Case 1:22-cv-00311-WCB Document 592 Filed 07/26/24 Page 1 of 8 PageID #: 30147
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Civil Action No. 22-311-WCB
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`IMPOSSIBLE FOODS INC.,
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`Plaintiff,
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`MOTIF FOODWORKS, INC., and
`GINKGO BIOWORKS, INC.,
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`v.
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`Defendants.
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`MEMORANDUM OPINON AND ORDER
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`In this patent case, plaintiff Impossible Foods Inc. has moved to amend its infringement
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`contentions against Motif Foodworks, Inc., and Ginkgo Bioworks, Inc (collectively
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`“Defendants”). Defendants oppose the motion. For the reasons set forth in this opinion,
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`Impossible’s motion is GRANTED.
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`1. Background
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`Impossible’s initial complaint asserted 162 claims across seven different patents against
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`Motif. Ginkgo was later added as a defendant, after which I ordered that the claims of infringement
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`of U.S. Patent Nos. 10,273,492 and 10,689,656 (collectively the “yeast patents”) be tried
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`separately from claims of infringement of the other five patents in the case. Dkt. No. 161. I set a
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`new schedule for the “yeast patents” case, in which the following case narrowing procedures apply:
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`By February 9, 2024, Impossible should reduce the number of asserted claims against
`Ginkgo and Motif in the Yeast Patent case to 14. By March 1, 2024, Ginkgo and Motif
`should reduce the number of asserted prior art references in the Yeast Patent case to 18.
`By April 5, 2024, Impossible should reduce the number of asserted claims against Ginkgo
`and Motif in the Yeast Patent case to 6. By May 17, 2024, Ginkgo and Motif should reduce
`the number of asserted prior art references in the Yeast Patent case to 10. Either party may
`move to deviate from the above procedures upon a showing of good cause, including but
`not limited to subsequent events such as IPR institution decisions or the court’s claim
`construction order.
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`1
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`Case 1:22-cv-00311-WCB Document 592 Filed 07/26/24 Page 2 of 8 PageID #: 30148
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`Id. at 8.
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`Defendants served their initial Identification of Asserted Prior Art References in early
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`March 2024. Dkt. No. 373 (Ginkgo notice of service); Dkt. No. 382 (Motif notice of service); see
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`also Dkt. No. 527-1, Ex. 2 at 2 (Motif references); id., Ex. 3 at 2 (Ginkgo references). Both lists
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`include a paper by Krainer et al., which is attached as Exhibit 1 to this Order. The Krainer study
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`sought to increase the availability of “cofactors” in the heme protein production process.
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`Cofactors, in this context, are proteins other than the heme proteins themselves, that assist in the
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`production of the heme proteins. To achieve that goal, Krainer engineered yeast cells to produce
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`those proteins under a strong constitutive promoter,1 and a methanol inducible promoter.2 Ex. 1
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`at 2–3. All yeast strains in Krainer “were based on the P. pastoris wildtype strain CBS 7435.” See
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`Ex. 1 at 6.
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`On March 22, 2024, the court issued an order construing various claim terms used in the
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`yeast patents. Dkt. No. 414. One of the critical terms in that order was “a Mxr1 transcriptional
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`activator sequence.” The parties disputed whether that phrase refers to the DNA or RNA encoding
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`the Mxr1 protein, or to the DNA sequence to which Mxr1 binds when it is doing its job as a
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`transcriptional activator. I agreed with Impossible that the term refers to the DNA sequence to
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`which Mxr1 binds.
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`On April 19, 2024, Defendants served their Final Invalidity Contentions, which included
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`arguments based on the CBS 7435 P. pastoris strain. Dkt. No. 486 (notice of service); Dkt. No.
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`1 A promoter is the portion of a gene that determines the degree to which the gene is
`expressed, i.e., how much protein the gene makes. A constitutive promoter is a promoter that is
`active all the time, regardless of environmental condition. A strong constitutive promoter is one
`with a high degree of expression.
`2 A methanol inducible promoter is one which regulates gene expression based on the
`presence of methanol.
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`2
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`Case 1:22-cv-00311-WCB Document 592 Filed 07/26/24 Page 3 of 8 PageID #: 30149
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`527-1, Ex. 1 (contentions). Specifically, Defendants argued that claim 5 of the ’492 patent would
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`cover naturally existing CBS 7435 P. pastoris under the court’s claim construction, rendering the
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`claim invalid under 35 U.S.C. § 101.3 See Dkt. No. 527-1, Ex. 1 at 47–49 (citing Diamond v.
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`Chakrabarty, 447 U.S. 303, 310 (1980)). On May 17, 2024, Defendants reduced their asserted
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`invalidity references from two lists of 18 references to a single list of 10 references. See Dkt. No.
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`527-1, Ex. 4 at 2. While the total number of references was reduced, the CBS 7435 Pichia pastoris
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`strain was added as an asserted reference for the first time in the list of 10 references.
