Laboratories v. Grifols Diagnostic Sols. Inc.

ABBOTT LABORATORIES, Plaintiff/Counter-Defendant, v. GRIFOLS DIAGNOSTIC SOLUTIONS INC.,GRIFOLS WORLDWIDE OPERATIONS LIMITED,and NOVARTIS VACCINES AND DIAGNOSTICS, INC., Defendants/Counter-Plaintiffs.

No. 19 C 6587

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

December 1, 2020

Judge Sara L. Ellis

OPINION AND ORDER

Abbott Laboratories ("Abbott") brought this declaratory judgment action against Defendants Grifols Diagnostic Solutions Inc. ("Grifols Diagnostic"), Grifols Worldwide Operations Limited ("Grifols Worldwide"), and Novartis Vaccines and Diagnostics, Inc. ("Novartis"), asserting that the claims of U.S. Patent No. 7,205,101 ("the '101 Patent") are invalid. Defendants deny that the claims of the '101 Patent are invalid, and they brought a counterclaim asserting that Abbott infringes claim 7 of the '101 Patent.¹ Abbott now moves under Federal Rule of Civil Procedure 12(b)(6) to dismiss Defendants' infringement counterclaim on the basis that claim 7 of the '101 Patent is invalid as a matter of law under 35 U.S.C. § 101. Because Abbott has not demonstrated that claim 7 is directed to a patent-ineligible natural phenomenon, the Court denies Abbott's motion to dismiss [53].

BACKGROUND²

The '101 Patent, titled "Human Immunodeficiency Virus (HIV) Nucleotide Sequences, Recombinant Polypeptides, and Applications Thereof," relates to the diagnosis, prevention, and treatment of HIV, the virus that causes acquired immunodeficiency syndrome ("AIDS"). See, e.g., Doc. 1-1 ("'101 Pat.") at Abstract, 1:1-4, 2:56-3:4, 6:8-11; HIV/AIDS - Symptoms and causes, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/hiv-aids/symptoms-causes/syc-20373524 (last visited Nov. 13, 2020). In particular, the '101 Patent is "directed to nucleotide sequences, such as DNA, encoding human immunodeficiency virus polypeptides, the use of such nucleotide sequences in diagnostic procedures and in the production of recombinant protein, as well as the use of such proteins in diagnostic, prophylactic, and therapeutic applications."³ '101 Pat. at 1:27-32.

The United States saw its first documented cases of AIDS in 1981, and by 1984, three groups had independently identified HIV as the suspected cause of AIDS. Because an individual infected with HIV can transmit the virus to others while remaining asymptomatic for years, a focus at that time was developing the ability to accurately screen large numbers of asymptomatic individuals (e.g., healthy appearing blood donors) to detect for HIV infection. Researchersdiscovered immortalized cell lines that they could chronically infect with HIV in vitro, which enabled them to produce HIV in substantial quantities. This in turn led to the development of immunoassays to detect HIV-specific antibodies in the blood of blood donors or patients suspected of having HIV.⁴ Researchers could construct an HIV immunoassay using natural HIV proteins by growing live, fully intact HIV in large quantities; breaking the HIV into pieces; collecting the HIV proteins and sticking them to a surface; and then washing the patient's blood over the surface. If HIV antibodies were present in the blood, they would bind to the HIV proteins and remain attached to them when the blood was washed away from the surface. Researchers could then detect the HIV antibodies by using enzymes that change color or fluorescent markers that emit light in the presence of HIV antibodies.

However, because growing large amounts of live, intact HIV in vitro exposed workers to risk of infection and required expensive laboratory facilities, the number of facilities and individuals available to work with the virus was limited. Moreover, although tissue culture could "provide viral polypeptides suitable for use in diagnostic assays, it [was] highly undesirable to employ polypeptides produced by tissue culture in vaccine compositions due to the risk of infectivity posed by live, intact virus." '101 Pat. at 2:22-27.

A potential solution was to produce HIV proteins using recombinant (as opposed to natural) means, and in 1984, scientists began trying to use recombinant DNA technology⁵ tomake proteins and partial proteins from HIV's outer layer, called the envelope ("env"). Scientists focused on identifying DNA fragments that encoded HIV env proteins because they suspected that the env layer would react or bind with HIV-specific antibodies.

