Citations
- 329 F. Supp. 3d 1070
Full opinion text
SUSAN ILLSTON, United States District Judge
Before the Court are the parties' post-trial motions (Dkt. Nos. 648, 649, 650, 661, 662, 666), plaintiffs' motion for a permanent injunction (Dkt. Nos. 660, 666), and two administrative motions to seal (Dkt. Nos. 684, 697). After hearing argument and considering the parties' materials, the Court rules as follows.
LEGAL STANDARD
I. Motion for judgment as a matter of law
"A renewed motion for judgment as a matter of law is properly granted only if the evidence, construed in the light most favorable to the nonmoving party, permits only one reasonable conclusion, and that conclusion is contrary to the jury's verdict." Castro v. Cty. of Los Angeles , 833 F.3d 1060, 1066 (9th Cir. 2016) (en banc) (quoting Pavao v. Pagay , 307 F.3d 915, 918 (9th Cir. 2002) ) (internal quotation marks omitted), cert. denied sub nom. Los Angeles Cty., Cal. v. Castro , --- U.S. ----, 137 S.Ct. 831, 197 L.Ed.2d 69 (2017) (Mem.). "A jury's verdict must be upheld if it is supported by substantial evidence, which is evidence adequate to support the jury's conclusion, even if it is also possible to draw a contrary conclusion." Id. (quoting Pavao , 307 F.3d at 918 ). In ruling on such a motion, the trial court may not weigh the evidence or assess the credibility of witnesses in determining whether substantial evidence exists to support the verdict. William Inglis & Sons Baking Co. v. ITT Cont'l Baking Co. , 668 F.2d 1014, 1026 (9th Cir. 1981) ; see also Mosesian v. Peat, Marwick, Mitchell & Co. , 727 F.2d 873, 877 (9th Cir. 1984). "Substantial evidence is more than a mere scintilla." Consol. Edison Co. v. NLRB , 305 U.S. 197, 229, 59 S.Ct. 206, 83 L.Ed. 126 (1938) ; Chisholm Bros. Farm Equip. Co. v. Int'l Harvester Co. , 498 F.2d 1137, 1140 (9th Cir. 1974). Judgment as a matter of law is appropriate "when the jury could have relied only on speculation to reach its verdict." Lakeside-Scott v. Multnomah Cty. , 556 F.3d 797, 803 (9th Cir. 2009).
II. Motion for new trial
Federal Rule of Civil Procedure 59(a)(1) states, "[t]he court may, on motion, grant a new trial on all or some of the issues-and to any party-as follows: (A) after a jury trial, for any reason for which a new trial has heretofore been granted in an action at law in federal court...." Fed. R. Civ. P. 59(a)(1). As the Ninth Circuit has noted, " Rule 59 does not specify the grounds on which a motion for a new trial may be granted...." Zhang v. Am. Gem Seafoods, Inc. , 339 F.3d 1020, 1035 (9th Cir. 2003). Instead, the court is "bound by those grounds that have been historically recognized." Id. "Historically recognized grounds include, but are not limited to, claims 'that the verdict is against the weight of the evidence, that the damages are excessive, or that, for other reasons, the trial was not fair to the party moving.' " Molski v. M.J. Cable, Inc. , 481 F.3d 724, 729 (9th Cir. 2007) (quoting Montgomery Ward & Co. v. Duncan , 311 U.S. 243, 251, 61 S.Ct. 189, 85 L.Ed. 147 (1940) ). The Ninth Circuit has held that "[t]he trial court may grant a new trial only if the verdict is contrary to the clear weight of the evidence, is based upon false or perjurious evidence, or to prevent a miscarriage of justice." Passantino v. Johnson & Johnson Consumer Prods., Inc. , 212 F.3d 493, 510 n.15 (9th Cir. 2000).
DISCUSSION
I. Ariosa's renewed motion for judgment as a matter of law and motion for a new trial on issues for which Ariosa bore the burden of proof (Dkt. No. 648)
Defendant Ariosa Diagnostics, Inc. renews its motion for judgment as a matter of law ("JMOL") under Rule 50(b), and for a new trial under Rule 59, based on Ariosa's express license defense and the alleged invalidity of plaintiffs Illumina, Inc. and Verinata Health, Inc.'s patents. The background and procedural history of this case are described in the Court's Summary Judgment Order (Dkt. No. 517). As such, only portions of the record relevant to this motion are recounted here.
Plaintiff Verinata developed and offered non-invasive tests (such as the verifi® prenatal test) for the early identification of fetal chromosomal abnormalities. Dkt. No. 1 ¶ 11. Plaintiff Illumina develops, manufactures, and markets life science tools and integrated systems for large-scale analysis of DNA. Case No. 15-cv-2216, Dkt. No. 1 ¶ 4. Defendant Ariosa is a molecular diagnostics company that researches, evaluates, and develops non-invasive prenatal tests for chromosomal abnormalities in a fetus. Dkt. No. 283 ¶ 10.
This consolidated patent infringement action concerns the following patents: U.S. Patent Nos. 8,318,430 ("the '430 patent") and 7,955,794 ("the '794 patent"). Verinata owns the '430 patent, which is directed to methods for non-invasive prenatal screening of fetal chromosomal abnormalities. See '430 Patent. Illumina owns the '794 patent, which issued in June 2011 and is directed to methods for simultaneously detecting multiple target nucleic acids in a sample. See '794 Patent.
In January 2012, Ariosa and Illumina entered into a three-year Sale and Supply Agreement ("SSA"), under which Illumina agreed to supply specific consumables, hardware, and software to Ariosa. Dkt. No. 402-6. The SSA provided Ariosa with a non-exclusive license to Illumina's "Core IP Rights in Goods" in the "Customer Field of Use." Id. §§ 1, 3. "Core IP Rights in Goods" included "Illumina Intellectual Property Rights that pertain to the Goods (and use thereof in accordance with their Documentation) other than Secondary Illumina IP Rights in Goods[.]" Id. § 1. "Secondary IP Rights in Goods" was defined as "secondary Illumina Intellectual Property Rights that pertain to the Goods (and use thereof) only with regard to particular field(s) or application(s), and are not common to the Goods in all applications and fields." Id. "Customer Field of Use" was defined as "(a) commercial services for the cell-free detection of fetal chromosomal abnormalities having a length greater than one megabase by pre-natal screening using DNA sequencing, ... and (b) internal, non-commercial experimental research[.]" Id.
