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Replimune Limited v. Amgen Inc.

Docket IPR2023-00106, Patent Trial and Appeal Board (Nov. 2, 2022)
Cynthia Hardman, Jamie Wisz, Kristi Sawert, presiding
Case TypeInter Partes Review
Patent10034938
Patent Owner Amgen Inc.
Petitioner Replimune Limited
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20 Termination Decision Post DI Settlement: Termination Decision Post DI Settlement

Document IPR2023-00106, No. 20 Termination Decision Post DI Settlement - Termination Decision Post DI Settlement (P.T.A.B. Sep. 13, 2023)
With the Board’s authorization, Petitioner and Patent Owner (collectively referred to as “the Parties”) filed a Joint Motion to Terminate the above-identified proceeding due to settlement.
In support of the Joint Motion, the Parties filed a Settlement Agreement (Ex. 1054 (“Settlement Agreement”)), as well as a Joint Request to Treat the Settlement Agreement as Business Confidential Information (Paper 18 (“Joint Request”)) pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74.
In the Joint Motion, the Parties represent that they have reached an agreement to jointly seek termination of this inter partes review proceeding, and that the filed copy of the Settlement Agreement is a true copy.
Under 35 U.S.C. § 317(a), “[a]n inter partes review instituted under this chapter shall be terminated with respect to any petitioner upon the joint request of the petitioner and the patent owner, unless the Office has decided the merits of the proceeding before the request for termination is filed.” Section 35 U.S.C. § 317(a) also provides that if no petitioner remains in the inter partes review, the Office may terminate the review.
We have no such procedure to serve upon the Parties a request for access to the Settlement Agreement, and, further, our regulations do not require us to do so.
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12 Order Other: SCHEDULING ORDER

Document IPR2023-00106, No. 12 Order Other - SCHEDULING ORDER (P.T.A.B. May. 18, 2023)
8 IPR2023-00106 Patent 10,034,938 B2 weeks after the filing of an opposition to the motion to amend (or the due date for the opposition, if none is filed) for the Board to issue its preliminary guidance, if requested by Patent Owner.
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11 Institution Decision Grant: Granting Institution of Inter Partes Review 35 USC § 314

Document IPR2023-00106, No. 11 Institution Decision Grant - Granting Institution of Inter Partes Review 35 USC § 314 (P.T.A.B. May. 18, 2023)
The ’938 patent describes a study to “determine the safety and tolerability of talimogene laherparepvec in combination with ipilimumab as assessed by incidence of dose-limiting toxicities (DLT) in subjects with previously untreated, unresectable, stages IIIb to IV melanoma.” Ex. 1001, 18:34–19:37.
3 Natarajan discloses that the agents discussed in the article “are enabling the rational design of novel combination trials to simultaneously increase antigen presentation, deplete regulatory T cells and block immune
Natarajan discloses that OncoVEXGM-CSF is “an oncolytic herpes simplex virus type 1 (HSV-1) [strain JS1] that has been engineered” to include “deletion of ICP34.5”; “deletion of ICP47”; and “insertion of the open-reading frame of GM-CSF” and discusses the results of clinical trials of OncoVEXGM-CSF administered to patients with stages IIIc to IV melanoma.
Second, we credit the unrebutted testimony of Dr. Sosman that “a POSA would have been motivated to combine OncoVEXGM-CSF and ipilimumab because she would have known, among other things, their respective biological compositions, mechanisms of action, common patient population, successful clinical trial results, and dosing regimens.” Ex. 1002 ¶¶ 74–76 (citing references disclosing the properties of these agents).
Overall, on the current record, we determine that Petitioner sufficiently explains why an ordinarily skilled artisan would have been motivated to combine OncoVEXGM-CSF with ipilimumab for the treatment of a patient with stage IIIb to IV melanoma based on the disclosure in Natarajan, and would have had a reasonable expectation of success in doing so.
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5 Notice Notice filing date accorded: Notice Notice filing date accorded

Document IPR2023-00106, No. 5 Notice Notice filing date accorded - Notice Notice filing date accorded (P.T.A.B. Nov. 22, 2022)
For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.
Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.
The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.
Many non-profit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.
If the parties actually engage in alternative dispute resolution, the PTAB would be interested to learn what mechanism (e.g., arbitration,
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Method of Antigen-Binding Protein Production

Docket 17/821,835, U.S. Patent Application (Aug. 24, 2022)

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ACTIVATABLE POLYPEPTIDE COMPLEX

Docket 63/370,897, U.S. Patent Application (Aug. 9, 2022)

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AUTOINJECTOR APPARATUS

Docket 17/813,702, U.S. Patent Application (July 20, 2022)

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