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Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH

Docket IPR2018-01696, Patent Trial and Appeal Board (Sept. 10, 2018)
Bart Gerstenblith, Hyun Jung, James Mayberry, presiding
Case TypeInter Partes Review
Patent9526844
Patent Owner Sanofi-Aventis Deutschland GmbH
Petitioner Mylan Pharmaceuticals Inc.
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21 Refund Approval: Notice of Refund

Document IPR2018-01696, No. 21 Refund Approval - Notice of Refund (P.T.A.B. Apr. 20, 2020)
Petitioner’s request for a refund of certain post-institution fees paid on September 10, 2018 in the above proceeding is hereby granted.
The amount of $15,000.00 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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19 Institution Decision: Trial Instituted Document

Document IPR2018-01696, No. 19 Institution Decision - Trial Instituted Document (P.T.A.B. Apr. 3, 2019)
To institute an inter partes review, we must determine whether the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a).
Patent 9,526,844 B2 Steenfeldt-Jensen relates to “injection syringes of the kind apportioning set doses of a medicine from a cartridge ... [and] are mainly made for users who have to inject themselves frequently, e.g. diabetics.” Id. at 1:12–17.
We preliminarily adopt Mylan’s asserted level of ordinary skill solely to determine whether there is a reasonable likelihood that Mylan would prevail with respect to at least one of the claims challenged in the Petition.
Mr. Leinsing declares that “[i]n my opinion, a person of ordinary skill in the art would have understood end wall 4 is ‘rotatably fixed relative to the housing’ since it is an integral part of the housing.” Ex. 1011 ¶ 725 (referencing Ex. 1014, 5:66–6:41).
The Petition fails to explain adequately how this disclosure is consistent with Mylan’s contention that a person having ordinary skill in the art would have understood that wall 4 is rotatably fixed relative to the housing as required by the “piston rod holder” limitation of claim 21.
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15 Order: Order 37 CFR 4210

Document IPR2018-01696, No. 15 Order - Order 37 CFR 4210 (P.T.A.B. Mar. 15, 2019)
Granting Petitioner’s Motions for Admission Pro Hac Vice of Elham F. Steiner
On February 28, 2019, Petitioner filed motions for admission pro hac vice of Elham F. Steiner in each of the above-identified proceedings (collectively, “Motions”).
In its notice authorizing motions for pro hac vice admission, the Board requires a statement of facts showing there is good cause for the Board to recognize counsel pro hac vice and an affidavit or declaration of the individual seeking to appear in this proceeding.
Based on the facts set forth in the Motions and the accompanying Declarations, we conclude that Ms. Steiner has sufficient legal and technical qualifications to represent Petitioner in these proceedings, that Ms. Steiner has demonstrated sufficient familiarity with the subject matter of these proceedings, and that Petitioner’s intent to be represented by counsel with litigation experience is warranted.
Accordingly, Petitioner has established good cause for pro hac vice admission of Ms. Steiner.
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10 Order: Authorizing Reply and Sur Reply37 CFR § 42108c 37 CFR § 425

Document IPR2018-01696, No. 10 Order - Authorizing Reply and Sur Reply37 CFR § 42108c 37 CFR § 425 (P.T.A.B. Feb. 20, 2019)
A conference call was held on February 13, 2019, between counsel for each party and Judges Jung, Gerstenblith, and Mayberry.
On February 15, 2019, the parties sent an email to the Board indicating that they had reached a partial, but not complete, agreement on this issue.
One dispute between the parties centers on Petitioner’s request to expand the number of pages of its reply as compared to these other proceedings, because Patent Owner’s
Patent Owner’s sur-replies, however, shall be due by March 18, 2019, given the deadlines for the Board to issue decisions on institution in these and related proceedings.
Richard Torczon Douglas Carsten Wesley Derryberry Tasha Thomas Lorelei Westin Nicole Stafford
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8 Notice of Filing Date Accorded to Petition: Notice of Accord Filing Date

Document IPR2018-01696, No. 8 Notice of Filing Date Accorded to Petition - Notice of Accord Filing Date (P.T.A.B. Nov. 28, 2018)
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.
Richard Torczon Douglas Carsten Wesley Derryberry Tasha Thomas Lorelei Westin Nicole W. Stafford Jeffrey W. Guise Arthur Dykhuis Franklin Chu
If the parties actually engage in alternative dispute resolution, the PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.
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20 Refund Request: Petitioners Refund Request

Document IPR2018-01696, No. 20 Refund Request - Petitioners Refund Request (P.T.A.B. Apr. 17, 2020)
Case IPR2018-01696 Patent No. 9,526,844 On April 3, 2019, the Patent Trial and Appeal Board denied Petitioner’s Petition for Inter Partes Review in this case.
Accordingly, Petitioner requests a refund of $15,000 for the Post-Institution Fees under 37 C.F.R. §42.15.
Upon approval of this request, Petitioner respectfully requests that the Board credit the Post-Institution Fees to Deposit Account No. 23-2415.
Respectfully submitted, Dated: April 17, 2020 /Tasha Thomas/ Tasha Thomas, Reg. No. 73,207 Case IPR2018-01696 Patent No. 9,526,844
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16 Reply: Patent Owners Sur reply in Support of Patent Owner Preliminary Response

Document IPR2018-01696, No. 16 Reply - Patent Owners Sur reply in Support of Patent Owner Preliminary Response (P.T.A.B. Mar. 18, 2019)
To the contrary—Mylan continues its quest for its “second bite” by seeking to preserve its ability to assert invalidity positions in the District Court that Mylan contends are not “specific[ally]” identical to those in the IPR.
Mylan tries to avoid those admissions by repeating the argument that “the litigation timeline is speculative.” As explained in detail in Sanofi’s POPR, that assertion is contrary to the facts and ignores the “unique” and “more urgent” transition date issues in this case.
Mylan’s failure to explain its delay in filing, beyond citing § 315(b), is particularly telling given that Mylan has long had knowledge of the challenged patent based on its listing in the FDA’s Orange Book, as well as the asserted prior art, which was before the Examiner during prosecution.
Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018), and here Mylan chose its course, preparing and timing its Petition such that it is squarely within the case-specific NHK Spring and General Plastic factors that all weigh strongly in favor of denying institution.
Thus, properly understood, the legislative compromise discussed in Click-to-Call balanced the advantages to petitioners of the limitless filing period for inter partes reexamination under pre-AIA law with the need to provide patent
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