Case 1:17-cv-00072-SLR Document 1 Filed 01/25/17 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ___________________
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`))))))))))))
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`SHIONOGI INC.
`AND ANDRX LABS, L.L.C.,
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`Plaintiffs,
`
`v.
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`AUROBINDO PHARMA LTD. and
`AUROBINDO PHARMA USA, INC.,
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`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Shionogi Inc. and Andrx Labs, L.L.C. (collectively, “Plaintiffs”), by their
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`undersigned attorneys, hereby allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the
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`United States. This action relates to Abbreviated New Drug Application (“ANDA”) 20-9694
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`filed by Aurobindo Pharma USA, Inc. with the U.S. Food and Drug Administration (“FDA”) for
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`approval to engage in the commercial manufacture, use or sale of Metformin Extended Release
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`500 mg and 1000 mg Tablets, a generic version of Shionogi’s FORTAMET® Tablets, prior to
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`expiration of U.S. Patent Nos. 6,790,459 (the “’459 Patent”) and 6,866,866 (the “’866 Patent”)
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`(collectively, the “Patents-in-Suit”).
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`1
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`PARTIES
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`2.
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`Shionogi Inc. (“Shionogi”) is a corporation organized and existing under the laws
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`of the State of Delaware, having a principal place of business at 300 Campus Drive, Florham
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`Park, New Jersey 07932.
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`3.
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`Andrx Labs, L.L.C. (“Andrx”) is a Delaware limited liability company having a
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`place of business at 4955 Orange Drive, Davie, Florida 33314.
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`4.
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`Upon information and belief, Aurobindo Pharma Ltd. is a company organized and
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`existing under the laws of India, having a registered office at Plot No. 2 Maitrivihar, Ameerpet,
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`Hyderabad 500038, India, and a principal place of business at Water Mark Building, Plot No. 11,
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`Survey No. 9, Kondapur, Hitech City, Hyderabad 50084, Telangana, India. Upon information
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`and belief, Aurobindo Pharma Ltd. itself and through its wholly-owned subsidiary and agent,
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`Aurobindo Pharma USA, Inc., develops, manufactures and/or distributes generic drug products
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`for marketing, sale and/or use throughout the United States, including in this judicial district.
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`5.
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`Upon information and belief, Aurobindo Pharma USA, Inc. (“Aurobindo Pharma
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`USA” and collectively with Aurobindo Pharma Ltd., “Aurobindo”) is a company organized and
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`existing under the laws of the State of Delaware, having a principal place of business at 6
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`Wheeling Road, Dayton, New Jersey 08810. Upon information and belief, Aurobindo Pharma
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`USA is in the business of, among other things, developing, manufacturing, and selling generic
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`versions of branded pharmaceutical products for the U.S. market. Upon information and belief,
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`Aurobindo Pharma USA is a wholly owned subsidiary of Aurobindo Pharma Ltd. and is
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`controlled and/or dominated by Aurobindo Pharma Ltd. Upon information and belief,
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`Aurobindo Pharma USA develops, manufactures, and/or distributes generic drugs for marketing,
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`sale, and/or use throughout the United States, including in this judicial district, at the direction,
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`under the control, and for the benefit of Aurobindo Pharma Ltd.
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`2
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`6.
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`Upon information and belief, Aurobindo Pharma Ltd. established Aurobindo
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`Pharma USA for the purposes of developing, manufacturing, and distributing its generic drug
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`products throughout the United States, including in this judicial district.
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`7.
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`Upon information and belief, Aurobindo Pharma Ltd. operates in the United
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`States through Aurobindo Pharma USA.
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`8.
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`Upon information and belief, and consistent with their past practices, Aurobindo
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`Pharma Ltd. and Aurobindo Pharma USA acted collaboratively in the preparation and
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`submission of ANDA No. 20-9694.
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`9.
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`Upon information and belief, and consistent with their past practices, following
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`any FDA approval of ANDA No. 20-9694, Aurobindo Pharma Ltd. and Aurobindo Pharma USA
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`will work in concert with one another to make, use, offer to sell, and/or sell the generic drug
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`products that are the subject of ANDA No. 20-9694 throughout the United States, and/or impart
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`such generic drug products into the United States, including in this judicial district.
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`JURISDICTION AND VENUE
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`10.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100 et
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`seq., and jurisdiction exists under 28 U.S.C. §§ 1331 and 1338(a). Venue is proper in this Court
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`under 28 U.S.C. §§ 1391(c) and 1400(b).
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`11.
