Astellas Pharm. v. Ascent Pharm.

1

ASTELLAS PHARMA INC., ASTELLAS IRELAND CO., LTD., and ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC., Plaintiffs, v. ASCENT PHARMACEUTICALS, INC., Defendant.

Civil Action No. 23-486-JFB-CJB

United States District Court, D. Delaware

August 15, 2024

MEMORANDUM AND ORDER

Joseph F. Bataillon Senior United States District Judge

I. INTRODUCTION

This matter is before the Court on parties' motions for claim construction regarding an action for patent infringement of United States Patent No. 10,842,780 (“the '780 Patent”). D.I. 49 and D.I. 50; see D.I. 1; D.I. 12. Defendant, Ascent Pharmaceuticals Inc. (“Ascent”), and Plaintiffs, Astellas Pharma Inc. Astellas Ireland Co., Ltd., and Astellas Pharma Global Development, Inc. (jointly, “Astellas”), have filed a Joint Claim Construction Chart and Appendix, Joint Claim Construction Brief and Appendix, and separate Supplemental Claim Construction Briefs. D.I. 39; D.I. 40; D.I. 45; D.I. 46; D.I. 47; D.I. 63; D.I. 64; D.I. 65; D.I 66. The Court adopts Astellas's proposed claim construction. The Court concludes the disputed terms should be given their plain and ordinary meaning.

II. BACKGROUND

A. Prosecution History

Astellas obtained the ‘780 Patent in November 2020. D.I. 46-1 at 25. It claims a time-release formula for the popular bladder-control drug, Myrbetriq®. D.I. 45 at 8.

Astellas filed the ‘780 Patent application on February 14, 2017. D.I. 46-2 at 6. Claim 6 in the initial application included six polymers and stated, “The pharmaceutical composition for modified release according to Claim 1, wherein the hydrogel-forming polymer is one compound, or two or more compounds selected from the group consisting of polyethylene oxide, hydoxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose sodium, hydroxyethyl cellulose, and a carboxyvinyl polymer.” Id. at 11. Claim 7 likewise claimed, “The pharmaceutical composition for modified release according to Claim 6, wherein the hydrogel-forming polymer is one compound, or two or more compounds selected from the group consisting of polyethylene oxide, hydoxypropyl methylcellulose, and hydroxypropyl cellulose.” Id. at 11-12.

The Patent Examiner (“Examiner”) responded on October 18, 2017, with a restriction and an election requirement. D.I. 46-2 at 18-20, 73-74. First, the Examiner required Astellas to select from three different sets of claims because each set was directed to a different invention under 35 U.S.C. 121. Id. at 20; D.I. 45 at 30. The Examiner restricted Astellas to select one of the following inventions:

I. Claims 1-15 and 19-20, drawn to pharmaceutical compositions for modified release comprising 2 -(2-aminothiazol-4-yl)-4'-[2 -[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, an additive, and a hydrogel forming polymer, classified in CPC A61K 31/381.

II. Claims 16-18, drawn to a method of manufacturing a composition comprising (R)-2-(2-aminothiazol-4-yl)-4'-[2 -[(2-hydroxy -2-phenylethyl)amino]ethyl]acetic acid anilide, an additive, and a hydrogel forming polymer, classified in CPC A61K 31/381.

III. Claims 21-37, drawn to methods of reducing an effect of food intake by administering a composition comprising 2 -(2-aminothiazol-4-yl)-4'-[2 -[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, an additive, and a hydrogel forming polymer, classified in CPC A61K 31/381.

D.I. 46-2 at 20. Next, regardless of the invention selected, the Examiner required Astellas to elect a single disclosed species from the six proposed polymers. Id. at 23-25. The Examiner stated,

Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-20 are generic to at least one species.

D.I. 46-2 at 25-27, 80-82.

On April 16, 2018, Astellas responded to Restriction Requirement in the October 18, 2017, filing. D.I. 46-2 at 30, 86. Astellas selected the Group I invention without traverse, and elected polyethylene oxide as the species of polymer but did so with traverse and for search purposes only. Id. at 40, 96. Astellas's response stated,

In response to the restriction requirement, but without conceding the propriety thereof, Applicants elect Group I, claims 1-15, 19-20, and new claims 38-65 without traverse, and without prejudice to the presentation of the claims of the other Groups in later applications.

In addition, Applicants elect “polyethylene oxide” as the hydrogel-forming polymer formulation and “polyethylene glycol” as the additive that ensure penetration of water into the pharmaceutical composition with traverse and for search purposes only.

