Fate Therapeutics, Inc. v. Shoreline Biosciences, Inc.

• Court: U.S. District Court — Southern District of California
• Writing for the Court: MARILYN L. HUFF, District Judge
• Citation: 664 F.Supp.3d 1125
• Docket Number: Case No.: 22-cv-00676-H-MSB
• Decision Date: 27 March 2023
• Parties: FATE THERAPEUTICS, INC.; and Whitehead Institute for Biomedical Research, Plaintiffs, v. SHORELINE BIOSCIENCES, INC.; and Dan S. Kaufman, Defendants.

664 F.Supp.3d 1125

FATE THERAPEUTICS, INC.; and Whitehead Institute for Biomedical Research, Plaintiffs, v. SHORELINE BIOSCIENCES, INC.; and Dan S. Kaufman, Defendants.

Case No.: 22-cv-00676-H-MSB

United States District Court, S.D. California

Signed March 27, 2023

Aimee Housinger, Pro Hac Vice, Greenberg Traurig, LLP, Houston, TX, Brent Douglas Sokol, Lisa Christine McCurdy, Greenberg Traurig, LLP, Los Angeles, CA, Danielle Marie Zapata, Pro Hac Vice, Giancarlo Luca Scaccia, Pro Hac Vice, Jonathan David Ball, Pro Hac Vice, Jeffrey Ray Colin, Pro Hac Vice, Rose Cordero Prey, Pro Hac Vice, Greenberg Traurig, LLP, New York, NY, Daniel Doft, Duane Morris LLP, San Diego, CA, Joseph Thomas Ergastolo, Wright, L'Estrange & Ergastolo, San Diego, CA, for Plaintiffs.

Eric Martin Acker, Brian M. Kramer, Wesley W.l. Chen, Drew Alan Hillier, Sarah Jane Vandervalk, Morrison & Foerster LLP, San Diego, CA, Jose Luis Ramos, Hooper, Lundy & Bookman, P.C., San Diego, CA, Michael Allen Jacobs, Morrison

and Foerster LLP, San Francisco, CA, for Defendant Shoreline Biosciences, Inc.

Justin T. Goodwin, Dto Law, Los Angeles, CA, Nicole G. Malick, Delgado Tarango O'Neill LLP, Los Angeles, CA, Robin Assaf Wofford, Jason Michael Avelar, Wilson Turner Kosmo LLP, San Diego, CA, Sudip Kundu, Pro Hac Vice, Dto Law, New York, NY, for Defendant Dan S. Kaufman.

Molly A. Jones, Crowell & Moring LLP, San Francisco, CA, for Amicus Lonza Walkersville, Inc.

ORDER DENYING DEFENDANT SHORELINE'S MOTION FOR PARTIAL SUMMARY JUDGMENT

MARILYN L. HUFF, District Judge

On January 27, 2023, Defendant Shoreline Biosciences, Inc. ("Shoreline") filed a motion for partial summary judgment. (Doc. No. 127.) On February 13, 2023, the Court ordered supplemental briefing on an additional issue related to Shoreline's motion. (Doc. No. 153.) On February 13, 2023, Plaintiffs Fate Therapeutics, Inc. ("Fate") and Whitehead Institute for Biomedical Research ("Whitehead") filed a response in opposition to Shoreline's motion for summary judgment. (Doc. No. 154.) On February 17, 2023, Shoreline filed its reply. (Doc. No. 174.) On February 21, 2023, the parties filed their respective supplemental briefs. (Doc. Nos. 181, 186.) On March 13, 2023, Plaintiffs filed a notice of supplemental authority. (Doc. No. 223.)

The Court held a hearing on the matter on February 27, 2023. Jonathan D. Ball, Rose C. Prey, Giancarlo L. Scaccia, Danielle M. Zapata, and Joseph T. Ergastolo appeared for Plaintiffs. Eric M. Acker, Drew A. Hillier, and Sarah J. Vandervalk appeared for Defendant Shoreline. Sudip Kundu and Nicol Malick appeared for Defendant Dan S. Kaufman. For the reasons below, the Court denies Shoreline's motion for partial summary judgment.

