THERAVANCE BIOPHARMA R&D IP, LLC v. EUGIA PHARMA SPECIALTIES LTD.
1:23-cv-00926
D.N.J.Jun 9, 2025Check TreatmentDocket
NOT FOR PUBLICATION
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
CAMDEN VICINAGE
THERAVANCE BIOPHARMA R&D PB, ! HONORABLE KAREN M. WILLIAMS
LLC, et al.,
Plaintiffs, Civil Action
! No. 23-926 (KXMW-AMD)
¥ !
□
EUGIA PHARMA SPECIALTIES LTD., ef 3 OPINION
al,
Defendants.
APPEARANCES:
KATHERINE ANN ESCANLAR, ESQ.
ARNOLD B. CALMANN, ESQ.
SAIBER LLC
18 COLUMBIA TURNPIKE, SUITE 200
FLORHAM PARK, NJ 07932
Counsel for Plaintiffs Theravance Biopharma US, Inc., Theravance Biopharma freland
Limited, Mylan Ireland Limited, and Viatris Specialty LLC.
R TOUHEY MYER, ESQ.
KRATZ & BARRY LLP
800 N. WEST STREET
WILMINGTON, DE 19801
Counsel for Defendants Eugia Pharma Specialities, LTD., Eugia US LLC, Aurobindo
Pharma USA, Inc.,, and Aurobindo Pharma Limited.
DMITRY V. SHELHOFF, ESQ.
SHELHOFF CANFIELD & CHIN LLC
30 CHATHAM ROAD, SUITE 19
SHORT HILLS, NJ 07078
JAY P. LESSLER, ESQ.
BLANK ROME LLP
1271 AVENUE OF THE AMERICAS
NEW YORK, NY 10020
MICHAEL RAY DARBEE, ESQ.
BLANK ROME LLP
300 CARNEGIE CENTER, SUITE 220
PRINCETON, NJ 08540
Counsel for Defendants Mankind Pharma LTD., and Lifestar Pharma LLC
LOLY G. TOR, ESQ.
K&L GATES, LLP
ONE NEWARK CENTER
NEWARK, NJ 07102
Counsel for Defendants Cipla Limited, and Cipla USA, Inc.
WILLIAMS, District Judge:
I. INTRODUCTION
This matter comes before this Court on Plaintiff Theravance Biopharma US, Inc.,
Theravance Biopharma Ireland Limited, Mylan Ireland Limited, and Mylan Specialty LLC’s,
(collectively, “Plaintiffs”), Motion to Seal, (ECF No. 293), Eugia US LLC, Aurobindo Pharma
USA, Inc., and Aurobindo Pharma Limited’s, (““Eugia Defendants”), Motion to Seal, (ECF No.
347), Defendant Cipla Limited, Cipla USA, Inc, (“Cipla Defendants”), and Mankind Pharma Ltd,
and Lifestar Pharma LLC’s, (“Mankind Defendants”), joint Motion to Seal, (ECF No. 359), and
Cipla Defendants’ individual Motion to Seal, (ECF No, 381). All motions are unopposed.
For the reasons that foliow, the Court GRANTS the pending Motions to Seal, (ECF Nos,
293, 347, 359, 381).
II. BACKGROUND
The Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-99governs the process by which a company seeking to market a new brand-name drug brings the product to market after the Food and Drug Administration (“FDA”) is satisfied that there is sufficient safety and effectiveness. See Celgene Corp. vy. Teva Pharms, USA, Inc,,412 F. Supp. 2d 439, 440
(D.N.J. 2006). The Hatch- Waxman Act, (codified at21 U.S.C. § 355
and35 U.S.C. §§ 156
, 271, and 282), amended the
process to enable generic manufacturers to bring generic products to the market faster by allowing
them to avoid the costly process of additional testing through the Abbreviated New Drug
Application (“ANDA”) which allows the generic to utilize the safety and effectiveness information
that the brand-name manufacturers had to submit to bring their new drug to market provided that
the proposed generic drug is chemically bioequivalent. Jd, at 440-41,
ANDAs must address the patents that are applicable to the generic drug for which approval
is sought and pursuant to 21 U.S.C. 355G)(2)(A)(vii) and certify the ANDA in one of four ways:
1) that the patent information has not been filed before (1.c. the patent is for a new product), 2) that
the patent has expired, 3) that the generic will wait to launch when the applicable patent at issue
expires, or 4) that the applicable patent is invalid, or will not be infringed by the manufacture, use
or sale of the generic. See 21 U.S.C. 355q)(2)(A)(vii)(-IV). “Applicants use Paragraph IV
Certifications to essentially challenge the validity of the brand-name drug manufacturers’
patents[,]” and thus the certification is considered an “artificial” act of infringement, requiring the
ANDA applicant to give notice to the brand-name manufacturer and permit the brand-name
manufacturer to litigate to protect its patent rights. Ce/egene Corp., 412 Supp. 2d at 441; see also
Eli Lilly & Co, v. Medtronic, Inc., 496 U.S. 661, 678 (1990).