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`This Court has personal jurisdiction over Aurobindo Pharma Ltd. because, among
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`other things, Aurobindo Pharma Ltd. has committed, or aided, abetted, contributed to and/or
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`participated in the commission of, the tortious act of patent infringement in filing ANDA No. 20-
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`9694 that has led to foreseeable harm and injury to Plaintiffs, including Shionogi, a Delaware
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`corporation.
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`12.
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`This Court also has personal jurisdiction over Aurobindo Pharma Ltd. because of,
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`among other things, its marketing and sales activities in this judicial district, including but not
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`limited to the substantial, continuous, and systematic distribution, marketing, and/or sales of
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`pharmaceutical products in this judicial district, and the fact that it has availed itself of the rights
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`afforded in this judicial district. On information and belief, Aurobindo Pharma Ltd. has
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`purposefully conducted and continues to conduct substantial business in this judicial district,
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`from which it has derived, directly or indirectly, substantial revenue.
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`13.
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`This Court has personal jurisdiction over Aurobindo Pharma Ltd. because, on
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`information and belief, Aurobindo Pharma Ltd. develops, formulates, manufactures, markets and
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`sells pharmaceutical drug products, including generic drug products, throughout the United
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`States, and in this judicial district, through various directly or indirectly owned operating
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`subsidiaries, including its wholly-owned subsidiary Aurobindo Pharma USA. Moreover, on
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`information and belief, upon receiving FDA approval, Aurobindo Pharma Ltd. intends to market
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`and sell the proposed generic products at issue in this litigation in this judicial district.
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`14.
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`This Court also has personal jurisdiction over Aurobindo Pharma Ltd. because,
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`upon information and belief, Aurobindo Pharma Ltd. and Aurobindo Pharm USA work in
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`concert for purposes of developing, formulating, manufacturing, marketing and selling its
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`generic drug products throughout the United States, including Delaware, and Delaware is a likely
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`destination of Aurobindo Pharma Ltd.’s generic products.
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`15.
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`This Court has personal jurisdiction over Aurobindo Pharma USA because
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`Aurobindo Pharma USA is a citizen of the State of Delaware and has engaged in systematic and
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`continuous contacts with the State of Delaware. Upon information and belief, Aurobindo
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`Pharma USA is in the business of, among other things, importing, marketing, and selling generic
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`copies of branded pharmaceutical products for the U.S. market, including in this judicial district.
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`4
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`16.
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`Upon information and belief, Aurobindo Pharma USA holds a Pharmacy
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`Wholesale License from the State of Delaware under License No. A4-0001270. On information
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`and belief, Aurobindo Pharma USA holds a Distributor/Manufacturer License 00006550.
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`Moreover, on information and belief, Aurobindo Pharma USA is registered to do business in
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`Delaware (File Number 3769913) and has appointed a registered agent in Delaware (located at
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`The Corporation Service Company, 2711 Centerville Road Suite 400, Wilmington, DE 19808)
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`for the receipt of service of process.
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`17.
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`This Court also has personal jurisdiction over Aurobindo Pharma Ltd. and
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`Aurobindo Pharma USA because, upon information and belief, Aurobindo Pharma Ltd. and
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`Aurobindo Pharma USA have purposely availed itself of the rights and benefits of the laws of the
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`State of Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the
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`United States District Court for the District of Delaware. See, e.g., Allergan Sales LLC v.
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`Aurobindo Pharma Limited et al., Civil Action No. 15-1032 (D. Del.); Reckitt Benckiser LLC v.
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`Aurobindo Pharma Limited et al., Civil Action No. 14-1203 (D. Del.).
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`18.
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`Upon information and belief, Aurobindo Pharma Ltd. has, directly or through its
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`agent Aurobindo Pharma USA, filed an ANDA, and/or been actively involved in the preparation
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`and submission of an ANDA, for the purpose of seeking approval to engage in the commercial
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`manufacture, use, offer for sale, sale and/or importation of the generic drug product described in
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`ANDA No. 20-9694 in the United States, including Delaware.
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`19.
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`Upon information and belief, Aurobindo Pharma USA has filed an ANDA, and/or
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`been actively involved in preparation and submission of an ANDA, on behalf of Aurobindo
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`Pharma Ltd. for the purpose of seeking approval to engage in the commercial manufacture, use,
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`5
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`offer for sale, sale, and/or importation of the generic drug product described in ANDA No. 20-
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`9694 in the United States, including Delaware.
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`20.
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`On information and belief, Aurobindo Pharma Ltd. and Aurobindo Pharma USA
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`will act in concert, and intend to offer to sell and sell in this judicial district, the generic drug
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`product that will be manufactured as a result of any FDA approval of Aurobindo’s ANDA No.
