Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 1 of 17 PageID #: 1
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`Epitopix, LLC d/b/a Vaxxinova US,
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`Plaintiff,
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`v.
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`Elanco Animal Health, Inc.,
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`Defendant.
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
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`Cause No.
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`JURY TRIAL DEMANDED
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`COMPLAINT
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`Plaintiff Epitopix, LLC d/b/a Vaxxinova US (“Plaintiff” or “Vaxxinova”), by its
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`undersigned attorneys, for its complaint against Elanco Animal Health, Inc. (“Defendant” or
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`“Elanco”), hereby states and alleges as follows:
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`The Parties
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`1.
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`Vaxxinova is a limited liability company organized and existing under the laws of
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`the State of Minnesota and has a principal place of business at 1801 Biotech Avenue NE,
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`Willmar, Minnesota 56201. Vaxxinova is a wholly owned subsidiary of Vaxxinova International
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`BV, a company organized and existing under the laws of The Netherlands.
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`2.
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`Elanco is a corporation organized and existing under the laws of the State of
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`Indiana and has a principal place of business at 2500 Innovation Way, Greenfield, Indiana
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`46140.
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`3.
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`Upon information and belief, Elanco was originally a division of Eli Lilly and
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`Company and later became a subsidiary of Eli Lilly and Company. Through the 2000s and
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`2010s, Elanco engaged in a series of acquisitions, including acquiring Lohmann Animal Health
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`1
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 2 of 17 PageID #: 2
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`and Novartis Animal Health in or about 2014-2015. In 2018, Elanco announced that it would go
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`public and separate from Eli Lilly. In 2019, Elanco became a publicly traded company and was
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`fully divested from Eli Lilly.
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`Jurisdiction
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`4.
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`This is a claim of patent infringement arising under the Acts of Congress relating
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`to patents, namely, 35 U.S.C. §§ 271, 281-285.
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`5.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
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`1338(a).
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`6.
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`This Court has personal jurisdiction over Elanco because Elanco is incorporated
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`in the State of Indiana and resides within this judicial district.
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`7.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. § 1400(b) because
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`Elanco resides within, and has a physical place of business within, this judicial district.
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`Factual Background
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`8.
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`Vaxxinova is a privately held animal health research and development company,
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`specializing in the discovery and development of veterinary vaccines to improve animal health
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`and food safety.
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`9.
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`Vaxxinova began as the laboratory service division of Willmar Poultry Company
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`(“WPC”) in Willmar, Minnesota. During the 1980s, in an effort to combat bacterial and viral
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`infections and improve the health of its turkey breeding stock, WPC created a USDA-licensed
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`vaccine laboratory and selected a premier team of scientists to pioneer novel vaccine technology.
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`Through many years of research, the WPC (now Vaxxinova) team developed groundbreaking
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`technology in the form of siderophore receptor protein (“SRP”) vaccines, which immunize
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`against bacterial infections utilizing a cell-free purified extract of SRPs.
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`2
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 3 of 17 PageID #: 3
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`10.
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`Epitopix, LLC was formed in 2002 to continue developing and commercialize
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`SRP® technology, and to discover new vaccine technologies that improve animal health and
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`human food safety. In 2018, Epitopix was acquired by Vaxxinova International to develop and
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`distribute products in the United States. Vaxxinova continues its discovery and development
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`today, to bring novel vaccine products to additional markets including livestock, poultry, and
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`companion animals.
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`11.
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`Vaxxinova’s proprietary SRP® vaccines work by starving bacteria of iron, which
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`is an essential element for bacterial growth and survival. To compete with the host animal for
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`iron, bacteria utilize special transport proteins called siderophore receptors (“siderophore” comes
`
`from Greek, meaning “iron carrier”) located on the outer surfaces of the bacterial cells.
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`Siderophore receptors are a class of tube-shaped proteins called porins, which transport nutrients
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`through the bacterial cell wall.
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`12. Many bacterial species have identical siderophore receptor proteins, even though
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`the rest of their exterior structures are unique. Vaxxinova thus targeted SRPs for vaccine
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`development because the commonality enables the production of a single vaccine that combats
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`multiple types of bacteria.
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`13.
