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Amneal Pharmaceuticals LLC v. Almirall, LLC

Docket IPR2019-00207, Patent Trial and Appeal Board (Nov. 6, 2018)
Christopher Paulraj, Ryan Flax, Susan Mitchell, presiding
Case TypeInter Partes Review
Patent9517219
Orange Book Patent9517219
Patent Owner Almirall, LLC
Petitioner Amneal Pharmaceuticals LLC
Petitioner Mylan Pharmaceuticals
...
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69 Other fed circuit mandate: Other fed circuit mandate

Document IPR2019-00207, No. 69 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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70 Other other court decision: Other other court decision

Document IPR2019-00207, No. 70 Other other court decision - Other other court decision (P.T.A.B. Sep. 16, 2022)
Almirall owns the ’219 patent, which relates to meth- ods of treating acne or rosacea with dapsone formulations that include an acrylamide/sodium acryloyldimethyl tau- rate copolymer (“A/SA”) thickening agent and the solvent diethylene glycol monoethyl ether (“DGME”).
The Board relied on prior art and expert testimony in determining that a person of ordinary skill would have recognized Carbopol® and Sepineo® as closely related gel- ling agents that could be interchangeably used in dapsone formulations in the same concentration range.
We are therefore not persuaded that the Board erred in analyzing the evidence provided by Amneal and its impact on whether a skilled artisan would have had a reasonable expectation of success in combining these prior art teachings to achieve the claimed invention.
Amneal coun- ters that the Board relied on expert testimony in correctly determining that a person of ordinary skill would have had a reasonable expectation of success because Bonacucina taught using Sepineo® at overlapping concentrations and because carbomers had known drawbacks which were re- solved by Sepineo®.
We are not persuaded that the Board erred in analyzing the evidence provided by Amneal and its im- pact on whether a skilled artisan would have had a reason- able expectation of success in combining these prior art teachings to achieve the claimed invention.
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68 Order Other: Order Denying Request for Director Review

Document IPR2019-00207, No. 68 Order Other - Order Denying Request for Director Review (P.T.A.B. Sep. 28, 2021)
Before ANDREW HIRSHFELD, Commissioner for Patents, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
The Office has received a request for Director review of the Final Written Decision in this case.
The request was referred to Mr. Hirshfeld, Commissioner for Patents, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
It is ORDERED that the request for Director review is denied; and FURTHER ORDERED that the Patent Trial and Appeal Board’s Final Written Decision is the final decision of the agency.
Patent 9,517,219 B2 For PETITIONER: Representing Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC: Dennies Varughese Adam LaRock Tyler Liu
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63 Order Conduct of Proceeding: CONDUCT OF THE PROCEEDINGExpunging Unauthorized New Evidence37 CFR ¿¿ 427

Document IPR2019-00207, No. 63 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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62 Order: DECISIONDenying Patent Owner¿¿¿s Request for Rehearing37 CFR ¿¿ 4271d

Document IPR2019-00207, No. 62 Order - DECISIONDenying Patent Owner¿¿¿s Request for Rehearing37 CFR ¿¿ 4271d (P.T.A.B. Jul. 23, 2020)
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58 Termination Decision Document: Termination Decision Document

Document IPR2019-00207, No. 58 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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57 Order Conduct of Proceeding: Denying Authorization for Patent OwnerMotion to file Supplemental Information37 CFR sec 425a sec 42123b

Document IPR2019-00207, No. 57 Order Conduct of Proceeding - Denying Authorization for Patent OwnerMotion to file Supplemental Information37 CFR sec 425a sec 42123b (P.T.A.B. May. 22, 2020)
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