Starting late 2012, plaintiffs filed a number of lawsuits accusing Ariosa's Harmony™ Prenatal Test of infringing the patents-in-suit. Dkt. No. 22; Dkt. No. 517 at 8-9. Two versions of the Harmony™ Prenatal Test were at issue-"Harmony V1" and "Harmony V2." Dkt. No. 517 at 6. Harmony V1 was made commercially available in 2012 and relied on sequencing (using Illumina sequencers) to obtain genetic data, while Harmony V2 was released in 2015 and relied on a microarray platform instead of sequencing. Id. ; Dkt. No. 283 ¶ 12. The two versions used different protocols for processing the samples. Dkt. No. 416 at 3-7; Dkt. No. 517 at 6-7, 37. Verinata alleged Harmony V1 infringed the '430 patent, and Illumina alleged both Harmony versions infringed the '794 patent. Dkt. No. 349; Case Nos. 14-cv-1921, 15-cv-2216. Ariosa argued that the patents-in-suit were invalid and that it had an express license to the '794 patent. Dkt. No. 352; Case No. 14-cv-1921, Dkt. No. 68. Ariosa also asserted a counterclaim for breach of contract. Case No. 14-cv-1921, Dkt. No. 68.
The Court held a jury trial from January 8 to 25, 2018. On January 22, 2018, Ariosa filed a motion for JMOL under Rule 50(a) on Ariosa's defenses and affirmative counterclaims. Dkt. No. 618. Ariosa argued, inter alia , that no reasonable juror could find: that the '794 and '430 patents were not invalid; that the SSA did not grant Ariosa an express license to the '794 patent ; or that Illumina did not breach the SSA by suing Ariosa. Id. The motions were denied without prejudice. On January 25, 2018, the jury returned a verdict, which found the '794 and '430 patents valid and infringed by Ariosa; found that Ariosa did not have an express license to the '794 patent under the SSA; and found that Illumina did not breach the SSA by suing Ariosa. Dkt. No. 633. The jury awarded plaintiffs approximately $27 million in damages. Id. The Court entered judgment on January 29, 2018. Dkt. No. 642.
Ariosa moves for JMOL under Rule 50(b) and for a new trial under Rule 59 based on Ariosa's defenses and affirmative counterclaims. Dkt. No. 648. Ariosa argues that the jury's verdict on its licensing defense, affirmative counterclaims, and invalidity defenses is not supported by substantial evidence or is against the clear weight of evidence. Id.
A. Express license and breach of the SSA
The parties dispute whether the license to Illumina IP granted in the SSA encompassed the '794 patent. Ariosa contends that the Court should interpret the terms "Core IP Rights in Goods" and "Secondary IP Rights in Goods" in the SSA as a matter of law and argues that the '794 patent is not "Secondary IP," but rather is "Core IP," to which the SSA gave Ariosa a license. Dkt. No. 650 at 2-6. According to Ariosa, the Court should interpret "Illumina Intellectual Property Rights that pertain to the Goods," Dkt. No. 648 at 3 (quoting Ex. 615 (SSA) § 1.), to mean intellectual property rights that have "a connection with" Illumina's sequencing equipment. Dkt. No. 648 at 5. Ariosa points to the testimony of Illumina's expert witness, Dr. Cooper, who stated that Ariosa's use of an Illumina sequencer met the "detecting" limitation of the asserted '794 patent claims, as evidence that the '794 patent"has 'a connection with' Illumina's sequencing equipment and clearly fits within the definition of 'Core IP Rights in Goods.' " Dkt. No. 648 at 4-5. Ariosa argues that Illumina's position during trial, that "Core IP Rights" included only patents "inherent" in the use of Illumina's sequencers, is contrary to the language of the SSA. Dkt. No. 648 at 5-6.
Ariosa also argues that Illumina's interpretation of the SSA renders the grant of an express license under the SSA "nugatory" because under the doctrine of patent exhaustion, sale of Illumina's sequencer to Ariosa "automatically exhausted Illumina's right to enforce against Ariosa any patents that were inherently practiced in the use of those sequencers." Id. Ariosa argues that because of Ariosa's express license to the '794 patent through the SSA, Illumina was bound by a covenant not to sue Ariosa under the '794 patent. Dkt. No. 648 at 6. Thus, Ariosa contends that Illumina breached the SSA by asserting the '794 patent against Ariosa. Id. Ariosa argues that there is "no conflicting extrinsic evidence" related to the interpretation of these terms because "the testimony of both sides' witnesses concerning their personal understanding of the meaning of the SSA is irrelevant under California law to the interpretation of the agreement." Id. at 2.
Illumina responds that whether it granted a license to the '794 patent under the SSA is a question of fact, and there was substantial evidence to support the jury's verdict finding that there was no such grant of license. Dkt. No. 672 at 10-11. Illumina argues that the trial evidence showed that the '794 patent related to the library prep product, which Ariosa did not buy, and not the sequencers; that the SSA gave Ariosa a license to use the sequencer, but not to use products that Ariosa did not purchase; that the SSA explicitly restricted Ariosa's right to "practice any patents supposedly exhausted by the sale of the goods"; and that the trial evidence demonstrated the '794 patent does not require the use of the Illumina sequencer to perform the detection step. Id. at 14-16. Illumina contends that even if the '794 patent were to pertain to "Goods," it would be "Secondary IP" excluded by the SSA. Id. at 16-17.
In California, a trial court employs a three-step process when the meaning of a contract term is disputed. Wolf v. Walt Disney Pictures & Television , 162 Cal. App. 4th 1107, 1126, 76 Cal.Rptr.3d 585 (2008), as modified on denial of reh'g (June 4, 2008). "First, it provisionally receives any proffered extrinsic evidence that is relevant to prove a meaning to which the language of the instrument is reasonably susceptible." Id. (citations omitted). Second, if "in light of the extrinsic evidence, the language is reasonably susceptible to the interpretation urged, the extrinsic evidence is then admitted to aid the court in its role in interpreting the contract." Id. (citations omitted). Third, if "there is no material conflict in the extrinsic evidence, the trial court interprets the contract as a matter of law." Id. (citations omitted). "If, however, there is a conflict in the extrinsic evidence, the factual conflict is to be resolved by the jury." Id. at 1127, 76 Cal.Rptr.3d 585 (citations omitted); First Nat. Mortg. Co. v. Fed. Realty Inv. Tr. , 631 F.3d 1058, 1067 (9th Cir. 2011) (" Federal Realty ") ("As trier of fact, it is the jury's responsibility to resolve any conflict in the extrinsic evidence properly admitted to interpret the language of a contract.") (quoting Morey v. Vannucci , 64 Cal. App. 4th 904, 912-913, 75 Cal.Rptr.2d 573 (1998) ).
Furthermore, under California law, "[a] contract must be so interpreted as to give effect to the mutual intention of the parties" when they executed the contract. Cal. Civ. Code § 1636. Under the objective theory of contracts, "the objective intent, as evidenced by the words of the contract, rather than the subjective intent of one of the parties, ... controls interpretation." Founding Members of the Newport Beach Country Club v. Newport Beach Country Club, Inc. , 109 Cal. App. 4th 944, 956, 135 Cal.Rptr.2d 505 (2003). "The parties' undisclosed intent or understanding is irrelevant to contract interpretation." Id. However, a witness's own understanding of a contract may be relevant to its interpretation "when that understanding is not simply a private interpretation, but rather is founded in personal knowledge of the negotiations and the parties' expressed intent." Onyx Pharm., Inc. v. Bayer Corp. , 863 F.Supp.2d 894, 897 (N.D. Cal. 2011) (citing Fed. Realty , 631 F.3d at 1068 ; ASP Props. Grp. v. Fard, Inc. , 133 Cal. App. 4th 1257, 1271, 35 Cal.Rptr.3d 343 (2005) ); Pac. Gas & Elec. Co. v. G. W. Thomas Drayage & Rigging Co. , 69 Cal. 2d 33, 39, 69 Cal.Rptr. 561, 442 P.2d 641 (1968).
