Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 1 of 17 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`_______________________________________
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`SHILPA PHARMA, INC.,
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`
`
`
`
`
`Plaintiff,
`
`v.
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`
`
`
`
`C.A. No. _________
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`JURY TRIAL DEMANDED
`
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
`
`Defendant.
`
`
`COMPLAINT
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`
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`Plaintiff Shilpa Pharma, Inc. by its attorneys hereby alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is a civil action for patent infringement arising under the laws of the United
`
`States, Title 35, United States Code. This action relates to Defendant Novartis Pharmaceuticals
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`Corporation’s manufacture, use, offer to sell, and/or sale in the United States, and/or importation
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`into the United States of its GILENYA® Capsules, 0.5 mg and 0.25 mg strengths.
`
`PARTIES
`
`2.
`
`Shilpa Pharma, Inc. (“Shilpa”) is the U.S. operating company of Shilpa Medicare
`
`Limited, and is located at 1980 S Easton Rd., #220, Doylestown, Pennsylvania 18901.
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`3.
`
`Upon information and belief, Novartis Pharmaceuticals Corporation (“Novartis”)
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`is organized and existing under the laws of the state of Delaware, with its principal place of
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`business in East Hanover, New Jersey 07936.
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 2 of 17 PageID #: 2
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`JURISDICTION AND VENUE
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`4.
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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 this Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331
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`and 1338(a), and pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201, et seq.
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`5.
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`Upon information and belief, Novartis is in the business of manufacturing,
`
`marketing, and selling pharmaceutical products. Upon information and belief, Novartis directly,
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`or indirectly through its affiliates and/or distributors, markets, distributes, offers to sell and sells
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`its pharmaceutical products, including GILENYA®, within and throughout the United States,
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`including in the State of Delaware and throughout this judicial district.
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`6.
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`This Court has personal jurisdiction over Novartis because Novartis has engaged in
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`continuous and systematic contacts with the State of Delaware and/or purposefully availed itself
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`of this forum by, among other things, making, marketing, shipping, using, offering to sell or
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`selling, or causing others to use, offer to sell, or sell, Novartis’s pharmaceutical products in this
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`judicial district, including GILENYA®, and deriving substantial revenue from such activities.
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`Upon information and belief, this Court has personal jurisdiction over Novartis because Novartis
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`has committed, or aided, abetted, contributed to and/or participated in the commission of, the
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`tortious action of patent infringement that has led to foreseeable harm and injury to Shilpa, such
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`that Novartis should anticipate being haled into court in this judicial district.
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`7.
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`This Court also has personal jurisdiction over Novartis because it has frequently
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`availed itself of the legal protections of the State of Delaware by, among other things, admitting
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`jurisdiction in the United States District Court for the District of Delaware in numerous cases,
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`especially those relating to fingolimod hydrochloride. See e.g., Novartis AG et al. v. Actavis, Inc.,
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 3 of 17 PageID #: 3
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`et al., Civ. No. 1:14-cv-01487-LPS (D. Del., Dec. 16, 2014); Novartis AG et al. v. HEC Pharm
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`Co. Ltd., et al., Civ. No. 1:15-cv-00151-LPS (D. Del., Feb. 11, 2015); Novartis AG et al. v. Ezra
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`Ventures, LLC, Civ. No. 1:15-cv-00150-LPS (D. Del., Feb. 11, 2015); Novartis AG et al. v. Apotex
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`Inc. et al., Civ. No. 1:15-cv-00975-LPS (D. Del., Oct. 26, 2015); Novartis AG et al. v. Mylan
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`Pharmaceuticals, inc., et al., Civ. No. 1:16-cv-00289-LPS (D. Del., April 22, 2016); Novartis AG
`
`et al. v. Aurobindo Pharma Ltd., et al., Civ. No. 1:15-cv-00048-LPS (D. Del., Jan. 13, 2017); and
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`Novartis Pharm’s. Corp. v. Accord Healthcare Inc., et al., Civ. No. 1:18-cv-01043-KAJ (D. Del.,
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`July 16, 2018). Moreover, Novartis did not challenge that this Court had personal jurisdiction
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`over it in, e.g., Actavis Elizabeth LLC v. Novartis Pharmaceuticals Corp., et al., (C.A. 1:16-cv-
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`00604-RGA).
