On April 09, 2021, Purdue Pharma L.P., Purdue Pharmaceuticals L.P., and Rhodes Technologies (collectively, “Purdue'' or “Plaintiffs”), represented by Christopher M. Morrison of Jones Day (Boston), filed an intellectual property lawsuit against Collegium Pharmaceutical, Inc. (“Collegium” or “Defendant”), seeking a judgement, permanent enjoinment and damages for allegedly unlawfully infringing the process for preparing oxycodone compositions. This case was filed in the U.S. District Court for the District of Massachusetts with Judge F. Dennis Saylor, IV presiding.
The Plaintiff has claimed that “Purdue is the lawful owner of all right, title, and interest in the ’434 patent, entitled “process for preparing oxycodone compositions,” including all right to sue and to recover for past infringement thereof, which patent is listed in the FDA’s Orange Book as covering the drug OxyContin, which is the subject of approved NDA No. 022272. The ’434 patent was duly and legally issued on September 10, 2019, naming Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert Kupper as the inventors.”
In their complaint, the Plaintiffs alleged that, “Defendant has infringed the ’434 patent. The ’434 patent is listed in the FDA Approved Drug Products with Therapeutic Equivalence. Evaluations (“Orange Book”) as covering Purdue’s OxyContin® (oxycodone hydrochloride) (“OxyContin”), an extended-release pain medication. Collegium has infringed the ’434 patent under 35 U.S.C. § 271(e)(2)(A) by filing the Collegium NDA on the Collegium NDA Products and under 35 U.S.C. §§ 271(a), (b), (c), and (g) by actual marketing of the Collegium NDA Products. Upon information and belief, Collegium submitted Collegium’s NDA to the FDA under § 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2)), seeking approval to engage in the commercial manufacture, use, sale, offer for sale, or importation of the Collegium NDA Products. On or about April 26, 2016, the FDA issued its final approval of Collegium’s NDA based on Collegium’s filings as of that date. On June 20, 2016, Collegium issued a press release announcing the commercial launch of the Collegium NDA Products.”
The Plaintiffs further alleged that, “Collegium has begun commercial manufacture of the Collegium NDA Products, has begun offering for sale and selling the Collegium NDA Products, and continues to manufacture (or have manufactured), offer for sale, sell, and distribute the Collegium NDA Products, including in this district. After having already begun marketing the Collegium NDA Products, on or about October 4, 2016, Collegium filed a supplemental application relating to Collegium’s NDA (“Collegium’s sNDA”). On or about November 6, 2017, the FDA issued its final approval of Collegium’s sNDA. On information and belief, Collegium has marketed the Collegium NDA Products according to Collegium’s sNDA”.
There are two claims for relief laid down by the Plaintiffs. The first claim is that Collegium’s filing of its NDA constitutes an alleged infringement of the ’434 Patent. The second claim is that Collegium’s marketing of the Collegium NDA products allegedly infringes, and has infringed, the’434 Patent.
In their prayer for relief, the Plaintiffs have requested the court to adjudge that Collegium has infringed, and that Collegium’s commercial sale, offer for sale, use, manufacture, and/or importation of the Collegium NDA Products has infringed, induced infringement of, and/or contributed to the infringement of the ’434 patent, preliminarily and permanently enjoining, pursuant to 35 U.S.C. §§ 271(e)(4)(B) and 283 and Rule 65, Fed. R. Civ. P, and awarding, pursuant to 35 U.S.C. §§ 271(e)(4)(C) and 284, damages to Purdue.
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1:21-CV-10598
04/09/2021
Pending - Other Pending
Intellectual Property - Patent
F. Dennis Saylor, IV
PURDUE PHARMA, LP
Rhodes Technologies
Purdue Pharmaceuticals L.P.
Collegium Pharmaceutical, Inc.
Christopher M. Morrison
Attorney at Jones Day (Bos)
100 High Street, 21St Flr.
Boston, MA 02110
Jacob M. Holdreith
Attorney at Robins, Kaplan LLP
2800 Lasalle Plaza, 800 Lasalle Avenue
Minneapolis, MN 55402
Ellen K. Levish
Attorney at Robins Kaplan, LLP
800 Lasalle Avenue, Suite 2800, 2800 Lasalle Plaza
Minneapolis, MN 55402
Oren D. Langer
Attorney at Robins Kaplan LLP
601 Lexington Avenue, Suite 3400
New York, NY 10022
Emily J. Tremblay
Attorney at Robins Kaplan, LLP
800 Lasalle Avenue, Suite 2800, 2800 Lasalle Plaza
Minneapolis, MN 55402
Christopher A. Pinahs
Attorney at Robins Kaplan LLP
800 Lasalle Avenue, 2800 Lasalle Plaza
Minneapolis, MN 55402
Kelsey J McElveen
Attorney at Robins Kaplan, LLP
Christopher P. Sullivan
Attorney at Robins, Kaplan, Miller & Ciresi L.L.P.