The trial testimony of witnesses who were parties to the SSA negotiations presented conflicting extrinsic evidence, rendering the factual dispute proper for a jury's consideration. Illumina's Mr. Naclerio and Ariosa's Dr. Stuelpnagel, for example, presented conflicting evidence of the relevant meaning given by the parties to the SSA's terms. Accordingly, because this trial testimony is relevant to interpreting the SSA so as to give effect to the mutual intention of the parties in forming and executing the SSA, the jury's verdict will stand. Defendant's motion is denied.
Mr. Naclerio, head of Illumina's corporate development from 2010 until 2016, presented testimony relevant to interpreting the meaning of the SSA's disputed terms. Naclerio testified that he was personally involved in the negotiation of the SSA and testified as to Illumina's express intent with regard to the SSA. Trial Tr. at 439:2-4 (Q. "Did you participate in discussions with Ariosa for a Supply Agreement?" A. "Yes."). Naclerio was responsible for corporate strategy, business development, negotiating acquisitions, divestitures, and investments with other companies before moving to Illumina Ventures, an investment fund targeting early-stage companies developing new products, primarily in the fields of genomics and precision medicine. Id. at 394:15-395:6. Naclerio stated Illumina's expressed intent was that Ariosa would simply acquire the sequencer and not the library prep. Trial Tr. at 440:4-6. He testified, "the goal of these agreements was to convey the rights to the kind of commercial diagnostic testing in the NIPT field, and to make sure that we were giving them the rights to use our sequencer, but that we weren't giving up any other rights." Id. at 441:23-442:1.
Naclerio's testimony evidences Illumina's expressed intent to license solely the sequencer and not the library prep universe. Id. at 449:23-450:1 ("I would be surprised if it was their expectation that they were getting rights to sample prep by buying the sequencer. It just doesn't pass the common sense test."). Contradicting Ariosa's assertions, Illumina's intent was limited in scope. Id. at 444:16-18. ("[W]e're giving you the sequencer. You can develop your own stuff with it; but we're not giving you anything else. That was the idea."). Naclerio noted that rights pertaining to the goods were intended to mean "rights to the goods in this case is the sequencer. And we're saying that you have the right to use the sequencer to sequence." Id. at 445:2-4. When asked whether Illumina intended to convey the rights to use the library prep selection step, Naclerio stated, "[C]learly not." Id. at 445:8. Naclerio's testimony makes clear that in Illumina's view, the SSA defined Core IP as related to the product being purchased (i.e., the sequencer), not Core IP in other products, and that all other Secondary IP were excluded from Core IP. Id. at 449:23-450:1.
Dr. John Stuelpnagel, Ariosa's founder and Executive Chairman, presented conflicting evidence that is relevant to understanding the SSA. Id. at 777:13-15 (Q. "In terms of the negotiating team for the Sale and Supply Agreement, that was your general counsel, Ms. DeVore and Ken Song and yourself; is that correct?" A. "Correct"). According to Dr. Stuelpnagel, Ariosa's view was that the terms of the SSA created, "without any doubt, that Ariosa would have 'Freedom to Operate,' with using Illumina Core IP Rights." Id. at 778:24-779:1. Dr. Stuelpnagel stated that the '794 patent was Core IP and was included in the license obtained in the SSA. Id. at 809:24-810:1 (Q. "Now, did this agreement cover any patent licenses from Illumina to Ariosa?" A. "It did."). According to Dr. Stuelpnagel, Core IP Rights are defined as "intellectual property rights held by Illumina [that] gives [Ariosa] a license to those Illumina Intellectual Property Rights that we need to use the goods, which is the sequencing, and consumables, and/or pertains or relates to the goods. And so it's anything associated with performing that test." Id. at 810:7-11. Dr. Stuelpnagel's testimony evidenced his belief and Ariosa's expressed intent that the Core IP Rights in Goods at the time of the SSA included the following: "Illumina's intellectual property rights that pertain-relate-to the goods, and use thereof, in accordance with their documentation, other than secondary Illumina IP rights." Id. at 811:9-12. Dr. Stuelpnagel elaborated that "if Illumina held intellectual property-intellectual property means patents and patent applications, and other things-if they owned those, we had the right to use those, if they were sort of general purpose and required to use the sequencer and the sequencing reagents." Id.
The trial testimony demonstrated that the SSA is reasonably susceptible to conflicting interpretations and contradictory expressed intent. The testimony of Mr. Naclerio and Dr. Stuelpnagel presented conflicting extrinsic evidence founded in personal knowledge of the negotiations and are evidence of the relevant meaning that the parties gave to the terms of the SSA. Accordingly, the Court properly submitted the question of whether the '794 patent fell within "Core IP Rights in Goods" under the SSA to the jury. Id. at 1866:5-15. Defendant's motion on express licensing is DENIED.
B. Invalidity of the '794 and '430 patents
Ariosa argues that at least the clear weight of evidence is against the jury's findings that the '794 patent was not invalid as anticipated by U.S. Patent Application No. 09/333,110 ("Straus") under 35 U.S.C. § 102, and that the '430 patent was not invalid for lack of enablement under Section 112. Dkt. No. 648 at 7-15.
Under the Patent Act, each claim of a patent is presumed to be valid, and the "burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity." 35 U.S.C. § 282. To overcome the presumption of validity, a defendant must prove invalidity by clear and convincing evidence. Microsoft Corp. v. i4i Ltd. P'ship , 564 U.S. 91, 95, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011).
1. Anticipation of the '794 patent by Straus
As a threshold matter, Illumina argues that Ariosa is barred from challenging the '794 patent under the doctrine of assignor estoppel because Drs. Stuelpnagel and Oliphant are inventors of the '794 patent, they assigned their rights to the patent to Illumina, and they are in privity with Ariosa. Dkt. No. 672 at 2; Dkt. No. 661. The Court agrees with Illumina. As is discussed more fully in part IV, below, the Court finds that assignor estoppel applies to Ariosa and that the asserted claims of the '794 patent are within the scope of the rights assigned by Drs. Stuelpnagel and Oliphant to Illumina. Accordingly, Ariosa's invalidity defense against the '794 patent must fail. See Diamond Sci. Co. v. Ambico, Inc. , 848 F.2d 1220, 1224 (Fed. Cir. 1988). However, even if assignor estoppel did not bar Ariosa from challenging the validity of the '794 patent, the Court finds there was substantial evidence at trial to support the jury's findings on this issue.
