Amgen Inc. v. Aurobindo Pharma Ltd.

          MEMORANDUM

          MITCHELL S. GOLDBERG, J.

         Pending before me are several evidentiary issues raised by the parties in connection with a patent infringement trial commencing on March 5, 2018. (D.I. 294-1, Ex. 8 & Ex. 8.1). I will address two of these evidentiary issues below.

         I. CLAIM CONSTRUCTION

         In the Proposed Joint Pretrial Order, Plaintiff Amgen, Inc. (“Amgen”) argues that the Markush groups in the binder and disintegrant limitations should be “open sets.” (D.I. 294-1, Ex. 8 at ¶ 2(b)). Amgen also urges that Defendants should be precluded from raising any claim construction issues, and that the time to raise this issue was at the Markman hearing. Id at ¶ 2. Conversely, Defendants urge that the Markush groups are “closed.” (D.I. 294-1, Ex. 7.1 at p. 318-19, ¶¶ 32-33).

         Claim construction is a “fluid process, ” Cadence Pharma., Inc. v. Innopharma Licensing LLC, 2016 WL 3661751, at *3 n.2 (D. Del. July 8, 2016), and that process is “not final until judgment is entered, ” Eaton Corp. v. Parker-Hannifin Corp., 292 F.Supp.2d 555, 572 n.2 (D. Del. 2003). Until then, “[t]he court may re-construe the claims if it finds the original claim construction to be in error based upon a more developed record, ” and/or “may add claim constructions for terms that become disputed through the course of trial.” Eaton Corp., 292 F.Supp.2d at 572 n.2.

         Here, the claim construction issues Defendants now raise appear to have developed after the Markman hearing. Because these issues will substantially effect how the parties present their theories of infringement or non-infringement at trial, I will resolve this dispute now.

         Independent claims 1 and 20 of United States Patent No. 9, 375, 405 (“the '405 patent”) contain three Markush groups defining the list of excipients permitted for use as diluents, binders, and disintegrants. (D.I. 294-1, Ex. 7.1 at p. 36, ¶ 21).

         Claim 1 states:

(1) A pharmaceutical composition comprising:

(a) from about 10% to about 40% by weight of cinacalcet HCl in an amount of from about 20 mg to about 100 mg;

(b) from about 45% to about 85% by weight of a diluent selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof;

(c) from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and

(d) from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovidine (sic), sodium starch glycolate, croscarmellose sodium, and mixtures thereof, wherein the percentage by weight is relative to the total weight of the composition, and wherein the composition is for the treatment of at least one of ...