Plaintiff OssiFi-Mab LLC (“OMAB” or “Plaintiff”) and Defendant Amgen Inc. (“Amgen” or “Defendant”) (collectively, the “Parties”) hereby jointly move the Court to grant leave to exchange supplements and/or amendments to their Preliminary Patent-Related Disclosures under L.R.

16.6(d)(4); WHEREAS, on June 21, 2024, the Court issued its Markman Claim Construction Order and Memorandum (Dkt. No. 99), construing the terms “being treated with” and “administering .

sequentially with” and “serially with,” which are used in the patents-in-suit; WHEREAS, on July 19, 2024, the Parties jointly moved the Court to extend the deadline to seek leave to exchange Amendments to Preliminary Patent-Related Disclosures as a result of the Court’s Markman Claim Construction Order (Dkt. No. 99) pursuant to L.R.

16.6(d)(5)(A) for two weeks, from July 19, 2024 to August 2, 2024, while the Parties worked to reach agreement on a proposed process for serving amended and supplemental Patent-Related Disclosures of subsections (d)(1) and (d)(4) of L.R.

16.6(d)(5), including based on the Court’s Markman Claim Construction Order (Dkt. No. 99) and/or based on discovery of facts and information not previously discovered or located despite diligent efforts; NOW, THEREFORE, the Parties jointly move and respectfully request that the Court enter an Order providing the following:    OMAB may serve amended and/or supplemental Preliminary Patent-Related Disclosures on or before August 7, 2024; Amgen may serve amended and/or supplemental Preliminary Patent-Related Disclosures on or before August 26, 2024; and OMAB will serve its supplement responses to Amgen’s Interrogatories Nos. 2 and 3 on or before September 4, 2024.

Plaintiff OssiFi-Mab LLC (“OMAB” or “Plaintiff”) and Defendant Amgen Inc. (“Amgen” or “Defendant”) (collectively, the “Parties”) hereby jointly move the Court to toll the deadline to seek leave to exchange their Amendments to Preliminary Patent-Related Disclosures as a result of the Court’s Markman Claim Construction Order under Local Rule 16.6(d)(5)(A), by fourteen days.

In support thereof, the Parties state: WHEREAS, on September 5 and November 17, 2023, OMAB served its Preliminary Patent-Related Disclosures including its Preliminary Infringement Claim Charts pertaining to U.S. Patent Nos. 11,608,373 (the “’373 patent”), 8,178,099 (the “’099 patent”), 8,877,196 (the “’196 patent”), and 11,807,681 (the “’681 patent) (hereinafter, the “patents-in-suit”) in accordance with Local Rule 16.6(D)(1); WHEREAS, on October 17, 2023 and January 18, 2024, Amgen served its Preliminary Patent-Related Disclosures including its Preliminary Noninfringement and Invalidity Claim Charts related to the patents-in-suit, in accordance with Local Rule 16.6(D)(4)(d); WHEREAS, on June 21, 2024, the Court issued its Memorandum and Order construing certain terms contained in the asserted claims of the patents-in-suit (Dkt. No. 99); WHEREAS, pursuant to Local Rule 16.6(d)(5)(A), the Preliminary Patent-Related Disclosures of subsections (d)(1) and (d)(4) may be amended and supplemented by leave of Court and for good cause, where circumstances supporting a finding of good cause include a claim construction by the Court that is different from that proposed by the party seeking amendment within 28 days of the Court’s claim construction ruling; WHEREAS, on July 16 and 18, 2024, the Parties met and conferred to discuss an ordered process for the Parties to amend the Preliminary Patent-Related Disclosures of subsections (d)(1) and (d)(4) of Local Rule 16.6, and to toll the deadline for seeking leave to amend and supplement their respective Preliminary Patent-Related Disclosures under Local Rule 16.6(d)(5)(A) for two weeks while they work to reach agreement on a proposed process for the Parties to serve amended and supplemental Patent-Related Disclosures of subsections (d)(1) and (d)(4) of Local Rule 16.6; and WHEREAS, good cause exists for a two-week extension to the foregoing deadline.

The Parties continue to engage in good-faith negotiations over the timing and order for the exchange of Amended Preliminary Patent-Related Disclosures, and that additional time to complete these discussions would facilitate the efficient and orderly conduct of the litigation.

NOW, THEREFORE, the Parties jointly move and respectfully request that the Court enter an Order extending the deadline to seek leave to exchange Amendments to Preliminary Patent-Related Disclosures as a result of the Court’s Markman Claim Construction Order (Dkt. No. 99) pursuant to Local Rule 16.6(d)(5)(A) from July 19, 2024 to August 2, 2024.

conferred by email on July 16 and 18, 2024 regarding the subject of this Joint Motion.

