Bioverativ Inc. v. CSL Behring LLC

• Decision Date: 04 March 2020
• Docket Number: Civil Action No. 17-914-RGA
• Parties: BIOVERATIV INC., BIOVERATIV THERAPEUTICS INC., and BIOVERATIV U.S. LLC, Plaintiffs, v. CSL BEHRING LLC, CSL BEHRING GMBH, and CSL BEHRING LENGNAU AG, Defendants.
• Court: U.S. District Court — District of Delaware

BIOVERATIV INC., BIOVERATIV THERAPEUTICS INC.,and BIOVERATIV U.S. LLC, Plaintiffs, v. CSL BEHRING LLC, CSL BEHRING GMBH,and CSL BEHRING LENGNAU AG, Defendants.

Civil Action No. 17-914-RGA

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

March 4, 2020

MEMORANDUM ORDER

Before me are five motions submitted by Bioverativ and CSL Behring regarding Defendants' alleged infringement of patents by the accused pharmaceutical product Idelvion. This order will address Defendants' Motion to Exclude Certain Opinions of Dr. Robert Sidonio and Dr. Matthew Lynde (D.I. 213) and Defendants' Motion to Exclude Certain Opinions of Dr. Rodney Camire and Dr. E. Sally Ward (D.I. 215). I have reviewed the parties' briefing and related papers. (D.I. 217, 227, 237). I heard oral argument on February 21, 2020. After full consideration of the briefing, the motions are resolved as follows.

I. BACKGROUND

Plaintiffs Bioverativ Inc., Bioverativ Therapeutics Inc., and Bioverativ U.S. LLC filed this lawsuit against Defendants CSL Behring LLC, CSL Behring GmbH, and CSL Behring Lengau AG on July 7, 2017, asserting infringement of U.S. Patent Nos. 9,670,475 ("the '475 patent"), 9,623,091 ("the '091 patent"), and 9,629,903 ("the '903 patent") (collectively, "the Asserted Patents"). (D.I. 1). Defendants move to exclude certain opinions of Plaintiffs' experts Dr. Robert Sidonio and Dr. Matthew Lynde regarding convoyed sales and patient compliance with prescribed dosing regimens. (D.I. 217). Defendants also seek to exclude Dr. Camire's and Dr. Ward's opinions regarding (1) reliance on material that Plaintiffs allege is "incorporated by reference" into the Asserted Patents' specification and (2) the use of the phrase "representative subspecies." (Id.).

II. LEGAL STANDARD

Federal Rule of Evidence 702 sets out the requirements for expert witness testimony and states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. The Third Circuit has explained:

Rule 702 embodies a trilogy of restrictions on expert testimony: qualification, reliability, and fit. Qualification refers to the requirement that the witness possess specialized expertise. We have interpreted this requirement liberally, holding that a broad range of knowledge, skills, and training qualify an expert. Secondly, the testimony must be reliable; it must be based on the methods and procedures of science' rather than on 'subjective belief or unsupported speculation; the expert must have good grounds for his or her belief. In sum, Daubert holds that an inquiry into the reliability of scientific evidence under Rule 702 requires a determination as to its scientific validity. Finally, Rule 702 requires that the expert testimony must fit the issues in the case. In other words, the expert's testimony must be relevant for the purposes of the case and must assist the trier of fact. The Supreme Court explained in Daubert that Rule 702's helpfulness standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.

By means of a so-called "Daubert hearing," the district court acts as a gatekeeper, preventing opinion testimony that does not meet the requirements of qualification, reliability and fit from reaching the jury. See Daubert ("Faced with a proffer of expert scientific testimony, then, the trial judge must determine at the outset, pursuant to Rule 104(a) of the Federal Rules of Evidence whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue.").

Schneider ex rel Estate of Schneider v. Fried, 320 F.3d 396, 404-05 (3d. Cir. 2003) (cleaned up).

Qualification refers to the requirement that the witness possess specialized expertise. "We have interpreted this requirement liberally, holding that a broad range of knowledge, skills, and training qualify an expert." TQ Delta, LLC v. 2Wire, Inc. 373 F. Supp. 3d 509, 516 (D. Del. 2019) (citing Schneider, 320 F.3d at 404-05); see also Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003). "Rule 702's liberal policy of admissibility extends to the substantive as well as formal qualifications of experts." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir. 1994). The Third Circuit has "eschewed imposing overly rigorous requirements of expertise and ha[s] been satisfied with more generalized qualifications." Id.

