... due dates in the scheduling order, the parties must be cognizant that the Board requires four weeks after the filing of an opposition to the motion to amend (or the due date for the opposition, if 6 IPR2019-00451 Patent 9,763,876 B2 none ...

On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Meezan ’962’s disclosure when seeking to enhance the bioavailability of the therapeutic agents in the compositions disclosed in Gwozdz.

For the reasons stated supra with regard to claims 8–10 and 15, Petitioner’s assertion that Patent Owner never showed any unexpected results with respect to the amount of ethanol and benzyl alcohol is not sufficiently supported by the evidence of record.

We are not persuaded that Petitioner and Dr. Peppas have provided sufficient argument and supporting evidence to explain why one of ordinary skill in the art would have reasonably expected success in achieving the bioavailabilities recited in claims 34–36 of the ’876 patent when combining the teachings of Gwozdz and Meezan ’962.

Petitioner argues that, since neither Gwozdz nor Meezan ’962 provide specific dosing regimens for benzodiazepines/diazepam, one of ordinary skill in the art would look to the similar reference of Cartt ’784, titled “Nasal Administration of Benzodiazepines,” for these teachings.

On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Cartt ’784’s disclosure when seeking dosing regimens for the compositions disclosed in Gwozdz and Meezan ’962.

United States Court of Appeals for the Federal Circuit

Appeal from the United States District Court for the Eastern District of Texas in No. 2:15-cv-01455-WCB, Circuit Judge William C. Bryson.

In accordance with the judgment of this Court, entered November 13, 2018, and pursuant to Rule 41 of the Federal Rules of Appellate Procedure, the formal mandate is hereby issued.

Costs are awarded to appellee Teva Pharmaceuticals USA, Inc. in the amount of $534.80 and taxed against the appellants Allergan, Inc. and Saint Regis Mohawk Tribe.

March 13, 2019

Patent Owner may file a preliminary response to the petition no later than three months from the date of this notice.

Patent Owner may also file an election to waive the preliminary response to expedite the proceeding.

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.

Such motions shall be filed in accordance with the “Order -- Authorizing Motion for Pro Hac Vice Admission” in Case IPR2013-00639, Paper 7, a copy of which is available on the Board Web site under “Representative Orders, Decisions, and Notices.” 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 Review Processing System (PRPS), accessible from the Board Web site at http://www.uspto.gov/PTAB.

In each Final Decision, we denied Petitioner’s motion to seal portions of its sur- sur-reply that reference Exhibits 2065–2069 without prejudice to Patent Owner.

That standard includes a showing that “(1) the information sought to be sealed is truly confidential, (2) a concrete harm would result upon public disclosure, (3) there exists a genuine need to rely in the trial on the specific information sought to be sealed, and (4) on balance, an interest in maintaining confidentiality outweighs the strong public interest in having an open record.” Argentum Pharms.

In particular, Patent Owner represents that Petitioner’s sur-sur-reply “summarizes and quotes confidential submissions made by Hoechst Marion Roussel to, and records of correspondence with, the FDA regarding the approval of its insulin glargine product.” Id. Patent Owner further states that the sur-sur-reply “summarizes confidential and proprietary research and development, testing procedures, analyses and results regarding [Patent Owner’s] Lantus [product]” and that the updated exhibit list “refers to and describes now sealed EX2065–EX2069.” Id. (noting further that the sur-sur-reply and updated exhibit list refer to research, development, testing, clinical, manufacturing, packaging, and pharmacological information).

We further note that the record of each proceeding shall be preserved in its entirety and that no sealed document will be expunged or made public, pending the outcome of any appeal taken from the Final Decision.

Jeffrey Guise Douglas Carsten Richard Torczon Lorelei Westin Clark Lin Nancy Zhang Alina Litoshyk Nicole W. Stafford

In each Final Decision, we denied Petitioner’s motion to seal portions of its sur- sur-reply that reference Exhibits 2065–2069 without prejudice to Patent Owner.

That standard includes a showing that “(1) the information sought to be sealed is truly confidential, (2) a concrete harm would result upon public disclosure, (3) there exists a genuine need to rely in the trial on the specific information sought to be sealed, and (4) on balance, an interest in maintaining confidentiality outweighs the strong public interest in having an open record.” Argentum Pharms.

In particular, Patent Owner represents that Petitioner’s sur-sur-reply “summarizes and quotes confidential submissions made by Hoechst Marion Roussel to, and records of correspondence with, the FDA regarding the approval of its insulin glargine product.” Id. Patent Owner further states that the sur-sur-reply “summarizes confidential and proprietary research and development, testing procedures, analyses and results regarding [Patent Owner’s] Lantus [product]” and that the updated exhibit list “refers to and describes now sealed EX2065–EX2069.” Id. (noting further that the sur-sur-reply and updated exhibit list refer to research, development, testing, clinical, manufacturing, packaging, and pharmacological information).

We further note that the record of each proceeding shall be preserved in its entirety and that no sealed document will be expunged or made public, pending the outcome of any appeal taken from the Final Decision.