Kindly withdraw my appearance on behalf of the Defendant and Counterclaim-Plaintiff Amgen Inc. Amgen continues to be represented by the law firm Groombridge, Wu, Baughman & Stone LLP, and Duane Morris LLP. Notice of said withdrawal has been served on Amgen and all other parties in the manner provided in Rule 5.2 (a).

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Many of the typical courtroom decorum rules were relaxed, such as whether an attorney might stand or sit during argument or when addressing the Court.

In-Person Testimony All witnesses are expected to testify in person barring exigent circumstances consistent with Ground Rule 13.6.1.

If such an emergency should arise and a witness is unable to travel and/or to testify in person due to Covid-19, or another illness or injury, that party must notify Page 1 of 3

The last day of the Hearing may be reserved for a witness who has been granted leave not to testify in person by a method chosen by Chambers.

We expect the individuals who are responsible for IT for each law firm to be present on the setup day so they can familiarize themselves with the Courtroom A equipment.

Pet. 21 n.7. “Petitioner does not believe that USP789 needs to be listed in Grounds 1-10,” but nonetheless includes this reference in each ground, “if necessary.” Id. For example, Petitioner alleges that “[a] POSITA would understand that ...

Even accepting Patent Owner’s contention as true – that USP789 does not dictate that the particulate content limitation be met in every situation – USP789 nonetheless teaches use of the particulate content limitation.

Although these new design features to the plunger rod and stopper may be described, in part, in the °631 patent (Ex. 2201 § 106), none of these 77 Regeneron Exhibit 1257.077 Regeneron v. Novartis IPR2021-00816 IPR2021-00816 ...

The Decision refers to exhibits and information that we have previously sealed pursuant to the Second Modified Default Protective Order (Paper 103) entered on July 8, 2022.

“There is a strong public policy for making all information filed in a quasi-judicial administrative proceeding open to the public, especially in an inter partes review which determines the patentability of claims in an issued patent and therefore affects the rights of the public.” Garmin Int’l v. Cuozzo Speed Techs., LLC, IPR2012-00001, Paper 34, 1–2 (PTAB Mar. 14, 2013).

The parties are advised that any papers or exhibits that are currently sealed in this case ordinarily would become public 45 days after final judgment.

Patent 9,220,631 B2 Further, we extend the deadline for filing a motion to expunge documents under 37 C.F.R. § 42.56 to ten business days after final disposition of an appeal.

In accordance with the foregoing, it is hereby: ORDERED that the joint motion to seal the confidential version of the Final Written Decision, Paper 113, is granted; FURTHER ORDERED that the jointly filed redacted version of the Final Written Decision, Exhibit 1257, shall be entered by the Board as available to the public; FURTHER ORDERED that the record in this proceeding shall be preserved, including all confidential pleadings and exhibits as sealed documents, until ten business days after final disposition of an appeal; and FURTHER ORDERED that the time for filing a motion to expunge documents under 37 C.F.R. § 42.56 is extended to ten business days after final disposition of an appeal.

Plaintiffs Teva Pharmaceuticals International GmbH and Teva Pharmaceuticals USA, Inc. have agreed to enter into this joint motion and stipulation to streamline the post-trial briefing process for the parties and the Court; WHEREAS, the jury in this case returned a verdict in favor of Teva on November 9, 2022; WHEREAS, the Parties wish to file certain post-trial motions; and WHEREAS, the Parties have agreed to a proposed judgment for review by the Court; NOW THEREFORE, IT IS HEREBY STIPULATED AND AGREED, by and between the Parties hereto, and subject to leave granted by the Court, as follows:

The Parties propose that the Court enter a judgment in the form of the jointly agreed draft attached to this stipulation as Exhibit A on December 30, 2022.

Any motion by Teva relating to equitable relief and damages shall also be due twenty-eight (28) days after the entry of judgment.

The parties jointly request that the Court grant leave for each party to file a single opening brief of 30 pages, excluding any accompanying cover motions, exhibits, or declarations.

To the extent the Court enters judgment after December 30, 2022, the parties agree that the post-trial briefing deadlines set forth above in Paragraphs 3, 5, and 7 shall remain in effect.

Lilly actively induced the infringement of each of claim 30 o Emgality® (galcanezumab-gnlm) in the United States in accordance with the product label for the preventative treatment of migraine.

Lilly also actively induced infringement of each of claim 30 Emgality® (galcanezumab-gnlm) in the United States in accordance with the product label for the treatment of episodic cluster headache.

