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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 or observation.") (citing Fed. R. Evid. 16

702, 703). Dr. Williams's knowledge of freeze-drying procedures and IVEK pumps, although 17 indirect, is sufficient to satisfy Daubert's minimum threshold of relevance and accuracy. See 18

(N.D. Cal. Mar. 29 2012) ("When the methodology is sound, and the evidence relied upon 20 sufficiently related to the case at hand, disputes about the degree or relevance or accuracy (above 21 this minimum threshold) may go to the testimony's weight, but not its admissibility."). Thus, 22

Cepheid's objections to the credibility of Dr. Williams's testimony must be resolved on cross-23 examination, not by wholesale exclusion of his testimony. See DSU Med. Corp. v. JMS Co., Ltd., 24

Accordingly, Abaxis's motion to exclude the technical opinions of Dr. Williams is

Williams' testimony regarding IVEK pumps is admissible as well.

United States District Court For the Northern District of California

Contrary to Abaxis's arguments, Rule 702 imposes no requirement that experts have Mformation Techs., Inc. v. Research in Motion Ltd.,08-CV-04990, JW2012 WL 1142537, at *3 19

296 F. Supp. 2d 1140, 1156 (N.D. Cal. 2003). 25



B.Dr. Williams's Non-Technical Opinions

1.Dr. Williams's Legal Opinions

Abaxis objects to what it alleges are Dr. Williams's legal opinions in paragraphs 157-60 and

182-87 of his expert report. Mot. 4. In particular, Abaxis argues that Dr. Williams improperly 4 opines that an agreement between Pfizer and R.P. Scherer, as well as various agreements between 5

Abaxis and Teramecs, constituted "offer[s] for sale." Id. Such opinions, according to Abaxis, are 6 inadmissible under Rule 702 as they are relevant only to conclusions of law rather than questions 7 of fact. Id. 8

Cepheid, however, maintains that Dr. Williams explicitly and repeatedly disavowed that he 9 was offering a legal opinion. Opp'n 9-10. Instead, Cepheid contends that Dr. Williams was only 10 offering his opinion as to whether the products that were the subjects of the various agreements actually embodied the asserted patent claims. Id. at 10. Because this is a proper subject of expert

United States District Court For the Northern District of California

testimony, Cepheid argues, Dr. Williams's opinions on such matters are admissible. Id. 13 14 matters. Cf. McHugh v. United Serv. Auto. Ass'n, 164 F.3d 451, 454 (9th Cir. 1999) ("[Expert] 15 testimony cannot be used to provide legal meaning . . . ."). Accordingly, Abaxis's motion to 16 exclude Dr. Williams's opinions on legal matters is GRANTED. This grant is narrow, however, 17 and only bars Dr. Williams from offering his opinion on legal conclusions, such as the legal rights 18 or obligations of various parties or the legal effects of particular agreements. It does not preclude 19

Dr. Williams from testifying about technical matters related to the various agreements mentioned 20 above. As Cepheid rightly points out, Dr. Williams's opinion as to whether the products in the 21 above agreements embodied the asserted claims is admissible. See Fed. R. Evid. 704(a) ("An 22 opinion is not objectionable just because it embraces an ultimate issue."). Nevertheless, any legal 23 conclusions Dr. Williams might have, such as whether a particular agreement constitutes an "offer 24 for sale" is hereby excluded.

27 products containing the patented technologies. Mot. 5. In particular, Abaxis wishes to exclude Dr. 28

The Court agrees with Abaxis that Dr. Williams cannot offer his opinion on purely legal

2.Dr. Williams's Opinions on "Commercial Success"

Abaxis also seeks to exclude Dr. Williams's opinions on the commercial success of Williams's opinion that some of the Abaxis products are not commercially successful, arguing that 2 such an opinion is not based on any technical knowledge and is therefore beyond the scope of Rule 3

702. Id. Cepheid contends, however, that Dr. Williams is not offering his opinion as to the 4 ultimate question of commercial success, but only to the limited question as to whether Abaxis's 5 commercial success (assuming it exists) is attributable to the patented invention. Opp'n 10-11. 6

7 whether or why any product enjoys commercial success is inadmissible. Nothing in Dr. Williams's 8 qualifications indicates that he is qualified to testify as an expert on such topics. Dr. Williams is an 9 expert in pharmacy, not in sales, marketing, or consumer preferences and demand. See Rodriguez 10 The Court is persuaded by Abaxis's arguments and agrees that Dr. Williams's opinion on

Decl. Ex. 3, at ¶¶ 8-10. Accordingly, Abaxis's motion to exclude Dr. Williams's opinions on

commercial success is GRANTED. Dr. Williams may not speculate as to what he believes is

United States District Court

For the Northern District of California

responsible for the commercial success of Abaxis's process and beads. However, Dr. Williams may 13 educate the jury on whether Abaxis's process and beads contain technology in the prior art or other 14 features not claimed in the patents-in-suit. The jurors are free to draw their own conclusions as to 15 whether the evidence establishes that the patented features, rather than other features, drive the sale 16 of Abaxis's process and beads. See Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299, 1311-12 (Fed. 17

Cir. 2006) ("Evidence of commercial success . . . is only significant if there is a nexus between the 18 claimed invention and the commercial success.").

21 copied by Cepheid. Mot. 5. Such a conclusion, Abaxis argues, is only based on deposition 22 testimony and does not draw at all upon Dr. Williams's technical background. Id. Accordingly, 23

Abaxis argues that Dr. Williams is simply acting as a layperson in giving this opinion, thereby 24 rendering it inadmissible under Rule 702. Id. Cepheid argues, however, that Dr. Williams has no 25 intention of offering his opinion on the ultimate question of copying, but instead only intends to 26 offer his analysis regarding a comparison of the two parties' technologies, how Cepheid's process 27 28

3.Dr. Williams's Opinions on Copying

Abaxis finally objects to Dr. Williams's opinion that the patented inventions were not was developed, and which parts of the technologies were well known in the art. Opp'n 11-12. 2

Such subjects, Cepheid contends, are proper subjects of expert testimony. Id. 3

Dr. Williams is not entitled to offer his opinion as to the ultimate question of whether

Cepheid copied Abaxis. Accordingly, insofar as Abaxis's motion objects to such an opinion, it is GRANTED. Nevertheless, Dr. Williams will be allowed to give his opinion regarding the 6 comparison of the technologies of the parties, the development of Cepheid's process, and whether 7 the parties' technologies were well-known in the art. Such subjects are beyond the scope of a 8 layperson's experience and within Dr. Williams's expertise. Dr. Williams's testimony on these 9 subjects is therefore proper, and to the extent Abaxis's motion seeks to exclude such testimony, it is DENIED.


United States District Court For the Northern District of California

For all of the foregoing reasons, Plaintiff's motion to exclude Dr. Williams's testimony is

GRANTED IN PART and DENIED IN PART as set forth above.



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