Pfizer Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al
ORDER DENYING TRANSFER re: pldg. (15 in DE/1:20-cv-01396, 13 in DE/1:20-cv-01407, 13 in DE/1:20-cv-01528, 13 in DE/1:20-cv-01530, 13 in DE/1:21-cv-00034, 13 in DE/1:21-cv-00078, 13 in DE/1:21-cv-00139, 19 in MDL No. 2990, 15 in WVN/1:20-cv-00244), ( 1 in MDL No. 2990), ( 2 in MDL No. 2990) The motion to transfe r, pursuant to 28 U.S.C. 1407, is DENIEDSigned by Judge Karen K. Caldwell, Chair, PANEL ON MULTIDISTRICT LITIGATION, on 6/4/2021. Associated Cases: MDL No. 2990, DE/1:20-cv-01396, DE/1:20-cv-01407, DE/1:20-cv-01528, DE/1:20-cv-01530, DE/1:21-cv-00034, DE/1:21-cv-00078, DE/1:21-cv-00139, WVN/1:20-cv-00244 (JC)
UNITED STATES JUDICIAL PANEL
IN RE: PALBOCICLIB (‘730) PATENT
LITIGATION (NO. II)
MDL No. 2990
ORDER DENYING MOTION TO CENTRALIZE
AND TRANSFERRING ONE ACTION TO MDL No. 2912
Before the Panel: Pfizer plaintiffs 1 move under 28 U.S.C. § 1407 to centralize this
litigation in the District of Delaware. The litigation consists of the eight actions listed on the
attached Schedule A, seven in the District of Delaware and one in the Northern District of West
Virginia. 2 Mylan Pharmaceuticals Inc., the sole defendant in the West Virginia action, does not
oppose transfer to the District of Delaware. No other party has responded to the motion.
The Pfizer plaintiffs filed these actions after the defendant pharmaceutical companies
submitted Abbreviated New Drug Applications (ANDAs) seeking approval by the U.S. Food and
Drug Administration (FDA) to manufacture and sell generic versions of IBRANCE (Palbociclib)
capsules, 3 75 mg, 100 mg, and 125 mg. All actions are Hatch-Waxman 4 patent infringement suits
Pfizer Inc., Warner-Lambert Company LLC, and PF PRISM IMB B.V.
Pfizer plaintiffs’ motion originally sought centralization of ten actions, but two of the involved
actions pending in the District of Delaware now have been voluntarily dismissed.
IBRANCE is a drug used to treat metastatic breast cancer.
Under the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98–
417, 98 Stat. 1585 (1984) (the “Hatch-Waxman Act”), Congress established an incentive for
companies to bring generic versions of branded drugs to market faster than they otherwise might
by granting the first company to file an ANDA an “exclusivity period” of 180 days, during which
the FDA may not approve for sale any competing generic version of the drug. See Teva Pharm.
USA, Inc. v. Sebelius, 595 F.3d 1303, 1304-05 (D.C. Cir. 2010). Submitting an ANDA with a
“paragraph IV certification”—stating that the patents listed in the FDA’s Orange Book as covering
the previously approved drug are invalid or will not be infringed by the generic drug—constitutes
a statutory act of infringement that creates subject-matter jurisdiction for a district court to resolve
any disputes regarding patent infringement or validity before the generic drug is sold. See 35
U.S.C. § 271(e)(2)(A); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676-78 (1990). If the
patent-holder initiates an infringement action against the ANDA filer within 45 days of receipt of
the paragraph IV certification, the FDA may not approve the ANDA until the earlier of either 30
-2in which the Pfizer plaintiffs allege that defendants have infringed U.S. Patent No. 10,723,730
(“the ‘730 Patent”).
The Pfizer plaintiffs previously filed a series of Hatch-Waxman actions against the
defendants named in seven of the present actions, alleging that their submission of ANDAs
infringed one or more of three IBRANCE patents. 5 Those actions were centralized in the District
of Delaware in 2019 as MDL No. 2912, and assigned to Judge Colm F. Connolly. See In re
Palbociclib Patent Litig., 396 F. Supp. 3d 1360 (J.P.M.L. 2019).
