Shire Viropharma Inc. v. CSL Behring LLC
| Decision Date | 31 March 2021 |
| Docket Number | CIVIL ACTION NO. 17-414 CONSOLIDATED |
| Parties | SHIRE VIROPHARMA INCORPORATED Plaintiff, v. CSL BEHRING LLC and CSL BEHRING GMBH Defendants. |
| Court | U.S. District Court — District of Delaware |
MEMORANDUM OPINION
This patent infringement case involves drugs used for the treatment and prevention of a condition known as hereditary angioedema. Plaintiff Shire ViroPharma Incorporated ("Plaintiff") alleges that Defendants CSL Behring LLC and CSL Behring GMBH (collectively, "Defendants") have infringed upon four of Plaintiff's patents used in treating this condition. Defendants asserts counterclaims for both invalidity and for a declaration of noninfringement.
At issue before me are the parties' competing motions to exclude all or portions of opinions contained in both parties' expert reports under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579. For the following reasons, I will grant only a small portion of the many challenges raised, as most are quibbles over basic evidentiary disputes or differing theories, which have no applicability to the Daubert analysis.
Hereditary angioedema ("HAE") is a rare genetic disorder causing insufficient natural production of functional or adequate amounts of a protein called C1 esterase inhibitor ("C1-INH"). This protein helps to regulate several complex processes involved in the immune system and fibrinolytic system functions. HAE exists in two forms. Type I occurs where the individual produces either no or low C1-INH. Type II is present where the individual has the normal amount of C1-INH, but that C1-INH does not properly function. Patients suffering from HAE experience symptoms including unpredictable, recurrent attacks of swelling commonly affecting the hands, feet, arms, legs, face, abdomen, tongue, genitals, and larynx. Currently, there are approximately 6,500 people in the United States who suffer from this condition.
HAE may be treated by administration of a drug containing a C1 esterase inhibitor in order to restore sufficient levels of C1-INH so as to prevent or reduce the frequency or severity of HAE attacks. HAE can be treated either acutely—meaning immediate treatment of an HAE attack in order to slow it down or stop it altogether, or prophylactically—meaning administration of a medication on a regular basis to prevent attacks.
On April 11, 2017, the United States Patent and Trademark Office ("PTO") issued U.S. Patent No. 9,616,111 (the "'111 patent"), entitled "C1-INH Compositions and Methods for the Prevention and Treatment of Disorders Associated with C1 Esterase Inhibitor Deficiency." The claims of the '111 patent are directed generally to methods "for treating hereditary angioedema (HAE) . . . comprising subcutaneously administering . . . a composition comprising a C1 esterase inhibitor, a buffer selected from citrate or phosphate, and having a PH ranging from 6.5-8.0,wherein the C1 esterase inhibitor is administered at a concentration of at least about 400 U/mL and a dose of at least about 1000 U. . . ." Plaintiff is the owner of all rights, title, and interest in the '111 patent.
On July 25, 2017, Defendants began U.S. sales of a prophylactic C1 esterase inhibitor treatment for subcutaneous administration. Defendants marketed the new C1 esterase inhibitor product as "Haegarda," which received FDA approval on June 22, 2017. The FDA also granted Haegarda orphan drug exclusivity. On July 25, 2017, Defendants issued a press release announcing the availability of Haegarda in the United States. The Haegarda product label instructs, in part, that the drug is a "plasma-derived concentrate of C1 Esterase Inhibitor (Human)" to be used for "routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients." The label further directs Haegarda's self-administration by subcutaneous injection.
Having obtained the '111 patent, Plaintiff began development of its own subcutaneous prophylactic C1-INH therapy, commonly referred to as either "Cinryze SC," "SHP616," or "TAK616 SC." Shortly after the release of Haegarda, Plaintiff ceased the development of this therapy.
Based on Defendants' intent to start selling Haegarda, Plaintiff initiated this action on April 11, 2017, the same day that the '111 patent issued. Plaintiff filed a first amended complaint on April 28, 2017, and a second amended complaint on August 24, 2017, setting forth allegations of direct infringement, inducement of infringement, contributory infringement, and willful infringement.