Ariosa argues its expert, Dr. Cantor, presented "unrebutted testimony" that Straus disclosed all elements of the asserted '794 patent claims. Dkt. No. 648 at 7. Ariosa also contends that Illumina's expert, Dr. Cooper, made "legally spurious" assertions at trial that for there to be anticipation of the '790 patent, Straus must disclose all elements of the claim in one disclosure or figure, such as Figure 5. Id. Ariosa points to Dr. Cooper's testimony contending that Straus's disclosure of three claim elements ("at least 100 different target sequences," "more than 100 different single stranded probes," and "identical universal priming sites") in the specification "should be disregarded" for not being "expressly linked to Figure 5." Id. Ariosa argues that, even though the Court properly instructed the jury on an anticipation standard that is "[c]onsistent with settled law," the jury erroneously credited Dr. Cooper's theory of anticipation when it found the '794 patent was not anticipated by Straus. Id. at 8, 10-11.
Illumina responds that Dr. Cantor's testimony fell short of showing by clear and convincing evidence that Straus discloses "identical universal priming sites," and that Dr. Cooper provided testimony rebutting Dr. Cantor. Dkt. No. 672 at 3-4. Illumina argues that Dr. Cooper did not misstate the legal standard for anticipation. Id. at 4-6.
A prior art reference anticipates a claim if "it discloses all the claimed limitations 'arranged or combined in the same way as in the claim.' " Kennametal, Inc. v. Ingersoll Cutting Tool Co. , 780 F.3d 1376, 1381 (Fed. Cir. 2015) (citations omitted). The disclosure of a prior art reference may not be limited to a preferred embodiment. Arthrocare Corp. v. Smith & Nephew, Inc. , 406 F.3d 1365, 1372 (Fed. Cir. 2005) (citing Ultradent Prod., Inc. v. Life-Like Cosmetics, Inc. , 127 F.3d 1065, 1068 (Fed. Cir. 1997) ). Rather, a prior art reference may anticipate a claim "if a person of skill in the art, reading the reference, would 'at once envisage' the claimed arrangement or combination" even without express disclosure of "all the limitations arranged or combined as in the claim." Kennametal , 780 F.3d at 1381 (citing Application of Petering , 301 F.2d 676, 681 (C.C.P.A. 1962) ).
The Court finds that a reasonable jury could find Ariosa did not prove by clear and convincing evidence that Straus anticipated the '794 patent. Ariosa's expert, Dr. Cantor, testified at trial that Straus disclosed each and every element of the asserted claims of the '794 patent. Trial Tr. at 1467:9-1476:7. In particular, Dr. Cantor relied on Straus's Figure 5, which disclosed "almost everything" needed to demonstrate how Straus disclosed every element of the claims. Id. at 1466:1-5. Dr. Cantor explained that Figure 5 did not disclose all the elements of the asserted claims, including the limitation of "100 different probes [having] identical universal priming sites" in claim 1. See id. at 1471:1-4. Thus, Dr. Cantor relied on, inter alia , the disclosure of "a single pair of amplification sequences" found elsewhere in Straus. Id. Illumina's expert, Dr. Cooper, testified that Straus did not make "clear" that the elements of the claimed method identified by Dr. Cantor by "dancing around the document" should be done "all together." Trial Tr. at 1654:7-17, 1654:25-1655: see Trial Tr. at 1599:10-1600:11.
In view of the conflicting evidence, the jury was entitled to assess the credibility of each party's experts to determine whether Straus disclosed all elements of claim 1 "arranged or combined in the same way as in the claim." See i4i Ltd. P'ship v. Microsoft Corp. , 598 F.3d 831, 848 (Fed. Cir. 2010), aff'd , 564 U.S. 91, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011) (denying defendant's motion for judgment as a matter of law on its invalidity defense because "the jury heard conflicting testimony" and was "free to disbelieve [the defendant's] expert" in evaluating the evidence).
Ariosa also argues that it was prejudiced when plaintiffs repeatedly raised the IPR proceedings during trial. Illumina contends that it did not specifically refer to IPR proceedings, nor did Ariosa object when Illumina allegedly made the "prejudicial" references to the IPR proceedings.
Although Illumina made reference to the inter partes review proceedings during trial, the Court finds that either the reference fell within the exceptions set forth in the Court's pre-trial order, or was not so prejudicial as to require a new trial on that basis. Regardless, assignor estoppel precludes Ariosa from challenging the '794 patent. Accordingly, the Court DENIES Ariosa's motion for judgment as a matter of law, or for new trial, on its defenses.
2. Enablement of the '430 patent
Ariosa argues the evidence at trial showed that the '430 patent does not meet the enablement requirement because the patent fails to disclose an algorithm for "determining the presence or absence of a fetal aneuploidy" in the context of a targeted sequencing approach as claimed. Dkt.
No. 648 at 12. Ariosa contends one of ordinary skill in the art would not be able to adapt known algorithms designed for analyzing random shotgun sequencing data for use on targeted sequencing data without undue experimentation. Id. at 13-15. Ariosa also argues evidence showed that the patent failed to disclose necessary steps to eliminate "noise" in the data to detect fetal DNA, or any examples showing that the claimed pooling and indexing worked as intended. Id. at 12. Lastly, Ariosa claims that "Verinata never actually reduced the alleged invention of the '430 patent to practice or used it in any of its own tests." Id. at 12-13 (citing Trial Tr. at 262:15-23, 349:1-5, 351:7-9, 1481:13-17.).
Illumina responds that Ariosa's expert, Dr. Cantor, testified there were prior art references "adequately" disclosing the elements of claim 1, and that Dr. Rava, an inventor of the '430 patent, and Dr. Cooper, Illumina's expert, testified that the patent referenced other patents that disclosed statistical methods to determine fetal aneuploidy. Dkt. No. 672 at 8-10. Illumina argues that Dr. Cooper testified that Ariosa itself used algorithms for analyzing random shotgun sequencing data in its proof of concept study of its Harmony assay. Id. at 10.
Section 112 of the Patent Act requires a patent specification to "contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains ... to make and use the same...." 35 U.S.C. § 112 ¶ 1. "To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without 'undue experimentation.' " MagSil Corp. v. Hitachi Glob. Storage Techs., Inc. , 687 F.3d 1377, 1380 (Fed. Cir. 2012) (citations omitted). Factors relevant for determining whether undue experimentation is required include the following: (1) "the quantity of experimentation necessary"; (2) "the amount of direction or guidance presented"; (3) "the presence or absence of working examples"; (4) "the nature of the invention"; (5) "the state of the prior art"; (6) "the relative skill of those in the art"; (7) "the predictability or unpredictability of the art"; and (8) "the breadth of the claims." In re Wands , 858 F.2d 731, 737 (Fed. Cir. 1988).
