Thereafter, on March 31, 2021, the Court ordered Celgene to supplement its motion to seal to provide additional authority and information in support (Dkt. No. 252).

On April 1, 2021, Mylan moved to seal its reply in support of its motion for leave to amend, and the Court ordered it to provide additional authority and information to support its request to seal this filing (Dkt. Nos. 254, 256).

Finally, on April 15, 2021, Celgene moved for leave to file under seal its reply in support of its objections (Dkt. No. 264).

Throughout these motions, the parties have asserted that the filings to be sealed discuss information deemed confidential or labeled “Highly Confidential” pursuant to the Protective Order entered in this case.

Thus, because the public’s right of does not extend to documents submitted in connection with a discovery proceeding, Chicago Tribune Co. v. Bridgestone/Firestone, Inc., 263 F.3d 1304, 1312 (11th Cir. 2001); accord Anderson v. Cryovac, Inc., 805 F.2d 1, 10 (1st Cir. 1986), or disclosure of the contents of an Abbreviated New Drug Application, AstraZeneca AB v. Mylan Pharm. Inc., No. 18-cv-00193-IMK (N.D. W. Va. Jan. 31, 2019), ECF No. 27, the Court GRANTS both Celgene’s motions to seal (Dkt. Nos. 249, 257, 264) and also Mylan’s motions to seal (Dkt. Nos. 254, 259), and DIRECTS the Clerk to file the exhibits attached to these motions under seal.

On March 24, 2021, Defendants Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan N.V. (“Defendants”) moved this Court for an extension of time to file their response to Celgene’s Motion to Extend Certain Scheduling Order Deadlines (ECF No. 229).

Celgene did not object to the requested extension.

For good cause shown, the Court ORDERS that Defendants’ response to Celgene’s Motion to Extend Certain Scheduling Order Deadlines is due on or before April 1, 2021 and Celgene’s reply in support of its Motion is due on or before April 8, 2021.

No other deadlines are changed or affected by this Order.

The Court DIRECTS the Clerk to transmit copies of this Order to all counsel of record.

MYLAN INC., and MYLAN N.V., Defendants.

Pending is PLAINTIFF’S MOTION FOR LEAVE TO FILE UNDER SEAL

SANCTIONS, AND EXHIBITS.

For good cause shown, the Court GRANTS the motion and directs that the Clerk of this Court file Plaintiff’s instant Reply in Further Support of Motion for Spoliation Sanctions, and attendant exhibits, under seal.

The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any unrepresented parties.

Civ.

P. 7.02(c), the Court REFERS this action to the Honorable Robert W. Trumble, United States Magistrate Judge, who is hereby designated and authorized to consider the record and rule on the pending motion to compel (Dkt. No. 134) and any discovery requests or subsequent non-dispositive pre-trial motions filed in the case including, without limitation, conducting a hearing on the motions, if necessary, and entering into the record an order as to the appropriate disposition of the motions.

The Court directs the Clerk to transmit copies to counsel of record and to the Honorable Robert W. Trumble, United States Magistrate Judge.

DATED: November 12, 2020.

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First, Patent Owner, with supporting testimony from Dr. Gizurarson, asserts that “the formulation of a benzodiazepine for intranasal administration is a difficult and complex science requiring a higher skill set and knowledge than a POSA with a bachelor’s degree ‘with several years of experience.’” Id. at 15 (citing Ex. 2012 ¶¶ 28–29).

Specifically, according to Patent Owner and Dr. Gizurarson, “the POSA would be working against physiological constraints of active ingredient uptake due to the nasal anatomy, as well as the very low solubility of benzodiazepines in formulating the pharmaceutical composition disclosed in the ’876 patent.” Id. at 15–16 (citing Ex. 2012 ¶¶ 28–29).

In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In the absence of such blazemarks, simply describing a large genus of compounds

Motivation to combine/reasonable expectation of success Petitioner argues that, since neither Gwozdz nor Meezan ’962 provide specific dosing regimens for benzodiazepines/diazepam, one of ordinary skill in the art would look to the similar reference of Cartt ’784, titled “Nasal Administration of Benzodiazepines,” for these teachings.

On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Cartt ’784’s disclosure when seeking dosing regimens for the compositions disclosed in Gwozdz and Meezan ’962, and would have had a reasonable expectation of success in achieving the claimed invention.

United States Court of Appeals for the Federal Circuit

Please make the following change: On page 20, footnote 4, line 2, “decision” is changed to “decisions”

One thing with the petition, and none of the Petitioner's papers address, is why a person skilled in the art would take this excipient that is used in aqueous formulations, put it in a non-aqueous formulation with the benzodiazepine? If we ...

JUDGE WISZ: I have none either.

The parties are directed to contact the Board at least ten (10) days in advance of the hearing if there are any concerns about disclosing confidential information.

The Board asks the parties to confine demonstrative exhibit objections to those identifying egregious violations that are prejudicial to the administration of justice.

The parties are directed to St. Jude Medical, Cardiology Division, Inc. v. The Board of Regents of the University of Michigan, IPR2013-00041 (PTAB Jan. 27, 2014) (Paper 65), for guidance regarding the appropriate content of demonstrative exhibits.

The parties are reminded that each presenter must identify clearly and specifically each demonstrative exhibit (e.g., by slide or screen number) referenced during the hearing to ensure the clarity and accuracy of the reporter’s transcript.

Jeffrey Guise Richard Torczon Lorelei Westin Lee Johnson Nathaniel Leachman Alina L. Litoshyk

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

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

Before ANDREI IANCU, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, ANDREW HIRSHFELD, Commissioner for Patents, and SCOTT R. BOALICK, Chief Administrative Patent Judge.

The Office received a request for Precedential Opinion Panel (POP) review of an issue raised in this case.

The request was referred to the POP panel referenced above.

Upon consideration of the request, it is ORDERED that the request for POP review is denied; and FURTHER ORDERED that the original panel maintains authority over all matters.

The Office has received a request for Precedential Opinion Panel (POP) review of an issue raised in these cases.

The request is under review.

The Office will provide another notification after a decision on the request has been made.

Neurelis, Inc. (“Patent Owner”) requests rehearing of the Board’s Decision (Paper 8) (“Decision”) instituting inter partes review of claims 1– 36 of U.S. Patent No. 9,763,876 B2 (Ex. 1001, “the ’876 patent”).

First, Petitioner did challenge the ’876 patent priority claim in contending that “the presence of any alkyl glycosides (either generally or particularly) – regardless of amount – was not disclosed, described, or enabled by [the] ’558 Provisional.” Petition 20.

Furthermore, with supporting testimony from Dr. Nicholas A. Peppas, Petitioner further asserted that the ’558 provisional’s “generic disclosure of ‘surface active agents (especially non-ionic materials)’ ... does not disclose, describe, and/or enable alkyl glycosides in general (or dodecyl maltoside in particular).” Id. (citing Ex. 1008 ¶ 152; Ex. 1041 ¶ 68).

As explained in Dynamic Drinkware, a petitioner has the initial burden of going forward to show that there is invalidating prior art.

On this record, Patent Owner fails to satisfy its burden of production to show entitlement to an earlier filing date.