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`On May 6, 2024, Impossible moved to add claim 11 of the ’492 patent to its infringement
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`contentions. Defendants did not oppose that motion, and the court granted the motion. See Dkt.
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`No. 498; Dkt. No. 507. Four days later, Impossible notified Defendants’ counsel that it intended
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`to seek leave to amend its infringement contentions by adding claim 5 and dropping claim 2 of the
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`’492 patent. Claims 2 and 5 both depend from claim 1. Those claims recite:
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`1. A methylotrophic Pichia yeast cell comprising:
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`a nucleic acid molecule encoding a heme-containing protein operably linked to a promoter
`element from P. pastoris and a Mxr1 transcriptional activator sequence from P. pastoris;
`and
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` nucleic acid molecule encoding at least one polypeptide involved in heme biosynthesis
`operably linked to a promoter element from P. pastoris and a Mxr1 transcriptional activator
`sequence from P. pastoris.
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`2. The yeast cell of claim 1, wherein the heme-containing protein is Leghemoglobin
`(LegH).
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`5. The yeast cell of claim 1, wherein the promoter element from P. pastoris is a constitutive
`promoter element from P. pastoris or a methanol-inducible promoter element from P.
`pastoris.
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` a
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`3 Impossible also represents that Defendants’ contentions introduce a new argument based
`on the CBS 7435 strain and 35 U.S.C. § 102. Only excerpts of Defendants’ Final Invalidity
`Contentions were attached to Impossible’s motion, and those excerpts do not contain any argument
`relating to CBS 7435 and section 102.
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`3
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`Case 1:22-cv-00311-WCB Document 592 Filed 07/26/24 Page 4 of 8 PageID #: 30150
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`Impossible filed its motion to amend on June 5, 2024, approximately seven weeks after
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`receiving the Final Invalidity Contentions, and approximately three weeks after the CBS 7435
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`strain was formally identified as a prior art reference. Defendants oppose the substitution of
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`claims.
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`2. Analysis
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`The scheduling order in this case provides that a party may amend its contentions for good
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`cause. See Dkt. No. 161 at 8; see also Fed. R. Civ. P. 16(b)(4) (“A schedule may be modified only
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`for good cause and with the judge's consent.”). “In determining whether a party has demonstrated
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`good cause to amend its contentions, the key factor that courts have considered is whether that
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`party has shown diligence both in discovering that an amendment was necessary and in moving to
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`amend after that discovery.” Brit. Telecomms. PLC v. IAC/InterActiveCorp, No. CV 18-366, 2020
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`WL 3047989, at *2 (D. Del. June 8, 2020) (citing O2 Micro Int’l Ltd. v. Monolithic Power Sys.,
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`Inc., 467 F.3d 1355, 1366–67 (Fed. Cir. 2006) and Bayer Cropscience AG v. Dow AgroSciences
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`LLC, No. CV 10-1045, 2012 WL 12904381, at *2 (D. Del. Feb. 27, 2012)). Even if a party can
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`establish good cause, however, “substantial or undue prejudice to the non-moving party is a
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`sufficient ground for denial of leave to amend.” See Cureton v. Nat’l Collegiate Athletic Ass’n,
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`252 F.3d 267, 273 (3d Cir. 2001) (discussing amendments to a complaint).
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`Impossible’s core theory is that it has good cause to amend because it acted quickly upon
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`learning that Defendants had raised new arguments in their final invalidity contentions and that
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`defendants were asserting a new prior art reference, the CBS 7435 strain. Defendants in turn argue
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`(1) that Impossible had all the necessary facts to assert claim 2 once it learned that some of
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`Defendants’ products contain leghemoglobin, (2) that Impossible was not diligent because it
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`waited to disclose its intention to assert a new claim until after Defendants agreed not to oppose a
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`4
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`separate amendment to the contentions, and (3) that the proposed amendment would be prejudicial
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`to Defendants at this stage in the case.
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`Prior to Defendants submitting their Final Invalidity Contentions, Impossible had no way
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`of anticipating that P. pastoris strain CBS 7435 would be used as a reference to argue the invalidity
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`of claim 5 under section 101. The fact that the CBS 7435 strain is referenced in Krainer did not
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`put Impossible on notice that the CBS 7435 strain might itself be used as a reference. Claim 1,
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`from which claim 5 depends, recites “a nucleic acid molecule encoding a heme-containing
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`protein.” ’492 patent at col. 77, ll. 50–51. Krainer, on the other hand, discusses a “P. pastoris
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`strain recombinantly producing the heme protein HRP,” meaning that the naturally occurring CBS
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`7435 strain was genetically modified to produce the heme protein. Ex. 1 at 3. Impossible cannot
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`have been expected to understand Krainer as disclosing a naturally occurring yeast strain meeting
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`the requirements of claim 1 because the strain in Krainer was modified to express the claimed
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`protein. A claim to a modified organism with “markedly different characteristics” is not invalid
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`under section 101. See generally Chakrabarty, 447 U.S. at 310.