800 Boylston Street, 25Th Floor
Boston, MA 02199-8001
Affidavit Certificate of Oren Langer
Affidavit Certificate of Kelsey McElveen
Affidavit Certificate of Jacob Holdreith
Affidavit Certificate of Emily Tremblay
Affidavit Certificate of Ellen Levish
Affidavit Certificate of Christopher Pinahs
Category Form
Exhibit Scheduling Order
Docket(#13) Chief Judge F. Dennis Saylor, IV: ELECTRONIC ORDER entered ALLOWING #12 Motion for Leave to Appear Pro Hac Vice Added Christopher A. Pinahs, Ellen K. Levish, Emily J. Tremblay, Jacob M. Holdreith, Kelsey J. McElveen and Oren D. Langer. Attorneys admitted Pro Hac Vice must register for electronic filing if the attorney does not already have an ECF account in this district. To register go to the Court website at www.mad.uscourts.gov. Select Case Information, then Electronic Filing (CM/ECF) and go to the CM/ECF Registration Form. (Vieira, Leonardo) (Entered: 05/12/2021)
[-] Read LessDocket(#12) MOTION for Leave to Appear Pro Hac Vice for admission of Christopher Pinahs, Ellen Levish, Emily Tremblay, Jacob Holdreith, Kelsey McElveen, Oren Langer Filing fee: $ 600, receipt number 0101-8769362 by Collegium Pharmaceutical, Inc.. (Attachments: #1 Affidavit Certificate of Christopher Pinahs, #2 Affidavit Certificate of Ellen Levish, #3 Affidavit Certificate of Emily Tremblay, #4 Affidavit Certificate of Jacob Holdreith, #5 Affidavit Certificate of Kelsey McElveen, #6 Affidavit Certificate of Oren Langer)(Sullivan, Christopher) (Entered: 05/11/2021)
[-] Read LessDocket(#11) MEMORANDUM in Support re #10 MOTION to Dismiss Complaint Alleging Infringement of U.S. Patent No. 10,407,434 filed by Collegium Pharmaceutical, Inc.. (Sullivan, Christopher) (Entered: 05/07/2021)
[-] Read LessDocket(#10) MOTION to Dismiss Complaint Alleging Infringement of U.S. Patent No. 10,407,434 by Collegium Pharmaceutical, Inc..(Sullivan, Christopher) (Entered: 05/07/2021)
[-] Read LessDocket(#9) Chief Judge F. Dennis Saylor, IV: ELECTRONIC ORDER entered granting in part and denying in part #7 MOTION for Extension of Time to May 14, 2021 to File Response/Reply. Defendant has until 5/7/21 to file Response/Reply. (McKillop, Matthew) (Entered: 04/28/2021)
[-] Read LessDocket(#8) Opposition re #7 MOTION for Extension of Time to May 14, 2021 to File Response/Reply as to #1 Complaint, filed by PURDUE PHARMA, LP, Purdue Pharmaceuticals L.P., Rhodes Technologies. (Morrison, Christopher) (Entered: 04/26/2021)
[-] Read LessDocket(#7) MOTION for Extension of Time to May 14, 2021 to File Response/Reply as to #1 Complaint, by Collegium Pharmaceutical, Inc..(Sullivan, Christopher) (Entered: 04/22/2021)
[-] Read LessDocket(#6) Chief Judge F. Dennis Saylor, IV: ELECTRONIC ORDER entered granting #2 Motion to Consolidate Cases (Halley, Taylor) (Entered: 04/21/2021)
[-] Read LessDocket(#5) Summons Issued as to Collegium Pharmaceutical, Inc.. Counsel receiving this notice electronically should download this summons, complete one for each defendant and serve it in accordance with Fed.R.Civ.P. 4 and LR 4.1. Summons will be mailed to plaintiff(s) not receiving notice electronically for completion of service. (Pacho, Arnold) (Entered: 04/12/2021)
[-] Read LessDocket(#4) ELECTRONIC NOTICE of Case Assignment. Chief Judge F. Dennis Saylor, IV assigned to case. If the trial Judge issues an Order of Reference of any matter in this case to a Magistrate Judge, the matter will be transmitted to Magistrate Judge M. Page Kelley. (Finn, Mary) (Entered: 04/12/2021)
[-] Read LessDocket(#3) Civil Cover Sheet & Category Sheet by PURDUE PHARMA, LP, Purdue Pharmaceuticals L.P., Rhodes Technologies. (Attachments: #1 Category Form)(Morrison, Christopher) (Entered: 04/09/2021)
[-] Read LessDocket(#2) Joint MOTION to Consolidate Cases with 15-CV-13099-FDS by PURDUE PHARMA, LP, Purdue Pharmaceuticals L.P., Rhodes Technologies. (Attachments: #1 Exhibit Scheduling Order)(Morrison, Christopher) (Entered: 04/09/2021)
[-] Read LessDocket(#1) COMPLAINT against Collegium Pharmaceutical, Inc. Filing fee: $ 402, receipt number 0101-8721229 (Fee Status: Filing Fee paid), filed by PURDUE PHARMA, LP, Purdue Pharmaceuticals L.P., Rhodes Technologies. (Attachments: #1 Exhibit US Patent No. 10,407,434)(Morrison, Christopher) (Entered: 04/09/2021)
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