Case 1:15-cv-00714-RGA Document 1 Filed 08/18/15 Page 1 of 9 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`DR. REDDY’S LABORATORIES, INC., and
`DR. REDDY’S LABORATORIES, LTD.,
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`Plaintiffs,
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`v.
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`FRESENIUS KABI USA, LLC,
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`Defendant.
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`Case No. __________
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`DR. REDDY’S LABORATORIES, LTD.’S AND
`DR. REDDY’S LABORATORIES, INC.’S
`COMPLAINT FOR DECLARATORY JUDGMENT
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`Plaintiffs Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively,
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`“DRL”) for their Complaint against Fresenius Kabi USA, LLC. (“Fresenius”) allege as follows:
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`PARTIES
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`1.
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`Plaintiff Dr. Reddy’s Laboratories, Ltd. is an Indian corporation, with its principal
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`place of business at Door No 8-2-337, Road No 3, Banjara Hills, Hyderabad - 500034, Andhra
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`Pradesh, India.
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`2.
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`Plaintiff Dr. Reddy’s Laboratories, Inc. is a New Jersey corporation, with its
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`principal place of business at 107 College Road East, Princeton, NJ 08540.
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`3.
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`Upon information and belief, Defendant Fresenius Kabi USA, LLC. (“Fresenius”)
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`is a Delaware limited liability company with its principal place of business at Three Corporate
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`Drive, Lake Zurich, Illinois 60047.
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`JURISDICTION AND VENUE
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`4.
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`DRL realleges and incorporates by reference each of the allegations of paragraphs
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`1-3.
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`5.
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`This action arises under, inter alia, the Patent Laws of the United States,
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`35 U.S.C. §§ 1 et seq.; the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202; and the
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`MMA, 28 U.S.C. § 355(j)(5)(C) and 35 U.S.C. § 271(e)(5).
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`6.
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`A substantial, present, genuine and justiciable controversy exists between DRL
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`and Fresenius with respect to United States Patent No. 8,476,010 (“the ‘010 patent”).
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`7.
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`This Court has original jurisdiction over the subject matter of this action under
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`28 U.S.C. §§ 1331 and 1338(a), because this action involves substantial claims arising under the
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`United States Patent Act, 35 U.S.C. §§ 1 et seq.; under the Declaratory Judgment Act, 28 U.S.C.
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`§§ 2201 and 2202, because it is an actual controversy concerning the ‘010 patent.
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`8.
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`This Court can and should declare the rights and legal relations of the parties
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`regarding the ‘010 patent pursuant to, inter alia, the United States Patent Act, 35 U.S.C.
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`§§ 1 et seq. and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
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`9.
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`This Court has personal jurisdiction over Fresenius, inter alia, because of
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`Fresenius’s continuous and systematic contacts with the State of Delaware, including its
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`conducting of substantial and regular business therein through the marketing and sales of its
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`pharmaceutical products in Delaware, and because Fresenius has availed itself of the jurisdiction
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`of this Court by initiating litigation in this District. See, e.g., Fresenius Kabi, USA, LLC v.
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`Dr. Reddy’s Laboratories, Ltd., et. al, No. 1:13-cv-925-RGA, filed June 10, 2013; Fresenius
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`Kabi, USA, LLC v. Dr. Reddy’s Laboratories, Ltd., et. al, No. 1:14-cv-160-RGA, filed
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`February 6, 2014.
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`10.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391(b) and
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`(c) and/or 1400(b).
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`BACKGROUND
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`11.
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`Upon information and belief, Fresenius is the holder of approved New Drug
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`Application (“NDA”) No. 19627, and markets Diprivan®, known generically as propofol
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`injectable emulsion product containing 10 mg propofol per 1 ml of emulsion, throughout the
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`United States pursuant to NDA No. 19627.
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`12.
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`Upon information and belief, Fresenius owns United States Patent No. 8,476,010
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`(“the ‘010 patent”). By virtue of patent information that Fresenius submitted to United States
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`Food and Drug Administration (“FDA”) in connection with NDA No. 19627, the ‘010 patent is
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`listed in FDA’s compilation of approved drugs and their respective patents entitled “Approved
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`Drug Products With Therapeutic Equivalence Evaluations,” commonly referred to as the
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`“Orange Book.”
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`13.
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`Upon information and belief, the ‘010 patent, entitled “Propofol Formulations
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`with Non-Reactive Container Closures”, issued on July 2, 2013 to Fresenius.
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`14.
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`Upon information and belief, Fresenius also owns United States Patent Nos.
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`5,714,520 (“the ‘520 patent”), 5,731,355 (“the ‘355 patent”), 5,731,356 (“the ‘356 patent”), and
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`5,908,869 (“the ‘869 patent”), which are also listed in the Orange Book.
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`15.