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`Krainer primarily relates to a different portion of claim 1, which addresses “polypeptide[s]
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`involved in heme biosynthesis.” ’492 patent at col. 77, ll. 54–55. Those are the polypeptides that
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`Krainer refers to as “cofactors.” The inclusion of Krainer in Defendants’ Initial Invalidity
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`Contentions therefore did not place Impossible on notice of a potential section 101 argument based
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`on P. pastoris strain CBS 7435 meeting all limitations of the claim.
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`After learning about Defendants’ new position on April 19, 2024, Impossible acted
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`reasonably promptly to amend its contentions. It informed Defendants of its intentions on May
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`10, 2024, three weeks after receiving the invalidity contentions containing the new argument.
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`Impossible formally moved to amend on June 5, 2024, approximately seven weeks after receiving
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`5
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`the final invalidity contentions. Whereas I previously held that Impossible was not diligent where
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`it took four months to initiate testing of sample after the sample was produced and did not begin
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`that process until after the deadline to amend had passed, see Dkt. No. 572 at 5, in this instance
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`Impossible acted with reasonable promptness upon learning of the new argument. Impossible
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`could not have made the change prior to the deadline to submit final infringement contentions
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`because the deadline had already passed at the time Impossible learned of Defendants’ new
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`argument. For that reason, I find that Impossible was diligent and therefore has good cause to
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`amend.
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`Defendants’ arguments to the contrary are not persuasive. Although it is true that
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`Impossible knew that some of Defendants’ products produced soy leghemoglobin, and thus had
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`information relevant to infringement, Impossible did not learn critical information relevant to
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`invalidity until Defendants submitted their Final Invalidity Contentions. By its nature, the case
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`narrowing procedure in the scheduling order invited Impossible to assert only the claims it believed
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`to be strongest. In making that determination, Impossible was entitled to decide which claims it
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`believed to be the strongest with the benefit of knowing what invalidity positions Defendants
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`would be taking. Defendants deprived Impossible of that opportunity by raising a new invalidity
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`position in their final contentions, based on a previously unlisted reference. As such, Defendants
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`cannot properly be said to have “narrowed” their contentions or “reduced” the number of asserted
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`invalidity references as contemplated by the scheduling order. See generally Dkt. No. 161 at 8.
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`Because they supplemented their invalidity references in substance while reducing them in
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`number, Defendants are partly responsible for Impossible’s need to reevaluate its position.
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`Defendants also argue that Impossible engaged in gamesmanship by waiting to inform
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`Defendants of its intention to amend until after the Defendants had agreed to permit a similar
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`6
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`amendment. While Defendants might have opposed both motions to amend if Impossible had
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`raised them together, Impossible would have been in the same position with respect to the present
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`motion, which Defendants have opposed. With respect to the motion at hand, Defendants were
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`not prejudiced by Impossible’s seriatim filing of its motions. The only difference in Defendants’
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`position is that they might have opposed the first motion as well as the current one. And the fact
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`that Defendants did not oppose the first motion is the best indication that they did not regard that
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`motion as prejudicial to them. The fact that Defendants may have behaved differently had
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`Impossible raised the issue sooner does not warrant denial of the present motion.
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`Similarly, although Defendants may suffer some prejudice from allowance of the
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`amendment, the prejudice is likely to be quite modest. Claims 2 and 5 both depend from the same
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`independent claim, so the overwhelming majority of Defendants’ work will be transferrable. That
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`is particularly true because Defendants’ invalidity contentions already address leghemoglobin, the
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`additional limitation added by claim 2, in some capacity. See generally Dkt. No. 527-1, Ex. 1. At
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`121; id. at 211. Additionally, the parties recently stipulated to extend the close of expert discovery
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`by almost a month. Dkt. No. 591. Defendants will have three weeks from the filing of this order
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`until the close of discovery, which will be sufficient time to adapt their positions from claim 5 to
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`claim 2. In short, the prejudice to Defendants weighs slightly in favor of denying the motion, but
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`not enough to overcome the arguments in favor of granting it.
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`* * * * *
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`For the foregoing reasons, Impossible’s motion is GRANTED. The briefs regarding this
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`issue were submitted under seal. For that reason, I have filed this opinion under seal. Within three
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`business days of the issuance of this order, the parties are directed to advise the court by letter
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`whether they wish any portions of this order to remain under seal, and if so which portions. Any
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`7
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`request that portions of the order remain under seal must be supported by a particularized showing
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`of need to limit public access to those portions of the order.
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`IT IS SO ORDERED.
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`SIGNED this 26th day of July, 2024.
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`______________________________
`WILLIAM C. BRYSON
`UNITED STATES CIRCUIT JUDGE
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