Case 1:20-cv-00580-LPS Document 1 Filed 04/28/20 Page 1 of 10 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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`JURY TRIAL DEMANDED
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`NOVO NORDISK HEALTHCARE AG and
`NOVO NORDISK INC.,
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`Plaintiffs,
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`v.
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`LABORATOIRE FRANCAIS DU
`FRACTIONNEMENT ET DES
`BIOTECHNOLOGIES S.A. and
`HEMA BIOLOGICS, LLC,
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`Defendants.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Novo Nordisk Healthcare AG and Novo Nordisk Inc. (together, “Novo
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`Nordisk”), by their undersigned attorneys, for their Complaint, 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 of U.S. Patent No. 9,102,762 (the
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`“’762 patent” or the “Asserted Patent,” Exhibit A) under the patent laws of the United States,
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`Title 35 of the United States Code by Novo Nordisk against Laboratoire Francais du
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`Fractionnement et des Biotechnologies S.A. and Hema Biologics, LLC (together, “Defendants”).
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`The invention of the ’762 patent relates to a novel method for improving the viral safety of liquid
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`Factor VII compositions, particularly those comprising active Factor VII (“FVIIa”) polypeptides.
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`Exhibit A at Abstract.
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`2.
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`This action arises from the Defendants’ current and/or imminent manufacture,
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`use, sale, offer to sell within the United States, and/or importation into the United States of
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`Defendants’ medicinal product “SEVENFACT®.” Exhibit B. According to its Highlights of
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`Prescribing Information, SEVENFACT® uses recombinant activated Factor VII (“rFVIIa”) to
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`promote hemostasis in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX,
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`respectively. Exhibit B at 2. On information and belief, Defendants use the novel method of the
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`’762 patent in the manufacture of SEVENFACT®.
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`THE PARTIES
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`3.
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`Plaintiff Novo Nordisk Healthcare AG (“NNHAG”) is an entity organized and
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`existing under the laws of Switzerland, and has its principal place of business at
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`Thurgauerstrasse 36-38, Zurich, Switzerland.
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`4.
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`Plaintiff Novo Nordisk Inc. (“NNI”) is a corporation organized and existing under
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`the laws of the State of Delaware, and has its principal place of business at 800 Scudders Mill
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`Road, Plainsboro, New Jersey, 08536.
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`5.
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`On information and belief, Laboratoire Francais du Fractionnement et des
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`Biotechnologies S.A. (“LFB S.A.”) is a corporation organized and existing under the laws of
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`France, having a principal place of business at 3 avenue des Tropiques, BP 40 305, 91 958
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`Courtaboeuf Cedex, Les Ulis, France. On April 1, 2020, the FDA granted approval of
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`SEVENFACT® to LFB S.A. Exhibit C at 2. LFB S.A. developed and manufactures and/or will
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`imminently manufacture SEVENFACT® for sale in the United States. Exhibit C at 2; see also
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`Exhibit B at 23.
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`6.
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`On information and belief, Hema Biologics, LLC (“Hema”) is a limited liability
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`company organized and existing under the laws of the State of Delaware, having a principal
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`place of business at 4441 Springdale Road, Louisville, Kentucky, 40241. Hema has
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`commercialization and distribution rights for SEVENFACT® in the United States and sells
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`and/or will imminently sell SEVENFACT® in the United States. Exhibit C at 2; see also Exhibit
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`B at 23.
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`SUBJECT MATTER JURISDICTION
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`7.
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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., generally, and 35 U.S.C. § 271(a) and (g), specifically. This Court has jurisdiction over the
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`subject matter of this action pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202.
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`PERSONAL JURISDICTION AND VENUE
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`8.
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`On information and belief, LFB S.A., directly or indirectly through its affiliates
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`and agents, including but not limited to Hema, markets and sells, or will imminently market and
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`sell, SEVENFACT® throughout the United States, including in this judicial district. Further, on
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`information and belief, LFB S.A., the manufacturer of SEVENFACT®, will import the product
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`into the United States for Hema to immediately or imminently sell throughout the United States,
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`including in this judicial district. Moreover, LFB S.A. has placed, and/or will imminently place,
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`the infringing SEVENFACT® into the stream of commerce, with the knowledge and/or
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`understanding that such product will be sold in the State of Delaware providing the LFB
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`Defendants with substantial revenues.
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`9.
