An overlapping range-based presumption of obviousness applies, if at all, only when a single reference discloses the same process or formulation as claimed, with ranges for certain variables that a POSA would have reason to optimize.

Patent Owner’s Request for Director Review swapping particular excipients in two specific combinations… that excipients and the active ingredient react differently depending on the formulation… leads the court to understand that swapping ingredients in complex chemical formulations is anything but ‘routine.’); Orexo AB, et al., v. Actavis Elizabeth LLC, 903 F.3d 1265, 1273 (Fed. Cir. 2018) (“The question is not whether the various references separately taught components of the [claimed] formulation, but whether the prior art suggested the selection and combination achieved by [the claimed invention].”).

The PVB’s interaction with the claimed formulation as-a-whole could significantly impact the viscosity, stability (chemical and physical), patient tolerability, adverse events, permeation rate, excipient compatibility, crystallization, particle size, etc. See Ex. 2057 ¶¶ 63, 67.

The Board’s failure to explicitly articulate the affirmative evidence for a motivation to combine the asserted prior art with a reasonable success is legal error, for which alone this Court should reverse the Board’s decision.

Currently, Drew Hirshfeld is “performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office

U.S. Patent No. 9,517,219 to Warner et al. Issue Date: December 13, 2016 Title: Topical dapsone and dapsone/adapalene compositions and methods for use thereof Inter Partes Review No.: IPR2019-01095

Pursuant to 37 C.F.R. §42.8(a)(3) and §42.8(b)(1), Petitioner Mylan Pharmaceuticals, Inc. (“Mylan”) hereby updates its mandatory notices as set forth below.

No other changes to any of the previously identified information under 37 C.F.R. §42.8 are being made pursuant to this Notice.

Each Real Party in Interest (37 C.F.R. § 42.8(b)(1)) On November 16, 2020, Viatris Inc. replaced Mylan N.V. as the parent company of all entities that were previously subsidiaries of Mylan N.V.

Dated: December 2, 2020 Respectfully submitted, Katten Muchin Rosenman LLP /Jitendra Malik/ Jitendra Malik (Reg. No. 55,823) for Petitioner Mylan Lead Counsel Pharmaceuticals, Inc. 146746847v1

Unable to discredit the reported experiments in his declaration, Petitioners took the 10-page opportunity to rehash its arguments already of record, misrepresenting Dr. Warner’s testimony in the process.

Petitioners’ arguments that Dr. Osborne lacked personal knowledge of the actual experiments performed and described in the Warner Declaration are irrelevant, a fact posturing him no differently than the same POSA, and the same Examiner.

Petitioners’ representations that Dr. Warner testified that Sepineo “was known in the art to have ‘better aesthetics,’ ‘improvements on particle size,’ ‘good suspension for stability of dapsone,’ as well as ‘ease in manufacturing’” are simply not borne out by the transcript.

It is in any event no matter; the question is whether, given Carbopol’s unexpected “crashing out” at higher DGME concentrations, the prior art would lead a POSA to expect that the claimed PVB comprising A/SA copolymer (Sepineo) would not have the same peculiarity.

The comparison is directly relevant to unexpected results because Carbopol plus a neutralizer is the polymeric viscosity builder (“PVB”) in the closest prior art.

Almirall knew since September 2019 that a deposition of Dr. Warner was possible but now faults the Board for failing to issue an order for “two and a half months.” Paper 50, 8; AMN1036, 4.

The residual exception is not “a broad license on trial judges to admit hearsay statements that do not fall within one of the other exceptions.” Conoco Inc. v. Dep’t of Energy, 99 F.3d 387, Case IPR2019-00207 Patent No. 9,517,219 392 (Fed. Cir. 1996).

The Patent Owner there chose not to seek the opportunity to cross-examine the declarant, and the Board there found circumstantial guarantees of trustworthiness because the witness was available for cross-examination.

Thus, FRE 703 holds that if the facts or data would otherwise be inadmissible, Almirall may only disclose them if their probative value substantially outweighs their prejudicial effects.

Case IPR2019-00207 Patent No. 9,517,219 CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)) I certify that the above-captioned "Petitioners’ Reply in Support of Their Motion to Exclude,” upon the following parties via electronic mail:

The right to explore and question the bases of an expert’s opinion is fundamental to an inter partes review, as in any exercise of due process.

It was not until Amneal’s counsel instructed its experts to not answer that the paragraphs in question were revealed as sword and shield attorney work product.

Patent Owner’s Reply Re Motion to Exclude Evidence (“I understand that Dr. Osborne conceded at his deposition that incompatibilities are either visibly present or they do not exist.”); see generally id. at 2-5, 7-9.

Amneal justifies the use of attorney argument as expert opinion by contending, “Almirall was also not deprived of the opportunity to cross-examine Dr. Michniak-Kohn or Dr. Gilmore about the ‘veracity’ of the information supplied by counsel.” Paper 46 at 7.

Amneal argues that Almirall had the opportunity to test the veracity of these statements by providing Dr. Osborne’s, Dr. Harper’s, or Dr. Kircik’s testimony to Dr. Michniak-Kohn or Dr. Gilmore during their respective deposition.

For this purpose, and only as ultimately deemed necessary, Petitioner requests entry of the Default Protective Order as set forth in Appendix B of the Office Patent Trial Practice Guide.

Relief Requested The parties have previously conferred and agreed upon the entry of the Default Protective Order of this Board (Appendix B of the Consolidated Trial Practice Guide (November 2019)).

In this case, Exhibit AMN1078 is the deposition transcript of co-inventor Dr. Kevin Warner, which was conducted as part of a related district court action, Almirall LLC v. Taro Pharmas.

These redactions maintain what Patent Owner believes to be confidential, yet provides the public access to the remaining portions of Petitioners’ brief.

Registration No. 61,868 Lead Attorney for Petitioners CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)) I certify that the above-captioned "Petitioners’ Motion to Seal,” upon the following parties via electronic mail:

Because the chainring products at issue in Fox Factory contained multiple unclaimed features that were “critical” to the alleged secondary considerations, no nexus existed.

Rather, the art repeatedly describes Sepineo as a Case IPR2019-00207 Patent 9,517,219 B2 prime thickener that works well across a wide range of other common excipients, such as ethoxydiglycol, without issue.

Almirall attempted to shield Dr. Warner from deposition and to delay producing his Taro action transcript in order to hide his admissions that undermine its case.

Although Dr. Warner was not deposed in this proceeding, Dr. Warner’s deposition testimony from the Taro action confirms that the ’219 patent is prima facie obvious and that no unexpected results exist.

Registration No. 61,868 Lead Attorney for Petitioners CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)) I certify that the above-captioned "Petitioners’ Supplemental Briefing Addressing New Evidence from Additional Discovery” upon the following parties via electronic mail:

To exclude expert testimony because of its reliance on the Warner Declaration would violate not just the letter of, but universal practice under, the Federal Rules of Evidence.

To exclude a § 1.132 declaration from post-grant proceedings under the AIA—or, as Petitioners soften it, to give it “little or no weight”—under the present circumstances would have arbitrary and thus unjust consequences for disparately- situated patent owners as regards their property rights.

If the declarant cannot be produced for deposition because he is deceased or unwilling, it would be profoundly unfair for the admissibility of any part of the patent’s file history to depend on whether its current owner controls a witness at the time of the post-grant proceeding.

At its root, the Warner Declaration reflects observations of the comparative compatibility of varied components within topical formulations comprising the active pharmaceutical ingredient dapsone.

The Warner Declaration concerns a material fact: observation of experiments with formulations embodied in the challenged claims that inform the validity of the ʼ219 patent.