"Enablement is a question of law based on underlying factual findings." MagSil , 687 F.3d at 1380 (citing In re Wands , 858 F.2d at 735 ). Where the enablement inquiry is factual in nature, "it is amenable to resolution by the jury." BJ Servs. Co. v. Halliburton Energy Servs., Inc. , 338 F.3d 1368, 1371 (Fed. Cir. 2003) (citing Spectra-Physics, Inc. v. Coherent, Inc. , 827 F.2d 1524, 1533 (Fed. Cir. 1987) ). In reviewing a jury finding based on its factual determinations, courts must "look to whether a reasonable jury could have made the underlying factual findings necessary to provide substantial evidence in support of its conclusion." Id. at 1371-72 (citing Allen Organ Co. v. Kimball Int'l, Inc. , 839 F.2d 1556, 1566 (Fed. Cir. 1988) );
accord Dow Chem. Co. v. Nova Chems. Corp. (Canada) , 809 F.3d 1223, 1226 (Fed. Cir. 2015).
The Court finds a reasonable jury could have weighed the facts presented at trial to provide substantial evidence supporting its finding that Ariosa failed to show, by clear and convincing evidence, that the '430 patent was not enabled. Specifically, there was no dispute as to the amount of guidance provided by the '430 patent regarding the algorithm for "determining the presence or absence of a fetal aneuploidy" because the '430 patent specification does not explicitly disclose such an algorithm. Trial Tr. at 344:18-23, 345:12-19. There was no dispute that the '430 patent claims recite a directed or "nonrandom" sequencing approach to detect fetal aneuploidy from a maternal blood sample. Id. at 321:13-322:12, 349:6-12. It was also undisputed that the specification incorporates by reference publications that disclose known statistical methods for determining fetal aneuploidy based on random sequencing techniques. Id. at 344:24-345:3.
The trial testimony confirms there was conflicting evidence concerning how much experimentation would have been necessary for one of ordinary skill in the art to adapt these previously known methods used for random sequencing data to the targeted sequencing approach as claimed. For instance, Ariosa's witness, Dr. Wang, testified as to the technical "challenges" Ariosa faced when developing an algorithm for analyzing targeted sequencing data to detect fetal aneuploidy in maternal blood. Id. at 1343:23-1348:6. Dr. Wang testified that Ariosa tried a "Z score" method, which "didn't work as well" and was rejected for use in the Harmony test. Id. at 1347:17-1348:6. In addition, Dr. Cantor testified that the algorithms for random shotgun sequencing described in the publications referenced in the '430 patent"definitely won't work" without "improv[ing] on them," and that the patent "wouldn't have helped me in the slightest" to make a targeted sequencing approach work. Id. at 1480:19-1481:12.
By contrast, Dr. Rava, a witness for Illumina, testified that the algorithms for random shotgun sequencing described in the publications referenced in the '430 patent"could be very similar to the ones that would be use[d] in a directed sequencing approach" but "would have to be optimized." Trial Tr. at 344:24-345:11. Finally, Dr. Cooper testified that the references cited in the '430 patent describe statistical methods ("Bayesian likelihood method," "Z score") that were similar to those used by Ariosa for "non-invasive detection of Trisomy 21 and 18 using selective sequencing of cell-free DNA from specific chromosomes." Trial Tr. at 1617:8-1621:1.
The Court finds a reasonable jury could have weighed the conflicting evidence and made a factual determination as to the amount of experimentation that would have been required for one skilled in the art to perform step 1(f). The Court also finds that the jury was "provide[d] substantial evidence in support of its conclusion" as to enablement of the '430 patent. See Halliburton Energy , 338 F.3d at 1371-72.
Ariosa argues that the inventor's failure to reduce to practice the invention claimed in the '430 patent"is strong evidence that the specification lacks enablement." Dkt. No. 648 at 12-13 (citing Ormco Corp. v. Align Tech., Inc. , 498 F.3d 1307, 1319 (Fed. Cir. 2007) ). The Court is unconvinced, and finds Ormco distinguishable from the present facts. In Ormco , the Federal Circuit affirmed the district court's summary judgment order finding certain claims of the asserted patents invalid for lack of enablement. Ormco , 498 F.3d at 1318-19. The patents at issue related "to the computer-aided design and manufacture of custom orthodontic appliances," and the claims were "construed to require automatic computer determination of the finish positions of the teeth without human adjustment of the final results." Id. at 1311, 1317. The district court was unconvinced by the inventors' testimony stating that the patentee's products "incorporated the automatic determination aspect of the invention." Id. at 1318. The district court was unconvinced because one of the inventors testified that the patentee "never attempted to create a computerized system that automatically determined tooth positions without human decision making" and that, while full automation "was a goal ..., variations in human anatomy had prevented the attainment of that goal." Id. The patentee presented "[n]o convincing countering evidence." Id. The Ormco court concluded "[i]f an inventor attempts but fails to enable his invention in a commercial product that purports to be an embodiment of the patented invention, that is strong evidence that the patent specification lacks enablement." Id.
Here, there is no evidence that the '430 patent inventors attempted and failed to enable the invention. First, Dr. Rava's inability to recall creating a "full algorithm" for analyzing the sequencing data alone is insufficient to show that the inventors attempted and failed to enable the invention. See Trial Tr. at 349:1-5. The evidence suggests the inventors did develop a method of analyzing the sequencing data because Dr. Rava testified that while developing the targeted approach described in the '430 patent, there "would have been a method" to "determin[e] from the [sequencing] results that we were getting whether or not we could differentiate between the aneuploidy samples and the non-aneuploidy samples" using "a lot of analysis in Excel spreadsheets." See id. at 348:15-25.
Nor does the fact that Verinata's prenatal testing product does not embody the invention claimed in the '430 patent demonstrate that the '430 patent inventors "attempt[ed] but fail[ed] to enable [their] invention in a commercial product that purports to be an embodiment of the patented invention." See Ormco , 498 F.3d at 1318. Dr. Rava testified that Verinata "decided that we wanted to [commercialize their prenatal testing product using] the whole genome approach, so that we could get information from across the genome," rather than use the targeted approach described in the '430 patent. See id. at 326:6-15, 349:1-5.
Ariosa also relies on Union Pacific Resources Company v. Chesapeake Energy Corporation , 236 F.3d 684 (Fed. Cir. 2001) to argue that because the '430 patent fails to enable any and all ways for determining aneuploidy using a nonrandom sequencing approach, "the full scope of the claims is thus indisputably not enabled." See Dkt. No. 648 at 14. This reliance is misplaced. In Chesapeake Energy , the Federal Circuit affirmed the district court's findings that the asserted patent was not enabled because the claimed method required a step involving "significant mathematical manipulation" of input data but the specification failed to disclose how to achieve such a "pivotal" process. 236 F.3d at 691. The asserted patent claimed "a particular method of horizontal drilling for the exploration of oil and natural gas" and disclosed "a method for locating a drill bit in a horizontal borehole relative to the surrounding strata." Id. at 688. However, the patent did not disclose how to "rescale" or "correlate" certain input data as required by the claimed methods because the patentee "kept as a trade secret the computer programs designed to perform the rescaling step." Id. at 690. Moreover, the Chesapeake Energy court noted the correlation process was recognized by the patentee's expert as being "probably the most unique part of the patent." Id. at 691.