Pfizer argues that the actions on the motion involve common questions of fact and that
centralization before Judge Connolly, as the judge presiding over MDL No. 2912, would best serve
the convenience of the parties and witnesses. There are substantial similarities between the actions
now before us and those in the existing MDL. In fact, seven of the eight actions are pending in
the District of Delaware and have been related to MDL No. 2912. During briefing of this matter,
the Clerk of the Panel directed the parties to submit supplemental briefs on whether the single
action pending in the Northern District of West Virginia should be transferred to the District of
Delaware for inclusion in MDL No. 2912. Among the defendants, only Mylan in the Northern
District of West Virginia action responded to the order, stating that it does not oppose transfer to
MDL No. 2912. The Pfizer plaintiffs are opposed. They argue that the ‘730 Patent cases differ
substantially in both substance and procedural posture from the MDL No. 2912 actions and
therefore should be centralized in a separate MDL.
On the basis of the papers filed and the hearing session held, 6 we conclude that the actions
on the motion involve common questions of fact with the actions centralized in MDL No. 2912,
and that creation of a separate MDL involving only the ‘730 Patent cases is not necessary to serve
the convenience of the parties and witnesses or to further the just and efficient conduct of this
litigation. These eight actions, like those in MDL No. 2912, involve claims that defendants
infringed one or more IBRANCE patents by seeking FDA approval to market generic Palbociclib
drugs in the United States. Nearly all defendants and ANDAs in the litigation also are involved in
MDL No. 2912. Seven of the actions on the motion are pending in the District of Delaware, where
they have been assigned to Judge Connolly and related to the actions in MDL No. 2912. In these
circumstances, pretrial proceedings in the ‘730 Patent actions can proceed most efficiently in the
existing MDL. The Pfizer plaintiffs’ concerns about any differences between the ‘730 Patent
actions and earlier-filed actions may be raised with Judge Connolly, who is free to establish
separate tracks for discovery and motion practice, as he deems appropriate.
months or the issuance of a decision by a court that the patent is invalid or not infringed by the
generic manufacturer’s ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii).
The ‘730 Patent was not issued until July 2020, and thus was not involved in these earlier actions,
which were filed in April 2019.
In light of the concerns about the spread of the COVID-19 virus (coronavirus), the Panel heard
oral argument by videoconference at its hearing session of January 28, 2021. See Suppl. Notice
of Hearing Session, MDL No. 2990 (J.P.M.L. May 10, 2021), ECF No. 26.
IT IS THEREFORE ORDERED that the motion for centralization of these actions is
IT IS FURTHER ORDERED that the action listed on Schedule A and pending outside the
District of Delaware is transferred to the District of Delaware and, with the consent of that court,
assigned to the Honorable Colm F. Connolly for inclusion in the coordinated or consolidated
pretrial proceedings occurring there in MDL No. 2912.
IT IS FURTHER ORDERED that the Clerk of the Panel shall enter a copy of this order in
the docket for MDL No. 2912.
PANEL ON MULTIDISTRICT LITIGATION
Karen K. Caldwell
Catherine D. Perry
Matthew F. Kennelly
Roger T. Benitez
Nathaniel M. Gorton
David C. Norton
Dale A. Kimball
IN RE: PALBOCICLIB (‘730) PATENT
LITIGATION (NO. II)
MDL No. 2990
District of Delaware
PFIZER INC., ET AL. v. ZYDUS PHARMACEUTICALS (USA) INC., ET AL.,
C.A. No. 1:20−01396
PFIZER INC., ET AL. v. SUN PHARMACEUTICAL INDUSTRIES, LTD., ET AL.,
C.A. No. 1:20−01407
PFIZER INC., ET AL. v. AUROBINDO PHARMA, LTD., ET AL.,
C.A. No. 1:20−01528
PFIZER INC., ET AL. v. DR. REDDY'S LABORATORIES, INC., ET AL.,
C.A. No. 1:20−01530
PFIZER INC., ET AL. v. AIZANT DRUG RESEARCH SOLUTIONS PVT. LTD.,
ET AL., C.A. No. 1:21−00034
PFIZER INC., ET AL. v. NATCO PHARMA, INC., ET AL.,
C.A. No. 1:21−00078
PFIZER INC., ET AL. v. MSN PHARMACEUTICALS INC., ET AL.,
C.A. No. 1:21−00139
Northern District of West Virginia
PFIZER INC., ET AL. v. MYLAN PHARMACEUTICALS INC., ET AL.,
C.A. No. 1:20−00244
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