In the spring of 1984, a team from Chiron Corporation ("Chiron") began working on creating a recombinant DNA env-based immunoassay. By October 1, 1984, Chiron had run sequence reactions on DNA fragments that spanned what has since been determined to be HIV's entire env layer. In connection with this work, Chiron filed U.S. Patent Application No. 06/667,501 ("the '501 Application") on October 31, 1984. Before Chiron filed the '501 Application, the production of recombinant HIV proteins was not possible. Scientists did not know the sequence of HIV nucleotides "that would enable the production of recombinant proteins," nor did they know "whether recombinantly produced viral protein would be sufficiently similar in antigenic properties to native HIV polypeptides so as to be generally useful in diagnostic assays or vaccine production." Doc. 41 at 20 (¶ 22); see also '101 Pat. at 2:28-37, 2:49-52.

On April 17, 1995, Chiron filed the patent application that issued as the '101 Patent. This application claims priority, through several divisional and continuation applications, to the '501 Application, which Chiron filed more than a decade earlier. The '101 Patent issued on April 17, 2007. Novartis, which later acquired Chiron, and Grifols Worldwide jointly own the '101 Patent. The '101 Patent has 19 claims, but Defendants only assert claim 7 against Abbott.

LEGAL STANDARD

A motion to dismiss under Rule 12(b)(6) challenges the sufficiency of the complaint, not its merits. Fed. R. Civ. P. 12(b)(6); Gibson v. City of Chicago, 910 F.2d 1510, 1520 (7th Cir.1990). In considering a Rule 12(b)(6) motion, the Court accepts as true all well-pleaded facts in the plaintiff's complaint and draws all reasonable inferences from those facts in the plaintiff's favor. Kubiak, 810 F.3d at 480-81. To survive a Rule 12(b)(6) motion, the complaint must assert a facially plausible claim and provide fair notice to the defendant of the claim's basis. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007); Adams v. City of Indianapolis, 742 F.3d 720, 728-29 (7th Cir. 2014). A claim is facially plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678.

Patent eligibility under 35 U.S.C. § 101 "is a question of law based on underlying facts." Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 749 (Fed. Cir. 2019). The Court may resolve patent eligibility on a Rule 12(b)(6) motion but only "when the undisputed facts require a holding of ineligibility." Id.; Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, 1125 (Fed. Cir. 2018) ("[P]atent eligibility can be determined at the Rule 12(b)(6) stage . . . only when there are no factual allegations that, taken as true, prevent resolving the eligibility question as a matter of law."). "If there are claim construction disputes at the Rule 12(b)(6) stage," the Court must either adopt "the non-moving party's constructions" or "resolve the disputes to whatever extent is needed to conduct the § 101 analysis, which may well be less than a full, formal claim construction." Aatrix, 882 F.3d at 1125. In addressing a motion to dismiss based on patent eligibility, the Court may consider the patent itself, as well as "plausible and specific factual allegations" in the patent owner's complaint about the patent and its claims. See, e.g., CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368-71 (Fed. Cir. 2020) (considering claim language and the patent's written description); Cellspin Soft, 927 F.3d at 1316-19 (considering allegations in the complaint). Ultimately, the party raising a § 101challenge bears the burden of demonstrating that the patent claim is not eligible for patenting. Illumina, Inc. v. Ariosa Diagnostics, Inc., 967 F.3d 1319, 1328 (Fed. Cir. 2020) ("[T]he party challenging the validity of the patents . . . bear[s] the burden of proof on its § 101 challenge[.]"); see also Cellspin Soft, 927 F.3d at 1319 ("To the extent the district court . . . conclud[ed] that issued patents are presumed valid but not presumed patent eligible, it was wrong to do so.").

ANALYSIS

Section 101 of the Patent Act defines patentable subject matter as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." 35 U.S.C. § 101. This provision, however, "contains an important implicit exception": "[l]aws of nature, natural phenomena, and abstract ideas" are not patentable subject matter. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012) (citations omitted); accord Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1374 (Fed. Cir. 2016); In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig. ("In re BRCA"), 774 F.3d 755, 762-63 (Fed. Cir. 2014). At the same time, "an invention is not rendered ineligible for [a] patent simply because it involves" one of these exceptions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217 (2014).

Abbott asserts that claim 7 of the '101 Patent is invalid because it impermissibly claims a natural phenomenon. In Alice and Mayo, the Supreme Court set forth a two-part test "[t]o distinguish claims to patent-eligible applications of . . . natural phenomena from claims that impermissibly tie up such . . . phenomena." Illumina, 967 F.3d at 1324-25. For step one of the Alice/Mayo test, the Court asks whether claim 7 is "directed to" a natural phenomenon. Id. If the answer...