Genentech, Inc. et al v. Apotex Inc.
COMPLAINT for Patent Infringement against Apotex Inc.. Filing fee $ 350.00 receipt number 113C-3770120, filed by Genentech, Inc., Roche Palo Alto LLC. (Attachments: # 1 Civil Cover Sheet, # 2 Summon(s), # 3 Exhibit Exhibit "A" - '953 Patent)(Marod, Edward)
UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF FLORIDA
Case No. ________________________
GENENTECH, INC. and
ROCHE PALO ALTO LLC,
Plaintiffs Genentech, Inc. and Roche Palo Alto LLC, by their attorneys, for
their Complaint in this action allege:
Genentech, Inc. (“Genentech”) is a corporation organized and existing
under the laws of the State of Delaware, having its principal place of business at 1
DNA Way, South San Francisco, California 94080-4990.
Roche Palo Alto LLC (“Roche Palo Alto”) is a limited liability
company organized and existing under the laws of the State of Delaware, having
its principal place of business at 3431 Hillview Avenue, Palo Alto, California
On information and belief, Apotex Inc. (“Apotex”) is a company
organized and existing under the laws of Canada, having a place of business at 150
Signet Drive, Toronto, Ontario, Canada.
This action arises under the Patent Act of 1952, as amended, 35
U.S.C. §§ 1-376.
This Court has subject matter jurisdiction to hear this action under 28
U.S.C. §§ 1331 and 1338(a).
THE PATENT IN SUIT
On July 4, 2000, the United States Patent and Trademark Office
issued U.S. Patent No. 6,083,953 (the “’953 patent”), entitled “2- (2-amino-1,6dihydro-6-oxo-purin-9-yl) methoxy-1,3-propanediol Derivative.” Roche Palo Alto
is the owner by assignment of all right, title and interest in the ’953 patent. A copy
of the ’953 patent is attached hereto as Exhibit A.
Genentech markets and sells an FDA-approved pharmaceutical
product, called VALCYTE®, in the form of tablets containing 450 mg of the
active pharmaceutical ingredient, valganciclovir hydrochloride in crystalline form.
The ’953 patent is listed in the FDA’s publication of approved drugs, Approved
Drug Products with Therapeutic Equivalence Evaluations (known as the “Orange
Book”), as covering VALCYTE® 450 mg tablets and their use.
APOTEX’S ANDA AND NOTICE LETTER
By letter to Roche Palo Alto and certain of its affiliates dated April 6,
2011 (the “Notice Letter”), Apotex gave notice under Section 505(j)(2)(B) of the
Food, Drug and Cosmetic Act (“FDCA”) that it had submitted Abbreviated New
Drug Application (“ANDA”) No. 202785 to the FDA, seeking the FDA’s approval
to manufacture, use and sell valganciclovir hydrochloride 450 mg tablets prior to
expiration of the ’953 patent.
In the Notice Letter, Apotex notified Roche Palo Alto that its ANDA
contained a “Paragraph IV Certification” that the claims of the ‘953 patent will not
be infringed by the commercial manufacture, use, offer for sale and sale of certain
valganciclovir hydrochloride 450 mg tablets (the “Apotex Generic Product”). The
Apotex Notice Letter asserts that such commercialization will not infringe the ’953
patent because the Apotex Generic Product purportedly will comprise
“amorphous,” rather than crystalline, valganciclovir hydrochloride.
In truth and in fact, amorphous valganciclovir hydrochloride is
hygroscopic and prone to conversion to crystalline form during use by patients, e.g.
upon exposure to ambient conditions of temperature and humidity.
Apotex has provided Roche Palo Alto and its affiliates with
confidential access to a portion of its ANDA but has refused to provide physical
samples of the Apotex Generic Product and related materials for testing.
On information and belief, Apotex threatens to market and sell the
Apotex Generic Product in Florida and elsewhere in the United States and thereby
to cause massive infringement of the ‘953 patent in Florida, in this district, and
elsewhere in the United States. On information and belief, Apotex has appointed
an agent in Weston, Florida with authority to accept service of process, limited to a
patent infringement action based on Apotex’s notice of its Paragraph IV
On information and belief, Apotex is not qualified to do business in
any State of the United States. On information and belief, Apotex is not subject to
jurisdiction in any state court of general jurisdiction in the United States. On
information and belief, Apotex derives substantial revenue from sales of
pharmaceutical products in Florida, in this district, and elsewhere in the United
This complaint is being filed before the expiration of forty-five days
from the date Roche Palo Alto and its affiliates received the Apotex Notice Letter.
