Immunogen, Inc. v. Iancu

523 F.Supp.3d 773

IMMUNOGEN, INC., Plaintiff,

v.Andrei IANCU, Defendant.

Case No. 1:20-cv-274

United States District Court, E.D. Virginia, Alexandria Division.

Signed March 4, 2021

Craig Crandall Reilly, Law Office of Craig C. Reilly, Alexandria, VA, John Christopher Rozendaal, Sterne, Kessler, Goldstein & Fox PLLC, Washington, DC, for Plaintiff.

Matthew J. Mezger, Dennis Carl Barghaan, Jr., United States Attorney's Office, Alexandria, VA, for Defendant.

MEMORANDUM OPINION

T. S. Ellis, III, United States District Judge Plaintiff ImmnuoGen, Inc. brought this 35 U.S.C. § 145 action following the Patent Trial and Appeal Board's ("PTAB") decision affirming an examiner's rejection of all pending claims in plaintiff's U.S. Patent Application Serial No. ’14/509,809 (the "’809 Application"). In the ‘809 Application, plaintiff seeks to patent a dosing method for treating patients with certain ovarian or peritoneal cancers using a class of antibody-drug conjugates that include IMGN853 at a dose of 6 milligrams per kilogram of adjusted ideal body weight ("AIBW"). A patent examiner and the PTAB rejected all of plaintiff's claims in the ’809 Application on two grounds: (i) that the ‘809 Application is unpatentable under 35 U.S.C. § 103 ; and (ii) that the ‘809 Application is unpatentable under the doctrine of obviousness-type double patenting.¹

Following the PTAB's rejection of the ‘809 Application, plaintiff filed this § 145 action contesting the PTAB's ruling and, as the law allows, provided expert reports as part of discovery in this litigation. Also, as the law allows, Defendant Andrei Iancu's² answer raised the additional ground for the rejection of the ‘809 Application – a ground not previously relied upon by the PTAB – that the ‘809 Application is unpatentable because its claims are fatally indefinite. See 35 U.S.C. § 112.

At issue now, on defendant's motion for summary judgment are the following issues: (i) whether ‘809 Application's claims are fatally indefinite under 35 U.S.C. § 112(b) ; (ii) whether ‘809 Application's claims are obvious such that they are unpatentable under 35 U.S.C. § 103 ; and (iii) whether ‘809 Application's claims are unpatentable under the obviousness-type double patenting doctrine. See Abbvie , 764 F.3d at 1372. The parties have fully briefed these issues and oral argument on the motion was heard telephonically on January 5, 2021, focusing chiefly on the indefiniteness issue. Because defendant's motion has been fully briefed and argued orally, it is now ripe for disposition. For the reasons that follow, defendant's motion for summary judgment must be granted.

I.

Summary judgment is appropriate only where there are no genuine disputes of material fact. See Rule 56, Fed. R. Civ. P. To this end, defendant, pursuant to Rule 56 and Local Rule 56, set forth a statement of material facts that defendant contends are undisputed. Plaintiff then, as required by Rule 56 and Local Rule 56, responded to defendant's statement of material facts and supporting any alleged disputes of fact with admissible evidence. Plaintiff also set forth a set of "Disputed Material Facts Precluding Summary Judgment." Neither the Federal Rules nor the Local Rules invite, permit, or forbid plaintiff, or any nonmovant, from setting forth the nonmovant's enumeration of disputed facts.³ In this case, plaintiff's inclusion of plaintiff's alleged Disputed Statement of Facts does not alter the focus of the summary judgment analysis, which remains the movant's statement of undisputed facts and the nonmovant's response to those facts, for it is from this statement of undisputed facts and the nonmovant's response that a district court determines whether genuine issues of fact are disputed.

Accordingly, the following statement of facts is derived from a careful review of defendant's statement of undisputed facts, the nonmovant's response, and the record.

1. Plaintiff is the assignee of the ‘809 Application, which claims the benefit of the filing date of a provisional application filed on October 8, 2013.

2. As the parties agree, the ’809 Application concerns methods of treating patients having ovarian cancer or cancers of the peritoneum that express folate receptor 1 ("FOLR1") with a specific type of immunoconjugate.

3. More specifically, the ‘809 Application claims methods of treating a patient with FOLR1-expressing ovarian cancer or cancer of the peritoneum by administering an immunoconjugate that comprises an antibody or antibody fragment that binds to FOLR1, a chemical linker, and a maytansinoid⁴ drug.

4. Each of the independent claims of the ’809 Application in this litigation also requires administering immunoconjugate to the patient "at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient."