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`8.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and 1400(b)
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`because, among other things, Novartis is incorporated in the State of Delaware and therefore
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`“resides” in this judicial district for purposes of 28 U.S.C. § 1400(b).
`
`THE PATENT IN SUIT
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`9.
`
`United States Patent No. 9,266,816 (the “’816 Patent”), entitled “Fingolimod
`
`Polymorphs and Their Processes,” was duly and legally issued by the United States Patent and
`
`Trademark Office (“USPTO”) on February 23, 2016 naming inventors Vimal Kumar Shrawat,
`
`Veereshappa, Vinod Kumar Singh and Prashant Purohit, and was based on Application Ser. No.
`
`13/635,207 filed September 17, 2013. The ‘207 Application is in turn based on PCT Appln. No.
`
`PCT/IN2011/000586, filed August 29, 2011. A true and correct copy of the ’816 Patent is attached
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`hereto as Exhibit A.
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`10.
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`The ’816 Patent is assigned to Shilpa. Shilpa has the right to sue for and obtain
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`equitable relief and damages for infringement of the ’816 patent.
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`11.
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`The ‘816 patent disclosure is generally directed to novel polymorphic forms of
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`fingolimod, designated α-, β-, and µ- and processes for making the same. Fingolimod
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`hydrochloride has the IUPAC name of 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
`
`hydrochloride and has the following structure:
`
`
`
`12.
`
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`Fingolimod is a sphingosine 1-phosphate receptor (S1PR) modulator that reversibly
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`traps a proportion of lymphocytes in the lymph nodes, thereby reducing their recirculation in the
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`bloodstream and the central nervous system (CNS).
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`13.
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`The ‘816 patent describes and claims polymorphic Form-β and processes for
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`obtaining it by combining fingolimod hydrochloride with a specified solvent, heating to a specified
`
`temperature, cooling, and isolating the polymorphic form by recrystallization using a co-solvent.
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`Polymorphic Form-β is characterized by reference to specific peaks 2θ in a PXRD spectrum and
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`specific endothermic peaks in a DSC scan. The polymorphs are disclosed as highly pure (>99.5
`
`by HPLC) according to the process of the invention and useful in pharmaceutical preparations
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`when formulated with pharmaceutically acceptable excipients.
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 5 of 17 PageID #: 5
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`
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`ACTS GIVING RISE TO THIS ACTION
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`14.
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`Novartis is the holder of New Drug Application No. 022527 by which the FDA
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`granted approval for the commercial manufacturing, marketing, sale, and use of GILENYA®
`
`capsules. GILENYA® 0.5 mg was first approved by the FDA in September, 2010 and
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`GILENYA® 0.25 mg was approved by the FDA in May, 2018. GILENYA® is the brand name
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`for a drug whose active ingredient is fingolimod hydrochloride, useful for the treatment of
`
`relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older.
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`15.
`
`Upon information and belief, Novartis began commercialization of GILENYA®
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`0.5 mg and GILENYA® 0.25 mg (together, “GILENYA® Products”) after each product was
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`approved by the FDA.
`
`16.
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`GILENYA® is listed in the FDA’s “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” online book (the “Orange Book”). The product details for the 0.5 mg
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`EQ
`
`and
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`0.25
`
`mg
`
`EQ
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`presentations
`
`are
`
`found
`
`at
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`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=0
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`22527#21207.
`
`17.
`
`The Orange Book presently lists the following patents against the 0.5 mg
`
`GILENYA® product: U.S. Pat. No. 8,324,283 (the “‘283 patent”), U.S. Pat. No. 9,187,405 (the
`
`“‘405 patent”) and U.S. Pat. No. 10,543,179 (the “‘179 patent”). The 0.25 mg GILENYA®
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`product presently has a single patent listed against it: U.S. Pat. No. 9,592,208 (the “‘208 patent”).
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`The ‘283 and ‘208 patent claims are generally directed to compositions that include fingolimod,
`
`whereas the ‘405 and ‘179 patents are generally directed to methods of using fingolimod.
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`18.
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` On information and belief, fingolimod and other related compounds were first
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`disclosed in U.S. Pat. No. 5,604,229 (the “‘229 patent”), and found to be useful in the treatment
`
`or prevention of various autoimmune conditions, including multiple sclerosis. The ‘229 patent
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`issued February 18, 1997, was entitled “2-Amino-1,3-Propanediol Compound and
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`Immunosuppressant,” and claimed a number of compounds, including fingolimod.
