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Biomerieux, S.A. v. Hologic Inc.

United States District Court, D. Delaware

September 25, 2018

BIOMERIEUX, S.A. and BIOMERIEUX, INC., Plaintiffs,
v.
HOLOGIC, INC., GRIFOLS S.A., and GRIFOLS DIAGNOSTIC SOLUTIONS INC., Defendants,

          Daniel M. Silver, MCCARTER & ENGLISH, LLP, Wilmington, DE, Paul B. Gaffney, Stanley E. Fisher, Charles L. McCloud, Shaun P. Mahaffy, WILLIAMS & CONNOLLY LLP, Washington, DC Attorneys for Plaintiffs

          Karen L. Pascale, Pilar G. Kraman, YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington, DE, Matthew M. Wolf, ARNOLD & PORTER KAYE SCHOLER LLP, Washington, DC, David K. Barr, Kyle D. Gooch, ARNOLD & PORTER KAYE SCHOLER LLP, New York, NY, Jennifer A. Sklenar, ARNOLD & PORTER KAYE SCHOLER LLP, Los Angeles, CA Attorneys for Defendants

          MEMORANDUM OPINION

          STARK, UNITED STATES DISTRICT JUDGE

         Plaintiffs bioMerieux, S.A., and bioMerieux, Inc.'s (together, "Plaintiffs" or "bioMerieux") assert in their February 2, 2017 Complaint (D.I. 1) ("Complaint" or "Compl.") that Defendants Hologic, Inc. ("Hologic"), Grifols Diagnostic Solutions Inc. ("GDS"), and Grifols, S.A. ("GSA") (together, "Defendants") infringe Plaintiffs' U.S. Patent Nos. 8, 697, 352 ("the '352 patent") and 9, 074, 262 ("the '262 patent"). On April 3, 2017, Hologic and GDS filed a motion to dismiss, pursuant to Federal Rule of Civil Procedure 12(b)(6), on the grounds that Plaintiffs "failed to allege sufficient facts to make its claims plausible, leaving required elements of its claims unaddressed." (D.I. 18; D.I. 17) On May 2, 1027, GSA filed its own motion to dismiss, adopting by reference the briefing provided by Hologic and GDS. (D.I. 26; D.I. 27) Then, on January 3, 2018, the parties consented to transfer the case from the Middle District of North Carolina to this Court. (D.I. 56; D.I. 57) Defendants refiled their motion to dismiss. (D.I. 69) Later, the Court ordered and obtained supplemental letter briefs on the effect of the transfer on which Circuit's law to apply. (See D.I. 119; D.I. 120)

         The Court will deny Defendants' motion.

         I. BACKGROUND

         The present dispute revolves around alleged infringement of Plaintiffs' patents relating to HIV-1 testing technology. "bioMerieux has developed innovative tests for screening for infectious diseases in the blood and blood products received by transfusion recipients, surgical patients, and clinical trial participants." (Compl. at ¶ 13) The Complaint asserts that Plaintiff discovered an improved means of screening for HIV-1 in the 1990s. (Id. at ¶ 14) In particular, the asserted patents responded to the need to test for mutations and strains of HIV-1 that were being missed by other tests. (Id. at ¶¶ 23-25) The scientists collaborating on the project "identified nucleotide sequences derived from a particular part of the HIV-1 genome that, when used in primer sets with a transcription-based amplification technique, were capable of detecting nearly all known HIV-1 subtypes. The resulting methods were much more sensitive than methods disclosed in the prior art, and delivered results much faster." (Id. at ¶ 27)

         Plaintiffs' inventions are purportedly claimed in the '352 and '262 patents. The '352 patent is entitled, "Nucleic Acid Sequences that Can Be Used as Primers and Probes in the Amplification and Detection of All Subtypes of HIV-1," and was issued on April 15, 2014; it claims priority to a European Patent Application filed August 8, 1997. (Id. at ¶ 29) The '262 patent, entitled "Nucleic Acid Sequences that Can Be Used as Primers and Probes in the Amplification and Detection of All Subtypes of HIV-1," claims priority to the same application. (Id. at ¶¶ 29-30) Plaintiffs are co-assignees to both patents. (Id.)

         The Complaint alleges with respect to Defendants' infringement:

In particular, Defendants have been party to a distribution agreement under which Hologic will manufacture in the United States products used for amplifying and detecting HIV-1. Those products are sold to Grifols, S.A. and Grifols USA and then resold in the United States and the rest of the world, marketed under the names Procleix HIV-1/HCV Assay, Procleix Ultrio Assay, and Procleix Ultrio Plus Assay (the 'Procleix Tests'). Under their contractual arrangement, Hologic ships the Accused Products to customers identified and contracted by Grifols, S.A. and Grifols USA. The Defendants split the net proceeds of those sales.

(Id. at ¶ 35) Plaintiffs accuse two sets of products: the Procleix tests and Aptima tests (Aptima HIV-1 RNA Qualitative Assay and Aptima HIV-1 Quant DX Assay), together the "Accused Tests." (Id. at¶36)

         The Complaint further alleges:

The manufacture, use, offer for sale, and sale of the Accused Tests in the United States, with accompanying instructions, infringe and/or induce or contribute to infringement of the Asserted Patents because the tests amplify and detect HIV-1 through the use of oligonucleotide primers, promoters, methods, and kits, that are covered by the claims of the Asserted Patents.

(Id. at ¶ 38) Plaintiffs assert that Defendants infringe one or more of the claims, including at least claim 1 of each of the two patents, and that the infringement is willful. (Id. at ¶¶ 41-43) With respect to willfulness, the Complaint alleges "that Hologic has had knowledge of the Asserted Patents through its efforts over the last several years to revoke foreign counterparts of these patents that issued from the European Patent Office" and by GSA and GDS' relationship with Hologic. (Id. at ΒΆ 43) ...


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