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`Vaxxinova developed methods of extraction to harvest SRPs and porins from
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`bacterial fermentations. Using these extracted proteins, Vaxxinova developed proprietary SRP
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`extract compositions that form the core of Vaxxinova’s SRP® vaccine technology. The vaccines
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`work by generating an antibody mediated immune response in the host animal, whose immune
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`cells then target any bacterial infection having the common SRPs used in the vaccine.
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`14.
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`Additionally, Vaxxinova’s SRP® technology includes processes to reduce the
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`concentration of lipopolysaccharides, which are endotoxins present on the cell membranes of
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`3
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 4 of 17 PageID #: 4
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`bacteria. This reduction of endotoxins results in vaccines that are less likely to negatively impact
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`the animals following vaccination.
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`15.
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`Vaxxinova has protected its valuable SRP® vaccine technology through a robust
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`family of patents. The U.S. Patent and Trademark Office (“USPTO”) has awarded Vaxxinova
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`no fewer than 13 issued patents covering various aspects of Vaxxinova’s novel SRP®
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`technology, which claim priority to provisional applications filed in January 2001. These issued
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`patents include U.S. Patent Nos. 7,138,124; 7,138,125; 7,147,857; 7,341,732; 7,160,549;
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`7,371,393; 7,943,150; 7,943,151; 8,637,048; 8,282,941; 8,425,916; 8,575,315; and 8,993,252.
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`Among this patent family are the patents at issue in this case, identified specifically below,
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`although Vaxxinova believes that as it learns more about Elanco’s production methods there may
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`be additional Vaxxinova patents that Elanco is infringing.
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`16.
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`Vaxxinova is the owner by assignment of U.S. Patent No. 8,282,941, titled
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`“Immunizing Compositions and Methods of Use” (“the ’941 Patent”), and has all rights to
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`enforce and collect damages and remedies for infringement of the ’941 Patent. The ’941 Patent
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`was duly issued by the U.S. Patent and Trademark Office on October 9, 2012 to inventors Daryll
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`A. Emery and Darren E. Straub and assignee Epitopix, LLC and is in full force and effect. A
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`true and correct copy of the ’941 Patent is attached hereto as Exhibit A.
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`17.
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`Vaxxinova is the owner by assignment of U.S. Patent No. 7,943,150, titled
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`“Immunizing Compositions and Methods of Use” (“the ’150 Patent”), and has all rights to
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`enforce and collect damages and remedies for infringement of the ’150 Patent. The ’150 Patent
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`was duly issued by the U.S. Patent and Trademark Office on May 17, 2011 to inventors Daryll
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`A. Emery and Darren E. Straub and assignee Epitopix, LLC and is in full force and effect. A
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`true and correct copy of the ’150 Patent is attached hereto as Exhibit B.
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`4
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 5 of 17 PageID #: 5
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`18.
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`Vaxxinova is the owner by assignment of U.S. Patent No. 7,943,151, titled
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`“Immunizing Compositions and Methods of Use” (“the ’151 Patent”), and has all rights to
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`enforce and collect damages and remedies for infringement of the ’151 Patent. The ’151 Patent
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`was duly issued by the U.S. Patent and Trademark Office on May 17, 2011 to inventors Daryll
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`A. Emery and Darren E. Straub and assignee Epitopix, LLC and is in full force and effect. A
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`true and correct copy of the ’151 Patent is attached hereto as Exhibit C.
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`19.
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`Vaxxinova produces its own lines of vaccine products utilizing the SRP®
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`technology that are the subject of the ’941, ’150, and ’151 Patents and related patents. These
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`products include vaccines for cattle, poultry, and swine. Vaxxinova’s vaccines target bacteria
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`such as E. coli, Salmonella, Klebsiella, and Pasteurella.
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`20.
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`Over the years, Vaxxinova has discussed its proprietary SRP® technology with
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`Elanco and Novartis Animal Health (subsequently acquired by Elanco, as set forth above). At
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`various times between about 2005-2011, Elanco and Novartis Animal Health engaged in
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`discussions with Epitopix concerning potential business opportunities relating to SRP®
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`technology. Both Elanco and Novartis were aware of Vaxxinova’s SRP® patent portfolio
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`(including the ’941, ’150, and ’151 patents) and applicability to Elanco’s products and methods.
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`21.
