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Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH

Docket IPR2018-01678, Patent Trial and Appeal Board (Sept. 10, 2018)
Bart Gerstenblith, Hyun Jung, James Mayberry, James Tartal, Lynne Browne, presiding
Case TypeInter Partes Review
Patent8992486
Patent Owner Sanofi-Aventis Deutschland GmbH
Petitioner Mylan Pharmaceuticals Inc.
Petitioner Pfizer Inc.,1
...
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86 Other Fed Circuit mandate: Other fed circuit mandate

Document IPR2018-01678, No. 86 Other Fed Circuit mandate - Other fed circuit mandate (P.T.A.B. Aug. 3, 2022)
United States Court of Appeals for the Federal Circuit
Appellee ANDREW HIRSHFELD, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Intervenor
Appellee ANDREW HIRSHFELD, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Intervenor
ANDREW HIRSHFELD, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Intervenor
In accordance with the judgment of this Court, entered December 29, 2021, and pursuant to Rule 41 of the Federal Rules of Appellate Procedure, the formal mandate is hereby issued.
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87 Other other court decision: Other other court decision

Document IPR2018-01678, No. 87 Other other court decision - Other other court decision (P.T.A.B. Aug. 3, 2022)
TASHA THOMAS, RICHARD TORCZON, Wilson, Sonsini, Goodrich & Rosati, PC, Washington, DC; ELHAM FIROUZI STEINER, San Diego, CA.
The three patents, which share a specification, address a pen-type injection device that allows a user to set and ad- minister a dose of medication.
The Board determined that all challenged claims are unpatentable on two independent grounds—obvious- ness over Burroughs and obviousness over Steenfeldt-Jen- sen. We limit our discussion to the latter ground, addressed in IPR2018-01670, IPR2018-01676, IPR2018- 01678, and IPR2019-00979.
The Board found that these two elements were interchangeable, crediting Mylan’s testimony that using either component as a radial stop would have been a routine and predictable SANOFI-AVENTIS DEUTSCHLAND v.
That conclusion moots the appeals from the final written decisions in IPR2018-01675 and IPR2019-00122, which involve no claims other than those already covered by the Steenfeldt- Jensen reviews.
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84 Termination Decision Document: JUDGMENTFinal Written DecisionDetermining All Challenged Claims UnpatentableDenying Petitioner’s Motion to Exclude35 USC § 318a

Document IPR2018-01678, No. 84 Termination Decision Document - JUDGMENTFinal Written DecisionDetermining All Challenged Claims UnpatentableDenying Petitioner’s Motion to Exclude35 USC § 318a...
Nonetheless, Steenfeldt-Jensen expressly teaches an alternative configuration wherein a piston rod guide is in wall 4 and a driver tube rotates a nut element instead of a piston rod guide.
Importantly, none of the challenged claims of the ’486 patent recite Lantus® or any other medication as a required limitation.
... an easy-to-use pen that was particularly well suited to administer medication with a low injection force.” Id. at 74. a) Purported Evidence of Alleged Long-felt Need and Any Challenged Claim of the ’486 Patent There is no dispute that none ...
None of the challenged claims requires any maximum dose capability or “differentiation features.” As with the proffered evidence of long-felt need discussed above, Patent Owner does not demonstrate nexus between the purported ...
Nonetheless, to the extent Exhibit 2011 was cited during this proceeding, we do not wish to disturb the record by excluding it as a duplicate.
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81 Order: ORDERGranting Patent Owners Motion for Withdrawal of Counsel

Document IPR2018-01678, No. 81 Order - ORDERGranting Patent Owners Motion for Withdrawal of Counsel (P.T.A.B. Apr. 1, 2020)
Patent Owner filed a Motion for Withdrawal of Counsel in each of the above-listed proceedings.2 Paper 77 (“Motion”).3 Patent Owner states that Petitioner does not oppose the Motion.
Patent Owner requests withdrawal of back-up counsel Brian C. Chang.
Patent Owner must file updated Mandatory Notices removing Mr. Chang as back-up counsel, in accordance with 37 C.F.R. § 42.8(b)(3) within seven (7) calendar days of the entry of this Order.
2 Patent Owner did not seek authorization prior to filing its Motion.
For the purposes of this Motion, we sua sponte authorize their filing in this Order.
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80 Order: ORDER Adjusting One Year Pendency Due to Joinder 35 USC ¿¿ 316a11 37 CFR ¿¿ 42100c

Document IPR2018-01678, No. 80 Order - ORDER Adjusting One Year Pendency Due to Joinder 35 USC ¿¿ 316a11 37 CFR ¿¿ 42100c (P.T.A.B. Mar. 25, 2020)
Paper 28.3 The Board instituted inter partes review in the remaining proceedings on April 3, 2019.
Pursuant to 35 U.S.C. § 316(a)(11), “the final determination in an inter partes review [shall] be issued not later than 1 year after the date on which the Director notices the institution of a review under this chapter, except that the Director ... may adjust the time periods in this paragraph in the case of joinder under section 315(c).” The Director has delegated the authority to adjust the one-year period to the Board.
In particular, 37 C.F.R. § 42.100(c) provides: An inter partes review proceeding shall be administered such that pendency before the Board after institution is normally no more than one year.
It is ORDERED that the time of pendency in these proceedings, which involve joinder, is adjusted; and
FURTHER ORDERED that the Board shall issue a Final Written Decision in each proceeding no later than May 29, 2020.
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78 Hearing Transcript: Hearing Transcript

Document IPR2018-01678, No. 78 Hearing Transcript - Hearing Transcript (P.T.A.B. Feb. 25, 2020)
... (Patent 8,992,486 B2) Case IPR2018-01684 (Patent 9,604,008 B2) And now we are going to apply an FEA analysis to that even though you never said that your second rib was going to be identically structured, identically sized, none ...
And in fact, none of the five distinct embodiments in Steenfeldt- Jensen has a threaded driver tube which is required by the challenged claims. And none of the passages in Steenfeldt-Jensen that petitioner relies on suggests a threaded ...
... we go to slide 9, none of the embodiments in Steenfeldt-Jensen has a driver tube with internal threads. This is Figures 3, 8, 13, 14 and 17 and I have highlighted in yellow the driver tube in the 1st, 3rd, 4th, and 5th embodiments and none ...
The first is that Steenfeldt-Jensen expressly suggests this modification of the fifth embodiment and I will go through the passages that they rely on and explain how none of those make the suggestion of a threaded driver tube or ...
None of the prior art except Steenfeldt-Jensen’s second embodiment discloses a piston rod with two sets of threads.
Now despite this teaching away, the petitioners put forth a few reasons why a POSA would have nonetheless had a reason to make the combination supposedly.
Not claimed to be reduced from anything, not claimed to be an actual limits, none of that.
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66 Order Conduct of Proceeding: Order Conduct of the Proceeding

Document IPR2018-01678, No. 66 Order Conduct of Proceeding - Order Conduct of the Proceeding (P.T.A.B. Dec. 17, 2019)

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