As the Examiner is aware, restriction is discretionary, and a restriction requirement is made only to avoid placing an undue examination burden on the Examiner and the Patent Office. Here, there is no undue burden to examine all the claims as there is no evidence of record that the searches are of different classes, subclasses or fields. Further, Applicants note that these species were elected in the parent application and have already been examined by Office. Thus, where claims can be examined together without undue burden, the Examiner must examine the claims on the merits, even if they are directed to independent and distinct inventions. M.P.E.P. § 803.

D.I. 46-2 at 40, 96. Astellas amended Claim 6 but did not remove the six polymers. Id.at 32, 88. Astellas also amended Claim 7 to but did not remove the refence to Claim 6 or the listed polymers. Id.

The Examiner performed the first prior art search in August and September 2018. D.I. 40-2 at 185-90. The Examiner's search notes show the Examiner limited the first prior art search to the elected species “polyethylene oxide.” Id.

On November 19, 2018, the Examiner acknowledged the elections made by Astellas in the April 16 filing. D.I. 40-2 at 99-123. The Examiner stated, “Applicant's election without traverse of Group I (Claims 1-15, 19-20, 38-65), as well as polyethylene oxide as the species of hydrogel forming polymer and polyethylene glycol as the species of additive in the reply filed on April 16, 2018[,] is acknowledged.” Id. at 102. The Examiner analyzed the prior art and the claimed invention with the elected species of polyethylene oxide, and stated Claims 1-3, 6-7, and 47 to be unpatentable over prior art. Id. at 108-19. The Examiner further rejected dependent Claims 4-5, 19, 20, 38-41, 4245, 46, 48-55, 56-60, and 61-65 because they were unpatentable over prior art. Id. at 119-20. The Examiner concluded that no claims were allowed. Id. at 122.

On May 13, 2019, Astellas filed an Amendment, Petition for Extension of Time, and Statement of the Substance of the Interview. D.I. 64 at 150. Astellas amended Claims 1-4, 6, 46, and 61; cancelled Claims 16-18, 21-41, 43-45, 47-60, and 62-65; and added new Claims 66 and 67. D.I. 46-2 at 42-46, 128. Astellas again amended Claim 6 but did not remove the six polymers. Id. at 43. Astellas did not amend Claim 7. Id.

On December 26, 2019, the Patent Office reassigned the application to a new Examiner, who “acknowledged and entered” the “Applicant's amendments filed May 13, 2019.” D.I. 46-2 at 128. The new Examiner additionally stated,

Applicant's election without traverse of Group I (Claims 1-15, 19-20, 38-65), as well as polyethylene oxide as the species of hydrogel forming polymer and polyethylene glycol as the species of additive in the reply filed on April 16, 2018[,] is acknowledged. Claims 8-15 stand withdrawn for the reasons set forth in the Office Action dated October 18, 2017.

D.I. 46-2 at 128. The Examiner maintained and reiterated the rejection of claims under 35 U.S.C. § 103 as being unpatentable over prior art. Id. at 138-39. The Examiner concluded that “no claims are allowed in this application” and “Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, this action is made final. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).” D.I. 46-2 at 156-57 (citation omitted).

On February 18, 2020, Astellas filed an amendment under 37 C.F.R. § 1.116 in response to the December 26, 2019, letter. D.I. 46-2 at 47. Astellas did not amend Claims 6 and 7. Id. at 49.

On March 2, 2020, the Examiner filed an advisory action in response to Astellas's amendments in the February 18 filing. D.I. 46-2 at 191, 290. The Examiner did not enter the proposed amendments and stated the amendment “removing the phrase ‘an additive that ensures penetration of water' would overcome the 112, 2nd paragraph rejection of record; however, by removing this requirement, the instant claims would encompass a number of compositions comprising only mirabegron and a hydrogel-forming polymer.” Id. at 193, 292.

On March 10, 2020, Astellas had a phone interview with the Examiner. D.I. 40-2 at 193-94. On March 16, 2020, Astellas filed a submission under 37 C.F.R. § 1.114 and statement of the substance of the interview in response to the December 26 filing, and further to Astellas's amendments in the February 18 filing. D.I. 46-2 at 53. Again, Astellas did not amend Claims 6 and 7. Id. at 55.

On June 26, 2020, Astellas filed a Preliminary Amendment. D.I. 46-2 at 59. Astellas amended Claim 1 by adding the six polymers recited in Claim 6 to Claim 1, and cancelled Claim 6. Id. at 60-61. Astellas amended Claim 7 to reference the newly amended Claim 1 but did not remove the listed polymers. Id. at 61. Claim 7 became Claim 5 in the final patent. Id. at 66. Astellas's remarks state, “claims 1 and 69 being independent” and “Claims 2 and 6 have been cancelled without prejudice or disclaimer and their...