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`This Court has personal jurisdiction over LFB S.A. because, inter alia, LFB S.A.,
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`on information and belief: (1) has substantial, continuous, and systematic contacts with this
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`State, either directly or through at least one of its wholly-owned subsidiaries or agents; (2)
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`intends to market, sell, and/or distribute infringing products to residents of this State directly or
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`through at least one of its wholly-owned subsidiaries or agents; (3) enjoys or imminently will
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`enjoy substantial income from sales of its pharmaceutical products in this State on its own and
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`through Hema, a Delaware limited liability company; and (4) is a partner in Hema.
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`10.
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`In the alternative, this Court may exercise jurisdiction over LFB S.A. pursuant to
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`Fed. R. Civ. P. 4(k)(2) because: (a) Novo Nordisk’s claims arise under federal law; (b) LFB
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`S.A. would be a foreign defendant not subject to personal jurisdiction in the courts of any State;
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`and (c) LFB S.A. has sufficient contacts with the United States as a whole, including, but not
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`limited to, filing a BLA with the FDA and conducting clinical trials throughout the United
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`States, such that this Court’s exercise of jurisdiction over LFB S.A. satisfies due process. See,
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`e.g., Exhibit C.
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`11.
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`On information and belief, Hema, directly or indirectly through its affiliates and
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`agents, markets and sells, or will imminently market and sell, SEVENFACT® throughout the
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`United States, including in this judicial district.
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`12.
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`This Court has personal jurisdiction over Hema because, inter alia, Hema, on
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`information and belief: (1) is organized under the laws of the State of Delaware and (2) intends
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`to market, sell, and/or distribute the infringing SEVENFACT® to residents of this State directly
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`or through at least one of its wholly-owned subsidiaries or agents.
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`13.
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`This Court additionally has personal jurisdiction over Hema because, on
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`information and belief, Hema has knowingly induced and/or contributed to, and/or will
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`imminently knowingly induce and/or contribute to, infringement within this District by
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`advertising, marketing, offering for sale, and/or selling infringing SEVENFACT® within this
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`District, to consumers, customers, distributors, resellers, partners, and/or end users, and
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`providing instructions, advertising, and/or marketing materials that facilitate, direct, or encourage
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`the use of infringing products with knowledge thereof.
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`14.
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`Venue is proper in this Court because, inter alia, 1) Hema resides in this judicial
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`district (28 U.S.C. § 1400(b)) and 2) LFB S.A. is a foreign corporation not residing in any United
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`States district and may be sued in any judicial district (28 U.S.C. § 1391(c)).
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`THE ASSERTED PATENT
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`15.
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`On August 11, 2015, the United States Patent and Trademark Office issued the
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`ʼ762 patent, entitled “Virus Filtration of Liquid Factor VII Compositions.” Exhibit A. NNHAG
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`is the owner of all right, title, and interest in the ’762 patent.
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`16.
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`The ’762 patent explains that the purification and handling of Factor VII must be
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`done carefully, due to the possibility for degradation of the molecule. Exhibit A at col.1 ll.45-51.
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`Accordingly, the prior art processes for manufacturing Factor VII involved the step of virus-
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`filtration of a solution comprising inactive Factor VII. Exhibit A at col.1 l.66-col.2 l.3.
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`17.
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`Contrary to the prior art processes and conventional wisdom, the inventors of the
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`’762 patent nanofiltered a partially-activated recombinant Factor VII solution. Exhibit A at
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`Example 5, col.17-18. Recombinant activated Factor VII is used to promote hemostasis in
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`hemophilia A or B patients with inhibitors to Factor VIII or Factor IX, respectively. Surprisingly
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`they found that degradation barely increased following filtration of rFVIIa. Exhibit A at Example
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`5, col.17-18. This led them to conclude that nanofiltration may be applied even after the Factor
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`VII polypeptide has been partially or fully activated and, thereafter, they applied for and obtained
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`the ’762 patent. Exhibit A at col.3 ll.46-48.
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`18.
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`Claim 1 of the ’762 patent claims:
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`A method for removing viruses from a liquid composition of recombinant Factor VII
`comprising one or more Factor VII polypeptides having a concentration in the range of
`0.01 to 5 mg/mL, the method comprising subjecting the liquid composition to
`nanofiltration using a nanofilter having a pore size of 80 nm or less, wherein 50-100% of
`the Factor VII polypeptides in the composition subjected to the nanofilter are in an
`activated form (FVIIa) prior to nanofiltration.