Here, Plaintiffs developed and launched YUPELRI®, (revefenacin), a prescription
medication for patients with chronic obstructive puimonary disease (“COPD”), See Amend.
Compl. at J] 166-67. COPD is a chronic inflammatory disease of the lungs, with progressive
persistent airflow obstruction, causing patients to have difficulty breathing both when inhaling and
exhaling. YUPELRI® is a long-acting muscarinic antagonist, (a bronchodilator), that can be
administered orally once per day via jet nebulizer, enabling COPD patients with low expiratory
volume, (measured as FEV,' of equal to or greater than 30% and less than 50% being “severe”
and FEV of less than 30% as “very severe”), and low inspiratory flow rate, (measured as
suboptimal PIFR? of less than 60 L/min, which may prevent a patient from achieving clinical
benefit of a dry powder inhaler, and a PIFR of less than 30 L/min being insufficient to use a dry
power inhaler), to properly respire the medication. at [J 167, 173-179. The following patents
1 Forced Expiratory Volume in One Second.
2 Peak Inspiratory Flow Rate.
ate related to YUPELRI® and are listed in the FDA’s “Orange Book”?: °451, ’028, 081, °289,
°531, and °948, (collectively, the “Orange Book Patents”). fd. at ff] 136-153.
In January of 2023, each of the Eugia, Cipla, and Mankind Defendants submitted their
notice to Plaintiffs pursuant to 21 U.S.C. § 35 5()(2)(B) and 21 C.ER. § 314.95, alerting Plaintiffs
that each had submitted an ANDA to the FDA pursuant to 21 U,S.C, G)(1) and 2(A), seeking
approval to engage in the commercial manufacture, use, or sale of a generic version of YUPELRI®
prior to the expiration of patents °451, ’028, ’081, °289, °531. dd, at {J 180, 207, 373. Each notice
letter also included Paragraph IV Certification asserting that the patents at issue were invalid,
unenforceable, and/or not infringed upon by the generic product. fd. at [J 181, 208, 374. In July
of 2023, the °948 patent related to YUPELRI® was granted and included in the Orange Book, and
subsequently each of the Eugia, Cipla, and Mankind Defendants submitted their notice and
Paragraph IV Certifications related to the °948 patent. fd. at FJ 185-189, 213-216, 378-381. On
December 4, 2023, Plaintiffs amended their Complaint to further assert that Defendants are
infringing upon additional patents that are not listed in the Orange Book: ’783, ’099, °013, °209,
(the “non-Orange Book patents”).’ See Mot. to Dismiss at 5. Since the Amended Complaint was
filed, Plaintiffs have filed two other actions, which have since been consolidated.’ Jd. at 5,
Plaintiffs and Defendants have engaged in substantial briefing in this matter, and as a result,
all of the parties have filed for Motions to Seal for various documents pursuant to New Jersey
Local Civil Rule 5.3 to protect their confidential business information.
1 The U.S. Food and Drug Administration (“FDA”) publishes the Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly known as the “Orange Book” which identifies drug products approved on the
basis of safety and effectiveness, along with patent and exclusivity information. See “Approved Drug Products with
Therapeutic Equivalence Evaluations | Orange Book,” U.S. Food & Drug Administration,
hitps:/Avww.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-
evaluations-orange-book (last visited on May 27, 2025).
4 These patents do not have any certifications against them because they are not listed in the Orange Book.
5 The Court notes that two other actions were consolidated to the case at bar, which brings two additional patents to
this matter (898, °692}. See Mot, to Dismiss at 7 n.6; Opp at. 5.
