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

• Docket Number: 22-cv-00676-H-MSB
• Decision Date: 30 August 2023
• Parties: FATE THERAPEUTICS, INC.; and WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, Plaintiffs, v. SHORELINE BIOSCIENCES, INC., Defendant.
• Court: U.S. District Court — Southern District of California

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FATE THERAPEUTICS, INC.; and WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, Plaintiffs,
v.
SHORELINE BIOSCIENCES, INC., Defendant.

No. 22-cv-00676-H-MSB

United States District Court, S.D. California

August 30, 2023

ORDER: (1) GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT; AND [DOC. NO. 290.] (2) DENYING PLAINTIFFS' MOTION FOR PARTIAL SUMMARY JUDGMENT AS MOOT [DOC. NO. 289.]

MARILYN L. HUFF, District Judge.

On July 14, 2023, Defendant Shoreline Biosciences, Inc. (“Shoreline”) filed a motion for summary judgment, and Plaintiffs Fate Therapeutics, Inc. (“Fate”) and Whitehead Institute for Biomedical Research (“Whitehead”) filed a motion for partial summary judgment. (Doc. Nos. 289, 290.) On July 28, 2023, the parties filed their respective responses in opposition. (Doc. Nos. 307, 312.) On August 4, 2023, the parties filed their respective replies. (Doc. Nos. 335, 340.)

The Court held a hearing on the matter on August 28, 2023. Jonathan D. Ball, Rose

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C. Prey, Giancarlo L. Scaccia, Danielle M. Zapata, Joseph T. Ergastolo, Jeffrey R. Colin, Ben Witte, Aimee Housinger, and Wen Xue appeared for Plaintiffs. Eric M. Acker, Michael A. Jacobs, Drew A. Hillier, and Regan Rundio appeared for Defendant Shoreline. For the reasons below, the Court grants Shoreline's motion for summary judgment, and the Court denies Plaintiffs' motion for partial summary judgment as moot.

Background

In the present action, Plaintiffs assert claims for patent infringement under 35 U.S.C. §§ 271(a), (b), and (g) against Defendant Shoreline, 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 Shoreline makes, uses, sells, offers for sale, and/or imports induced pluripotent stem cells (“iPSCs”) that infringe one or more claims of the asserted patents.^[1],^[2] (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

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that comprises at least each step of claim 1 of the '856 Patent.”).)

Plaintiff Whitehead is the owner via assignment of the patents-in-suit. 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.^[3] (See Doc. No. 149 at 5 & n.2; Doc. No. 151 at 2 & n.2 (the parties 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]

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(“The invention provides methods for reprogramming somatic cells to generate multipotent or pluripotent cells.”).

The asserted composition patents are the '369 Patent, the '797 Patent, and the '490 Patent. Independent claim 1 of the '369 Patent claims:

A composition comprising an isolated primary somatic cell that comprises an exogenously introduced nucleic acid encoding an Oct4 protein operably linked to at least one regulatory sequence

'369 Patent col. 20 ll. 40-43.

Independent claim 1 of the '797 Patent claims:

A composition comprising an isolated primary somatic cell that comprises an exogenously introduced nucleic acid encoding Oct 4, wherein the exogenously introduced nucleic acid increases Oct4 expression in the cell.

'797 Patent col. 20 ll. 40-43.

Independent claim 1 of the '490 Patent claims:

A somatic cell comprising an exogenous nucleic acid encoding Oct4 and an amount of Oct4 expression comparable to the amount of Oct4 expression in an embryonic stem cell.

'490 Patent col. 20 ll. 39-41.

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 Oct 4 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 Oct 4 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

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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 Oct 4 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 Shoreline and Dan S. Kaufman, 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. ¶¶ 66236.) 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.)

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On February 28, 2023, the Court issued a claim construction order construing agreed up and disputed claim terms from the asserted patents.^[4] (Doc. No. 208.) On March 27, 2023, the Court denied Shoreline's motion for partial summary judgment. (Doc. No. 226.) On March 30, 2023, the Court denied Defendants' partial motion to dismiss Plaintiffs' supplemental first amended complaint. (Doc. No. 234.) On June 9, 2023, the Court dismissed Defendant Kaufman from the action with prejudice pursuant to Plaintiffs' motion. (Doc. No. 273.)

By the present motions for summary judgment, Defendant Shorelines moves for summary judgment of all of Plaintiffs' claims for patent infringement - Plaintiffs' claims for direct infringement under 35 U.S.C. § 271(g); Plaintiffs' claims for induced infringement under § 271(b); and Plaintiffs' claims for direct infringement under § 271(a). (Doc. No. 354 at 1-2.) In addition, Plaintiffs move for partial summary judgment of: (1) the underlying direct infringement of the '369 Patent by ThermoFisher in support of their claim for induced infringement under § 271(b); and (2) of certain affirmative defenses and certain counterclaims that the asserted method claims are invalid...