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`19.
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`The claimed processes of the ’762 patent are used in the manufacture of Novo
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`Nordisk’s medicinal product NovoSeven®. NovoSeven® is composed of recombinant human
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`coagulation Factor VIIa (rFVIIa) and has multiple indications, including promoting hemostasis
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`in hemophilia A or B patients with inhibitors. The manufacture of NovoSeven® includes a
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`chromatographic purification process, during which recombinant Factor VII is converted to the
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`active form. Exhibit D. This purification process for NovoSeven® removes viruses. Id.
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`DEFENDANTS’ INFRINGING PRODUCT AND ACTIVITIES
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`20.
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`LFB S.A. developed the medicinal product SEVENFACT® using recombinant
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`activated Factor VII (rFVIIa) and intends to begin commercial manufacture of the product as
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`promoting hemostasis in hemophilia A or B patients with inhibitors. Exhibit E at 37; see also
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`Exhibit B at 2.
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`21.
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`SEVENFACT® is a sterile, white to off-white lyophilized powder in a single-use
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`vial containing either 1 mg or 5 mg of rFVIIa as the active ingredient. SEVENFACT® is
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`produced by recombinant DNA technology using genetically engineered rabbits into which the
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`DNA coding sequence for human Factor VII has been introduced. During purification and
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`processing, Factor VII is enzymatically converted to activated Factor VII. The manufacturing
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`process of SEVENFACT® includes specific steps to reduce impurities. Exhibit B at 12-13.
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`Defendants have indicated that the purification process for SEVENFACT® also includes steps
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`that are validated to inactivate or remove viruses. Id.
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`22.
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`LFB S.A. has acknowledged that its manufacturing facility in France “is capable
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`of carrying out the process claimed in the ’762 patent for producing products using rFVIIa,” as
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`well as acknowledged its desire to manufacture products by carrying out the process claimed in
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`the ’762 patent. See Exhibit E at 38.
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`23.
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`Upon information and belief, Defendants have infringed and/or will imminently
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`infringe (literally and/or under the doctrine of equivalents), directly, and/or through agents or
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`intermediaries, one or more claims of the ’762 patent, including at least claim 1 of the ’762
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`patent, by making, using, offering for sale, and/or selling in the United States, SEVENFACT®.
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`24.
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`On information and belief, LFB S.A. manufactures SEVENFACT® using the
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`method set forth in claim 1 of the ’762 patent. Specifically, LFB S.A., in manufacturing
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`SEVENFACT®, removes viruses from a liquid composition of rFVIIa; the rFVIIa polypeptides
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`in the liquid composition have a concentration in the rage of 0.01-5 mg/mL; nanofiltration of the
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`liquid composition is performed using a nanofilter having a pore size of 80 nm or less; and at
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`least about 50% of the Factor VII polypeptides in the composition subjected to the nanofilter are
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`activated prior to nanofiltration.
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`25.
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`Unless enjoined by this Court, now that SEVENFACT® has been approved by the
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`FDA, Defendants will immediately make, use, offer to sell, or sell SEVENFACT® within the
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`United States, and/or will immediately import SEVENFACT® into the United States.
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`26.
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`LFB S.A. has announced that it is building new industrial facilities in France “to
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`substantially increase [LFB S.A.’s] bioproduction capacities for recombinant medicinal products,
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`particularly for [LFB S.A.’s] activated Factor VII.” See Exhibit F at 3.
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`27.
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`LFB S.A. has also announced that it “continued the extension of its cell culture
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`plant [], giving it the capacities to meet needs for activated Factor VII production. . . .” Exhibit F
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`at 6.
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`28.
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`LFB S.A. has also announced that it began construction of a plant in the United
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`States in 2016 for the purification process of recombinant products resulting from its claimed
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`proprietary rPRO technology with which it makes SEVENFACT®. See Exhibit F at 6.
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`29.
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`On October 7, 2016, LFB S.A. filed a petition with the Patent Trial and Appeal
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`Board (“PTAB”) seeking inter partes review of the ’762 patent. On April 5, 2018, the PTAB
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`issued its Final Written Decision on the initially instituted grounds, rejecting LFB S.A.’s validity
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`challenges as to all claims of the ’762 patent. Still pending is the Final Written Decision on the
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`grounds that were originally rejected by the PTAB, then instituted, fully briefed, and argued
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`following and in view of the Supreme Court’s decision in SAS Institute, Inc. v. Iancu.