On May 17, 011, Genentech and Roche Palo Alto commenced a first action against
Apotex in the Northern District of California, Case No. CV11-2410-DMR,
asserting the same claims for relief that are stated herein. This case is filed here in
an abundance of caution as a protective action to preserve the procedural rights of
Genentech and Roche Palo Alto in the event that Apotex were to assert that the
United States District Court for the Northern District of California lacks
jurisdiction over the person of Apotex and the Northern District of California were
to agree with such an assertion by Apotex.
FIRST CLAIM FOR RELIEF
INFRINGEMENT OF THE ’953 PATENT
Each of the preceding paragraphs 1 to 14 is incorporated herein as if
set forth in full.
Plaintiffs believe and expect that following receipt of relevant Apotex
physical materials, investigation will confirm that the valganciclovir hydrochloride
active ingredient in the proposed Apotex Generic Product will comprise or convert
to crystalline valganciclovir hydrochloride at least during use by patients, e.g. upon
exposure to ambient atmospheric humidity during storage in pill trays.
On information and belief, Apotex’s commercial use, offer for sale,
and sale of the proposed Apotex Generic Product would infringe the ’953 patent at
least under 35 U.S.C. §§ 271(b) and (c).
On information and belief, Apotex infringed the ’953 patent under 35
U.S.C. § 271(e)(2) by filing ANDA No. 202785.
SECOND CLAIM FOR RELIEF
DECLARATORY AND EQUITABLE RELIEF
AGAINST THREATENED PATENT INFRINGEMENT
Each of the preceding paragraphs 1 to 18 is incorporated herein as if
set forth in full.
Apotex has proposed and threatens to market, sell, and actively induce
use of the Apotex Generic Product throughout the United States including in
California and this federal judicial district.
On information and belief, Apotex’s proposed and threatened use,
offer for sale, and sale of the Apotex Generic Product will infringe or actively
induce or contribute to infringement of the ’953 patent.
An actual controversy exists between Plaintiffs and Apotex
concerning whether offer for sale, sale, or use of the Apotex Generic Product in the
United States will infringe the ’953 patent.
Offer for sale, sale or use of the Apotex Generic Product in the United
States would cause injury to Plaintiffs for which there is no adequate remedy at
PRAYER FOR RELIEF
WHEREFORE Plaintiffs pray that the Court:
declare, adjudge, and decree that Apotex has infringed the ’953 patent
by submitting ANDA No. 202785;
declare, adjudge, and decree that Apotex’s commercial use, offer for
sale and sale of the Apotex Generic Product will infringe the ’953 patent;
issue an Order pursuant to 35 U.S.C. § 271(e)(4)(A) that the effective
date of any FDA approval of the Apotex Generic Product be no earlier than the
expiration date of the ’953 patent, or any later expiration of exclusivity to which
Roche Palo Alto is or becomes entitled;
issue a permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), 35
U.S.C. § 283, and 28 U.S.C. § 1331 restraining and enjoining Apotex and its
officers, agents, attorneys and employees, and those acting in privity or concert
with them, from engaging in commercial activity that would directly or indirectly
infringe the ’953 patent; and
award such other and further relief as the Court may deem just and
May 19, 2011
STEPHEN S. RABINOWITZ
RANDY C. EISENSMITH
FRIED, FRANK, HARRIS, SHRIVER
& JACOBSON LLP
ONE NEW YORK PLAZA
NEW YORK, NEW YORK 10001
EDWARD A. MAROD, P.A.
Counsel for Plaintiffs Genentech, Inc.,
and Roche Palo Alto LLC
P.O. Box 3606
West Palm Beach, Florida 33402
(561) 832-6324 Fax
By: /s/ Edward A. Marod
Edward A. Marod, Esq.
Fla. Bar No. 238961
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