Rather, obviousness additionally requires that a person of ordinary skill at the time of the invention “would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention.” Id.

In opposition, Patent Owner argues, in part, that Petitioner fails to show the asserted combination of references teaches: “(1) the rAAV ‘concentration exceeding 1x1013vg/ml up to 6.4x1013vg/ml’; (2) ‘the ionic strength of the composition is greater than 200 mM’; and (3) the respective aggregate limitations of claims 5 and 6.” Prelim. Resp. 13.

To prove inherency in the context of obviousness, a party must “meet a high standard” and establish that “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014).

Petitioner offers no testing or other persuasive evidence in support of its contentions, arguing instead that a person of ordinary skill in the art “would have reasonably expected” Liu’s compositions to meet the average particle radius limitation of claim 5.

Patent Owner argues that Petitioner “cannot possibly meet the high standard for inherency relying on Liu’s Example 17, which applies only visual methods that the [person of ordinary skill in the art] would have understood could not determine the presence (or absence) of significant aggregation to the degree of claim 6’s product

Granting Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Katherine A. Helm

On May 26, 2023, Patent Owner filed an Unopposed Motion for Pro Hac Vice Admission of Katherine A. Helm in each of the above-identified proceedings.

Based on the facts set forth in the Motion and the accompanying Declaration, we determine that all requirements for admission pro hac vice have been met and there is good cause to admit Ms.

FURTHER ORDERED that Patent Owner continue to have a registered practitioner represent it as lead counsel for the above-identified proceedings, but that Ms.

Helm is subject to the Office’s disciplinary jurisdiction under 37 C.F.R. § 11.19(a), and the USPTO Rules of Professional Conduct set forth in 37 C.F.R. §§ 11.101 et seq.

Granting Patent Owner’s Unopposed Motion for Admission Pro Hac Vice of Katherine A. Helm

On May 26, 2023, Patent Owner filed an Unopposed Motion for Pro Hac Vice Admission of Katherine A. Helm in each of the above-identified proceedings.

Based on the facts set forth in the Motion and the accompanying Declaration, we determine that all requirements for admission pro hac vice have been met and there is good cause to admit Ms.

FURTHER ORDERED that Patent Owner continue to have a registered practitioner represent it as lead counsel for the above-identified proceedings, but that Ms.

Helm is subject to the Office’s disciplinary jurisdiction under 37 C.F.R. § 11.19(a), and the USPTO Rules of Professional Conduct set forth in 37 C.F.R. §§ 11.101 et seq.

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.

Courtenay Brinckerhoff Foley & Lardner LLP 3000 K Street, N.W., Suite 600 Washington D.C. 20007-5109 Case IPR2023-00608 Patent No. 9,051,542 B2

If the parties actually engage in alternative dispute resolution, the PTAB would be interested to learn what mechanism (e.g., arbitration, Case IPR2023-00608 Patent No. 9,051,542 B2 mediation, etc.) was used and the general result.

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.

Courtenay Brinckerhoff Foley & Lardner LLP 3000 K Street, N.W., Suite 600 Washington D.C. 20007-5109 Case IPR2023-00609 Patent No. 9,051,542 B2

If the parties actually engage in alternative dispute resolution, the PTAB would be interested to learn what mechanism (e.g., arbitration, Case IPR2023-00609 Patent No. 9,051,542 B2 mediation, etc.) was used and the general result.

U.S. Patent No. 9,051,542 Pursuant to 37 C.F.R. § 42.10(c), the Board’s Notice of Filing Date Accorded (authorizing this motion), and the representative order Novartis Gene Therapies, Inc and Novartis Pharmaceuticals Corporation v. Genzyme Corporation, IPR2023-00608, Paper 5 (PTAB March 15, 2023) (concerning the content of a motion for pro hac vice admission), Patent Owner respectfully requests that the Board recognize Katherine A. Helm as counsel pro hac vice in this proceeding.

Helm is partner in the law firm of Dechert LLP and a member of the Litigation Department and the Intellectual Property Group in the New York Office.

The vast majority of these contested proceedings involved patents relating to products in the pharmaceutical or biotechnology industry.

Helm has carefully reviewed, developed an extensive familiarity with, and acquired a substantial understanding of the ’542 patent and prosecution history, the legal subject matter, the factual and technical subject matter including pharmaceutical formulations, and the prior art and expert testimony presented in Petitioner’s request for inter partes review of the ’542 patent, which forms the basis of this proceeding.

Accordingly, good cause exists for the granting of this motion, and Patent Owner respectfully requests that Katherine A. Helm be admitted pro hac vice.

Case No. IPR2023-00608 U.S. Patent No. 9,051,542 On February 22, 2023, Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation (Petitioner) filed a petition for an Inter Partes review of claims 1, 2, 5, and 6 of U.S. Patent No. 9,051,542.

The Board entered a decision in IPR2023-00608 on August 30, 2023, denying institution of Inter Partes Review under 35 U.S.C. § 314.

In accordance with 37 C.F.R. § 42.15(a)(2), the post-institution fees paid at the time of filing should be returned.

Petitioner hereby requests a refund of $22,500 for the post-institution fees previously paid in this case.

The payment was provided via PTO Account No. 060916 and processed in Patent Trial and Appeal Case Tracking System (P-TACTS) on February 22, 2023.