Background

In the present action, Plaintiffs assert claims for patent infringement under 35 U.S.C. §§ 271(a), (b), and (g) against Defendants Shoreline and Dan S. Kaufman, alleging claims for infringement of U.S. Patent Nos. 8,071,369 ("the '369 Patent"), 8,932,856 ("the '856 Patent"), 8,951,797 ("the '797 Patent"), 8,940,536 ("the '536 Patent"), 9,169,490 ("the '490 Patent"), 10,457,917 ("the '917 Patent"), and 10,017,744 ("the '744 Patent") (collectively, "the asserted patents"). (Doc. No. 162, Supp. FAC ¶¶ 157-414.) Specifically, Plaintiffs allege that Defendants, individually and acting in concert, make, use, sell, offer for sale, and/or import induced pluripotent stem cells ("iPSCs") that infringe one or more claims of the asserted patents.¹ (Id.¶ 140; see, e.g., id. ¶ 162 ("Defendants' use of their 'iPSC-derived cell therapy manufacturing platform' infringed at least claim 1 of the '369 Patent."), ¶ 212 ("iPSCs used by Defendants to make at least the iPSC-derived natural kill (NK) cell platforms are made by a process that comprises at least each step of claim 1 of the '856 Patent.").)

Plaintiff Whitehead is the owner via assignment of the asserted patents. See U.S. Patent No. 8,071,369, at [73] (issued Dec. 6, 2011); U.S. Patent No. 8,932,856, at [73] (issued Jan. 13, 2015); U.S. Patent No. 8,951,797, at [73] (issued Feb. 10, 2015); U.S. Patent No. 8,940,536, at [73] (issued Jan. 27, 2015); U.S. Patent No. 9,169,490, at [73] (issued Oct. 27, 2015); U.S. Patent No. 10,017,744, at [73] (issued Jul. 10, 2018); U.S. Patent No. 10,457,917, at [73] (issued Oct. 29, 2019). Plaintiffs allege that Fate is the exclusive licensee of the asserted patents. (Doc. No. 162, Supp. FAC ¶¶ 16, 19.)

The '369 Patent is entitled "Compositions for reprogramming somatic cells" and was issued on December 6, 2011. '369 Patent at [45], [54]. The '856 Patent is entitled "Methods for reprogramming somatic cells" and was issued on January 13, 2015. '856 Patent at [45], [54]. The '797 Patent is entitled "Compositions for identifying reprogramming factors" and was issued on February 10, 2015. '797 Patent at [45], [54]. The '536 Patent is entitled "Methods for making somatic cells more susceptible to reprogramming" and was issued on January 27, 2015. '536 Patent at [45], [54]. The '490 Patent is entitled "Methods for reprogramming somatic cells" and was issued on October 27, 2015.-'490 Patent at [45], [54]. The '744 Patent is entitled "Methods for reprogramming somatic cells" and was issued on Jul. 10, 2018. '744 Patent at [45], [54]. The '917 Patent is entitled "Methods for reprogramming somatic cells" and was issued on October 29, 2019. '917 Patent at [45], [54].

The asserted patents are all related and all share a common specification.² (See Doc. No. 149 at 5 & n.2; Doc. No. 151 at 2 & n.2 (agreeing that the asserted patents all share the same specification); see also Doc. No. 162, Supp. FAC ¶ 132.) The shared specification states that the disclosed invention is directed to "methods for reprogramming somatic cells to a less differentiated state." '369 Patent col. 2 ll. 24-25; see also id. at [57] ("The invention provides methods for reprogramming somatic cells to generate multipotent or pluripotent cells.").