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`For example, in June 2008, Vaxxinova shared with Elanco some of the SRP®
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`patent portfolio, including patents in the same family as the patents-at-issue in this action.
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`22.
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`Additionally, between about 2008-2010, Vaxxinova was engaged in active
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`collaborative negotiations with Elanco, including disagreements about ownership of intellectual
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`property rights. These negotiations ceased in or about May 2010.
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`5
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`23.
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`Despite rebuffing any license or other business arrangement with Vaxxinova,
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`Elanco proceeded to develop and acquire (through Novartis Animal Health) technology that
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`infringes upon Vaxxinova’s SRP® technology and patents.
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`24.
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`Upon information and belief, Elanco’s and Novartis Animal Health’s
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`unauthorized use of Vaxxinova’s patented SRP® technology has been intentional and willful.
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`Furthermore, as the successor in interest to Novartis Animal Health, Elanco is responsible for the
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`wrongdoings of the acquired entity and all acquired infringing products and methods.
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`25.
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`At present, Vaxxinova is aware of two Elanco products that infringe or are likely
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`to infringe the patented SRP® technology. Vaxxinova has analyzed Elanco’s Nuplura PH
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`product and confirmed that it infringes one or more claims of at least the ’941, ’150, and ’151
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`patents, as detailed below.
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`26.
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`On or about March 4, 2021, Elanco announced the launch of a new product family
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`called Nuplura PH+. This announcement came after Elanco had engaged in discussions with
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`Vaxxinova concerning Vaxxinova’s infringement allegations, and thus was with full knowledge
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`of Vaxxinova’s allegations and the asserted SRP® patents. Upon information and belief,
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`Nuplura PH+ products infringe one or more claims of at least the ’941, ’150, and ’151 patents for
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`the same reasons identified below with respect to Nuplura PH.
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`27.
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`As set forth in the claim charts below, Nuplura PH is representative of Elanco’s
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`infringing products. Nuplura PH contains at least two siderophore receptor polypeptides, at least
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`two porins, and lipopolysaccharide concentration below that of the reference composition
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`according to the claims of the ’941, ’150, and ’151 Patents.
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`6
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`28.
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`Elanco’s own marketing materials are consistent with Vaxxinova’s bases of
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`infringement set forth herein. Non-limiting examples of Elanco’s marketing admissions are
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`noted in the claim charts below.
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`29.
`
`The following is a claim chart detailing how Nuplura PH infringes at least claim 9
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`of the ’941 Patent:
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`’941 Patent, Claim 9
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`A siderophore receptor polypeptide (SRP) composition
`comprising:
`
`at least two SRPs isolated from a gram negative
`microbe; and
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`NUPLURA PH
`
`NUPLURA PH is indicated “for use in healthy cattle, 3
`months of age and older, as an aid in the prevention of
`respiratory disease caused by M. haemolytica.” As
`explained below, NUPLURA PH contains SRPs.
`
`The NUPLURA PH product label states that it “contains
`Mannheimia haemolytica Outer Membrane Proteins and
`recombinant leukotoxoid.”
`NUPLURA PH contains at least two SRPs, confirmed by
`western blot analysis, as depicted in the following image
`of an SDS-PAGE gel run with a NUPLURA PH sample.
`
`
`
`7
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 8 of 17 PageID #: 8
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`NUPLURA PH contains a reduced concentration of
`endotoxin compared to a reference sample produced
`according to the claimed method. Upon information and
`belief, the concentration of LPS in NUPLUA PH is nearly
`1000 times lower than that of the claimed reference
`sample.
`the “outer
`to Elanco’s “Tech Specs,”
`According
`membrane proteins have been extracted and purified.”
`Elanco has publicized: “By using outer membrane
`proteins and not the complete cell wall, the volume of
`endotoxin
`is
`reduced”; and, “the extraction and
`purification processing of outer membrane proteins
`reduces the amount of endotoxin.” Additionally, Elanco
`scientists have stated that “the outer membrane proteins
`are extracted from the bacterial cell walls of a wild-type
`isolate using filtration processes.”