Case No. IPR2023-00609 U.S. Patent No. 9,051,542 On February 22, 2023, Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation (Petitioner) filed a petition for an Inter Partes review of claims 1, 2, 5, and 6 of U.S. Patent No. 9,051,542.

The Board entered a decision in IPR2023-00609 on August 30, 2023, denying institution of Inter Partes Review under 35 U.S.C. § 314.

In accordance with 37 C.F.R. § 42.15(a)(2), the post-institution fees paid at the time of filing should be returned.

Petitioner hereby requests a refund of $22,500 for the post-institution fees previously paid in this case.

The payment was provided via PTO Account No. 060916 and processed in Patent Trial and Appeal Case Tracking System (P-TACTS) on February 22, 2023.

Case No. IPR2023-00608 U.S. Patent No. 9,051,542 Pursuant to 37 C.F.R. § 42.63(e), Petitioner Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation hereby submits a current listing of its exhibits.

Exhibit Description Ex. 1011 Potter M., et, al. Chapter 24, Streamlined Large-Scale Production of Recombinant Adeno-Associated Virus (rAAV) Vectors” in Methods in Enzymol., 346:413 (2002) Ex. 1012 Clark, K., Recent advances in recombinant adeno-associated virus vector production, Kidney Int’l, Vol.

), Rational Design of Stable Protein Formulations: Theory and Practice, Vol.

Exhibit Description Ex. 1022 Ainley Wade and Paul J Weller (Eds.

Respectfully Submitted By: / John D. Livingstone / John D. Livingstone Reg. No. 59,613 Lead Counsel for Petitioners Novartis Gene Therapies, Inc., and Novartis Pharmaceuticals Corporation Case No. IPR2023-00608 U.S. Patent No. 9,051,042

Case No. IPR2023-00609 U.S. Patent No. 9,051,542 Pursuant to 37 C.F.R. § 42.63(e), Petitioner Novartis Gene Therapies, Inc. and Novartis Pharmaceuticals Corporation hereby submit a current listing of its exhibits.

Exhibit Description Ex. 1011 Potter M., et, al. Chapter 24, Streamlined Large-Scale Production of Recombinant Adeno-Associated Virus (rAAV) Vectors” in Methods in Enzymol., 346:413 (2002) Ex. 1012 Clark, K., Recent advances in recombinant adeno-associated virus vector production, Kidney Int’l, Vol.

), Rational Design of Stable Protein Formulations: Theory and Practice, Vol.

Exhibit Description Ex. 1022 Ainley Wade and Paul J Weller (Eds.

Respectfully Submitted By: / John D. Livingstone / John D. Livingstone Reg. No. 59,613 Lead Counsel for Petitioners Novartis Gene Therapies, Inc., and Novartis Pharmaceuticals Corporation Date: August 23, 2023

If the Board allows Novartis’s delayed Sotera stipulation to overcome the Fintiv issue, it will also reward gamesmanship disadvantaging Genzyme.

Novartis failed to identify—and Genzyme is unaware of—any precedent to support its argument that the requirement to address foreseeable discretionary denial issues in a Petition does not apply to Fintiv.

Indeed, the Board held that discretionary denial based on parallel litigation under precedential decision NHK Spring must be addressed in the Petition.

Consideration of the Late Stipulation Will Reward Gamesmanship Novartis benefitted from omitting Fintiv by dedicating more of its Petition to merits arguments.

If the Board finds Novartis’s stipulation to obviate Fintiv, Novartis will have unfairly benefited from its delay while prejudicing Genzyme.

If the Board allows Novartis’s delayed Sotera stipulation to overcome the Fintiv issue, it will also reward gamesmanship disadvantaging Genzyme.

Novartis failed to identify—and Genzyme is unaware of—any precedent to support its argument that the requirement to address foreseeable discretionary denial issues in a Petition does not apply to Fintiv.

Indeed, the Board held that discretionary denial based on parallel litigation under precedential decision NHK Spring must be addressed in the Petition.

Consideration of the Late Stipulation Will Reward Gamesmanship Novartis benefitted from omitting Fintiv by dedicating more of its Petition to merits arguments.

If the Board finds Novartis’s stipulation to obviate Fintiv, Novartis will have unfairly benefited from its delay while prejudicing Genzyme.

Exhibit Description Ex. 1012 Clark, K., Recent advances in recombinant adeno-associated virus vector production, Kidney Int’l, Vol.

), Rational Design of Stable Protein Formulations: Theory and Practice, Vol.

Exhibit Description Ex. 1023 Joint Claim Construction Brief, Case Number, C.A.

Discretionary Denial is Not Appropriate in View of Petitioner’s Stipulation In Director Vidal’s June 21, 2022 Guidance on Discretionary Denials, she stated that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Director’s Interim Guidance at 7.1 In the interest of efficiency, Petitioner has filed a Sotera stipulation (Ex. 1030) in the related litigation in order to moot the Fintiv issues raised by Patent Owner (see POPR at 61-67).

Respectfully Submitted By: / John D. Livingstone / John D. Livingstone Reg. No. 59,613 Lead Counsel for Petitioner Novartis Gene Therapies, Inc., and Novartis Pharmaceuticals Corporation