The asserted method patents are the '856 Patent, the '536 Patent, the '744 Patent, and the '917 Patent. Independent claim 1 of the '856 Patent claims:

A method of making a somatic cell more susceptible to reprogramming to a pluripotent state comprising introducing at least one exogenous nucleic acid encoding Oct4 operably linked to at least one regulatory sequence into the cell, thereby increasing expression of Oct4 protein in the somatic cell, wherein increased expression of Oct4 protein makes the cell more susceptible to reprogramming to a pluripotent state.

'856 Patent col. 20 ll. 38-44.

Independent claim 1 of the '536 Patent claims:

A method of making a primary somatic cell more susceptible to reprogramming to a less differentiated state, comprising: introducing an exogenous nucleic acid encoding an Oct4 protein operably linked to at least one regulatory sequence into the somatic cell, wherein expression of the exogenously introduced nucleic acid results in making the somatic cell more susceptible to reprogramming to a less differentiated state.

'536 Patent col. 20 ll. 37-44.

Independent claim 1 of the '744 Patent claims:

A method of making a somatic cell more susceptible to reprogramming to a cell having a less differentiated state, comprising:

obtaining a somatic cell that comprises an exogenously introduced polynucleic acid encoding Oct4 protein, and an exogenously introduced polynucleic acid encoding Sox2 or Nanog protein;

wherein the exogenously introduced polynucleic acids result in making the somatic cell more susceptible to reprogramming to a less differentiated state.

'744 Patent col. 21 ll. 14-23.

Independent claim 1 of the '917 Patent claims:

A method of making a somatic cell more susceptible to reprogramming to a less differentiated state, comprising: introducing an exogenous nucleic acid encoding an Oct4 protein operably linked to at least one regulatory sequence into the somatic cell, thereby increasing expression of Oct4 protein in the somatic cell, wherein increased expression of Oct4 protein makes the cell more susceptible to reprogramming; and wherein the exogenous nucleic acid is transiently transfected into the somatic cell.

'917 Patent col. 21 ll. 16-24.

On May 13, 2022, Plaintiffs filed a complaint against Defendants, alleging claims for infringement of the '369 Patent, the '856 Patent, the '797 Patent, the '536 Patent, the '490 Patent, and the '917 Patent. (Doc. No. 1, Compl. ¶¶ 66-236.) On August 12, 2022, the Court issued a scheduling order. (Doc. No. 51.) On January 3, 2023, Plaintiffs filed a first amended complaint against Defendants, adding a claim for infringement of the '744 Patent. (Doc. No. 112, FAC ¶¶ 375-414.) On January 10, 2023, the Court issued an amended scheduling order. (Doc. No. 115.)

On February 14, 2023, Plaintiffs filed a supplemental first amended complaint - the operative complaint. (Doc. No. 162, Supp. FAC.) On February 17 and 23, 2023, Defendants filed answers and counterclaims to Plaintiffs' supplemental first amended complaint. (Doc. Nos. 184, 199.) On February 28, 2023, the Court issued a claim construction order construing disputed claim terms from the asserted patents. (Doc. No. 208.)

By the present motion, Shoreline moves for partial summary judgment that its use of iPSCs manufactured by Lonza Walkersville, Inc. ("Lonza") does not infringe the asserted method patents under 35 U.S.C. § 271(g). (Doc. No. 146 at 1; Doc. No. 181 at 1.) Specifically, Shoreline argues that it is entitled to summary judgment of Plaintiffs' § 271(g) claims because § 271(g) does not apply to domestically manufactured products. (Doc. No. 181 at 1, 10.) In addition, Shoreline argues that it is entitled to summary judgment that its affirmative defense under 28 U.S.C. § 1498 bars Plaintiffs from suing it under 35 U.S.C. § 271(g) based on the Lonza line of iPSCs. (Doc. No. 146 at 9-11.)

Discussion

I. Legal Standards Governing Summary Judgment

Summary judgment is appropriate under Federal Rule of Civil Procedure 56 if the moving party demonstrates "that...