Therefore, we exercise our discretion to issue a single order to be filed in each case.

Pursuant to 37 C.F.R. § 42.10(e), Patent Owner filed a Motion for Withdrawal of Counsel in each of the above-listed proceedings (collectively “Motions”).

We instruct Patent Owner to file updated mandatory notices removing Mr. Pereira as back-up counsel.

Pereira is withdrawn as counsel for Patent Owner in the above-listed proceedings; and FURTHER ORDERED that Patent Owner shall file an updated mandatory notice in each of the above-referenced proceedings removing Mr. Pereira as back-up counsel in accordance with 37 C.F.R. § 42.8(b)(3).

Jeffrey Guise Douglas Carsten Richard Torczon Lorelei Westin Clark Lin Alina Litoshyk Nicole W. Stafford Elham Steiner

In each Final Decision, we denied Petitioner’s motion to seal portions of its sur- sur-reply that reference Exhibits 2065–2069 without prejudice to Patent Owner.

That standard includes a showing that “(1) the information sought to be sealed is truly confidential, (2) a concrete harm would result upon public disclosure, (3) there exists a genuine need to rely in the trial on the specific information sought to be sealed, and (4) on balance, an interest in maintaining confidentiality outweighs the strong public interest in having an open record.” Argentum Pharms.

In particular, Patent Owner represents that Petitioner’s sur-sur-reply “summarizes and quotes confidential submissions made by Hoechst Marion Roussel to, and records of correspondence with, the FDA regarding the approval of its insulin glargine product.” Id. Patent Owner further states that the sur-sur-reply “summarizes confidential and proprietary research and development, testing procedures, analyses and results regarding [Patent Owner’s] Lantus [product]” and that the updated exhibit list “refers to and describes now sealed EX2065–EX2069.” Id. (noting further that the sur-sur-reply and updated exhibit list refer to research, development, testing, clinical, manufacturing, packaging, and pharmacological information).

We further note that the record of each proceeding shall be preserved in its entirety and that no sealed document will be expunged or made public, pending the outcome of any appeal taken from the Final Decision.

Jeffrey Guise Douglas Carsten Richard Torczon Lorelei Westin Clark Lin Nancy Zhang Alina Litoshyk Nicole W. Stafford

Each milliliter of the injectable solution contains 100 IU of biosynthetic insulin, 0.058 mg zinc chloride, 6 mg trometamol, 20 mg glycerol, 0.01 mg poly(oxyethylene, oxypropylene)glycol, 2.7 mg phenol (a preservative), 3.7 mg hydrochloric acid, and up to 1 ml water.

c. Analysis Turning first to reason to combine, we disagree with Patent Owner that, to meet its burden as a matter of law, Petitioner must provide prior art evidence that insulin glargine had a tendency to aggregate.

To the contrary, as noted above, the ’652 patent describes the hydrophobic surfaces of glass storage vials, stopper materials of sealing caps, the air-water interface, and siliconized daily use syringes as promoting aggregation.

As to pH, the background of the ’652 patent states that “[e]specially at acidic pH, insulins ... show a decreased stability and an increased proneness to aggregation on thermal and physicomechanical stress, which can make itself felt in the form of turbidity and precipitation (particle formation) (Brange et al., J. Ph.

As noted previously, Patent Owner also argues that Petitioner fails to account for the potential negative consequences of adding a nonionic surfactant to the Lantus Label and Owens insulin glargine formulations.

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 ...

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.

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

The parties are not authorized to use this style heading for subsequent papers without prior Board approval.

The Order set forth a single, consolidated hearing in the proceedings for 1:00 PM EST on September 6, 2018, on the ninth floor of the Madison Building East, 600 Dulany Street, Alexandria.

Due to a scheduling conflict, the oral hearing shall commence, instead, at 10:00 AM EST on September 6, 2018.

All other conditions set forth in the Trial Hearing Order shall remain unchanged.

Jeffrey W. Guise Douglas Carsten Richard Torczon Lorelei Westin Clark Lin Nancy Zhang