C.F.R. § 42.8(a)(3), Petitioner Mylan Pharmaceuticals Inc. (“Mylan”), hereby submits the following updated notices in connection IPR2017- 01528.
Feb. 21, 2018) (dismissed); Sanofi -Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., No. 19-1451, 592 U.S. _ (Oct. 5, 2020) (cert.
1700 K Street N.W., 5th Floor, Washington, DC 20006-3817 Tel.
Electronic Service Mylan consents to electronic service by email at the email addresses provided above.
Date: 6 November 2020 Respectfully submitted, /Richard Torczon/ Richard Torczon Reg. No. 34,448 Case IPR2017-01528 Patent No. 7,731,930
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100 Notice: Petitioners Mandatory Change of Information Notices

Document IPR2017-01526, No. 100 Notice - Petitioners Mandatory Change of Information Notices (P.T.A.B. Nov. 6, 2020)
Case IPR2017-01526 Patent No. 7,476,652 Pursuant to 37 C.F.R. § 42.8(a)(3), Petitioner Mylan Pharmaceuticals Inc. (“Mylan”), hereby submits the following updated notices in connection with IPR2017- 01526.
Feb. 21, 2018) (dismissed); Sanofi -Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., No. 19-1451, 592 U.S. _ (Oct. 5, 2020) (cert.
1700 K Street N.W., 5th Floor, Washington, DC 20006-3817 Tel.
Electronic Service Mylan consents to electronic service by email at the email addresses provided above.
Date: 6 November 2020 Respectfully submitted, /Richard Torczon/ Richard Torczon Reg. No. 34,448 Case IPR2017-01526 Patent No. 7,476,652
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26 Other Not for motions: PARTIES JOINT SUBMISSION OF PATENT OWNERS ID...

Document IPR2019-00451, No. 26 Other Not for motions - PARTIES JOINT SUBMISSION OF PATENT OWNERS IDENTIFICATION OF NEW ARGUMENTS AND PETITIONERS RESPONSES THERETO (P.T...

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71 Order: Order Adjusting Oral Hearing Time

Document IPR2017-01528, No. 71 Order - Order Adjusting Oral Hearing Time (P.T.A.B. Aug. 29, 2018)

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73 Order: Order Adjusting Oral Hearing Time

Document IPR2017-01526, No. 73 Order - Order Adjusting Oral Hearing Time (P.T.A.B. Aug. 29, 2018)

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70 Order: Trial Hearing37 CFR § 4270

Document IPR2017-01528, No. 70 Order - Trial Hearing37 CFR § 4270 (P.T.A.B. Aug. 27, 2018)

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72 Order: Trial Hearing37 CFR § 4270

Document IPR2017-01526, No. 72 Order - Trial Hearing37 CFR § 4270 (P.T.A.B. Aug. 27, 2018)

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45 Notice of Appeal: Patent Owner Neurelis, Incs Notice of Appeal

Document IPR2019-00451, No. 45 Notice of Appeal - Patent Owner Neurelis, Incs Notice of Appeal (P.T.A.B. Oct. 8, 2020)

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94 Motion: Patent Owners Motion for Withdrawal of Counsel

Document IPR2017-01528, No. 94 Motion - Patent Owners Motion for Withdrawal of Counsel (P.T.A.B. Jan. 29, 2020)

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