Third Party Subpoenas Ad Testificandum v. Nexus Pharmaceuticals, Inc.

District Court, District of Columbia·Decided April 21, 2023·No. Misc. No. 2023-0008·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

)

CHIDAMBARAM S. IYER, ESQ., )

) Case No. 23-mc-8 (CKK/GMH)

Petitioner, )

)

v. ) Ingenus Pharms., LLC v. Nexus ) Pharms, Inc., Case No. 22-cv-2868 NEXUS PHARMACEUTICALS, INC., ) (Related case pending in the U.S.

) District Court for the Northern Respondent. ) District of Illinois)

____________________________________)

MEMORANDUM OPINION AND ORDER Petitioner Chidambaram S. Iyer, a lawyer who helped to prosecute a patent for a chemotherapy drug that is the subject of an infringement action in the Northern District of Illinois styled Ingenus Pharmaceuticals, LLC v. Nexus Pharmaceuticals, Inc. (“Ingenus”), has moved to quash a deposition subpoena issued to him by the defendant in that matter, Nexus Pharmaceuticals, Inc. (“Nexus”), on the basis that he now serves as trial counsel for the patent owner in the infringement case. ECF No. 1. Nexus asks the Court to transfer the motion to quash to the Northern District of Illinois for resolution or, in the alternative, to deny the motion to quash and compel the deposition. ECF No. 4. For the reasons that follow, Nexus’ request to transfer the motion to quash is granted.

I. BACKGROUND

A. Prosecution of the ’952 Patent and FDA Applications The plaintiffs in the underlying Ingenus case—Ingenus Pharmaceuticals, LLC (“Ingenus”)

and Leiutis Pharmaceuticals, LLP (Leiutis”)— are owners and assignees of a patent (known as the ’952 patent) “relat[ing] to stable ready to use, liquid parenteral formulations of Cyclophosphamide solution for intravenous use in the treatment of various cancers and process and preparation

thereof.” Exh. to Complaint at 2, Ingenus, No. 22-cv-2868 (N.D. Ill. June 1, 2022) (the ’952 patent document), ECF No. 1-1; see Complaint at 5, Ingenus, No. 22-cv-2868 (N.D. Ill. June 1, 2022), ECF No. 1. Chandrashekhar Kocherlakota and Nagaraju Banda, the inventors of what became the ’952 patent, applied for patent protection in August 2017. ECF No. 1-10 at 424. The application went through a number of iterations over the course of the next approximately three-and-one-half years until the U.S. Patent and Trademark Office (“PTO”) issued the patent in May 2021. See ECF No. 1-10 at 34; see also Exh. to Complaint, Ingenus Pharm., No. 22-cv-2868, ECF No. 1-1. Two individuals helped shepherd the application through its prosecution, including participating in six interviews with the patent examiner to explain why the patent was non-obvious—Adolph Bohnstedt, a non-attorney patent agent who took part in four interviews between October 2019 and September 2020; and Iyer, a patent attorney who replaced Bohnstedt in December 2020 and participated in the remaining two interviews in January and March 2021, soon after which the examiner provided notice that the patent would be allowed. See ECF No. 1-10 at 2–3 (noting the acceptance of a power of attorney filed on Dec. 11, 2020), 15–26 (Notice of Allowance dated March 29, 2021, and related documents); 27–28 (summary of Mar. 22, 2021 interview between patent examiner and Iyer); 96–98 (summary of Jan. 5, 2021 interview between patent examiner and Iyer); 118–19 (summary of Sept. 8, 2020 interview between patent examiner and Bohnstedt); 165–67 (summary of Apr. 6, 2020 interview between patent examiner and Bohnstedt); 201-02 (summary of Dec. 19, 2019 interview between patent examiner and Bohnstedt); 210–12 (summary of Oct. 4, 2019 interview between patent examiner and Bohnstedt); see also ECF No. 1-2 at 7. In connection with those interviews, Bohnstedt and Iyer submitted to the PTO a number of affidavits from inventors Kocherlakota and Banda. See ECF No. 1-10 at 77–81 (declaration of Kocherlakota dated Jan. 14, 2021); 139–43 (declaration of Banda dated Apr. 8, 2020); 144–48 (declaration of

Kocherlakota dated Apr. 8, 2020); 223–30 (declaration of Banda dated Oct. 1, 2019); 231–38 (declaration of Kocherlakota dated Oct. 1, 2019).

The patent examiner ultimately found that the invention now protected by the ’952 patent had better stability compared to the formulations in the prior art and that the stability was “unexpected.” 1 ECF No, 1-10 at 25. Consequently, the patent’s four remaining claims were allowed and the patent issued in May 2021. See ECF No. 1-10 at 19–26; see also Exh. to Complaint at 1, 5, Ingenus, No. 22-cv-2868.

Prior to issuance of the ’952 patent, Ingenus and Leiutis filed a New Drug Application (“NDA”) for its injectable cyclophosphamide solution for use in cancer treatment, which was approved by the Food and Drug Administration (“FDA”) in July 2021; an NDA regarding a supplemental dosage was approved in November 2021. Complaint at 4–5, Ingenus, No. 22-cv- 2868. Later, in December 2021, Nexus filed an Abbreviated New Drug Application (“ANDA”) to obtain approval for the manufacture, use, or sale of purported generic versions of the Ingenus product prior to the expiration of the ’952 patent. 2 Id. at 6; see also ECF No. 5 at 24. The ANDA included a so-called “paragraph IV certification” that the ’952 patent is invalid or will not be

11 An invention is not patentable “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. “Unexpected results” can be “probative of nonobviousness.” Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 739 (Fed. Cir. 2013). 2 The Food, Drug, and Cosmetic Act requires a company that seeks to market a new brand-name drug to submit an NDA that includes “among other things, evidence of the drugs’ safety and effectiveness, as well as information about patents that cover or might cover the drugs.” Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 879 (D.C. Cir. 2004). The so-called “Hatch-Waxman” amendments to that statute allow companies seeking to sell generic versions of approved brand-name drugs to submit ANDAs “that ‘piggyback’ on the safety-and-effectiveness information that the brand-name manufacturers submitted in their NDAs.” Id. To address the patents that cover or might cover the generic drugs, companies can “include[e] in their ANDAs one of several ‘certifications’ that explain why the FDA should approve the application despite the patent’s claim on the drug.” Id. Among these is a certification that the patent is invalid or will not be infringed by the new drug. Id. Once an ANDA applicant provides notice to a patent holder of its application, the FDA must wait 45 days before approving the ANDA, “thereby giving the patent holder that much time to file a patent-infringement suit.” Id.

infringed by the new drug. See Complaint at 6, Ingenus, No. 22-cv-2868; see also Purepac Pharm., 354 F.3d at 879 (“[A] ‘paragraph IV certification,’ named for the subsection of the law that describes it[,] states ‘that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug.’” (quoting 35 U.S.C. § 355(j)(2)(A)(vii)(IV)). In light of Nexus’ ANDA and paragraph IV certification, Ingenus and Leiutis filed their patent infringement suit in the Northern District of Illinois in June 2022, which was assigned to District Judge Mary M. Rowland. Complaint, Ingenus, No. 21-cv-2868.

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Third Party Subpoenas Ad Testificandum v. Nexus Pharmaceuticals, Inc., (D.D.C. 2023).

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