JSR Corp. v. Cytiva Bioprocess R&D AB

• Decision Date: 19 April 2023
• Docket Number: IPR2022-00036,IPR2022-00043,Patent 10,213,765 B2
• Parties: JSR CORPORATION and JSR LIFE SCIENCES, LLC, Petitioner, v. CYTIVA BIOPROCESS R&D AB, Patent Owner.
• Court: Patent Trial and Appeal Board

1

JSR CORPORATION and JSR LIFE SCIENCES, LLC, Petitioner, v. CYTIVA BIOPROCESS R&D AB, Patent Owner.

IPR2022-00036, IPR2022-00043

Patent 10,213,765 B2

United States Patent and Trademark Office, Patent Trial and Appeal Board

April 19, 2023

FOR PETITIONER:

Naveen Modi

Eric Dittmann

Phillip Citroen

Isaac Ashkenazi

PAUL HASTINGS LLP

FOR PATENT OWNER:

David Krinsky

David Berl

WILLIAMS & CONNOLLY LLP

Before ULRIKE W. JENKS, SHERIDAN K. SNEDDEN, and SUSAN L. C MITCHELL, Administrative Patent Judges.

JUDGMENT

CONSOLIDATED FINAL WRITTEN DECISION

DETERMINING ALL CHALLENGED CLAIMS UNPATENTABLE

35 U.S.C. § 318

JENKS, Administrative Patent Judge.

I. INTRODUCTION

This is a Final Written Decision in an inter partes review of claims 1-7, 10-20, and 23-26 ("the challenged claims") of U.S. Patent No. 10,213,765 B2 (Ex. 1001, "the '765 patent"). We have jurisdiction under 35 U.S.C. § 6, and enter this Consolidated Final Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that JSR Corporation and JSR Life Sciences, LLC (collectively, "Petitioner") has shown, by a preponderance of the evidence, that the challenged claims are unpatentable. See 35 U.S.C. § 316(e).

A. Consolidated Proceedings

The two captioned proceedings (IPR2022-00036 and IPR2022-00043 (or "the '043 IPR") involve the '765 patent and challenge the same set of claims. The asserted grounds and prior art contentions are different in each proceeding. Consolidation is appropriate where, as here, the Board can more efficiently handle the common issues and evidence, and also remain consistent across proceedings. Under 35 U.S.C. § 315(d), the Director may determine the manner in which these pending proceedings may proceed, including "providing for stay, transfer, consolidation, or termination of any such matter or proceeding." See also 37 C.F.R. § 42.4(a) ("The Board institutes the trial on behalf of the Director."). There is no specific Board Rule that governs consolidation of cases. But 37 C.F.R. § 42.5(a) allows the Board to determine a proper course of conduct in a proceeding for any situation not specifically covered by the rules and to enter non-final orders to administer the proceeding. Therefore, on behalf of the Director under § 315(d), and for a more efficient administration of these proceedings, we consolidate IPR2022-00036 and IPR2022-00043 for purposes of rendering this Final Written Decision.

B. Procedural History

JSR Corporation and JSR Life Sciences, LLC (collectively, "Petitioner") filed a Petition for an inter partes review of claims the challenged claims under 35 U.S.C. § 311 in each proceeding. Paper 1^[1]("Pet."). Petitioner supported the Petition with the Declaration of Dr. Steven M. Cramer. Ex. 1002. Cytiva Bioprocess R&D AB ("Patent Owner") filed a Patent Owner Preliminary Response to the Petition. Paper 9 ("Prelim. Resp.").

On April 21, 2022, pursuant to 35 U.S.C. § 314(a), we instituted trial ("Decision" or "Dec." (Paper 10)) to determine whether any challenged claim of the '765 patent is unpatentable.

In IPR2022-00036, Petitioner asserts the following grounds of unpatentability (Pet. 4):

Claim(s) Challenged

35 U.S.C. §^[2]

Reference(s)/Basis

1-4,12,14-17,25

103(a)

Linhult, Abrahmsen

1-7, 10-20,23-26

103(a)

Linhult, Hober

1-7, 10-20,23-26

103(a)

Linhult, Abrahmsen, Hober

1-7, 10-20,23-26

103(a)

Abrahmsen, Hober

In IPR2022-00043, Petitioner asserts the following grounds of unpatentability ('043 IPR Pet. 4):

Claim(s) Challenged

35 U.S.C. §^[3]

Reference(s)/Basis

1-7,10-20,23-26

103(a)

Berg, Linhult

2,3, 15, 16

103(a)

Berg, Linhult, Hober

1,2,5-7,10-15,18-20,23-26

103(a)

Berg, Abrahmsen

2-4,15-17

103(a)

Berg, Abrahmsen, Hober

Patent Owner filed a Patent Owner Response to the Petition. Paper 16 ("PO Resp."). Patent Owner supported the Response with the Declaration of Dr. Daniel Bracewell (Ex. 2025). See PO Resp., iv (Exhibit List). Petitioner filed a Reply to the Patent Owner Response. Paper 29 ("Reply"). Petitioner supported the Reply with a Reply Declaration from Dr. Steven M. Cramer. Ex. 1061. Patent Owner filed a Sur-reply to Petitioner's Reply. Paper 35 ("Sur-reply").

