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Mylan Pharmaceuticals Inc. v. Almirall, LLC

Docket IPR2019-01095, Patent Trial and Appeal Board (June 7, 2019)
Christopher Paulraj, Ryan Flax, Susan Mitchell, presiding
Case TypeInter Partes Review
Patent9517219
Orange Book Patent9517219
Patent Owner Almirall, LLC
Petitioner Mylan Pharmaceuticals Inc.
Petitioner Amneal Pharmaceuticals of New York
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16 Other Fed Circuit mandate: Other fed circuit mandate

Document IPR2019-01095, No. 16 Other Fed Circuit mandate - Other fed circuit mandate (P.T.A.B. Sep. 16, 2022)
United States Court of Appeals for the Federal Circuit
Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2019-
In accordance with the judgment of this Court, entered March 14, 2022, and pursuant to Rule 41 of the Federal Rules of Appellate Procedure, the formal mandate is hereby issued.
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17 Other other court decision: Other other court decision

Document IPR2019-01095, No. 17 Other other court decision - Other other court decision (P.T.A.B. Sep. 16, 2022)
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14 Order Conduct of Proceeding: CONDUCT OF THE PROCEEDINGExpunging Unauthorized New Evidence37 CFR ¿¿ 427

Document IPR2019-01095, No. 14 Order Conduct of Proceeding - CONDUCT OF THE PROCEEDINGExpunging Unauthorized New Evidence37 CFR ¿¿ 427 (P.T.A.B. Aug. 20, 2020)
Subsequent thereto, Patent Owner filed a Request for Rehearing under 37 C.F.R. § 42.71(d) (Paper 61, “Request for Rehearing”), and therewith new Exhibits 2071 and 2072.
Exhibits 2071 and 2072 were not of record at the time Patent Owner filed its Request for Rehearing on June 29, 2020, and Patent Owner has not made a showing of “good cause” to admit this new evidence into the record.
To which Patent Owner responded via a second email to the Board, stating: In response to Petitioners’ July 27, 2020 and August 13, 2020 e-mails, Patent Owner respectfully submits that the Board should not expunge Exhibits 2071 and 2072 from the IPR Record.
Huawei Device Co., Ltd. v. Optis Cellular Tech., LLC, IPR2018-00816, Paper 19 at 4 (PTAB Jan. 8, 2019) (precedential).
Furthermore, Patent Owner did not otherwise show that good cause exists for admitting the new evidence.
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13 Termination Decision Document: Termination Decision Document

Document IPR2019-01095, No. 13 Termination Decision Document - Termination Decision Document (P.T.A.B. May. 29, 2020)
Although the example in Garret only studied a 5% dapsone topical formulation, we find that a POSA would have nonetheless considered it relevant in determining whether higher concentrations of the active agent within Garrett’s ...
Dr. Osborne may seek to minimize the apparent burden of neutralizing Carbopol before its use, but nonetheless, it is an added step not required of Sepineo.
Thus, Garrett’s example, although not necessarily establishing that 7.5% dapsone formulations were effective, is nonetheless significant in Garrett’s disclosure by indicating that its 5–10% dapsone formulations are safe for treating acne, ...
Nonetheless, because an expert witness may rely upon hearsay evidence, we have considered Dr. Osborne’s expert opinions based upon the Warner Declaration and have examined the Warner Declaration for the limited purpose of ...
Although Dr. Kircik testified that dapsone failed to gain FDA approval for treating rosacea, he nonetheless opined that, in 2012, it would have been reasonable to prescribe dapsone along with other medications (e.g., Finacea, azelaic ...
Garrett II indicated success in treating rosacea with both the vehicle MetroGel alone and with dapsone in combination with Metrogel, and even if the difference was insubstantial we find this nonetheless evidences some success, not ...
We recognize, however, that Patent Owner’s experts may nonetheless rely upon Warner Declaration in forming their opinions even if the declaration itself constitutes inadmissible hearsay.
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12 Institution Decision: Trial Instituted Document

Document IPR2019-01095, No. 12 Institution Decision - Trial Instituted Document (P.T.A.B. Nov. 27, 2019)
For the sake of 5 IPR2019-01095 Patent 9,517,219 B2 completeness, however, we nonetheless address each of the General Plastic factors as applied to the circumstances presented in this case.
None of the General Plastic factors weigh in favor of exercising our discretion to deny institution here.
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10 Order: ORDERAuthorizing Reply to Preliminary Response to Petitionerand Sur reply to Patent Owner37 CFR ¿¿ 42108c

Document IPR2019-01095, No. 10 Order - ORDERAuthorizing Reply to Preliminary Response to Petitionerand Sur reply to Patent Owner37 CFR ¿¿ 42108c (P.T.A.B. Oct. 7, 2019)
Petitioner emailed the Board on September 12, 2019, stating ... Mylan would like to respectfully seek the panel’s permission to submit a short 10 page Reply to Patent Owner’s Preliminary Response (“POPR”).
Mylan notes that the PTAB granted a similar request in the underlying IPR.
... “A petitioner may seek leave to file a reply to the preliminary response in accordance with [37 C.F.R.] §§ 42.23 and 42.24(c).
Patent Owner, however, devoted the entirety of its Preliminary Response to argue that institution should be denied under § 314(a).
Accordingly, it is: ORDERED that Petitioner is authorized to file a Reply of no more than ten (10) pages, within five (5) business days after issuance of this Order, responsive to the allegations under 35 U.S.C. § 314(a) as set forth in Patent Owner’s Preliminary Response.
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5 Notice of Filing Date Accorded to Petition: Notice of Accord Filing Date

Document IPR2019-01095, No. 5 Notice of Filing Date Accorded to Petition - Notice of Accord Filing Date (P.T.A.B. Jun. 10, 2019)

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