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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)
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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)
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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)
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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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56 Order: Order Adjusting One Year Pendency Due to Joinder

Document IPR2019-00207, No. 56 Order - Order Adjusting One Year Pendency Due to Joinder (P.T.A.B. May. 5, 2020)
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55 Hearing Transcript: Hearing Transcript

Document IPR2019-00207, No. 55 Hearing Transcript - Hearing Transcript (P.T.A.B. Feb. 26, 2020)
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44 Order: Order Conduct of the Proceeding Modifying Schedule

Document IPR2019-00207, No. 44 Order - Order Conduct of the Proceeding Modifying Schedule (P.T.A.B. Jan. 21, 2020)
Patent Owner argued that the schedule of the proceedings could be modified to allow for a late deposition of Dr. Warner and related briefing, as well as related motions to exclude evidence, and alternatively argued to reserve the right to provide Dr. Warner at the final hearing whereat he might testify live as a substitute for his deposition.
Patent Owner also argued that if supplemental briefing and evidence was submitted by Petitioner as provided for in the December 31, 2019 Order, Patent Owner lacked an opportunity to object and move to exclude such evidence on the current schedule of the proceedings.
Petitioner explained its understanding of the circumstances and argued that a deposition of Dr. Warner on January 30, 2020 would not be practical in view of its proximity to the final hearing, scheduled to occur on February 7, 2020.
After considering the positions of each party set forth above, we conclude that this proceeding shall remain on its current schedule as set forth in the Scheduling Order (Paper 14) regarding Due Dates 5–8 and as provided for in the December 31, 2020 Order (Paper 39) regarding additional discovery and authorized briefing.
The Panel is sensitive to Patent Owner’s point regarding an opportunity to object and move to exclude any additional evidence and related briefing; therefore, we authorize
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40 Order: ORDER Oral Hearing

Document IPR2019-00207, No. 40 Order - ORDER Oral Hearing (P.T.A.B. Jan. 6, 2020)
Oral arguments will commence at 1:00 PM Eastern Time on February 7, 2020, on the ninth floor of Madison Building East, 600 Dulany Street, Alexandria, Virginia.
The parties are directed to contact the Board at least ten (10) days in advance of the hearing if there are any concerns about disclosing confidential information.
The parties are directed to St. Jude Medical, Cardiology Division, Inc. v. The Board of Regents of the University of Michigan, IPR2013-00041, Paper 65 (PTAB Jan. 27, 2014), regarding the appropriate content of demonstrative exhibits.
The parties are also reminded that the presenter must clearly and specifically identify each demonstrative exhibit (e.g., by slide or screen number) referenced during the hearing to ensure the clarity and accuracy of the reporter’s transcript.
The Board requests such identification for all exhibits discussed during oral argument in the interest of providing a clear record.
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39 Order: ORDER Granting Patent Owner¿¿¿s Motion for Additional Discovery37 CFR ¿¿ 4251b2

Document IPR2019-00207, No. 39 Order - ORDER Granting Patent Owner¿¿¿s Motion for Additional Discovery37 CFR ¿¿ 4251b2 (P.T.A.B. Dec. 31, 2019)
We agree with Petitioner that its requests for discovery outlined above are not merely speculative, but are tailored, based on Petitioner’s knowledge, to obtain the limited production of relevant evidence on objective indicia of non-obviousness.
It is not apparent why the production of existing transcripts or cross examination on unexpected results would inappropriately reveal any litigation position of Patent Owner that is not relevant.
We agree with Petitioner; Patent Owner and its former witness (in the related district court litigation), Dr. Warner, appear to be the only sources for the sought discovery of the factual information presented in Dr. Warner’s declaration upon which Dr. Osborne relies.
Petitioner argues its request for discovery is easily understood because it merely “seeks basic factual information about how [Dr. Warner’s] compositions were prepared and what he observed.” Patent Owner does not refute Petitioner’s rationale here.
Patent 9,517,219 B2 make Dr. Warner available for deposition by January 17, 2020, that is, in enough time prior to the scheduled oral argument for any necessary further briefing and submission of new evidence to be made.
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35 Order: DECISION Granting Institution of Inter Partes Review 35 USC ¿¿ 314 Granting Motion for Joinder 35 USC ¿¿ 315c, 37 CFR ¿¿ 42122