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`20-9694, and based upon information and belief, this judicial district will be a destination of
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`products that will be manufactured and sold as a result of any FDA approval of Aurobindo’s
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`ANDA No. 20-9694.
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`21.
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`Aurobindo is subject to specific personal jurisdiction in this District based on the
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`filing of its ANDA with Paragraph IV certifications regarding the Patents-in-Suit. See Acorda
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`Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755 (Fed. Cir. 2016), cert. denied, 2017 WL
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`69716 (Jan. 9, 2017). Aurobindo’s ANDA filing, including its Paragraph IV certifications
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`regarding the Patents-in-Suit, is suit-related and has a substantial connection with this District
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`because it reliably, non-speculatively predicts activities in this District by Aurobindo.
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`Aurobindo “has taken the costly, significant step of applying to the FDA for approval to engage
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`in future activities – including the marketing of its generic drugs – that will be purposefully
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`directed at,” on information and belief, this District and elsewhere. Id. at 759. Aurobindo’s
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`“ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the
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`proposed generic drugs.” Id. at 760. On information and belief, Aurobindo “intends to direct
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`sales of its drugs into [Delaware], among other places once it has the requested FDA approval to
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`market them.” Id. at 758. “[T]he minimum-contacts standard is satisfied by the particular
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`actions [Aurobindo] has already taken – its ANDA filing[ ] – for the purpose of engaging in that
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`injury-causing and allegedly wrongful marketing conduct in” this District. Id. at 760.
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`6
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`22.
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`Exercising personal jurisdiction over Aurobindo in this District would not be
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`unreasonable given Aurobindo’s contacts in this District, the fact that Shionogi and Andrx are
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`both Delaware corporations, and the interest in this District of resolving disputes relating to
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`products to be sold herein.
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`23.
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`For these reasons, the Court has personal jurisdiction over Aurobindo.
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`PATENTS-IN-SUIT
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`24.
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`Andrx is the owner of United States Patent No. 6,790,459, which was duly and
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`legally issued on September 14, 2004, and is titled “Methods for Treating Diabetes Via
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`Administration of Controlled Release Metformin.” Shionogi has an exclusive license under the
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`’459 Patent in the United States. A copy of the ’459 Patent is attached as Exhibit A.
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`25.
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`Andrx is the owner of United States Patent No. 6,866,866, which was duly and
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`legally issued on March 15, 2005, and is titled “Controlled Release Metformin Compositions.”
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`Shionogi has an exclusive license under the ’866 Patent in the United States. A copy of the ’866
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`Patent is attached as Exhibit B.
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`ACTS GIVING RISE TO THIS ACTION
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`26.
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`Andrx is the holder of New Drug Application (“NDA”) No. 21-574, by which the
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`FDA granted approval for 500 mg and 1000 mg extended-release metformin hydrochloride
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`tablets. The metformin hydrochloride tablets described in Andrx’s NDA are indicated as an
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`adjunct to diet and exercise to lower blood glucose to improve glycemic control in adults with
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`Type 2 diabetes mellitus. Shionogi markets these tablets in the United States under the
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`tradename “FORTAMET®.”
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`27.
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`FORTAMET® and the use of FORTAMET® in accordance with its label is
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`covered by one or more claims of the Patents-in-Suit.
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`28.
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`The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations
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`(the “Orange Book”) lists the Patents-in-Suit in connection with FORTAMET®.
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`29.
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`By letter dated December 12, 2016 (the “Notice Letter”), Aurobindo notified
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`Andrx that it had submitted to the FDA ANDA No. 20-9694, seeking approval for the
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`commercial manufacture, use, and sale of Metformin Extended Release 500 mg and 1000 mg
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`Tablets (“the Aurobindo ANDA Products”) in the United States prior to the expiration of the
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`Patents-in-Suit.
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`30.
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`In the Notice Letter, Aurobindo notified Andrx that, as a part of its ANDA, it had
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`filed a certification under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) with respect to the Patents-in-Suit, asserting that those patents are invalid,
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`unenforceable and/or will not be infringed by the commercial manufacture, use, and sale of the
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`Aurobindo ANDA Products in the United States.
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`31.
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`By filing ANDA No. 20-9694, Aurobindo has necessarily represented to the FDA
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`that, upon approval, the Aurobindo ANDA Products will have the same active ingredient,
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`method of administration, dosage form, and strength as FORTAMET®, and will be
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`bioequivalent to FORTAMET®.
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`32.
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`This Complaint is being filed before the expiration of forty-five days from the
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`date Andrx received the Notice Letter.
