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Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH

Docket IPR2019-01658, Patent Trial and Appeal Board (Oct. 7, 2019)
Case TypeInter Partes Review
PatentRE47614
Patent Owner Sanofi-Aventis Deutschland GmbH
Petitioner Mylan Pharmaceuticals Inc.
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11 Refund Approval: Notice of Refund

Document IPR2019-01658, No. 11 Refund Approval - Notice of Refund (P.T.A.B. Apr. 24, 2020)
Petitioner’s request for a refund of certain post-institution fees paid on October 7, 2019 in the above proceeding is hereby granted.
The amount of $16,800 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 Institution Decision: Denying Institution of Inter Partes Review35 USC sec 314

Document IPR2019-01658, No. 9 Institution Decision - Denying Institution of Inter Partes Review35 USC sec 314 (P.T.A.B. Apr. 2, 2020)
An inter partes review may not be instituted unless “the information presented in the petition ... and any response ... shows that there is 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) (2018).
In deciding whether to institute inter partes review, we consider the guidance in the Trial Practice Guide Update, which states, Based on the Board’s prior experience, one petition should be sufficient to challenge the claims of a patent in most situations.
As noted above, however, the Trial Practice Guide Update explains that a second petition may be warranted “when the patent owner has asserted a large number of claims in litigation.” TPGU 26 (emphasis added).
Here, there is no district court litigation involving the ’614 patent (see Pet. 2; Paper 5, 2), and, thus, the example rationale for instituting a second petition set forth in the Trial Practice Guide Update and cited by Petitioner is not applicable here.
Petitioner also argues that, “[i]n the event of an amendment for these claims, the parties, the Board and the public are all best served if likely prior art is already of record and under consideration to focus the scope of the amendment.” Notice 2.
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4 Notice of Filing Date Accorded to Petition: NOTICE OF FILING DATE ACCORDED TO PETITIONAND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Document IPR2019-01658, No. 4 Notice of Filing Date Accorded to Petition - NOTICE OF FILING DATE ACCORDED TO PETITIONAND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE (P.T...
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, mediation, etc.) was used and the general result.
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8 Reply: Patent Owner¿¿¿s to Petitioner¿¿¿s Explanation of Multiple Petitions and Ranking of Petitions

Document IPR2019-01658, No. 8 Reply - Patent Owner¿¿¿s to Petitioner¿¿¿s Explanation of Multiple Petitions and Ranking of Petitions (P.T.A.B. Jan. 21, 2020)
The substantial overlap between the two petitions filed with respect to the ’614 patent and similarity (and in the case of De Gennes, duplicity) of the references relied upon reveals that this is just such a scenario.
For Case IPR2019-01658 Attorney Docket No: 28328-0015IP2 example, both petitions rely on their respective base references (Burren and Bitdinger) in precisely the same way—as a generic injection device to which the alleged spring washers and fixing elements from other references can be applied.
The petitions also rely on Venezia and Schofield (respectively) in almost the exact same manner, as allegedly disclosing a spring washer used in an injection device.
Similarly, reviewing and analyzing such arguments regarding these similar/same features of the references in parallel proceedings would be an inefficient drain on the Board’s resources.
However, as discussed in Patent Owner’s Preliminary Response, Mylan never advocates for or adopts as its own means-plus-function construction for any claim term in either petition, thereby rendering this argument moot.
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3 Petition: Petition for Inter Partes Review

Document IPR2019-01658, No. 3 Petition - Petition for Inter Partes Review (P.T.A.B. Oct. 7, 2019)
A POSA prior to October 13, 2008, would include someone who had, through education or experience, the equivalent of a bachelor’s degree in mechanical engineering, or a related field, and an additional two years of work in, or at least an understanding of, the basics of medical-device design and manufacturing techniques.
As explained in detail in section IX.C, a POSA would have found it obvious to replace the stop illustrated in Bitdinger with a spring washer, like those De Gennes taught, to provide the same securing function for the cartridge.
As also explained more in section IX.C, a POSA would have understood the legs taught by De Gennes was a form of “fixing elements” that would successfully fix the spring washer to the housing in order to exert its biasing force on the cartridge.
As illustrated below in partial, annotated views of FIGS. 2 (left) and 3 (right), like Bitdinger’s stop, Schofield’s resilient cushion 14 also includes a low profile and a uniform base for applying a biasing force on the cartridge to secure it against movement within the device.
Finally, while Bitdinger has an overall aim to reduce the likelihood that an incorrect cartridge is installed in the injection pen, see, e.g., EX1009, 2:46-52, 2:58-63, 2:66-3:2, the POSA would have predictably implemented a spring-washer system that still minimized the risk of cross-installation by fine-tuning the washer such that it compensated for tolerance ranges associated with a specific cartridge- type.
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2 Other Not for motions: Petitioner Mylan Pharmaceuticals Incs Explanation of Multiple Petitions Challenging Patent No RE47,614 and Ranking of Petitions

Document IPR2019-01658, No. 2 Other Not for motions - Petitioner Mylan Pharmaceuticals Incs Explanation of Multiple Petitions Challenging Patent No RE47,614 and Ranking of Petitions (P.T.A.B. Oct. 7,...
Any additional burden on Sanofi should also be much less than usual because a single deposition will suffice for both trials and many of Sanofi’s arguments and proofs should be the same.
To address the apparent means-plus-function nature of the fixing limitation, both grounds use the same reference (De Gennes) to show a specific spring-washer structure.
The first ground starts with Burren, an injector pen disclosing a coil-like spring to secure the drug cartridge.
The references and accompanying exhibits and analysis show why one skilled in the art would modify Bitdinger’s drug-delivery device to use a spring washer in place of the stop.
If the Board should adopt a means-plus-function construction, then the Bitdinger reference of ground 2 provides a more direct equivalence to Sanofi’s corresponding structure.
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10 Refund Request: Petitioners Refund Request

Document IPR2019-01658, No. 10 Refund Request - Petitioners Refund Request (P.T.A.B. Apr. 22, 2020)
Case IPR2019-01658 Patent No. RE47,614 On April 2, 2020, the Patent Trial and Appeal Board denied Petitioner’s Petition for Inter Partes Review in this case.
Accordingly, Petitioner requests a refund of $16,800 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 22, 2020 /Tasha Thomas/ Tasha Thomas, Reg. No. 73,207 Case IPR2019-01658 Patent No. RE47,614
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