Abbott Labs. v. Grifols Diagnostic Sols.

• Decision Date: 27 April 2022
• Docket Number: 19 C 6587
• Parties: ABBOTT LABORATORIES, Plaintiff/Counter-Defendant, v. GRIFOLS DIAGNOSTIC SOLUTIONS INC., GRIFOLS WORLDWIDE OPERATIONS LIMITED, and NOVARTIS VACCINES AND DIAGNOSTICS, INC., Defendants/Counter-Plaintiffs.
• Court: U.S. District Court — Northern District of Illinois

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, N.D. Illinois, Eastern Division

April 27, 2022

OPINION AND ORDER

SARA L. ELLIS, UNITED STATES DISTRICT JUDGE

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 filed a counterclaim asserting that Abbott infringes the '101 Patent.^[1] The parties now seek construction of several terms in the '101 Patent, as well as a term in U.S. Patent No. 5, 156, 949 (“the '949 Patent”), on which Abbott relies for its obviousness-type double patenting argument. The Court held a claim construction hearing on February 25, 2022, and now construes the disputed terms as set forth below.

BACKGROUND

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”). 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.” JAppx0049.

By 1984, three groups had independently identified the suspected cause of AIDS, with those isolates called lymphadenopathy-associated virus (“LAV”), human T-cell lymphotropic virus type III (“HTLV-III”) and AIDS-associated retrovirus (“ARV”). Later, it became clear that these three isolates are all strains of the same virus, collectively named HIV.

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. A potential solution was to produce proteins from HIV's outer layer, called the envelope (“env”), using recombinant (as opposed to natural) means. 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.

Although Chiron ultimately abandoned the '501 Application, a number of patents trace their origins to the '501 Application. This includes the '949 Patent, titled “Immunoassays for Antibody to Human Immunodeficiency Virus Using Recombinant Antigens, ” as well as the ‘101 Patent, for which Chiron filed a patent application on April 17, 1995. The '101 Patent issued on April 17, 2007, and claims priority, through several divisional and continuation applications, to the '501 Application. Novartis, which later acquired Chiron, and Grifols Worldwide jointly own the '101 Patent.

LEGAL STANDARD

“Judicial ‘construction' of patent claims aims to state the boundaries of the patented subject matter, not to change that which was invented.” Fenner Invs., Ltd. v. Cellco P'ship, 778 F.3d 1320, 1323 (Fed. Cir. 2015). Not all claims require construction, only those in dispute and only to the extent necessary to resolve the dispute. Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).

The Court generally gives claim terms their plain and ordinary meaning as understood by a person of ordinary skill in the art. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). Where the “plain and ordinary meaning of the disputed claim language is clear, ” such as where the term “is comprised of commonly used terms” that have “no special meaning in the art, ” the Court may conclude that no construction is necessary. Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1291 (Fed. Cir. 2015); see also Phillips, 415 F.3d at 1314 (“In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words.”). But to the extent the plain and ordinary meaning does not resolve the parties' dispute or is not apparent, the Court must construe the claim term. O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360-61 (Fed. Cir. 2008).

In considering the disputed claim terms, the Court primarily relies on intrinsic evidence, which “includ[es] the claims themselves, the specification, and the prosecution history of the patent.” Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013). The Court considers a claim term “not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips, 415 F.3d at 1313. The prosecution history, which “consists of the complete record of the proceedings before the [U.S. Patent and Trademark Office] and includes the prior art cited during the examination of the patent, ” can help “inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Id. at 1317. The presumption of ordinary meaning prevails in all but two situations: (1) “when a patentee acts as his own lexicographer” or (2) “when the patentee disavows the full scope of the claim term in the specification or during prosecution.” Poly-Am., L.P. v. API Indus., Inc., 839 F.3d 1131, 1136 (Fed. Cir. 2016).

While the Court must construe claims in light of the specification, it cannot read limitations from the preferred embodiments or specific examples in the specification into the claims. Enercon GmbH v. Int'l Trade Comm'n, 151 F.3d 1376, 1384 (Fed. Cir. 1998). “[P]atent coverage is not necessarily limited to inventions that look like the ones in the figures.” MBO Lab'ys, Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007). Thus, while the Court may use the specification to aid in the interpretation of the claims, it may not use the specification as a source for adding extraneous limitations. Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). But the Court may limit the claims based on the specification “where the specification makes clear at various points that the claimed invention is narrower than the claim language might imply.” Alloc, Inc. v. Int'l Trade Comm'n, 342 F.3d 1361, 1370 (Fed. Cir. 2003).

“In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996). But the Court may in its discretion refer to extrinsic evidence, such as dictionaries, treatises, and expert testimony, to help “educate the court regarding the field of the invention and . . . determine what a person of ordinary skill in the art would understand claim terms to mean.” Phillips, 415 F.3d at 1319; Vitronics, 90 F.3d at 1585 n.6 (“Judges are free to consult such resources at any time in order to better understand the underlying technology and may also rely on dictionary definitions when construing claim terms, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents.”). Extrinsic evidence in general, however, is considered “less reliable than the patent and its prosecution history in determining how to read claim terms, ” SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1195 (Fed. Cir. 2013) (citation omitted), and “may not be used to vary or contradict the claim language” or “the import of other parts of the specification, ” Vitronics, 90 F.3d at 1584.

ANALYSIS

I. “A 20 bp Sequence of a Human Immunodeficiency Virus (HIV) Genome” ('101 Patent, Claim 1) and “A Env Sequence of HIV” ('101 Patent, Claim 3)

The parties' arguments concerning the construction of “a 20 bp sequence of a human immunodeficiency virus (HIV) genome” in claim 1 and “a env sequence of HIV” in claim 3 overlap, and so the Court considers them together. Their dispute centers around whether the claimed HIV genome refers only to that disclosed in Figure 4 of the '101 Patent, Abbott's proposed construction or more broadly encompasses all HIV strains, Defendants' proposed construction. The parties agree that the Court's consideration of the meaning of these terms depends on the understanding a person of ordinary skill in the art would have had in 1984, when Chiron filed the '501 Application. See Phillips, 415 F.3d at 1313 (a claim must be construed with “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application”); E.I. du Pont De Nemours & Co. v. Unifrax I LLC, 921 F.3d 1060, 1069-70 (Fed. Cir. 2019) (intrinsic evidence includes...