Lilly may defer payment of the damages amounts set forth above in subparagraphs (a)-(c) of paragraph 5 as well as any additional damages the Court may impose (e.g., as provided for in paragraph 8 below) until thirty (30) calendar days after the latest of: (a) a final mandate issues from the United States Court of Appeals for the Federal Circuit in this case; (b) a final order or judgment issues from the United States Supreme Court in this case; or (c) the period for appeal or review has expired.

This judgment may be updated to reflect the following issues to be raised by Teva in forthcoming post-trial briefing, once resolved by the Court: (a) pre-judgment interest; (b) post- judgment interest; (c) supplemental lost profits and reasonable royalty damages for the period from July 1, 2022 through October 31, 2022; (d) injunctive relief, including but not limited to a running royalty to be applied with respect to any post-verdict infringement by Lilly; (e) costs, and an award 285; and (f) an award of enhanced damages pursuant to

The parties further agree that nothing herein constitutes waiver of any issue to be briefed in post-trial motions on grounds that it has not been specifically enumerated herein.

Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov.

SUPPLEMENTARY INFORMATION: On August 10, 2020, the Commission instituted an investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based on a complaint filed by Overhead Door Corporation of Lewisville, Texas and GMI Holdings Inc. of Mount Hope, Ohio (collectively, “Complainants”).

The Commission further determined to: (1) issue a limited exclusion order against Chamberlain’s infringing products and a cease and desist order against Chamberlain (collectively, “the remedial orders”); and (2) set a bond during the period of Presidential review in the amount of one hundred (100) percent of the entered value of the infringing articles.

In accordance with Commission Rule 210.21(a)(1), 19 CFR 210.21(a)(1), Complainants represent that “there are no agreements, written or oral, express or implied, among the parties concerning the subject matter of this Enforcement Proceeding or [Complainants’] Motion for Partial Termination of this Proceeding.” See id.

In addition, the ID finds “no extraordinary circumstances that warrant denying the motion.” See id. No petition for review of the subject ID was filed.

Pursuant to Federal Rule of Civil Procedure 65(b)(2), Regeneron Pharmaceuticals, Inc. (“Regeneron”) moves the Court to extend its Temporary Restraining Order, issued on May 17, 2024, Case No. 1:23-cv-94-TSK, Dkt. No. 224, for an additional fourteen days beyond its original expiration on May 31, 2024, for good cause shown, particularly in view of the lengthy submissions submitted by the parties on May 24.

As detailed in Regeneron’s Brief in Support of its Motion for a Temporary Restraining Order, Dkt. No. 219-1, Regeneron has filed for preliminary injunctive relief in this case against the launch of Defendant’s allegedly infringing biosimilar product.

Jan. 5, 2024) (“The purpose of a TRO is to ‘preserve the status quo only until a preliminary injunction hearing can be held.’” (quoting Hoechst Diafoil Co. v. Nan Ya Plastics Corp., 174 F.3d 411, 422 (4th Cir. 1999))).

Cognizant of the length of that submission—and that of Defendant’s simultaneous submission, and those filed in the other cases in this multi-district litigation—Regeneron seeks to extend the TRO an additional fourteen days, in the event that it is not feasible for the Court to adjudicate the preliminary injunction motion before May 31, 2024.

There is “good cause” to extend a TRO under Federal Rule of Civil Procedure 65(b)(2) where “the grounds for originally granting the temporary restraining order continue to exist.” 11A WRIGHT & MILLER, FED. PRACT.

); WHEREAS, in its January 18, 2024 answer to OMAB’s First Amended Complaint in this matter, Amgen asserted, inter alia, affirmative defenses that each of the Patent-in-Suit are not infringed and are invalid, as well as counterclaims seeking declaratory judgment of the same.

All claims, counterclaims, and defenses relating to the ’099 patent in OMAB’s First Amended Complaint (Dkt. No. 73), Amgen’s Answer to OMAB’s First Amended Complaint (Dkt No. 76), and OMAB’s Answer to Amgen’s Counterclaims (Dkt. No. 84) are hereby dismissed with prejudice.1

1 For the avoidance of doubt, these claims, counterclaims and defenses are: Count I in OMAB’s First Amended Complaint (Dkt. No. 73) and Counts I and V of Amgen’s Counterclaims, as well as Amgen’s Second and Third Defenses in Amgen’s Answer to OMAB’s First Amended Complaint (Dkt. No. 76).

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I further certify that on January 27, 2025, the foregoing document was filed using the CM/ECF system and notice was served electronically to all counsel of record as indicated on the Notice of Electronic Filing (NEF).