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`COUNT ONE – INFRINGEMENT OF THE ’459 PATENT
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`Plaintiffs reallege paragraphs 1-33 as if fully set forth herein.
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`Aurobindo’s submission of ANDA No. 20-9694 to obtain approval to engage in
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`33.
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`34.
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`the commercial import, manufacture, use, offer for sale and/or sale of the Aurobindo ANDA
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`Products in the United States, prior to the expiration of the ‘459 patent, constitutes infringement
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`8
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`of the ‘459 patent pursuant to 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
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`equivalents.
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`35.
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`Upon information and belief, Aurobindo’s offering to sell, sale, making, and/or
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`importation of the Aurobindo ANDA Products, once ANDA No. 20-9694 is approved by the
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`FDA, would actively, intentionally, and knowingly induce infringement of at least one of the
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`claims of the ‘459 patent under 35 U.S.C. § 271(b), either literally or under the doctrine of
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`equivalents.
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`36.
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`On information and belief, the Aurobindo ANDA Products, if approved by the
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`FDA, will be imported by Aurobindo into the United States, offered for sale, and sold in the
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`United States by them or on their behalf, and will be administered by patients and/or medical
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`practitioners in the United States according to the directions and instructions in the proposed
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`package insert, which will constitute direct infringement by patients and/or medical practitioners
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`of at least one claim of the ’459 Patent, under 35 U.S.C. § 271(a), either literally or under the
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`doctrine of equivalents. On information and belief, the administration of the Aurobindo ANDA
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`Products will occur with Aurobindo’s specific intent and encouragement, and will be conduct
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`that Aurobindo knows or should know will occur. On information and belief, Aurobindo will
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`actively induce, encourage, aid, and abet that conduct by patients and/or medical practitioners,
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`with knowledge and specific intent that the conduct will be in contravention of Plaintiffs’ rights
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`under the ’459 Patent.
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`37.
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`Upon information and belief, Aurobindo’s offering to sell, sale, making, and/or
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`importation of the Aurobindo ANDA Products, once ANDA No. 20-9694 is approved by the
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`FDA, would contribute to infringement of at least one of the claims of the ’459 Patent under 35
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`U.S.C. § 271(c), either literally or under the doctrine of equivalents. On information and belief,
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`Aurobindo knows that the Aurobindo ANDA Products are especially made or adapted for use in
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`infringing the ’459 Patent, and that the Aurobindo ANDA Products are not suitable for
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`substantial non-infringing use.
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`38.
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`On information and belief, Aurobindo will induce infringement, under 35 U.S.C.
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`§ 271(b), or contribute to infringement, under 35 U.S.C. § 271(c) of at least independent claim 1
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`of the ’459 Patent, either literally or under the doctrine of equivalents. the Aurobindo ANDA
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`Products are “controlled release dosage form[s]” comprising “an effective dose of metformin,”
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`as required by claim 1. On information and belief, by the filing of ANDA No. 20-9694,
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`Aurobindo has necessarily represented that the Aurobindo ANDA Products have the same
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`indication, active ingredient, method of administration, dosage form, and strength as
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`FORTAMET®, and will be bioequivalent to FORTAMET®. On information and belief, the
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`Aurobindo ANDA Products therefore satisfy the remaining limitations of claim 1.
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`39.
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`In its Notice Letter, Aurobindo did not assert any independent basis for
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`noninfringement of any claim of the ’459 Patent apart from its allegation that the ’459 Patent
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`claims are invalid.
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`40.
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`Plaintiffs will be irreparably harmed if Aurobindo is permitted to make, use, sell,
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`offer to sell, and/or import the Aurobindo ANDA Products in or into the United States, and is not
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`enjoined from doing so. Plaintiffs are entitled to relief provided by 35 U.S.C. § 271(e)(4) and/or
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`283, including an order of this Court that the effective date of the approval of Aurobindo’s
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`ANDA No. 20-9694 be a date that is not earlier than the expiration date of the ’459 Patent, or
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`any later expiration of exclusivity for the ’459 Patent to which Plaintiffs are or become entitled,
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`and an injunction against such infringement. Plaintiffs do not have an adequate remedy at law.
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`COUNT TWO – INFRINGEMENT OF THE ‘866 PATENT
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`41.
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`Plaintiffs reallege paragraphs 1-41 as if fully set forth herein.
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`42.
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`Aurobindo’s submission of ANDA No. 20-9694 to obtain approval to engage in
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`the commercial import, manufacture, use, offer for sale and/or sale of the Aurobindo ANDA
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`Products in the United States, prior to the expiration of the ’866 Patent, constitutes infringement
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`of the ’866 Patent pursuant to 35 U.S.C. § 271(e)(2)(A), either literally or under the doctrine of
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`equivalents.