Here, in contrast, there was conflicting evidence as to whether the step of analyzing the sequencing data was "pivotal" to the invention claimed in the '430 patent. As discussed above, there was conflicting evidence regarding whether the '430 patent's reference to previously-described methods for analyzing random sequencing data to determine fetal chromosome aneuploidy was sufficient to teach one skilled in the art to perform data analysis in the context of a targeted sequencing approach. Dr. Rava, an inventor of the '430 patent, did not deny that the determining step of the claimed method on its own was not novel, and testified that the known algorithms could be used to perform the determining step with "some optimization." Trial Tr. 347:1-349:12. The Court finds that the jury could weigh the conflicting testimonies to provide substantial evidence supporting its verdict. Accordingly, defendant's motion on invalidity is DENIED.
II. Ariosa's renewed motion for judgment as a matter of law and motion for a new trial on issues for which plaintiffs bore the burden of proof (Dkt. No. 649)
Defendant moves for JMOL under Rule 50(b), and for a new trial under Rule 59 based on non-infringement and patent damages. Dkt. No. 649. Defendant argues that the jury's verdicts on infringement of the '794 and '430 patents and on damages are not supported by substantial evidence, or are against the clear weight of evidence. Id.
A. Non-infringement
Defendant moves for judgment as a matter of law, or for a new trial, on non-infringement on the grounds that plaintiffs failed to meet their burden to prove by a preponderance of the evidence that Harmony V1 and V2 perform each step of the asserted claims of the '794 patent, or that Harmony V1 performs each step of the asserted claims of the '430 patent.
Determining whether an accused product infringes a patent involves a two-step analysis: "First, the claim must be properly construed to determine its scope and meaning. Second, the claim as properly construed must be compared to the accused device or process." Carroll Touch, Inc. v. Electro Mech. Sys., Inc. , 15 F.3d 1573, 1576 (Fed. Cir. 1993) (citations omitted). Claim construction is a matter of law. Markman v. Westview Instruments, Inc. , 52 F.3d 967, 970-71 (Fed. Cir. 1995) (en banc), aff'd , 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). "The determination of infringement, whether literal or under the doctrine of equivalents, is a question of fact."
Ecolab, Inc. v. Envirochem, Inc. , 264 F.3d 1358, 1364 (Fed. Cir. 2001) ; Int'l Rectifier Corp. v. IXYS Corp. , 361 F.3d 1363, 1369 (Fed. Cir. 2004) ("Comparison of the claims to the accused [product] requires a factual determination that every claim limitation or its equivalent is found in the accused [product]."), subsequent mandamus proceeding sub nom. In re IXYS Corp. , 148 F. App'x 933 (Fed. Cir. 2005). "Direct infringement of a method claim requires all steps of the claimed method to be performed by or attributable to a single entity." LifeNet Health v. LifeCell Corp. , 837 F.3d 1316, 1325 (Fed. Cir. 2016). "The patent owner has the burden of proving infringement and must meet its burden by a preponderance of the evidence." Cradle IP, LLC v. Texas Instruments, Inc. , 5 F.Supp.3d 626, 636 (D. Del. 2013) (citing SmithKline Diagnostics, Inc. v. Helena Labs. Corp. , 859 F.2d 878, 889 (Fed. Cir. 1988) ), aff'd , 588 F. App'x 1000 (Fed. Cir. 2015).
1. Harmony V2
Claim 1 of the '794 patent is representative, and recites in relevant part:
1. A multiplex method for determining whether a sample contains at least 100 different target sequences, comprising:
a) providing a sample which may contain at least 100 different single-stranded target sequences attached to a first solid support;
b) contacting said target sequences with a probe set comprising more than 100 different single-stranded probes, wherein each of said more than 100 different probes comprises:
i) a first universal priming site ..., and
ii) a target specific domain, such that different double-stranded hybridization complexes are formed, each of the different hybridization complexes comprising one of said more than 100 different single-stranded probes and one of the different single-stranded target sequences from the sample;
c) removing unhybridized probes;
d) contacting said probes of the hybridization complexes with a first enzyme and forming different modified probes;
e) contacting said modified probes with:
i) at least a first primer that hybridizes to said universal priming site;
ii) NTPs; and
iii) an extension enzyme;
wherein said different modified probes are amplified and forming different amplicons;
f) immobilizing said different amplicons to a second solid support, and
g) detecting said different amplicons immobilized to said second solid support, thereby determining whether the sample contains at least 100 different target sequences."
U.S. Patent No. 7,955,794 col. 68 l. 44-col. 69 l. 12.
Defendant argues that no reasonable juror could find that Harmony V2 performs steps 1(a), 1(b) in the claimed order, or steps 1(f) and 1(g). Dkt. No. 649.
a. The '794 patent : Steps 1(a) and 1(b)
Defendant contends that the trial evidence failed to show Harmony V2 performs the "providing" (step 1(a) ) before the "contacting" (step 1(b) ) as required by the claims because plaintiffs' expert, Dr. Cooper, testified that in Harmony V2, the beads (solid support) are added after the probes for hybridization. Id. at 1-2. Defendant argues that it "does nothing" to contact single-stranded target sequences attached to a solid support with a probe set. Id. Plaintiffs respond that Dr. Cooper's testimony explained to the jury that during the Harmony V2 assay, there would be "a lot more than 100 single-stranded target sequences" in the reaction vessel at the end of the hybridization reaction, after which the solid support is added, and that therefore, Harmony V2 "inevitably" performs steps 1(a) and 1(b). Id.
A method "is defined as 'an act, or a series of acts.' " Kaneka Corp. v. Xiamen Kingdomway Grp. Co. , 790 F.3d 1298, 1305 (Fed. Cir. 2015) (citing Gottschalk v. Benson , 409 U.S. 63, 70, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972) ; In re Kollar , 286 F.3d 1326, 1332 (Fed. Cir. 2002) ("A process ... consists of doing something, and therefore has to be carried out or performed.") ); see NTP, Inc. v. Research In Motion, Ltd. , 418 F.3d 1282, 1318 (Fed. Cir. 2005) ("[T]he use of a process necessarily involves doing or performing each of the steps recited."), abrogated on other grounds , see IRIS Corp. v. Japan Airlines Corp. , 769 F.3d 1359, 1361 n.1 (Fed. Cir. 2014).
Here, the parties contest whether Harmony V2 follows the order of the steps in the '794 patent for steps 1(a) and 1(b). To uphold a jury verdict of infringement, a court must find that there was "substantial evidence" i.e., if "there is evidence upon which a reasonable jury could have found infringement." Ultradent Prods., Inc. v. Life-Like Cosmetics, Inc. , 127 F.3d 1065, 1070 (Fed. Cir. 1997). For infringement cases, "[w]here the evidence of infringement consists merely of one experts opinion, without supporting tests or data, the district court is under no obligation to accept it." W.L. Gore & Assocs., Inc. v. Garlock, Inc. , 842 F.2d 1275, 1280 (Fed. Cir. 1988).