`
`19.
`
`On information and belief, the ‘229 patent was owned by Mitsubishi Tanabe
`
`Pharma Corporation and Mitsui Sugar Co., Ltd. and exclusively licensed to Novartis. Novartis
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`listed the ‘229 patent in the Orange book with respect to its GILENYA® Products, and brought
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`multiple suits on the ‘229 patent against multiple defendants including at least Actavis, Inc., Ezra
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`Ventures, LLC, HEC Pharm Co., Ltd., Mylan Pharmaceuticals, Inc., Aurobindo Pharma Limited
`
`et al and Apotex, Inc. In each of those suits, Novartis asserted in its Complaint that GILENYA®
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`and methods for its use were covered by one or more claims of the ‘229 patent.
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`20.
`
`Novartis has obtained judgments of infringement of one or more of the ‘229 patent
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`claims against Actavis (D.I. 309, C.A. No. 14-1487-LPS (D. Del., June 9, 2017)); HEC Pharma
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`(D.I. 223, C.A. No. 15-00151-LPS (D. Del. June 9, 2017)); Ezra Ventures (D.I. 226, 15-00150-
`
`LPS (D. Del. June 9, 2017)), and Apotex (D.I. 142, 15-00975-LPS (D. Del. June 9, 2017)).
`
`21.
`
`On information and belief, the ‘229 patent was scheduled to expire on or about
`
`February 18, 2014. A February 12, 2014 patent term extension under 35 U.S.C. §156, extended
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`the term 5 years from the original expiration date. The ‘229 patent as extended has now expired,
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`and it is no longer listed in the Orange Book.
`
`22.
`
` In its November 8, 2010 Application for Patent Term Extension of the’229 patent
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`under §156, Novartis told the USPTO that the ‘229 patent contained product claims that covered
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`fingolimod, the active ingredient in GILENYA®. Novartis stated that Claims 1-3, 7-10, 35, 36
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`and 39 covered the fingolimod compound, and that Claims 40, 42, 48 and 52 claimed methods
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`using fingolimod. Claims 9, 10, 35 and 36 were said to name fingolimod specifically by its
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`chemical name, 2-amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol, and all four claims include
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`pharmaceutically acceptable salts of the compounds recited.
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`23.
`
`Novartis has represented to the above-identified parties it has sued, to this Court,
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`and to the USPTO that its GILENYA® Products are covered by multiple claims of the ‘229 patent,
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`whether by reference to chemical name or by appropriate substitution of generic formulae.
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`24.
`
`Example 28 of the ‘229 patent describes the preparation of fingolimod (2-amino-2-
`
`[2-(4-octylphenyl)ethyl]-1,3-propanediol), and Example 29 describes the preparation of its
`
`hydrochloride salt. In both Examples, the products are characterized by melting point and 1H-
`
`NMR analysis. Neither example refers to crystallinity of the compounds prepared and neither
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`PXRD data nor DSC data are provided.
`
`25.
`
` On information and belief, Novartis is aware that GILENYA® contains as an
`
`active ingredient a polymorphic form of fingolimod hydrochloride. In December 2009, Novartis
`
`Europharm Ltd submitted an application for Marketing Authorisation to the European Medicines
`
`Agency (EMA) for Gilenya. The application contained scientific and clinical information about
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`GILENYA® and its uses. A February 17, 2011 Assessment Report for GILENYA® by the EMA
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`states that “fingolimod hydrochloride exhibits polymorphism. The active substance used for
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`Gilenia [sic] is the polymorphic form I which is stable under the storage conditions specified in
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`the
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`SmPC
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`and
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`is
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`routinely
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`controlled
`
`in
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`the
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`specifications.”
`
`See
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`https://www.ema.europa.eu/documents/assessment-report/gilenya-epar-public-assessment-
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`report_en.pdf.
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`26.
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`Novartis Pharmaceuticals Australia Pty Limited applied for regulatory approval of
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`fingolimod hydrochloride in Australia, which was granted January 19, 2011. A March, 2011
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`Australian Public Assessment Report states that fingolimod hydrochloride “is a crystalline solid
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`that exists in at least five polymorphic forms.” See https://www.tga.gov.au/auspar/auspar-
`
`fingolimod.
`
`27.