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`DRL filed an Abbreviated New Drug Application (“ANDA”) with the FDA to sell
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`a generic version of Fresenius’s propofol injectable emulsion containing 10 mg propofol per 1 ml
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`of the emulsion, marketed by Fresenius under the name Diprivan®. The ANDA number is
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`205067.
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`16.
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`In conjunction with the filing of ANDA no. 205067, DRL filed “Paragraph IV
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`certifications” with respect to each of the patents which were then listed in the “the “Orange
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`Book,” with respect to Fresenius’s Diprivan®. Those patents are United States Patent Nos.
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`5,714,520 (“the ‘520 patent”), 5,731,355 (“the ‘355 patent”), 5,731,356 (“the ‘356 patent”), and
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`5,908,869 (“the ‘869 patent”). The ‘520, ‘355, ‘356, and ‘869 patents, each of which will expire
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`on September 22, 2015, are still listed in the Orange Book.
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`17.
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`DRL amended its ANDA No. 205067 to include a Paragraph IV certification for
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`the ‘010 patent after the ‘010 patent issued on July 2, 2013 and was subsequently listed in the
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`Orange Book for Diprivan®.
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`18.
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`DRL filed ANDA No. 205067 to obtain FDA approval to engage in the
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`commercial manufacture, use, and sale of DRL’s propofol injectable emulsion product prior to
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`expiration of the ‘520, ‘355, ‘356, ‘869, and ‘010 patents.
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`19.
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`Fresenius brought a patent infringement action against DRL in this Court on
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`May 23, 2013, asserting infringement of the ‘520, ‘355, ‘356, and ‘869 patents listed in the
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`Orange Book under Fresenius’ Diprivan® (Civil Action No. 1:13-cv-00925).
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`20.
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`This Court issued a decision and final judgment dated September 8, 2014 after
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`trial that DRL’s proposed propofol injectable emulsion product according to ANDA No. 205067
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`does not infringe the ‘520, ‘355, ‘356, and ‘869 patents. Fresenius did not appeal that decision
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`with the United States Court of Appeals for the Federal Circuit.
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`21.
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`After the ‘010 patent issued and was subsequently listed in the Orange Book,
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`Fresenius brought a separate patent infringement action against DRL in this Court asserting
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`infringement of the ‘010 patent (Civil Action No. 1:14-cv-00160, “the DRL ‘010 Patent Case”)
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`on February 6, 2014.
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`22.
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`DRL counterclaimed in the DRL ‘010 Patent Case for a declaratory judgment that
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`the ‘010 patent is either invalid and/or DRL will not infringe the ‘010 patent. Fresenius admitted
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`that this Court has subject matter jurisdiction over DRL’s declaratory judgment action in the
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`DRL ‘010 Patent Case.
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`23.
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`On March 3, 2015, the DRL ‘010 Patent Case was dismissed without prejudice.
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`The Hatch-Waxman Regulatory Framework
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`24.
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`The Hatch-Waxman Act provides that the first applicant to file a substantially
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`complete ANDA containing a Paragraph IV certification to a listed patent will be eligible for a
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`180-day period of marketing exclusivity beginning on the earlier of the date it begins commercial
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`marketing of its generic drug product, or from the date of a final decision of a court from which
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`no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be
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`taken.
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`25.
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`These two events - first commercial marketing and a court decision - are often
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`called “triggering events” because they trigger the beginning of the 180-day exclusivity.
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`26.
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`The 180-day exclusivity period will begin to run when any ANDA applicant
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`obtains a court decision of invalidity, unenforceability or non-infringement, even if the first-filer
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`has not yet received approval for its ANDA, or before the first-filer has begun commercial
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`marketing of its ANDA product.
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`27.
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`Conversely, if there is no court decision on an Orange Book-listed patent and the
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`first-filer does not begin commercial marketing of the generic drug, there may be prolonged
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`delays in the beginning of the first applicant’s 180-day exclusivity period. Because the FDA
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`cannot statutorily approve any subsequently-submitted ANDAs for the same drug until this 180-
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`day exclusivity period has expired, subsequent ANDA-filers have a strong economic incentive to
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`generate a triggering event allowing the FDA to approve their ANDAs immediately following
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`the expiration of the first-filer’s exclusivity. Without a triggering event, no subsequent
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`Paragraph IV filer’s ANDA can be approved until the first-filer’s exclusivity has expired.
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`28.
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`On information and belief, another ANDA filer was the first ANDA filer that filed
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`a Paragraph IV certification with respect to the ‘010 patent for a 10 mg/ml propofol injectable
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`emulsion, and thus and is entitled to a 180-day period of marketing exclusivity with respect to
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`the ‘010 patent. DRL was thus not the first generic drug manufacturer to file an ANDA
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`containing a Paragraph IV certification to the ‘010 patent for the 10 mg/ml propofol injectable
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`emulsion.