Document IPR2019-00207, No. 35 Order - DECISION Granting Institution of Inter Partes Review 35 USC ¿¿ 314 Granting Motion for Joinder 35 USC ¿¿ 315c, 37 CFR ¿¿ 42122 (P.T.A.B. Nov. 27, 2019)
Additionally, although “an objective of the AIA is to provide an effective and efficient alternative to district court litigation, ... [there is a] potential for abuse of the review process by repeated attacks on patents.” Id. at 16–17.
We are unaware of any prior case in which the General Plastic factors were found to be applicable to a petition filed with a timely request for joinder under 35 U.S.C. § 315(c).
Patent Owner explains that this “relationship” is based on the fact that these parties “are similarly situated in that both are frequent ANDA filers and manufacturers of generic pharmaceutical product.” Id. at 6.
Regarding factor 3, Patent Owner argues that the Preliminary Response and institution decision from IPR2019-00207 were available to Mylan prior to its filing of the Petition in this case, as well as all substantive briefing from IPR2018-00608.
On the record before us at this stage in the proceeding, Petitioner has demonstrated a reasonable likelihood of prevailing on Grounds 1 and 2 in showing that claims 1–8 of the ’219 patent would have been obvious over the cited prior art combinations.
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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)
Additionally, although “an objective of the AIA is to provide an effective and efficient alternative to district court litigation, ... [there is a] potential for abuse of the review process by repeated attacks on patents.” Id. at 16–17.
We are unaware of any prior case in which the General Plastic factors were found to be applicable to a petition filed with a timely request for joinder under 35 U.S.C. § 315(c).
Patent Owner explains that this “relationship” is based on the fact that these parties “are similarly situated in that both are frequent ANDA filers and manufacturers of generic pharmaceutical product.” Id. at 6.
Regarding factor 3, Patent Owner argues that the Preliminary Response and institution decision from IPR2019-00207 were available to Mylan prior to its filing of the Petition in this case, as well as all substantive briefing from IPR2018-00608.
On the record before us at this stage in the proceeding, Petitioner has demonstrated a reasonable likelihood of prevailing on Grounds 1 and 2 in showing that claims 1–8 of the ’219 patent would have been obvious over the cited prior art combinations.
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24 Order: CONDUCT OF THE PROCEEDINGS

Document IPR2019-00207, No. 24 Order - CONDUCT OF THE PROCEEDINGS (P.T.A.B. Oct. 11, 2019)
Patent Owner in this proceeding relies upon a declaration of co-inventor Dr. Kevin Warner.
(2) the production of the transcript of Dr. Kevin Warner’s deposition that occurred in the related district court litigation (Almirall LLC v. Taro Pharmaceutical Industries Ltd., No. 1-17-cv-00663 (D. Del.
Counsel for both parties are available for a teleconference with the Board any time on Thursday, October 10, per the Board’s convenience.
Accordingly, it is: ORDERED that Petitioners are granted authorization to file a motion, not exceeding ten (10) pages, on or before October 18, 2019, requesting additional discovery relating to the cross-examination of Kevin S. Warner, Ph.D. and to the production of a deposition transcript of Kevin S. Warner, Ph.D. from district court litigation Almirall LLC v. Taro Pharmaceutical Industries Ltd., No. 1-17-cv-00663 (D. Del); and
FURTHER ORDERED that Patent Owner is granted authorization to file an opposition to the aforementioned motion, not exceeding ten (10) pages, within five business days of receipt of said motion.
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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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66 Mandatory Notice: Patent Owner Almirall, LLCs Updated Mandatory Notices Under 37 CFR Section 428

Document IPR2019-00207, No. 66 Mandatory Notice - Patent Owner Almirall, LLCs Updated Mandatory Notices Under 37 CFR Section 428 (P.T.A.B. Aug. 27, 2021)
AMNEAL PHARMACEUTICALSLLC and AMNEAL
Counsel for Almirall, LLC
Patent Owner’s Updated Mandatory Notices Under 37 C.F.R. § 42.8
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