`
`lipopolysaccharide (LPS) at a concentration of no
`greater than the concentration of LPS in a reference
`composition comprising: the at least two siderophore
`receptor polypeptides isolated from the gram negative
`microbe and lipopolysaccharide; wherein the reference
`composition is produced by a process comprising:
`providing the gram negative microbe;
`disrupting the gram negative microbe in a buffer;
`solubilizing the disrupted gram negative microbe
`for greater than about 24 hours in a solution comprising
`sarcosine to result in solubilized and insoluble cellular
`material, wherein a ratio of the sarcosine to gram
`weight of disrupted gram negative microbe is between
`about 0.8 gram sarcosine per about 4.5 grams of
`disrupted gram negative microbe and about 1.2 grams
`sarcosine per about 4.5 grams of disrupted gram
`negative microbe; and
`isolating molecules of the gram negative microbe,
`wherein the isolated molecules comprise the at least
`two SRPs and LPS.
`
`
`
`30.
`
`The following is a claim chart detailing how Nuplura PH infringes at least claim
`
`23 of the ’150 Patent:
`
`’150 Patent, Claim 23
`
`NUPLURA PH
`
`A method for inducing the production of an antibody
`that specifically binds at least one SRP or at least one
`porin
`in
`an
`animal,
`the method
`comprising
`administering to an animal an effective amount of a
`composition comprising:
`
`NUPLURA PH is indicated “for use in healthy cattle, 3
`months of age and older, as an aid in the prevention of
`respiratory disease caused by M. haemolytica.” As
`explained below, NUPLURA PH
`induces antibody
`production for binding SRPs or porins.
`
`at least two siderophore receptor polypeptides
`(SRPs) isolated from a gram negative microbe;
`
`at least two porins isolated from the gram negative
`microbe;
`
`The NUPLURA PH product label states that it “contains
`Mannheimia haemolytica Outer Membrane Proteins and
`recombinant leukotoxoid.”
`NUPLURA PH contains at least two SRPs and at least
`two porins, confirmed by western blot analysis, as
`depicted in the following image of an SDS-PAGE gel run
`with a NUPLURA PH sample.
`
`8
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`

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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 9 of 17 PageID #: 9
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`lipopolysaccharide (LPS) at a concentration of no
`greater than the concentration of LPS in a reference
`composition comprising: the at least two siderophore
`receptor polypeptides isolated from the gram negative
`microbe and lipopolysaccharide; wherein the reference
`composition is produced by a process comprising:
`providing the gram negative microbe;
`disrupting the gram negative microbe in a buffer;
`solubilizing
`the disrupted gram negative
`microbe for greater than about 24 hours in a solution
`comprising sarcosine to result in solubilized and
`insoluble cellular material, wherein a ratio of the
`sarcosine to gram weight of disrupted gram negative
`microbe is between about 0.8 gram sarcosine per about
`4.5 grams of disrupted gram negative microbe and
`about 1.2 grams sarcosine per about 4.5 grams of
`disrupted gram negative microbe; and
`isolating molecules of the gram negative
`microbe, wherein the isolated molecules comprise the
`at least two SRPs and LPS; and
`
`a pharmaceutically acceptable carrier, wherein the
`composition induces in the animal antibody that
`specifically binds at least one SRP or at least one porin.
`
`
`
`NUPLURA PH contains a reduced concentration of
`endotoxin compared to a reference sample produced
`according to the claimed method. Upon information and
`belief, the concentration of LPS in NUPLUA PH is nearly
`1000 times lower than that of the claimed reference
`sample.
`the “outer
`to Elanco’s “Tech Specs,”
`According
`membrane proteins have been extracted and purified.”
`Elanco has publicized: “By using outer membrane
`proteins and not the complete cell wall, the volume of
`endotoxin
`is
`reduced”; and, “the extraction and
`purification processing of outer membrane proteins
`reduces the amount of endotoxin.” Additionally, Elanco
`scientists have stated that “the outer membrane proteins
`are extracted from the bacterial cell walls of a wild-type
`isolate using filtration processes.”
`
`NUPLURA PH is indicated for the vaccination of healthy
`cattle, 3 months of age and older, against respiratory
`disease caused by M. haemolytica. NUPLURA PH
`contains a pharmaceutically acceptable carrier suitable for
`subcutaneous administration. NUPLURA PH induces
`vaccinated cattle to produce antibodies that specifically
`bind at least one SRP or at least one porin.
`
`9
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`

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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 10 of 17 PageID #: 10
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`31.