Til. LEGAL STANDARD
Requests to seal are governed by New Jersey Local Civil Rule 5.3, which requires that a
request to seal must be presented by motion, and that the motion papers must describe “(a) the
nature of the materials or proceedings at issue, (b) the legitimate private or public interests which
warrant the relief sought, (c) the clearly defined and serious injury that would result if the relief
sought is not granted, and (d) why a less restrictive alternative to the relief sought is not available.”
Civ. R. 5.3(c)(2).
Although there is a well-established “common Jaw public right of access to judicial
proceedings and records,” /n re Cendant Corp., 260 F.3d 183, 192(3d Cir. 2001), “[i]n order to overcome this presumption of a public right of access, the movant must demonstrate that ‘good cause’ exists for the protection of the material at issue.” Securimetrics, Inc. y. Iridian Techs., Inc., No. 03-4394,2006 WL 827889
, at *2 (D.N.J. Mar. 30, 2006). Good cause exists when a party makes a particularized showing that disclosure will cause a “clearly defined and serious injury to the party seeking closure.” /d. (citing Pansy v. Borough of Stroudsburg,23 F.3d 772
, 786 Gd Cir. 1994)). Specifically, the movant must prove that the information is confidential in nature and that allowing the general public to access the information will cause a specific and serious injury. See Pansy,23 F.3d at 786
. “‘Broad allegations of harm, unsubstantiated by specific examples or articulated reasoning,’ do not support a good cause showing.”Id.
(citing Cipolfone v. Liggett Group, Inc.,785 F.2d 1108
, 1121 Gd Cir. 1986).
Iv. DISCUSSION
Plaintiffs, (ECF No. 293), Eugia Defendants, (ECF No. 347), Cipla and Mankind
Defendants jointly, (ECF No. 359), and Cipla Defendants individually (ECF No, 381), seek to seal
several Exhibits and redact certain portions of transcripts to preserve the confidentiality of
proprietary and non-public information related to the underlying patent dispute. Because these
requests to seal involve the same kinds of nonpublic, closely guarded business information, and
with all requests unopposed, the Court will address ali motions below.
The Court must review the pending motions against the four factors as promulgated in L.
Civ. R. 5.3(c)(2). First, all motions clearly describe the nature of the materials at issue, thus
meeting the first prerequisite, noting that these documents, while necessary for the Court’s review
to resolve the pending motions, contain sensitive, non-public information relating to the parties’
research, development, and commercialization of various products, as well as confidential
communications regarding the underlying patent dispute. See Mot. Seal (ECF No. 293), Decl.
Mary W. Bourke at □□ 2, 4, 5, 7-9; Decl. Matthew V. Anderson at ff 2, 4, 5, 7-9; Mot. Seal (ECF
No. 347), Decl. George J. Barry, II at fj 2, 6, 10; Mot. Seal (ECF No. 359), Decl. Loly G. Tor at
{9 2, 3, 4, 6, 8; Decl. Jay P. Lesser at ff] 2, 6; Mot. Seal No. 381), Decl. Loly G. Tor at □□ 2-
4, 6, 8.
Second, all motions assert the legitimate private and public interests which warrant the
relief sought, such as to protect the confidential proprietary information or trade secrets, nonpublic
regulatory and research development strategies, and confidential communications regarding
potential settlement of certain claims, all serving to maintain a competitive marketplace. See Mot.
Seal (ECF No. 293), Decl. Mary W. Bourke at J 8-9; Decl. Matthew V. Anderson at J 8-9; Mot.
Seal (ECF No, 347), Decl. George J. Barry, HI at §] 9; Mot. Seal (ECF No. 359), Decl. Loly G.
Tor at J 7-8; Decl. Jay P. Lesser at {ff 6; Mot. Seal (ECF No. 381), Decl. Loly G. Tor at Jf 7-8.
Third, all motions assert the clearly defined and serious injury that would result if the relief
sought is not granted, such as the exposure of sensitive research and development information and
trade secrets to the public, that is normally not widely available. See Mot. Seal GECF No. 293),
Decl. Mary W. Bourke at J 8; Decl. Matthew V. Anderson at {] 8; Mot. Seal (ECF No, 347), Decl.
George J. Barry, HI at {Y 8-9; Mot. Seal (ECF No. 359), Decl. Loly G. Tor at 97; Decl. Jay P.
