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Apotex Inc. v. Pfizer Inc.

Docket IPR2021-01132, Patent Trial and Appeal Board (June 17, 2021)

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11 Notice refund approved: Notice refund approved

Document IPR2021-01132, No. 11 Notice refund approved - Notice refund approved (P.T.A.B. Nov. 5, 2021)
Patent 6,890,927 Mailed: November 5, 2021
Petitioner’s request for a refund of certain post-institution fees paid on June 17 2021, in the above proceeding is hereby granted.
The amount of $22,500.00 has been refunded to Petitioner’s deposit account.
The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in the Patent Trial and Appeal Board End to End (PTAB E2E), accessible from the Board Web site at http://www.uspto.gov/PTAB.
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9 Termination Decision Pre DI settlement: Termination Decision Decision Settlemen...

Document IPR2021-01132, No. 9 Termination Decision Pre DI settlement - Termination Decision Decision Settlement Prior to Institution of Trial (P.T.A.B. Oct. 29, 2021)

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5 Notice of Filing Date Accorded to Petition: Notice of Accord Filing Date

Document IPR2021-01132, No. 5 Notice of Filing Date Accorded to Petition - Notice of Accord Filing Date (P.T.A.B. Jul. 12, 2021)

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8 Motion: Joint Motion to Terminate

Document IPR2021-01132, No. 8 Motion - Joint Motion to Terminate (P.T.A.B. Oct. 21, 2021)
Pursuant to 37 C.F.R. § 42.74(b), the Parties’ settlement agreement made in contemplation of termination of this proceeding is in writing, and a true and correct copy of such document is being filed herewith as Petitioner’s Exhibit 1025.
The Parties hereby jointly request that the settlement agreement at Petitioner’s Exhibit 1025 be treated as business confidential information, and be kept separate from the files of the above captioned IPR pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c).
On the same day (October 19, 2021), the Parties informed the Board of settlement and requested authorization to file a joint motion to terminate the proceeding with respect to both Apotex and Pfizer.
The Board additionally authorized the Parties to include with the joint motion to terminate a request to treat the settlement as business confidential information.
1022 Stahl 1023 Pharmeuropa 2000 1024 Aakeroy G. Steffen Paulekuhn et al., Trends in Active Pharmaceutical Ingredient Salt Selection Based on Analysis of the Orange Book Database, 50 J.
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1 Petition: Petition

Document IPR2021-01132, No. 1 Petition - Petition (P.T.A.B. Jun. 17, 2021)
Their high hydrophilic nature, favouring wettability probably as a result of the polar ionised groups being exposed on the crystal surfaces, leads to water vapour sorption (hygroscopicity) which on occasions, may be excessive.
Furthermore, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions,” a POSA “has good reason to pursue the known options within his or her technical grasp.
Secondary considerations, including long-felt need, failure of others, unexpected results, commercial success, copying, licensing, and industry praise, may provide “powerful tools for courts faced with the difficult task of avoiding subconscious reliance on hindsight.” Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir. 2012).
Here, Pfizer admitted before the PTO and in its Canadian patent application that written description support for the varenicline species and its salts, and methods for making them, are found in the substantively identical specifications of Coe and US ‘550.
Since the only “secondary consideration” Pfizer put before the examiner was the entirely expected hygroscopicity point, and as noted below (Section XIII) denying institution based on any other hypothetical secondary considerations would be premature at this stage, Galderma applies here to render claim 1 obvious.
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10 Refund Request: Petitioner Apotex Inc Request for Refund of Post Institution Fe...

Document IPR2021-01132, No. 10 Refund Request - Petitioner Apotex Inc Request for Refund of Post Institution Fees (P.T.A.B. Nov. 2, 2021)

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7 Notice: Patent Owners Update to Mandatory Notice

Document IPR2021-01132, No. 7 Notice - Patent Owners Update to Mandatory Notice (P.T.A.B. Oct. 19, 2021)

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