An expert is qualified to provide testimony if he/she "possess[es] at least ordinary skill in the pertinent art." Sonos, Inc. v. D & M Holdings Inc., 297 F. Supp. 3d 501, 508 (D. Del. 2017). An expert who lacks the literal qualifications of one ordinarily skilled in the art, but who otherwise has sufficient relevant technical experience that will assist the trier of fact to understand the evidence, may still be qualified to testify in the pertinent art. See, e.g., Tesco Corp. v. Weatherford Int'l, Inc., 750 F. Supp. 2d 780, 795 (S.D. Tex. 2010) ("Even if he does not have specific experience studying or working with pipe handling devices, his three degrees in engineering and his experience in oil fields sufficiently qualify Dr. Wooley as an expert on the subject matter of this case. Rule 702 does not require [ ] extreme specificity of expertise...."); Int'l Gamco, Inc. v. Multimedia Games Inc., 732 F. Supp. 2d 1082, 1088 (S.D. Cal. 2010) ("While Ms. Spielman may lack the context in which these patents and technologies at issue are designed and implemented... the main component of the [ ] patent and its technologies at issue is clearly the distributed computing system," with which the expert did have experience.).

"[I]t is not necessary that the expert have expertise in the precise technology that is the subject of the patent or patents in suit." Sonos, 297 F. Supp. 3d at 510; see also TQ Delta, 373 F. Supp. 3d at 527-28 (denying the defendant's motion to exclude patentee's technical expert, the court stated, "Defendant attempts to define the pertinent art too narrowly. I determine that [the expert] has sufficient experience with communications systems, including DSL, to offer specialized testimony that would be helpful to the jury."). "However, the level of expertise may affect the reliability of the expert's opinion." In re Paoli, 35 F.3d at 741.

III. DISCUSSION

a. Opinions of Dr. Sidonio and Dr. Lynde

Defendants move to exclude opinions of Plaintiffs' damages expert, Dr. Matthew Lynde, and infringement expert, Dr. Robert Sidonio, regarding convoyed sales and patient compliance with prescribed dosing regimens. (D.I. 217 at 26). Defendants argue that Dr. Lynde's opinions that non-infringing uses of Idelvion are convoyed sales upon which Plaintiffs can recover damages are based on an incorrect "but for" legal test. (Id.). Defendants also state that Dr. Lynde's damages calculation is based on Dr. Sidonio's assumption that 100% of Idelvion patients comply with their prescribed dosing regimen 100% of the time, which is unsupported by sufficient facts or a reliable methodology. (Id.).

i. Dr. Lynde's Convoyed Sales Opinion

Defendants argue that Dr. Lynde has improperly included certain non-infringing uses of Idelvion as part of his "convoyed sales" analysis. (Id. at 27). Defendants assert that Dr. Lynde has included as "convoyed sales": (1) any non-infringing on-demand Idelvion prescriptions for a patient on an allegedly infringing prophylaxis treatment regimen; (2) sales of Idelvion to patients who are on a non-infringing prophylactic dosing regimen outside the ranges described in the asserted claims and the Idelvion label, but who, at some prior point in time, were prescribed an allegedly infringing regimen; and (3) sales of Idelvion for on-demand or non-infringing use before the patient begins an allegedly infringing prophylaxis regimen. (Id. at 27). Defendants argue that these sales to patients on a non-infringing regimen should be excluded from the damages analysis. (Id.). I agree with Defendants.

Patentees are allowed to recover for damages based on the profits a patentee would have received had the infringer not infringed. Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476, 504 (1964), citing 35 U.S.C. § 284. Where it is reasonably foreseeable that the patentee would have benefited from a sale but for the infringement, the patentee is entitled to recover for that sale. Micro Chem., Inc. v. Lextron, Inc., 318 F.3d 1119, 1125 (Fed. Cir. 2003). In order to prevent a patentee from collecting damages that "constitute more than what is 'adequate to compensate for the infringement,'" the Federal Circuit has developed a "functional relationship" test. Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538, 1550 (Fed. Cir. 1995). "A patentee may recover lost profits on . . . a convoyed sale[] if both the patented and unpatented products 'together were considered to be components of a single assembly or parts of a complete machine, or they together constituted a functional unit,'" and the patent-related feature drives demand for the functional unit as a whole. Am. Seating Co. v. USSC Grp., Inc., 514 F.3d 1262, 1268 (Fed. Cir. 2008) (quoting Rite-Hite, 56 F.3d at 1549).

A convoyed sales analysis may apply to method patents and product patents. See State Contracting & Eng'g Corp. v. Condotte Am. Inc., 346 F.3d 1057, 1074 (Fed. Cir. 2003). For a patentee to recover damages on convoyed sales, there must be a functional relationship between the patented product and the sale of an unpatented product. Am. Seating Co., ...