`
`On information and belief, Novartis originally submitted to the FDA its New Drug
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`Application No. 022527 on December 18, 2009 for GILENYA® (fingolimod) 0.5 mg Capsules.
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`Included within its December 18, 2009 submission or any of its submissions dated between June
`
`15, 2009 and September 21, 2010 was data Novartis had developed characterizing the polymorphic
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`forms of fingolimod hydrochloride.
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`28.
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`In March, 2016, Shilpa Medicare Limited (parent company to Shilpa Pharma, Inc.)
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`advised Novartis of the issuance of the ‘816 patent. Representatives of each company met
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`subsequently when the ‘816 patent in respect of GILENYA® was discussed. After consideration,
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`Novartis did not further respond to Shilpa’s offer of a license. Thus, Novartis has had notice of
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`the ‘816 patent, and Shilpa’s view that the GILENYA® Products were covered by one or more of
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`its claims, since early 2016.
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`DEFENDANT’S INFRINGEMENT OF THE ‘816 PATENT
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`29.
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`The allegations provided below are exemplary and without prejudice to Plaintiff’s
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`infringement contentions that will be provided pursuant to the Court’s scheduling order, including
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`after discovery as provided under the Federal Rules of Civil Procedure. In providing these
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`allegations, Plaintiff does not convey or imply any particular claim constructions or the precise
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`scope of the claims of the ’816 patent. Plaintiff’s proposed claim constructions will be provided
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`pursuant to the Court’s scheduling order.
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`30.
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`PXRD analysis was performed on GILENYA® capsules, 0.5 mg. While the
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`strongest fingolimod peak at 3.600o 2θ was observed, on information and belief its peaks of lesser
`
`intensity were masked by peaks from other capsule ingredients, mannitol and magnesium stearate.
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`Fingolimod hydrochloride is present in an amount of 0.56 mg out of a 50 mg capsule fill weight,
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`and therefore comprises only about 1% of the formulation. In addition, on information and belief,
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`DSC analysis of fingolimod hydrochloride formulated as GILENYA® capsules 0.5 mg is not
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`directly possible. On information and belief, PXRD and DSC analyses on the active ingredient in
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`GILENYA® capsules 0.5 mg would yield data showing literal infringement of claims 2-4 of the
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`‘816 patent. Analysis of the GILENYA® capsules 0.25 mg was not performed because the amount
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`of fingolimod is even further reduced (by 50%) relative to the 0.5 mg. presentation. On
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`information and belief, the PXRD and DSC data analysis on the active ingredient in the 0.25 mg
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`presentation would be expected to be the same as that for the active ingredient in the 0.5 mg
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`presentation.
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`31.
`
`In order to analyze the solid state form of fingolimod hydrochloride, samples were
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`prepared according to Example 29 of the ‘229 patent in light of Novartis’ representations set forth
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`above. Fingolimod hydrochloride was prepared as described, followed by recrystallization from
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`ethanol. Although Example 29 is silent as to heating time, temperature, heating rate, the use of
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`vacuum, etc., those parameters were selected and the crystalline samples prepared thereby
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`contained representative PXRD peaks at 2θ = 3.5540o, 7.1022o, 10.6934o, 15.4036o, 20.5474o,
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`21.4795o and 25.1139o. These observed PXRD peaks are within the + 0.1o 2θ variance permitted
`
`by the ‘816 patent claims, which recite PXRD peaks at 2θ = 3.54o, 7.07o, 10.66o, 15.35o, 20.52o,
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`21.43o and 25.10o.
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`32.
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`The fingolimod hydrochloride prepared according to Example 29 was analyzed
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`using DSC, and the resultant thermogram contained four endotherms with well-defined peaks at
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`43.22oC, 68.36oC, 110.56oC, and 265.50oC. Each peak falls within the onset and the endpoint of
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`the endothermic event and each peak is squarely within the ranges of 40-45oC (Peak-1), 65-70oC
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`(Peak-2), 107-115oC (Peak-3) and 265-270oC (Peak-4) that are claimed in the ‘816 patent.
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`33.
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`On information and belief, Novartis’ GILENYA® Products contain as their active
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`ingredient crystalline fingolimod hydrochloride Form-β, having an X-ray powder diffraction
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`pattern that includes characteristic peaks at 2θ: 3.54o, 7.07o, 10.66o, 15.35o, 20.52o, 21.43o and
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`25.10o + 0.1 2θo, as claimed in the ‘816 patent.