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`29.
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`On information and belief, to date the FDA has not granted final approval to the
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`ANDA filer who was the first to file a Paragraph IV certification with respect to the ‘010 patent.
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`30.
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`To date the FDA has not approved DRL’s ANDA No. 205067 for its generic
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`propofol injectable emulsion product. Notwithstanding the prior dismissal of the DRL ‘010
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`Patent Case without prejudice, DRL’s ANDA for its propofol injectable emulsion product is not
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`eligible for final approval until the date that is 180 days after the earlier of 1) the start of
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`commercial marketing of the blocking ANDA product or 2) a final decision of a court from
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`which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or
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`can be taken holding that the ‘010 patent is invalid, unenforceable, or not infringed.
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`31.
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`As a result of the non-launch of the blocking applicant’s ANDA product, DRL
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`cannot obtain final FDA approval and cannot market its ANDA product.
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`32.
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`DRL is not only entitled to bring and maintain this lawsuit, but requires a Court
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`decision to avoid a lengthy delay in the approval of its ANDA No. 205067 notwithstanding that
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`its ANDA product does not infringe any claim of the ‘010 patent.
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`33. Moreover, unless DRL obtains a court order finding the ‘010 patent not infringed,
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`invalid, or unenforceable, DRL will be harmed by the inability to market its generic product. A
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`declaratory judgment from this Court as to the non-infringement of the ‘010 patent will alleviate
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`DRL’s harm by allowing DRL to obtain final approval of its ANDA product and compete in the
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`market for propofol injectable emulsion product.
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`34.
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`Accordingly, there is an actual, substantial, and continuing justiciable case and
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`controversy between DRL and Fresenius regarding the infringement of the ‘010 patent over
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`which this Court can and should exercise jurisdiction and declare the rights of the parties.
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`35.
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`DRL is entitled to a judicial declaration that the manufacture, sale, offer for sale,
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`use, or importation of DRL’s proposed propofol injectable emulsion product does not and will
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`not infringe any claim of the ‘010 patent.
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`36.
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`Absent the exercise of jurisdiction by this Court and such declaratory relief, DRL
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`will be harmed by the substantial delay in its market entry for generic Diprivan®.
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`THE ‘010 PATENT
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`37.
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`The ‘010 patent is listed in the FDA publication entitled Approved Drug Products
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`with Therapeutic Equivalence Evaluations (the “Orange Book”) as covering propofol injectable
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`emulsion, which is marketed by Fresenius under the brand name Diprivan®.
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`38.
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`The ‘010 patent, entitled “Propofol Formulations with Non-Reactive Container
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`Closures” issued on July 2, 2013. Upon information and belief, Fresenius is the owner of the
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`‘010 patent. The ‘010 patent is currently listed in the Orange Book for Diprivan®. The ‘010
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`patent is listed in the Orange Book as expiring on June 1, 2025 with pediatric exclusivity.
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`COUNT I
`DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ‘010 PATENT
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`39.
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`DRL realleges and incorporates by reference each of the allegations of paragraphs
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`1-38.
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`40.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the manufacture, use, offering for sale, or importation of the propofol injectable
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`emulsion product that is the subject of ANDA No. 205067 will infringe the ‘010 patent.
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`41.
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`DRL’s commercial manufacture, use, offer for sale, sale or importation of the
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`products covered by ANDA No. 205067 will not infringe any of the claims of the ‘010 patent,
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`either literally or under the doctrine of equivalents.
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`42.
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`DRL is entitled to a judicial declaration that it has not infringed and does not
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`infringe directly, by inducement, or by contribution of any claim of the ‘010 patent.
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`PRAYER FOR RELIEF
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`WHEREFORE, DRL respectfully requests the Court enter judgment and Order in its
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`favor and against Fresenius a declaration that DRL’s manufacture, use, offer for sale, sale or
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`importation of the products covered by ANDA No. 205067 will not infringe the claims of U.S.
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`Patent No. 8,476,010.
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`August 18, 2015
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`SMITH KATZENSTEIN & JENKINS LLP
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`Robert K. Beste
`/s/
`Neal C. Belgam (No. 2721)
`Robert K. Beste III (No. 3931)
`1000 West Street, Suite 1501
`P.O. Box 410
`Wilmington, DE 19899 (courier 19801)
`Phone: (302) 504-1688
`Fax: (302) 652-8405
`nbelgam@skjlaw.com
`rbeste@skjlaw.com
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`
`OF COUNSEL
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`Andrew J. Miller
`Frank D. Rodriguez
`Min Yang
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078
`973-379-4800
`amiller@buddlarner.com
`frodriguez@buddlarner.com
`myang@buddlarner.com
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`Attorneys for Plaintiffs
`Dr. Reddy’s Laboratories, Inc., and
`Dr. Reddy’s Laboratories, Ltd.
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