In Garlock , the Federal Circuit noted that whether an imprecise claim limitation is literally met is a question of fact for the trial court. Specifically, the court noted that, when construing the disputed meaning of the term "about," the correct determination was not the meaning assigned by the parties but rather "dependent on the factual situation presented." Garlock , 842 F.2d at 1280. The Federal Circuit noted, "[t]he only evidence on this point was the opinion testimony of Gore's expert that his estimated rate of 76.5% per second to 139% per second was 'about 100% per second' which the district court did not accept as proving infringement." Id. The Federal Circuit affirmed. Id. at 1281-82. The instant case is distinguishable from Garlock . In Garlock , there was no mention that proffered expert testimony relied upon any theoretical foundation for the notion that the estimated rate was about 100% per second. Here, Dr. Cooper's conclusion relies upon scientific principles and scientific theory. As a result, the instant case is analogous to Ultradent .
In Ultradent , the Federal Circuit held that theoretical evidence provided by an expert can fulfill the substantial evidence requirement. See Ultradent , 127 F.3d at 1070. In Ultradent , the plaintiff needed to prove that defendant's products contained "about 3.5% to about 12% by weight carboxypolymethylene defined as a slightly acidic vinyl polymer with active carboxyl groups." Id. There, the plaintiff's expert, Dr. Yost, testified that in his opinion defendant's products infringed. Dr. Yost based his explanation on a theoretical foundation, noting that "in solution, the ions are free to move around" and that "the hydrogen ions are free 'to dissociate and reassociate with the carboxyl group.' " Id. The court concluded that Dr. Yost's theoretical foundations were sufficient to fulfill the substantial evidence standard. Id. , 127 F.3d at 1070 ("Dr. Yost's testimony constitutes substantial evidence of infringement, and for purposes of the motion for a new trial, we cannot say that the district court committed a manifest abuse of discretion in ruling that the great weight of the evidence was not against the verdict."). Just as the parties in Ultradent were "in agreement that the only evidentiary basis upon which the jury could have reached the result it did is the testimony of Ultradent's expert witness, Dr. Yost," the jury here must have relied on Dr. Cooper's theory to find that infringement occurred. Id.
Dr. Cooper's testimony is similarly based on theoretical foundations. Dr. Cooper's assertion that in Harmony V2, at least 100 different single stranded target-sequences are left over after the two hour period of temperature reduction (and that they first hybridize to the solid support before annealing to the probes) is based on probability and scientific theory. Dr. Cooper explained that first, the earlier portions of the reaction at 70 degrees occur above the melting point of the probes, meaning that the hybridization of the target sequences to the probes only has an opportunity to occur in the latter portion of the process. Trial Tr. at 966:1-8. The jury could have reasonably inferred that this increases the chances of 100 different single-stranded target sequences being present after two hours.
Dr. Cooper also opined that there are billions of cell-free DNA fragments (some of which contain a target sequence and others of which do not), 6,800 types of target sequences, and over 20,000 different types of probes. See Id. at 965:10-13; 966:14-19. According to Dr. Cooper, because there are so many probes and fragments, they collide with one another and decrease the chances that the probes will hybridize to the proper target sequences within the first two hours. Id. at 966:25-967:1-4. The probes can only hybridize if they attach to a complementary single-stranded target sequence. Id. 966:20-24. Dr. Cooper testified that, even if one percent of the fragments remained un-hybridized and therefore single stranded, then there would be at least 100,000 different single-stranded DNA fragments left over. Id. at 967:15-21. Accordingly, by sheer number and probability, there would be at least 100 different single-stranded target sequences. Id.
Dr. Cooper also explains how the solid support first attaches to 100 different single-stranded target sequences and how the target sequences then hybridize to the probes. According to Dr. Cooper, after two hours, the solid support is added and the process is "allow[ed] continued time to proceed." See Trial Tr. 464:4-8, 465:1-4. The solid support streptavidin beads can then quickly attach to the target sequences when they are added because of streptavidin's properties and the interactions with biotin-coated cell-free DNA fragments. Trial Tr. 951:14-25-952:1-3. Dr. Cooper testified that the reaction is nonspecific and the strongest covalent reaction known on the order of 10-15. Id. at 952:12-14. Given the additional time to proceed following the addition of the solid support, there is still ample time for the 100 single-stranded target sequences (attached to the beads) to hybridize to their respective three probes. Id. at 964:9-965:4; (Hearing Tr. 6/8/2018; p. 21 Ariosa's Slides).
Just as the Federal Circuit in Ultradent found that expert testimony based on scientific theory fulfilled the requirement for substantial evidence, this Court finds that Dr. Cooper's testimony, founded upon scientific theory, "constitutes substantial evidence of infringement." See Ultradent at 1070. That Ariosa presented conflicting evidence is not enough to conclude Dr. Cooper's testimony is not substantial. As the Federal Circuit held in Ultradent , there was substantial evidence of infringement despite the defendant's presentation of conflicting evidence. See Id. at 1070. In sum, this Court upholds the jury's finding of infringement of steps 1(a) and 1(b) of Harmony V2.
b. The '794 patent : Steps 1(f) and 1(g)
Defendant contends that evidence at trial failed to show Harmony V2 performs steps 1(f) and 1(g) because Harmony V2 uses "readout cassettes," which are "indisputably different," or at least substantially different, from the claimed "amplicons." Dkt. No. 649 at 10, 12. Defendant argues that Harmony V2 does not detect immobilized amplicons, and asks the Court to reconsider its ruling on claim construction regarding step 1(f) ("immobilizing said different amplicons"). Id. at 10-15. Defendant argues that plaintiffs did not present "particularized testimony" required to support their DOE theory and relied on "conclusory and irrelevant testimony." Id. at 12-15. Plaintiffs respond that whether Ariosa's "readout cassettes" qualified as the claimed "amplicons" was a question of fact for the jury; that Ariosa admitted that it uses "cleaved amplicons"; and that there was detailed testimony describing the insubstantial difference between a readout cassette and an amplicon. Dkt. No. 670 at 7-10.
The Federal Circuit has ruled that "[w]hen addressing the doctrine of equivalents, a court must ask whether an asserted equivalent is an 'insubstantial difference' from the claimed element, or whether it matches the 'function, way, and result of the claimed element.' " Epos Techs. Ltd. v. Pegasus Techs. Ltd. , 766 F.3d 1338, 1348 (Fed. Cir. 2014) (citing Deere & Co. v. Bush Hog, LLC , 703 F.3d 1349, 1356 (Fed. Cir. 2012) ) (quoting Warner-Jenkinson Co. v. Hilton Davis Chem. Co. , 520 U.S. 17, 40, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997) ). A party may invoke DOE against the producer of the device "if it performs substantially the same function in substantially the same way to obtain the same result." Graver Tank & Mfg. Co. v. Linde Air Prod. Co. , 339 U.S. 605, 608, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). The Supreme Court has clarified DOE, stating that "the doctrine of equivalents must be applied to individual elements of the claim, not to the invention as a whole." Warner-Jenkinson , 520 U.S. at 29, 117 S.Ct. 1040.