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`34.
`
`On information and belief, Novartis’ GILENYA® Products contain as their active
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`ingredient crystalline fingolimod hydrochloride Form-β, having DSC curves for the heating scans
`
`that include endothermic peaks ranging between 40-45oC (Peak-1), 65-70oC (Peak-2), 107-115oC
`
`(Peak-3) and 265-270oC (Peak-4), as claimed in the ‘816 patent.
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`35.
`
` On information and belief, Defendant’s manufacture, use, offer to sell, and/or sale
`
`in the United States, and/or importation into the United States of its GILENYA® Products without
`
`authority literally infringes Claims 2-4 of the ‘816 patent under 35 U.S.C. § 271(a) because the
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`fingolimod hydrochloride active ingredient contained therein has the PXRD peaks and DSC
`
`endotherms claimed for Form β in Claims 2-4 of the ‘816 patent. In the alternative, if any claimed
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`peak or endotherm is not literally present in the GILENYA® Products’ fingolimod hydrochloride,
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`on information and belief any such difference would be insubstantial and the GILENYA®
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`Products will infringe one or more of Claims 2-4 of the ‘816 patent based on the doctrine of
`
`equivalents.
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`36.
`
`On information and belief, Defendant is liable for infringement of Claims 2-4 of
`
`Plaintiff’s ‘816 patent under 35 U.S.C. § 271(b) based on its active marketing and promotion of
`
`its GILENYA® Products, as well as the supply of its product label which encourages the use of
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`GILENYA® for at least the uses described therein. On information and belief Novartis has, and
`
`will continue to, intentionally encourage acts of direct infringement with knowledge of the ’816
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`Patent and knowledge that its acts are encouraging infringement.
`
`37.
`
`On information and belief, Defendant is liable for infringement of Claims 2-4 of
`
`Plaintiff’s ‘816 patent under 35 U.S.C. § 271(c). On information and belief, Defendant has had,
`
`and continues to have, knowledge of the ’816 Patent and knowledge that its acts will lead to
`
`infringement of the patent. On information and belief, Defendant has had, and continues to have,
`
`knowledge that its fingolimod hydrochloride active pharmaceutical ingredient is especially made
`
`or adapted for a use that infringes the ’816 Patent and that there are no substantial non infringing
`
`uses for its fingolimod hydrochloride product.
`
`38.
`
`As a separate basis for infringement, the crystal structures for two polymorphic
`
`forms of fingolimod hydrochloride have been published by Wang et al., “Insight into the
`
`conformational polymorph transformation of a block-buster multiple sclerosis drug fingolimod
`
`hydrochloride (FTY 720),” J. Pharm. Biomed. Anal. 2015, 109, 45-51. (“Wang”). These crystal
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`forms are referred to as “Form I” and “Form II”. The Wang authors state that three different
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`polymorphs (Forms I-III) were disclosed in Novartis’ 2010 published patent application, WO
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`2010/055028 A2, and that while PXRD and DSC data had been provided, single crystal diffraction
`
`data of fingolimod hydrochloride had not been reported.
`
`39.
`
`The Wang authors performed and obtained single crystal XRD on a sample of
`
`fingolimod hydrochloride (Form I) obtained from a commercial source. They reported the
`
`conversion from Form I to Form II and they submitted the crystal structure data for Forms I and II
`
`to the Cambridge Crystallographic Data Centre (“CCDC”), which serves as a depository for
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`crystallographic data collected by scientists throughout the world. Crystallographic data
`
`submitted to the CCDC used a standard file format called the “crystallographic information file”
`
`or “CIF” file format for short. CIF files are made available to the public for download from the
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`CCDC website. https://www.ccdc.cam.ac.uk/structures/
`
`40.
`
`The CIF file for Form I was submitted as No. 942684, and for Form II was
`
`submitted as No. 942685. The CIF file provides inter alia all the information necessary to describe
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`structures of the individual molecules contained within the crystal structure as well as a
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`mathematical description of how those molecules are packed in 3-dimensional space. This
`
`information can be used to prepare the chemical structure diagrams and molecular packing
`
`diagrams that, for example, are shown in Figures 3 -5 of Wang.
`
`41.
