Abbott Laboratories v. Grifols Diagnostic Solutions Inc.

693 F.Supp.3d 911

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

Signed September 20, 2023

Gregg F. Locascio, Pro Hac Vice, Michael Arthur Pearson, Jr., Pro Hac Vice, Nichole DeJulio, Pro Hac Vice, Noah S. Frank, Pro Hac Vice, Kirkland & Ellis LLP, Washington, DC, Bryan Scott Hales, Kirkland & Ellis LLP, Chicago, IL, for Plaintiff/Counter-Defendant.

Adam Robert Brausa, Bethany D. Bengfort, Pro Hac Vice, Morrison & Foerster LLP, San Francisco, CA, Alexandra Cho, Pro Hac Vice, David K. Barr, Pro Hac Vice, Stroock & Stroock & LaVan LLP, New York, NY, Devon Curtis Beane, Jeffrey R. Gargano, Katherine Louise Allor, Melissa Haulcomb, K&L Gates LLP, Chicago, IL, Louis Cullman, Pro Hac Vice, K&L Gates LLP, Irvine, CA, for Defendants/Counter-Plaintiffs Grifols Diagnostic Solutions Inc., Grifols Worldwide Operations Limited.

Adam Robert Brausa, Morrison & Foerster LLP, San Francisco, CA, Alexandra Cho, Pro Hac Vice, David K. Barr, Pro Hac Vice, Stroock & Stroock & LaVan LLP, New York, NY, Devon Curtis Beane, Jeffrey R. Gargano, Katherine Louise Allor, Melissa Haulcomb, K&L Gates LLP, Chicago, IL, Louis Cullman, Pro Hac Vice, K&L Gates LLP, Irvine, CA, for Defendant/Counter-Plaintiff Novartis Vaccines and Diagnostics, Inc.

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. In response, Defendants filed a counterclaim asserting that Abbott infringes the '101 Patent.¹ The parties have now filed motions for summary judgment.²

Because the asserted claims are not directed to a patent-ineligible natural phenomenon, the Court enters judgment for Defendants on Abbott's claim for declaratory judgment of invalidity under 35 U.S.C. § 101 and Abbott's patent ineligibility defense. But the Court finds that claims 1, 3, 7, and 10 of the '101 Patent are invalid for lack of a written description and as anticipated under § 102, leaving only claims 9 and 17 pending. Claims 9 and 17 are not invalid on the basis of obviousness-type double patenting. But Abbott's rpGO-11CKS, rpGO-9CK, HIV-1 rpCKS41, and rp41 HLH-M antigens do not infringe claims 9 and 17 under the doctrine of equivalents. To the extent that Defendants establish infringement of claims 9 and 17 based on Abbott's other products, they can only recover for those accused products that incorporate accused manufacturing steps performed in the United States after November 2, 2019. Finally, the question of Abbott's willfulness in any infringement remains for the jury.

BACKGROUND³

I. Overview of the '101 Patent and the Asserted Claims

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 provides a method for replicating HIV DNA. According to the '101 Patent, "the production of recombinant HIV proteins was not possible prior to the present invention." '101 Pat. at 2:30-31. The '101 Patent issued on April 17, 2007 and expires on April 17, 2024.

Defendants have accused Abbott of infringing claims 1, 3, 7, 9, 10, and 17 of the '101 Patent. Independent claim 1 recites:

A method for replicating DNA specific for HIV, which comprises:

(a) providing a DNA construct comprising an origin of replication recognized by a unicellular microorganism and a DNA sequence comprising at least a 20 bp sequence of a human immunodeficiency virus (HIV) genome; and

(b) growing a unicellular microorganism containing said DNA construct under conditions whereby said DNA sequence is replicated.

Id. at 75:57-66. Claims 3, 7, 9, and 10 depend from claim 1 and provide as follows:

3. The method according to claim 1 wherein the DNA construct contains a env sequence of HIV.

7. The method of claim 1, 2 or 3 wherein the unicellular microorganism is a yeast cell.

9. The method of claim 1, 2, or 3 wherein the HIV sequence is an env sequence of FIG. 4.

10. The method of claim 1, 2, or 3 wherein the HIV sequence is at least 45 base pairs long.

Id. at 76:34, 13-14, 17-20. Independent claim 17 recites:

A method for replicating DNA specific for HIV, which comprises:

(a) providing a DNA construct comprising an origin of replication recognized by a unicellular microorganism and a DNA sequence comprising at least a 20 base-pair sequence of a human immunodeficiency virus (HIV) env sequence as show in FIG. 4; and

(b) growing a unicellular microorganism containing the DNA construct under conditions whereby the DNA sequence is replicated.