Jeffrey Guise Douglas Carsten Richard Torczon Lorelei Westin Clark Lin Nancy Zhang Alina Litoshyk Nicole W. Stafford

The specification explains that, at acidic pH, insulins exhibit decreased stability and increased susceptibility to aggregation in response to thermal and physicomechanical stress, resulting in turbidity and precipitation (i.e., particle formation).

c. Analysis Turning first to reason to combine, we disagree with Patent Owner that, to meet its burden as a matter of law, Petitioner must provide prior art evidence that insulin glargine had a tendency to aggregate.

To the contrary, as noted above, the ’930 patent describes the hydrophobic surfaces of glass storage vials, stopper materials of sealing caps, the air-water interface, and siliconized daily use syringes as promoting aggregation.

As to pH, the background of the ’930 patent states that “[e]specially at acidic pH, insulins ... show a decreased stability and an increased proneness to aggregation on thermal and physicomechanical stress, which can make itself felt in the form of turbidity and precipitation (particle formation) (Brange et al., J. Ph.

As noted previously, Patent Owner also argues that Petitioner fails to account for the potential negative consequences of adding a nonionic surfactant to the Lantus Label and Owens insulin glargine formulations.

Each milliliter of the injectable solution contains 100 IU of biosynthetic insulin, 0.058 mg zinc chloride, 6 mg trometamol, 20 mg glycerol, 0.01 mg poly(oxyethylene, oxypropylene)glycol, 2.7 mg phenol (a preservative), 3.7 mg hydrochloric acid, and up to 1 ml water.

c. Analysis Turning first to reason to combine, we disagree with Patent Owner that, to meet its burden as a matter of law, Petitioner must provide prior art evidence that insulin glargine had a tendency to aggregate.

To the contrary, as noted above, the ’652 patent describes the hydrophobic surfaces of glass storage vials, stopper materials of sealing caps, the air-water interface, and siliconized daily use syringes as promoting aggregation.

As to pH, the background of the ’652 patent states that “[e]specially at acidic pH, insulins ... show a decreased stability and an increased proneness to aggregation on thermal and physicomechanical stress, which can make itself felt in the form of turbidity and precipitation (particle formation) (Brange et al., J. Ph.

As noted previously, Patent Owner also argues that Petitioner fails to account for the potential negative consequences of adding a nonionic surfactant to the Lantus Label and Owens insulin glargine formulations.

Aquestive fails to show why EX1013—a document that is cited only in support of a non-instituted ground—(and Dr. Peppas’ discussion thereof, EX1041, ¶¶171-191, 264-362, Appendix A (pp. 197-224), and EX1050) is relevant to the instituted grounds.

Aquestive’s reliance on Genzyme Therapeutic and/or Ariosa Diagnostics is disingenuous given that neither of those decisions involved the lack of notice, and resultant prejudice, that is present here.

The declaration does not provide any “personal knowledge” as required by FRE 901(b)(1), or any other evidence that EX1069 is what Aquestive purports it to be—a manual available to, and followed by, medical technicians in Florida prior to the priority date.

Separately, Dr. Wermeling’s experience in drug development does not qualify him to provide expert opinions on economics and/or regulatory procedures.

Aquestive block cites portions of Dr. Wermeling’s testimony in support of the alleged “expertise”—but, a closer look at the testimony reveals that he (1) is merely “familiar with economic principles” (EX2031, 8:19-22) and otherwise collaborated with trained economists for his written work (id., 10:2-14); (2) has never worked at, or received any formal certifications related to, FDA practice and procedure (id., 10:22-11:7); (3) has limited experience with pricing (id., 77:2-7) and could not make any pricing decisions on his own (id., 79:24-80:81:5), and; (4) is only “pretty familiar” with the 505(b)(2) pathway and would need to consult the “regulatory person at the company” for the answer to a complex question on the same (id., 85:6-86:13).

Committee Note to 2000 Amendment to Rule 703 (“[W]hen an expert reasonably relies on inadmissible information to form an opinion or inference, the underlying information is not admissible simply because the opinion or inference is admitted.”); Malletier v. Dooney & Bourke, Inc., 525 F. Supp.

807(a)(2); see Committee Note to 2019 Amendments (“proponent must show that the hearsay statement is more probative then any other evidence the proponent can obtain”).

Contrary to PO’s assertion, the narratives provided by PO’s expert in paragraphs 2, 5, 7 and 67 of his declaration is not relevant to the subject recited in the challenged claims of the ‘876 patent.

For example, PO’s expert opines, with insufficient personal knowledge, regarding the appropriate level of skill possessed by a POSA as of the invention date of the subject matter recited in the ’876 patent (e.g., ¶¶ 28-33), and the alleged secondary considerations PO attempts points to in an attempt to support patentability (e.g., ¶¶ 36, 48, 50-51).

PO’s expert, in paragraphs 34, 68-70, 75 and 114, offers his views on an ultimate question of law -- what constitutes sufficient incorporation by reference.