`
`The CIF file may be also used in combination with other software to provide a
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`simulated X-ray powder diffraction pattern (XRPD pattern) based on the locations of the atoms
`
`and molecules determined by the crystal structure analysis. These simulated XRPD patterns are
`
`not actual powder patterns collected on bulk samples, but are the idealized representations of the
`
`XRPD pattern for that given crystal form. Simulated XRPD patterns obtained from
`
`crystallographic data (also referred to as “calculated” XRPD patterns) offer an opportunity to
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`compare crystallographic data from single crystal structural analysis to XRPD data collected on
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`bulk samples. The data contained in a CIF file also provides the data required to generate a list
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`of XRPD peak locations in either D-space or degrees 2θ that would be expected to be present in
`
`the experimental XRPD pattern for the same crystal form of that material.
`
`42.
`
`Scientists rely on computer software to generate simulated XRPD patterns from the
`
`data contained in the CIF Files. Many programs are available but one common program is
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`“Mercury” which runs on a variety of computing platforms and is freely available through the
`
`Cambridge Crystallographic Data Centre:
`
`https://www.ccdc.cam.ac.uk/solutions/csd-
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`core/components/mercury/. Mercury allows for scientists to obtain summary listings of XRPD
`
`peak positions in D-space, which may be then converted to degrees 2θ using the well-known Bragg
`
`equation. Mercury also provides for the data for simulated XRPD patterns to be exported as a
`
`series of x-y data points that may be plotted using a number of mathematical graphing programs.
`
`43.
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`The crystallographic data in the CIF file for fingolimod hydrochloride Form I was
`
`used with the Mercury software to generate expected PXRD peak positions in degrees 2θ, and was
`
`compared to those identified for Form-β as disclosed in US Patent No. US 9,266,816. All peaks
`
`for claimed Form-β are present in the peak list for Form I as calculated from the Wang data.
`
`
`
`
`
`
`XRPD Peak Position Calculated from Wang
`Form I Structure CCDC No. 942684
`3.57
`7.15
`10.73
`15.46
`20.60
`21.55
`25.20
`
`XRPD Form Beta Peak Position Claim 1 of
`US 9,266,816 (+/- 0.1 deg 2-theta)
`3.54
`7.07
`10.66
`15.35
`20.52
`21.43
`25.10
`
`
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 14 of 17 PageID #: 14
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`44.
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`Based on the predictive PXRD pattern of fingolimod hydrochloride generated from
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`data in the Cambridge Crystal Database, the fingolimod hydrochloride in Defendant’s
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`GILENYA® contains each of the peaks recited in the ‘816 patent within the specified tolerances.
`
`COUNT ONE
`Infringement of the ‘816 Patent
`
`Plaintiff realleges and incorporates each of the preceding paragraphs as if fully set
`
`45.
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`forth herein.
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`46.
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`On information and belief, Defendant has infringed, and is infringing, claims 2-4
`
`of the ’816 patent through its manufacture, use, offer to sell, and/or sale in the United States of
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`GILENYA® Products or their active ingredient fingolimod hydrochloride, and/or importation of
`
`GILENYA® Products or their active ingredient fingolimod hydrochloride into the United States.
`
`Defendant is liable for infringement at least pursuant to 35 U.S.C. § 271(a), literally or under the
`
`doctrine of equivalents.
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`47.
`
`On information and belief, Defendant is liable for infringement of claims 2-4 of
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`Plaintiff’s ‘816 patent under 35 U.S.C. § 271(b) based on its active marketing and promotion of
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`its GILENYA® Products, as well as the supply of its product label which encourages the use of
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`GILENYA® for at least the uses described therein. Unless enjoined by this Court, Defendant will
`
`intentionally encourage acts of direct infringement with knowledge of the ’816 Patent and
`
`knowledge that its acts are encouraging infringement.
`
`48.
`
`On information and belief, Defendant is liable for infringement of claims 2-4 of
`
`Plaintiff’s ‘816 patent under 35 U.S.C. § 271(c). Defendant has had, and continues to have,
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`knowledge of the ’816 Patent and knowledge that its fingolimod hydrochloride active
`
`pharmaceutical ingredient is especially made or adapted for a use that infringes the ’816 Patent
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`14
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 15 of 17 PageID #: 15
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`and that there are no substantial non infringing uses for its fingolimod hydrochloride product.
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`Unless enjoined by this Court, Defendant will continue its contributory infringement of the ‘816
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`patent.
`
`49.