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`43.
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`On information and belief, the commercial manufacture, use, offer to sell, sale or
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`import of the Aurobindo ANDA Products that are the subject of ANDA No. 20-9694 would
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`infringe at least independent claim 1 of the ’866 Patent under 35 U.S.C. § 271(a), either literally
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`or under the doctrine of equivalents. The Aurobindo ANDA Products are “controlled release
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`oral dosage form[s]” comprising “an effective dose of metformin,” as required by claim 1. On
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`information and belief, by the filing of ANDA No. 20-9694, Aurobindo has necessarily
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`represented that the Aurobindo ANDA Products have the same indication, active ingredient,
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`method of administration, dosage form, and strength as FORTAMET®, and will be
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`bioequivalent to FORTAMET®. On information and belief, the Aurobindo ANDA Products
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`therefore satisfy the remaining limitations of claim 1.
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`44.
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`In its Notice Letter, Aurobindo did not assert any independent basis for
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`noninfringement of any claim of the ’866 Patent apart from its allegation that the ’866 Patent
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`claims are invalid.
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`45.
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`Plaintiffs will be irreparably harmed if Aurobindo is permitted to make, use, sell,
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`offer to sell, and/or import the Aurobindo ANDA Products in or into the United States, and is not
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`enjoined from doing so. Plaintiffs are entitled to relief provided by 35 U.S.C. § 271(e)(4) and/or
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`283, including an order of this Court that the effective date of the approval of Aurobindo’s
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`ANDA No. 20-9694 be a date that is not earlier than the expiration date of the ’866 Patent, or
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`any later expiration of exclusivity for the ’866 Patent to which Plaintiffs are or become entitled,
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`and an injunction against such infringement. Plaintiffs do not have an adequate remedy at law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs prays that this Court grant the following relief:
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`(a)
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`A judgment that Aurobindo’s submission of ANDA No. 20-9694 was an
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`act of infringement of one or more claims of the Patents-in-Suit, and that Aurobindo’s
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`manufacture, use, offer to sell, sale, or importation of the Aurobindo ANDA Products in or into
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`the United States prior to the expiration of the Patents-in-Suit, will infringe and/or actively
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`induce or contribute to the infringement of one or more claims of the Patents-in-Suit;
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`(b)
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`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
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`date of any FDA approval of Aurobindo’s ANDA No. 20-9694, shall not be earlier than the latest
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`expiration date of the Patents-in-Suit, including any extensions and/or additional periods of
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`exclusivity to which Plaintiffs are or become entitled;
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`(c)
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`An Order permanently enjoining Aurobindo, and its affiliates and
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`subsidiaries, and each of their officers, agents, servants, and employees, from making, having
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`made, using, offering to sell, selling, marketing, distributing, or importing in or into the United
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`States the Aurobindo ANDA Products, or any product or compound that infringes the Patents-in-
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`Suit, or inducing or contributing to the infringement of the Patents-in-Suit until after the latest
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`expiration date of the Patents-in-Suit, including any extension and/or additional periods of
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`exclusivity to which Plaintiffs are or become entitled;
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`(d)
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`Damages or other monetary relief to Plaintiffs if Aurobindo engages in
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`commercial manufacture, use, offers to sell, sale or importation in or into the United States of the
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`Aurobindo ANDA Products prior to the expiration of the latest expiration date of the Patents-in-
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`12
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`Suit, including any extensions and/or additional periods of exclusivity to which Plaintiffs are or
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`become entitled; and
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`(e)
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`Such further and other relief as this Court deems proper and just, including
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`any appropriate relief under 35 U.S.C. § 285.
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`Dated: January 25, 2017
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`BAYARD, P.A.
`
`OF COUNSEL:
`
`David B. Bassett
`Vinita Ferrera
`Wilmer Cutler Pickering Hale & Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, New York 10007
`(212) 230-8800
`David.Bassett@wilmerhale.com
`Vinita.Ferrera@wilmerhale.com
`
`Attorneys for Plaintiffs Shionogi Inc.
`
`/s/ Stephen B. Brauerman
`Stephen B. Brauerman (No. 4952)
`Sara E. Bussiere (No. 5725)
`222 Delaware Avenue, Suite 900
`P.O. Box 25130
`Wilmington, Delaware 19801
`(302) 655-5000
`sbrauerman@bayardlaw.com
`sbussiere@bayardlaw.com
`
`Attorneys for Plaintiffs Shionogi Inc. and
`Andrx Labs, L.L.C.
`
`13
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