Thereafter, on September 25, 2018, the PTO issued a continuation patent—the '788 patent. Plaintiff filed a new Complaint in this matter on the same day—under Civil Action No.18-1476—alleging that Defendants' Haegarda product also infringed at least claim 1 of the '788 Patent. The PTO then issued three more continuation patents—the '423 patent, the '690 patent, and the '595 patent. In response, Plaintiff amended its complaint twice to include those patents. On January 24, 2019, I consolidated both the original action, at Civ. A. No. 17-414, and the new action, at Civ. A. No. No. 18-1476.
Currently, only there are only three patents at issue—the '111 patent, the '788 patent, and the '423 patent (collectively, the "patents-in-suit"), with ten asserted claims. Following two claim construction hearings, the parties proceeded through and have completed both fact and expert discovery. Before me are competing motions to preclude expert testimony.
Federal Rule of Evidence 702 provides:
Fed. R. Evid. 702. Rule 702 places district courts in the role of "gatekeeper," requiring courts to "'ensure that any and all [expert] testimony . . . is not only relevant, but reliable.'" Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 147 (1999) (quoting Daubert, 509 U.S. at 589). The party offering an expert must demonstrate, by a preponderance of the evidence, that the expert's qualifications and opinions comply with Federal Rule of Evidence 702. See Daubert, 509 U.S. at 592-93 (citation omitted). Rule 702 has "a liberal policy of admissibility," Pineda v. Ford MotorCo., 520 F.3d 237, 243 (3d Cir. 2008) (quotation omitted), and "the rejection of expert testimony is the exception rather than the rule." Fed. R. Evid. 702, Advisory Comm Notes (2000). As the Court in Daubert stated: "Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." 509 U.S. at 595.
The Daubert inquiry "embodies a trilogy of restrictions on expert testimony: qualification, reliability, and fit." Schneider ex re. Estate of Schneider v. Fried, 320 F.3d 396, 404 (3d Cir. 2003) (citations omitted).
In Waldorf v. Shuta, 142 F.3d 601 (3d Cir. 1998), the United States Court of Appeals for the Third Circuit articulated the "qualification" standard for an expert:
Rule 702 requires the witness to have "specialized knowledge" regarding the area of testimony. The basis of this specialized knowledge "can be practical experience as well as academic training and credentials." . . . We have interpreted the specialized knowledge requirement liberally, and have stated that this policy of liberal admissibility of expert testimony "extends to the substantive as well as the formal qualification of experts." . . . However, "at a minimum, a proffered expert witness . . . must possess skill or knowledge greater than the average layman . . . ."
Id. at 625 (citations omitted).
Construing this standard, the Third Circuit has "eschewed imposing overly rigorous requirements of expertise and [has] been satisfied with more generalized qualifications." In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir. 1994). In other words, "an expert's qualifications should be assessed 'liberally,' recognizing that 'a broad range of knowledge, skills, and training qualify an expert as such.'" Thomas v. CMI Terex Corp., No. 07-3597, 2009 WL 3068242, at *5 (D.N.J. Sept. 21, 2009) (quoting Paoli, 35 F.3d at 741). An expert will notbe excluded "simply because [the court] does not deem the proposed expert to be the best qualified or because the proposed expert does not have the specialization that the court considers most appropriate." Holbrook v. Lykes, Bros. S.S. Co., 80 F.3d 777, 782 (3d Cir. 1996). The focus, instead, is on whether the qualifications that an expert does have provide a foundation for the witness to testify meaningfully on a given matter. See Buzzerd v. Flagship Carwash of Port St. Lucie, Inc., 669 F. Supp. 2d 514, 522 (M.D. Pa. 2009) (citing Rose v. Truck Ctrs, Inc., 611 F. Supp. 2d 745, 749 (N.D. Ohio 2009)) ("The issue with regard to expert testimony is not the qualifications of a witness in the abstract, but whether those qualifications provide a foundation for a witness to answer a specific question.") (quoting Berry v. City of Detroit, 25 F.3d 1342, 1351 (6th Cir. 1994)).
The reliability restriction requires that the testimony be based upon "the 'methods and procedures of science' rather than on 'subjective belief or unsupported speculation'" and that the expert have "'good grounds' for his or her belief." Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003) (quotations omitted). In that respect, reliability mandates an examination into the...
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