The Court agrees with plaintiffs and finds there was substantial evidence to support the jury's implicit finding that Ariosa performs steps 1(f) and 1(g) of the '794 patent when using "readout cassettes" to perform the Harmony V2 test, at least under the doctrine of equivalents. There was no dispute that in Harmony V2, modified probes are amplified to produce amplicons, and the amplicons are modified to produce the readout cassettes, which are then immobilized. Trial Tr. at 1074:17-1078:10 (Dkt. No. 603), 1398:7-1403:14 (Dkt. No. 598). There was conflicting evidence as to whether by using the readout cassettes, Ariosa was carrying out substantially the same function as steps 1(f) and 1(g) of claim 1, in substantially the same way, to achieve substantially the same result. Ariosa's witness Dr. Quackenbush testified that amplicons were substantially different from readout cassettes because the former "didn't work" but the latter did work, giving "much better accuracy, [and] much higher quality results" for Harmony V2. Trial Tr. at 1402:14-25 (Dkt. No. 598). Dr. Oliphant testified similarly, explaining that immobilizing amplicons was "not useful" and "doesn't work" in the context of Harmony V2. Id. at 178:7-10 (Dkt. No. 603).
In contrast, Dr. Cooper testified that immobilizing the readout cassettes and immobilizing the amplicons serve substantially the same function of "immobiliz[ing] onto a solid support"; the immobilizing is done in substantially the same method of "hybridization of [the] DNA molecule"; and achieves substantially the same result of "detection of the target sequences that were in the original mixture." Id. at 1682:6-1683:1; see Trial Tr. at 979:21-985:22 (Dkt. No. 603). In view of the trial testimony, the Court finds the jury's verdict should not be disturbed. Defendant's motion is DENIED.
2. Harmony V1
a. The '794 patent : Steps 1(a) and 1(b)
Defendant argues that no reasonable juror could find Harmony V1 performs steps 1(a) and 1(b) of the '794 patent because the evidence shows Harmony V1 does not perform the steps in the claimed order. Dkt. No. 649 at 1. Defendant contends the evidence shows that in Harmony V1, "the probes and solid support are added simultaneously to the sample containing target sequences." Id. Plaintiffs respond that in the reaction mixture, the single-stranded target sequences attach to the solid support before the probes hybridize. Dkt. No. 670 at 11-12.
This Court's claim construction determined that there is an order for the steps of the '794 patent ; for claim 1, "providing" must occur before "contacting." Trial Tr. at 1855:6-13. Accordingly, the relevant inquiry is whether adding the probe, target sequences, and solid support simultaneously, as Harmony V1 does, literally infringes the steps 1(a) and 1(b) of the '749 patent. See '794 Patent at claim 1; Kaneka , 790 F.3d at 1306.
Plaintiffs presented evidence that it did. Even adding the probes, target sequences and solid support simultaneously, Harmony VI still causes the steps in the '794 patent in first "providing" target sequences (with attached solid support) and then "contacting" the targeted sequences with the probes. There is an active step or performance of "providing" in the form of raising the temperature to 70 degrees, which allows at least 100 single-stranded sequences to be attached to the solid support. See Trial Tr. (1/16/2018) at 960:2-961:7. Afterwards, there is an active step of "contacting" in the form of decreasing the temperature from 70 degrees to 30 degrees, as this allows hybridization between the probe and the target sequences (that are already attached to the solid support). Id. at 962:2-962:5 (Dkt. No. 603). Harmony V1, therefore, directly follows the order (of "providing" and then "contacting") and content of claims 1(a) and 1(b).
Plaintiff's expert, Dr. Cooper explained that the melting point of 70 degrees does not allow probes to hybridize to the target sequences, whereas the target sequences are much more likely to attach to the solid support due to their inherent properties. Trial Tr. (1/16/2018) at 955:4-955:25 (Dkt. No. 603). In addition, the binding of the target sequences (through biotin) and the solid support (through streptavidin) is the strongest known non-covalent interaction. Trial Tr. (1/18/2018) at 1439:21-1440:2 (Dkt. No. 598).
The designer of Harmony V1, Dr. Oliphant, confirmed Dr. Cooper's position. Dr. Oliphant stated that the attachment of the solid support to the target sequences occurs first before the hybridization of the target sequences to the probes when stating that "[w]e attempt to-to attach all of the cell-free DNA to the beads," and that the "next step in the process" was to "hybridize the locus-specific oligonucleotides." Trial Tr. (1/16/2018) at 1091:10-1092:8 (Dkt. No. 603). Given the testimony from Dr. Cooper and Dr. Oliphant, the jury's verdict was not against the great weight of the evidence and the jury could reasonably conclude that the simultaneous addition in Harmony V1 is an insubstantial difference.
Accordingly, the evidence presented at trial is sufficient to support the jury's finding of infringement since the simultaneous addition of the solid support, probes, and target sequences in Harmony V1 does not prevent steps 1(a) and 1(b) from occurring in the order specified by the Court.
b. The '430 patent : Step (f)
Claim 1 of the '430 patent is representative, and recites in relevant part:
1. A method for determining a presence or absence of a fetal aneuploidy in a fetus for each of a plurality of maternal blood samples ... comprising fetal and maternal cell-free genomic DNA, said method comprising:
(a) obtaining a fetal and maternal cell-free genomic DNA sample ...;
(b) selectively enriching a plurality of non-random polynucleotide sequences of each fetal and maternal cell-free genomic DNA sample of (a) to generate a library ..., wherein said plurality of non-random polynucleotide sequences comprises at least 100 different non-random polynucleotide sequences selected from a first chromosome tested for being aneuploid and at least 100 different non-random polynucleotide sequences selected from a reference chromosome, wherein the first chromosome tested for being aneuploid and the reference chromosome are different ... [;]
(c) pooling the libraries generated in (b) to produce a pool of enriched and indexed fetal and maternal non-random polynucleotide sequences;
(d) performing massively parallel sequencing of the pool ... to produce sequence reads corresponding to enriched and indexed fetal and maternal non-random polynucleotide sequences ...;
(e) ... enumerating sequence reads corresponding to enriched and indexed fetal and maternal non-random polynucleotide sequences ...; and
(f) ... determining the presence or absence of a fetal aneuploidy comprising using a number of enumerated sequence reads corresponding to the first chromosome and a number of enumerated sequence reads corresponding to the reference chromosome of (e).
Dkt. No. 64-7.
According to the Court's claim construction, the term "comprising" "means including, but not limited to," and the term "reference chromosome" refers to "a chromosome different from the particular chromosome that is being tested for aneuploidy." Trial Tr. at 1854:17-18, 1855:3-5.
Ariosa argues no reasonable juror could find that Harmony V1 performs step 1(f) of the '430 patent because Harmony V1 does not determine the presence or absence of a fetal aneuploidy using "enumerated sequence reads" or a "reference chromosome." Dkt. No. 649 at 16-19. Ariosa points to evidence showing Harmony V1 uses "quantile normalization" derived from median sequence counts pooled from mul