Id. at 76:51-60.The Court held a Markman hearing on February 25, 2022 and issued its claim construction order on April 27, 2022. The Court construed the disputed terms of the '101 Patent as follows:

              Claim Term                                     Construction
  "a 20 bp sequence of a human                    "a 20 base pair sequence of human
  immunodeficiency virus (HIV) genome"            immunodeficiency virus (HIV) genome"
  ('101 Patent, claim 1)
  "a env sequence of HIV"                         "a env sequence of HIV"
  ('101 Patent, claim 3)
  "A method for replicating DNA specific for      Preamble is limiting
  HIV"
  ('101 Patent, claims 1 and 17)
  "DNA construct"                                 "a chimeric, human-made genetic structure
                                                  that does not exist in nature"
  ('101 Patent, claims 1, 3, and 17)
  "unicellular microorganism"                     Plain and ordinary meaning
  ('101 Patent, claims 1, 7, and 17)

Doc. 113 at 14.

II. Priority Applications

Application No. 08/442,748 (the "'748 Application"), which was filed on May 17, 1995, led to the '101 Patent. The '748 Application is a divisional application of Application No. 08/089,407 (the "'407 Application"), which was filed on July 8, 1993, and issued as U.S. Patent No. 7,273,695 on September 25, 2007. The '407 Application itself is a continuation of Application No. 07/931,154 (the "'154 Application"), which was filed on August 17, 1992, but later abandoned. The '154 Application is a continuation of Application No. 07/138,894 (the "'894 Application"), filed on December 24, 1987. The '894 Application issued on October 20, 1992, as U.S. Patent No. 5,156,949 (the "'949 Patent"). The '894 Application is a continuation-in-part of Application No. 06/773,447 (the "'447 Application"), which was filed on September 6, 1985, but later abandoned. The '447 Application is a continuation-in-part of Application No. 06/696,534 (the "'534 Application"), which was filed on January 30, 1985, and also later abandoned. The '534 Application is a continuation-in-part of Application No. 06/667,501 (the "'501 Application"), which was filed on October 31, 1984, and also later abandoned.

The '101 Patent claims priority to the '501 Application, the '534 Application, the '447 Application, the '894 Application, the '154 Application, and the '407 Application. Dr. Paul Luciw and Dr. Dino Dina, the named inventors of the '101 Patent, are the named inventors on all of these applications.

III. The '501 Application

The '501 Application described methods for preparing target HIV DNA, making a DNA construct comprising the HIV DNA, and growing a unicellular microorganism containing the DNA construct such that the HIV DNA is replicated. The '501 Application disclosed "a substantially complete sequence of ARV-2, indicating the amino acid sequences for the open reading frames for the individual genes" in Figure 4. Doc. 144 ¶ 10.

During prosecution of the patent family to which the '101 Patent belongs, the applicants stated that at the time of the '501 Application's filing, "the art clearly possessed all of the knowledge and skill required to make the claimed DNA sequences, constructs, cells, and polypeptides except for the 'novel aspects of [the] invention;' i.e., a coding sequence of an HIV gag polypeptide," which the '501 specification provided. Id. ¶ 47. Dr. Dina and Dr. Luciw similarly acknowledged that, prior to their invention, vectors used to clone HIV DNA, including the vector that they used, were known in the field. Dr. Luciw also acknowledged that most of the replication systems and bacterial hosts identified in the '101 Patent were known in the field before the filing of the '501 Application, as was molecular cloning from a bacterial host. Other patent applications from the same family explicitly acknowledged this, stating that "[c]loning and expression in bacteria was a routine matter in October 1984," Doc. 136 ¶ 20, and that "[b]efore October 31, 1984, scientists of ordinary skill routinely expressed heterologous genes whose sequence was known in a wide variety of expression systems, including bacteria, plants, yeast, insect cells, and mammalian cells," id. ¶ 21. And in prior litigation against Abbott in 1995, Grifols' predecessor, Chiron Corporation, admitted that at the time the '501 Application was filed, "the state of the art permitted ordinarily skilled scientists to routinely produce recombinant protein fragments of any desired length, and test them for immunoreactivity." Id. ¶ 22. Dr. Warner Greene, Defendants' technical expert, admitted that E. coli was a common bacterium used for cloning in the early 1980s, that cloning with an origin of replication was well known before 1984, and that it was typical in 1984 to clone the segments of a virus using a bacterial cell....