On February 16, 2023, the parties presented arguments at an oral hearing. Paper 36. The hearing transcript has been entered in the record. Paper 40 ("Tr.").

For the reasons set forth below, we determine that Petitioner has shown by a preponderance of the evidence that claims 1-7, 10-20, and 23-26 of the '765 patent are unpatentable.

C. Real Parties in Interest

Petitioner identifies itself, JSR Corporation and JSR Life Sciences, LLC, along with JSR Micro NV, as the real parties-in-interest. Pet. 2. Patent Owner identifies itself, Cytiva Bioprocess R&D AB, along with Cytiva Sweden AB and Danaher Corporation as real parties-in-interest. Paper 7, 1.

D. Related Matters

The '765 patent is at issue in Cytiva BioProcess R&D et al. v. JSR Corp. et al, Civil Action No. 1:21-cv-00310 (D. Del). Pet. 2; Paper 5, 1.

In addition to the '765 patent challenged here, Petitioner has filed Petitions for inter partes review of related U.S. patents as follows: U.S. Patent No. 10,343,142 B2 ("the '142 patent") in IPR2022-00041 and IPR2022-00044; and U.S. Patent No. 10,875,007 B2 ("the '007 patent") in IPR2022-00042 and IPR2022 00045. Pet. 2-3; Paper 7, 1-2. Petitioner indicates that the' 142 patent and the '007 patent are also being asserted in the above-cited district court case. Pet. 3. The parties further list a pending application in the same family, U.S. App. Serial No. 17/107,600. Pet. 2; Paper 7, 2.

E. Subject matter background

Antibodies (also called immunoglobulins) are glycoproteins, which specifically recognize foreign molecules. These recognized foreign molecules are called antigens. Ex. 2001, 1. A schematic representation of the structure of a conventional IgG and fragments is shown below:

(Image Omitted)

The figure (Ex. 2001, 2 (Fig. 1)), reproduced above, shows

the structure of a conventional IgG and fragments that can be generated thereof. The constant heavy-chain domains C_HI, C_H2 and C_H3 are shown in yellow, the constant light-chain domain (C_L) in green and the variable heavy-chain (V_H) or light-chain (V_L) domains in red and orange, respectively. The antigen binding domains of a conventional antibody are Fabs and Fv fragments. Fab fragments can be generated by papain digestion. Fvs are the smallest fragments with an intact antigen-binding domain. They can be generated by enzymatic approaches or expression of the relevant gene fragments (the recombinant version). In the recombinant single-chain Fv fragment, the variable domains are joined by a peptide linker. Both possible configurations of the variable domains are shown, i.e. the carboxyl terminus of VH fused to the N-terminus of VL and vice versa.

Ex. 2001, 2; see also PO Resp. 5.

Below is a generic, exemplary schematic that shows how affinity purification typically works:

(Image Omitted)

The figure shows the schematic of the loading, contact, and adsorbing step onto a column, followed by the wash step, and finally the elution and collection of the target compound. Ex. 1002 ¶ 24 (citing Ex. 1014 at §§ 1.1, 4.2.); see also PO Resp. 7 ("In a typical process, the composition containing the desired antibody then is loaded onto (i.e., pumped or injected into) the column."); Pet. 6; see generally Ex. 1014.

F. The '765 patent (Ex. 1001)

The '765 patent is titled "Chromatography Ligand Comprising Domain C from Staphylococcus Aureus Protein A for Antibody Isolation." Ex. 1001, (54). The '765 patent relates to an affinity ligand that is used for antibody isolation. Id. at 1:39-41. The '765 patent explains that chromatography is used in large-scale economic production of drugs and diagnostics in which proteins are produced by cell culture and then separated from the mixture of compounds and other cellular components to a sufficient purity. Id. at 1:52-61. One type of chromatography matrix for this purifying process includes immunoglobulin proteins, also known as antibodies, such as immunoglobulin G (IgG). Id. at 2:4-13. The '765 patent further explains that "[a]s in all process technology, an important aim is to keep the production costs low" by reusing matrices via cleaning protocols such as an alkaline protocol known as cleaning in place (CIP). Id. at 2:14-29. However, harsh treatments may impair the chromatography matrix materials such that there is a need for stability towards alkaline conditions for an engineered protein ligand. Id. at 2:31-48.

The '765 patent discloses that Protein A, known as SPA, is a constituent of the cell wall of the bacterium Staphylococcus aureus, and is widely used as a ligand in affinity chromatography matrices due to its ability to bind with IgG. Id. at 2:49-54. SPA is composed of five domains, designated in order from the N-terminus as E, D, A, B, and C, which are able to bind to antibodies at the Fc region, and it has been shown that each of these domains binds to certain antibodies at the Fab region. Id. at 2:54-63.

Domain C from SPA is defined by SEQ ID NO: 1 and is reproduced below.

(Image Omitted)

Id. at 4:27; 15:1-20. SEQ ID NO: 1 shows Domain C has Glycine (Gly) as an amino acid at the position 29 as annotated via red highlighting. According to the '765 patent, it has already been shown "that Domain C can act as a separate immunoglobulin adsorbent, not just as part of Protein A" and the '765 patent discloses that from experiments, "the present inventors have quite surprisingly shown that the SPA Domain C presents a much improved alkaline-stability compared to a commercially available Protein A product." Id. at 5:38-40 51-55. The '765 patent...