5. An immunoconjugate is a composition containing an antibody or the antigen-binding portion of an antibody coupled to a drug by a chemical linker. Immunoconjugates are designed to bind to a cell or cells of interest and to deliver a drug payload to that specific cell or cells. Immunoconjugates are also known as antibody-drug-conjugates, or sometimes as "ADCs."

6. Specifically, independent claims 1, 317, and 341 of the ‘809 Application read as follows:

a. 1. A method for treating a human patient having an FOLR1-expressing cancer or cancer of the peritoneum comprising administering to the patient an immunoconjugate which binds to FOLR1 polypetide,

Wherein the immunoconjugate comprises an antibody or antigen-binding fragment thereof that comprises the variable light chain (VL) complementarity determining region (CDR)-1, VH CDR-2, VL CDR-3, variable heavy chain (VH) CDR-1, VH CDR-2, and VH CDR-3 of SEQ. ID Nos.: 6-9, 11, and 12, respectively, and a maytansinoid, and

Wherein the immunoconjugate is administered at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.

b. 317. A method for treating a human patient having an FOLR1-expressing ovarian cancer comprising administering intravenously to the patient an immunoconjugate at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient

Wherein the immunoconjugate comprises DM4 and an antibody comprising (i) a heavy chain comprising the same amino acid sequence as the amino acid sequence of the heavy chain encoded by the plasmid deposited with the American Type Culture Collection (ATCC) as PTA-10772 and (ii) a light chain comprising the same amino acid sequence as the amino acid sequence of the light chain encoded by the plasmid deposited with the ATCC as PTA-10774, and

Wherein the DM4 is linked to the antibody by sulfo-SPDB.

c. 341. A method for treating a human patient having an FOLR1-expressing cancer of the peritoneum comprising administering intravenously to the patient an immunoconjugate at a dose of 6 milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient

Wherein the immunoconjugate comprises DM4 and an antibody comprising (i) a heavy chain comprising the same amino acid sequence as the amino acid sequence of the heavy chain encoded by the plasmid deposited with the American Type Culture Collection (ATCC) as PTA-10772 and (ii) a light chain comprising the same amino acid sequence as the amino acid sequence of the light chain encoded by the plasmid deposited with the ATCC as PTA-10774, and

Wherein the DM4 is linked to the antibody by sulfo-SPDB.

7. Claims 1, 317, and 341 are "independent" claims, while the remaining claims are "dependent" because they incorporate by reference all of the limitations recited in their respective independent claims. These dependent claims differ from the independent claims in that they recite a specific route of administration, a specific frequency of administration, a specific cancer to be treated, a specific linker, a specific maytansinoid, or a specific antibody or antibody fragment.

8. IMGN853 is an embodiment of the recited immunoconjugates.

9. In the "Definitions" section of the ’809 Application, the term "ideal body weight" or "IBW" is defined as

"an estimate of weight corrected for sex and height, and optionally frame size."

10. In the same definition, it is explained that

"IBW can be calculated, for example, using the formulas IBW = 0.9H-88 (for males) and IBW = .9H-92 (for females), wherein H = height in cm."

11. Also, in the "Definitions" section of the ’809 Application, the term "adjusted ideal body weight" (AIBW) or "adjusted body weight" (ADJ) refers to

"a size descriptor that accounts for sex, total body weight, and height."

12. In the same definition, it is explained that

"AIBW (ADJ) can be calculated, for example, using the formula ADJ = IBW + 0.4(weight in kg – IBW)."

13. Later, the ’809 Application includes a list of examples. The examples are prefaced with the explanation that "[i]t is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application."

14. In Example 4 of the ‘809 Application, IBW is defined as follows

a. IBW (male) = 0.9H-88

b. IBW (female) = 0.9H-92

15. Similarly, Example 4 of the ‘809 Application defines AIBW is defined as follows

a. AIBW = IBW + 0.4(Actual weight in kg – IBW).

16. The ’809 Application recognizes, as plaintiff admits, that "IMGN853 has previously been described in International Published Application Nos. WO 2011/106528 ["Ab ’528"], WO 2012/135675 ["Carrigan ’675"], and WO 2012/138749, and U.S. Published Application Nos. 2012/0009181 ["Ab ’181"], 2012/0282175 ["Carrigan ’175"], and 2012/0282282 ["Lutz ’282"].

17. The PTAB rejected claims 1, 230, 237, 238, 242, 252-255, 258-266, 300, 317-325, 329, 330, 341-349, and 354 of the ‘809 Application as obvious under 35 U.S.C. § 103 over the combined teachings of Lutz ’282, Ab ’528, Ab ’181, Armstrong et al., European Journal of

...