Lesser at | 7; Mot. Seal (ECF No. 381), Decl. Loly G. Tor at J 7-8.
Fourth, the Court agrees that there is no less restrictive alternative to filing the information
requested as proposed by the parties. Plaintiffs seek to apply limited redactions on Exhibits 2, 3,
10, and 11, (of ECF No, 261), limited redactions to Eugia Defendant’s letter and Exhibit Z, (of
ECF No. 270), and limited redactions to sections of the transcript (ECF No. 281). See Mot. to Seal
(ECF No. 293), Decl. Mary W. Bourke at 10; Decl. Matthew V. Anderson at 7 10. Regarding
Eugia Defendants’ Motion to Seal, the Eugia Defendants request that a page from Exhibit 2, four
pages of Exhibit 3, two pages of Exhibit 10, two pages of Exhibit 11, (of ECF No 261), one page
from Eugia’s letter, (of ECF No. 270), one page of Exhibit Z, (of ECF No. 270), and nine lines of
the transcript (of ECF No. 281) be redacted. The Court agrees that there is no less restrictive
alternative to filing the information requested under seal because records cited to in this motion
are entirely comprised of sensitive information. Mot. Seal, (ECF No, 347), Decl. George J. Barry,
III at Index in Support of Motion to Seal. Cipla Defendants and Mankind Defendants request
various redactions to Plaintiffs’ Opening Markman Brief, (of ECF No. 310), the sealing of Exhibits
2, 10, and 12 (of ECF No. 310), redactions to Plaintiffs’ Rebuttal Markman Brief, as well as Exhibit
20 in its entirety, (of ECF No. 333), redactions to Defendants’ Rebuttal Markman Brief, (of ECF
No. 335), and redactions to several pages of the Myerson Transcript, (of ECF No. 336). Mot. Seal
(ECF No. 359), Decl. Loly G. Tor at 9; Decl. Jay P. Lesser at 97. The Court found that Cipla
Defendants’ and Mankind Defendants’ approach of limited redaction and sealing applied to the
confidential, non-public information to be the least restrictive means of protecting the confidential
information contained in those documents. Similarly, Cipla Defendants request two pages to be
sealed of Exhibit 3 (of ECF No 332), one page of Defendants’ response (of ECF No. 354), seven
pages of Exhibit | (of ECF No. 356), and the entirety of Exhibit 3 (of ECF No. 357). The Court
notes that prior sealing orders have included the portions of documents that Cipla Defendants are
seeking to have sealed. The Court further notes that the approach taken here of limited redaction
and sealing applied to the confidential, non-public information to be the least restrictive means of
protecting the confidential information contained in those documents.
Further, the Court has reviewed the excerpts that all parties requested redactions be applied
to and reviewed the documents that the parties have requested to seal and agree that the redactions
and sealing of these select documents does not impede the public from understanding the legal
arguments, factual circumstances, and the issues of dispute in the instant case.
Finally, Court also finds that there is “good cause” to protect such confidential information
from. disclosure. See Faulman y, Sec, Mut. Fin. Life ins,, No. 04-5083, 2006 WL 1541059, at *1 (D.N.J. June 2, 2006) (“Generally, a court will protect materials containing ‘trade secret[s] or other confidential research, development, or commercial information’ to prevent harm to a litigant’s competitive standing in the marketplace.”); see also Morgan v. Wal-Mart Stores, Inc., No. 14- 4388,2015 WL 3882748
at *2 (D.N.J. June 23, 2015) (granting motion to seal where “disclosure
would result in the dissemination of confidential settlement negotiations and confidential
settlement amounts” and where “the public has no legitimate interest” in gaining access to such
confidential information in litigation between private parties). The fourth prerequisite is met, and
thus the Court is satisfied that all motions satisfy the requirements of New Jersey Local Civil Rule
5.3. Therefore, each Motion to Seal discussed herein is granted in its entirety.
Vv. CONCLUSION
For the reasons set forth above, the Court GRANTS the pending Motions to Seal, (ECF
Nos. 293, 347, 359, 381). An order consistent with this Opinion will be entered.
“4 a dew ‘ oN
June 2025 fs SA SONS eB etm
KAREN M. WILLIAMS, U.S.D.J.
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