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`30.
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`Defendants’ infringement has been willful. They have engaged in the claimed
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`methods of the ’762 patent with knowledge of the ’762 patent and its validity and without a
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`license or permission to practice the inventions claimed therein.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,102,762
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`31.
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`Novo Nordisk realleges and incorporates by reference the allegations of
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`paragraphs 1-30 as if fully set forth herein.
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`32.
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`Upon information and belief, as set forth above, Defendants’ sale, offer for sale or
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`commercial manufacture of SEVENFACT® within the United States, or importation of
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`SEVENFACT® into the United States, during the term of the ʼ762 patent infringes and will
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`infringe at least claim 1 of the ʼ762 patent under 35 U.S.C. § 271(a) and/or (g).
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`33.
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`As a result of Defendants’ infringement of the ’762 patent, Novo Nordisk will
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`suffer damages in an amount to be determined, but no less than a reasonable royalty.
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`34.
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`Defendants’ infringement of the ’762 patent was willful, wanton, and deliberate,
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`justifying an award to Novo Nordisk of increased damages under 35 U.S.C. § 284, and attorneys’
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`fees and costs incurred under 35 U.S.C. § 285.
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`35.
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`Novo Nordisk will be harmed substantially and irreparably if Defendants are not
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`enjoined from infringing the ʼ762 patent.
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`COUNT FOR DECLARATORY JUDGMENT OF
`INFRINGEMENT OF U.S. PATENT NO. 9,102,762
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`36.
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`Novo Nordisk realleges and incorporates by reference the allegations of
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`paragraphs 1-35 as if fully set forth herein.
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`37.
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`On information and belief, the FDA approval of SEVENFACT® to market in the
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`United States, coupled with Defendants’ intent to launch SEVENFACT® for sale in the United
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`States soon following that approval, create an actual, immediate, and real controversy under the
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`Declaratory Judgment Act that Defendants will directly or indirectly infringe the ’762 patent
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`prior to its expiration.
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`38.
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`Defendants’ infringement of the ’762 patent will be willful. LFB S.A. challenged
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`the validity of the ’762 patent before the PTAB, yet continued to develop and seek to
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`commercialize SEVENFACT® knowing that its practice of the claimed invention of the ’762
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`patent in manufacturing SEVENFACT® and subsequent sale and offer for sale would constitute
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`infringement.
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`PRAYER FOR RELIEF
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`WHEREFORE, Novo Nordisk prays for a judgment in its favor and against Defendants
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`and respectfully requests the following relief:
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`A.
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`A judgment that Defendants have infringed the ʼ762 patent;
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`B.
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`A judgment, pursuant to 35 U.S.C. § 283, preliminarily and permanently
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`enjoining Defendants, their officers, agents, servants, and employees, and those persons in active
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`concert or participation with any of them, from manufacturing, using, offering to sell, or selling
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`SEVENFACT® within the United States, or importing SEVENFACT® into the United States,
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`prior to the expiration of the ’762 patent, including any extensions, adjustments, and
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`exclusivities;
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`C.
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`A judgment awarding monetary damages, in the form of lost profits, but in no
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`event less than a reasonable royalty, on past and future infringing sales, together with interest for
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`Defendants’ sale, offer to sell, use, and/or commercial manufacture of SEVENFACT® within the
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`United States, or importation of SEVENFACT® into the United States, prior to the expiration of
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`the ’762 patent, including any extensions, adjustments, and exclusivities;
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`D.
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`A judgment that the infringement has been willful and an enhancement of
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`damages;
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`E.
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`A declaration that this is an exceptional case and an award of attorneys’ fees
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`pursuant to 35 U.S.C. § 285;
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`F.
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`An award of Novo Nordisk’s costs and expenses in this action; and
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`G.
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`Such other relief as the Court deems just and proper.
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`DEMAND FOR JURY TRIAL
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`Novo Nordisk requests a trial by jury on all issues properly triable by jury.
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`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
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`OF COUNSEL:
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`Jeffrey J. Oelke
`Catherine H. McCord
`Katy Easterling
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 430-2600
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`April 28, 2020
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`/s/ Brian P. Egan
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`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`began@mnat.com
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`Attorneys for Plaintiffs
`Novo Nordisk Healthcare AG and
`Novo Nordisk Inc.
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