`
`On information and belief, Defendant was aware of the ’816 patent since at least
`
`March, 2016, when Shilpa Medicare Limited first notified Defendant of the ‘816 patent and
`
`informed them of Plaintiff’s belief that GILENYA® was covered by one or more of its claims.
`
`50.
`
`On information and belief, Defendant knows or should know that the manufacture,
`
`use, offer to sell, and/or sale in the United States, and/or importation into the United States of its
`
`GILENYA® Products (and the active ingredient fingolimod hydrochloride therein) constitute
`
`infringement of the ’816 patent without a good faith belief that the ’816 patent is invalid or not
`
`infringed. On information and belief, despite this knowledge, Defendant deliberately and
`
`intentionally continues to manufacture, use, offer to sell, and/or sell in the United States, and/or
`
`import into the United States, its infringing GILENYA® Products without authorization from
`
`Plaintiff.
`
`51.
`
`Plaintiff has suffered and will continue to suffer damages as a direct and proximate
`
`result of Defendant’s infringement, and willful infringement, of the ’816 patent. Thus, Plaintiff is
`
`entitled to recover its costs and damages for such tortious actions pursuant to 35 U.S.C. § 284 in
`
`an amount to be proven at trial. This case is exceptional and Plaintiff is entitled to an award of
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`52.
`
`Plaintiff will be irreparably harmed by Defendant’s infringing activities unless it is
`
`enjoined by this Court. Plaintiff has no adequate remedy at law.
`
`
`
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`15
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 16 of 17 PageID #: 16
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`
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`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`A. A judgment that Defendant has infringed and is infringing the ’816 patent, and is
`
`liable for such infringement under 35 U.S.C. § 271(a);
`
`B. A declaratory judgment that Defendant’s commercial manufacture, use, offer to
`
`sell, and/or sale in the United States, and/or importation into the United States of its GILENYA®
`
`Products would infringe the ’816 patent;
`
`C.
`
`An order enjoining Defendant, its officers, agents, employees, attorneys, and all
`
`other persons or entities acting in concert, participation or in privity with one or more of them, and
`
`their successors and assigns, from infringing the ’816 patent;
`
`D.
`
`A permanent injunction restraining and enjoining Defendant, its officers, agents,
`
`employees, attorneys, and all other persons or entities acting in concert, participation or in privity
`
`with one or more of them, and their successors and assigns, from engaging in the commercial
`
`manufacture, use, offer to sell, and/or sale in the United States, and/or importation into the United
`
`States of its GILENYA® Products, until the expiration of the ’816 patent, including any extensions
`
`and/or additional periods of exclusivity to which Plaintiff is or may become entitled;
`
`E. A judgment, declaration or order that Defendant’s infringement is willful and
`
`increasing damages under 35 U.S.C. § 284;
`
`F.
`
`A judgment declaring that this is an exceptional case and awarding Plaintiff’s
`
`reasonable attorneys’ fees and costs in this action, as provided by 35 U.S.C. § 285;
`
`
`16
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`Case 1:21-cv-00558-UNA Document 1 Filed 04/21/21 Page 17 of 17 PageID #: 17
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`G.
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`Full compensatory monetary damages for actual loss, disgorgement of Defendant’s
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`profits unjustly obtained, reasonable royalties, and exemplary damages for infringement of
`
`Plaintiff’s ‘816 patent;
`
`H.
`
`A judgment awarding Plaintiff such damages, in an amount to be determined at
`
`trial, together with prejudgment and post-judgment interest and costs as fixed by the Court, and
`
`the expended costs and reimbursements of the action;
`
`I.
`
`Any and all other and further relief as the Court deems just and proper.
`
`JURY DEMAND
`
`Plaintiff demands a trial by jury on all issues so triable in this Complaint.
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`Dated: April 20, 2021
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`
`
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`
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`OF COUNSEL:
`
`SUGHRUE MION, PLLC
`Michael R. Dzwonczyk
`Chidambaram S. Iyer
`2000 Pennsylvania Ave., NW
`Washington, DC 20037
`(202) 293-7060
`mdzwonczyk@sughrue.com
`ciyer@sughrue.com
`
`
`
`
`
`
`
`
`
`
`
`
`SMITH, KATZENSTEIN & JENKINS LLP
`
`
`/s/ Neal C. Belgam
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`Attorneys for Plaintiff Shilpa Pharma, Inc.
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`17
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`