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Abaxis, Inc v. Cepheid

July 19, 2012


The opinion of the court was delivered by: Lucy H. Koh United States District Judge


Plaintiff-Counterclaimant Abaxis, Inc. ("Abaxis") moves to exclude the testimony of Defendant-Counterclaimant Cepheid's ("Cepheid") technical expert, Dr. Philip Williams. Pursuant 18 to Civil Local Rule 7-1(b), the Court finds the motion appropriate for determination without oral 19 argument. Having considered the submissions of the parties and the relevant law, the Court 20

GRANTS IN PART and DENIES IN PART Abaxis's motion to exclude. 21 I.LEGAL STANDARD

Federal Rule of Evidence 702 allows admission of "scientific, technical, or other 23 specialized knowledge" by a qualified expert if it will "help the trier of fact to understand the 24 evidence or to determine a fact in issue." Expert testimony is admissible pursuant to Rule 702 if it 25 is both relevant and reliable. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589 (1993). A 26 district court's decision to admit expert testimony under Daubert in a patent case follows the law of 27 the regional circuit. Micro Chem., Inc. v. Lextron, Inc., 317 F.3d 1387, 1390-91 (Fed. Cir. 2003). 28 When considering expert testimony offered pursuant to Federal Rule of Evidence 702, a district 2 court acts as a "gatekeeper" by "making a preliminary determination that the expert's testimony is 3 reliable." Elsayed Mukhtar v. Cal. State Univ., Hayward, 299 F.3d 1053, 1063 (9th Cir. 2002); see 4 136, 142 (1997); Daubert, 509 U.S. at 589-90. An expert witness may provide opinion testimony 6 if: (1) the testimony is based upon sufficient facts or data; (2) the testimony is the product of 7 reliable principles and methods; and (3) the expert has reliably applied the principles and methods 8 to the facts of the case. Fed. R. Evid. 702; see also Sundance, Inc. v. DeMonte Fabricating Ltd., 9 Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147-48 (1999); Gen. Elec. Co. v. Joiner, 522 U.S. 5 550 F.3d 1356, 1360 (Fed. Cir. 2008). Under Daubert, "a court should consider (1) whether a 10 theory or technique 'can be (and has been) tested;' (2) 'whether the theory or technique has been F.3d 977, 989 (9th Cir. 2012) (quoting Daubert, 509 U.S. at 593-94). admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the 16 burden of proof, not exclusion." Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010) (citing 17

Daubert, 509 U.S. at 594, 596). "Under Daubert, the district judge is 'a gatekeeper, not a fact 18 finder.' When an expert meets the threshold established by Rule 702 as explained in Daubert, the 19 expert may testify and the jury decides how much weight to give that testimony." Id. (quoting 20 United States v. Sandoval-Mendoza, 472 F.3d 645, 654 (9th Cir. 2006)). that Dr. Williams has no personal experience with the designing or making of freeze-dried 25 materials and lyophilization, rendering his opinions on these topics inadmissible under Rule 702 26 due to lack of proper foundation. Mot. 1, 3. According to Abaxis, Dr. Williams's deposition 27 revealed that he was so inexperienced in these matters that his testimony on such subjects would be subjected to peer review and publication;' (3) 'the known or potential rate of error;' and (4) whether it is generally accepted in the scientific community." Wagner v. Cnty. of Maricopa, 673 13 The inquiry into admissibility of expert opinion is a "flexible one," where "[s]haky but


A.Dr. Williams's Technical Opinions

Abaxis does not dispute Dr. Williams's qualifications as an expert. Rather, Abaxis contends unreliable. Id. at 3. Thus, Abaxis argues, any opinions of Dr. Williams that require knowledge of 2 the design or manufacture of freeze-dried materials and lyophilization, including his technical 3 evaluation of lyophilization or whether the prior art is enabling, are inadmissible under Daubert. 4

Similarly, Abaxis argues that Dr. Williams should be precluded from offering any opinion 6 relating to knowledge of precision pumps, including IVEK brand pumps, due to lack of experience 7 with this particular brand of pump. Id. at 3. Abaxis takes particular issue with Dr. Williams's 8 opinions that persons of ordinary skill in the art would have known about IVEK pumps, that the 9 pumps were "well known," and that they were known in pharmaceutical companies. Id. at 3-4. 10 Id. 5

Abaxis argues that Dr. Williams is unqualified to opine on IVEK pumps because Dr. Williams first became familiar with IVEK pumps during this litigation. Id. at 3. Moreover, Dr. Williams's United States District Court For the Northern District of California opinions about the popularity of IVEK pumps is based solely on: (1) IVEK advertisements; (2) the 13 testimony of a former employee of a company that used IVEK pumps (who now works at 14

Abaxis argues that Dr. Williams's opinions regarding IVEK pumps, as well as all other precision 16 pumps, should be barred. Id. 17 18 another, that Dr. Williams's lack of personal knowledge renders his testimony inadmissible. While 19 Abaxis is correct that Dr. Williams never personally executed a freeze-drying or lyophilization 20 procedure, the record indicates that Dr. Williams was, indeed, familiar with such procedures. In 21 fact, the record makes clear that Dr. Williams's research group had experience with freeze-drying 22 and lyophilization procedures and that Dr. Williams has directed students in his laboratory who 23 have conducted these procedures. See Carlson Decl. Ex. H, at ¶ 12; Williams Dep. 18:9-12, 19:5-6. 24

This experience, combined with Dr. Williams's extensive training in the field of pharmacy, is 25 sufficient to render his opinions on freeze-drying and lyophilization admissible under Rule 702. 26

See Carlson Decl. Ex. H, at ¶¶ 3-7. 27 28

Cepheid); and (3) the availability of IVEK pumps in a supply ordering catalog. Id. Accordingly, 15

The Court is not persuaded by Abaxis's arguments, all of which argue, in some form or 2 admissible. It is true that Dr. Williams admitted that he was unfamiliar with IVEK pumps prior to 3 his involvement in the instant case. Williams Dep. 57:7-15. However, Dr. Williams also testified 4 that he is familiar with a number of highly-precise pumps including syringe-driven, peristaltic, and 5 impeller-driven pumps. Id. at 56:7-10. Moreover, since becoming involved with this case, Dr. 6

Williams has been exposed to evidence in the record that he has used, in combination with his prior 7 experience with other similar pumps, to form his current opinion on IVEK pumps. See Rodriguez 8

Dr. Williams's opinions regarding precision pumps, including IVEK pumps, are similarly

Decl. Ex. 3, at ¶¶ 107, 122-23, 125-27. While Abaxis may dispute the credibility, reliability, or 9 sufficiency of the evidence that Dr. Williams used to form his opinions, there is a sufficient factual 10 basis in the record for Dr. William's opinion. Sundance, Inc., 550 F.3d at 1360. Thus, Dr. 13 personal experience in an area to offer admissible testimony relating to that area. See Daubert, 509 14

U.S. at 592 ("Unlike an ordinary witness, . . . an expert is permitted wide latitude to offer opinions, 15 including those that are not based on firsthand knowledge ...

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