`
`The following is a claim chart detailing how Nuplura PH infringes at least claim
`
`11 of the ’151 Patent:
`
`’151 Patent, Claim 11
`
`NUPLURA PH
`
`A method for inducing the production of an antibody
`that specifically binds at least one SRP in an animal,
`the method comprising administering to an animal an
`effective amount of a siderophore receptor polypeptide
`(SRP) composition comprising:
`
`NUPLURA PH is indicated “for use in healthy cattle, 3
`months of age and older, as an aid in the prevention of
`respiratory disease caused by M. haemolytica.” As
`explained below, NUPLURA PH contains SRPs and
`induces antibody production for binding SRPs.
`
`at least two SRPs isolated from a gram negative
`microbe;
`
`The NUPLURA PH product label states that it
`“contains Mannheimia haemolytica Outer Membrane
`Proteins and recombinant leukotoxoid.”
`NUPLURA PH contains at least two SRPs, confirmed
`by western blot analysis, as depicted in the following
`image of an SDS-PAGE gel run with a NUPLURA PH
`sample.
`
`
`
`10
`
`

`

`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 11 of 17 PageID #: 11
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`lipopolysaccharide (LPS) at a concentration of no
`greater than the concentration of LPS in a reference
`composition comprising: the at least two siderophore
`receptor polypeptides isolated from the gram negative
`microbe and lipopolysaccharide; wherein the reference
`composition is produced by a process comprising:
`providing the gram negative microbe;
`disrupting the gram negative microbe in a
`
`buffer;
`
`solubilizing the disrupted gram negative
`microbe for greater than about 24 hours in a solution
`comprising sarcosine to result in solubilized and
`insoluble cellular material, wherein a ratio of the
`sarcosine to gram weight of disrupted gram negative
`microbe is between about 0.8 gram sarcosine per about
`4.5 grams of disrupted gram negative microbe and
`about 1.2 grams sarcosine per about 4.5 grams of
`disrupted gram negative microbe; and
`isolating molecules of the gram negative
`microbe, wherein the isolated molecules comprise the
`at least two SRPs and LPS; and
`
`a pharmaceutically acceptable carrier, wherein the
`composition induces in the animal antibody that
`specifically binds at least one SRP.
`
`NUPLURA PH contains a reduced concentration of
`endotoxin compared to a reference sample produced
`according to the claimed method. Upon information
`and belief, the concentration of LPS in NUPLUA PH is
`nearly 1000 times lower than that of the claimed
`reference sample.
`According to Elanco’s “Tech Specs,” the “outer
`membrane proteins have been extracted and purified.”
`Elanco has publicized: “By using outer membrane
`proteins and not the complete cell wall, the volume of
`endotoxin
`is reduced”; and, “the extraction and
`purification processing of outer membrane proteins
`reduces the amount of endotoxin.” Additionally,
`Elanco scientists have stated that “the outer membrane
`proteins are extracted from the bacterial cell walls of a
`wild-type isolate using filtration processes.”
`
`NUPLURA PH is indicated for the vaccination of
`healthy cattle, 3 months of age and older, against
`respiratory disease caused by M. haemolytica.
`NUPLURA PH contains a pharmaceutically acceptable
`carrier suitable
`for subcutaneous administration.
`NUPLURA PH induces vaccinated cattle to produce
`antibodies that specifically bind at least one SRP.
`
`
`
`
`32.
`
`On or about December 23, 2020, Vaxxinova contacted Elanco concerning
`
`infringement of the ’941, ’150, and ’151 Patents. The parties engaged in discussions; however,
`
`to date, Elanco has refused to cease its infringing activity.
`
`33.
`
`Recently, on about March 4, 2021, Elanco announced the launch of a new
`
`product, Nuplura PH+.
`
`34.
`
`Among other characteristics, Elanco advertises Nuplura PH+ as containing
`
`Mannheimia haemolytica outer membrane proteins and recombinant leukotoxoid, similar to
`
`Nuplura PH.
`
`11
`
`

`

`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 12 of 17 PageID #: 12
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`35.
`
`Upon information and belief, Nuplura PH+ contains outer membrane proteins,
`
`including at least two siderophore receptor polypeptides and at least two porins.
`
`36.
`
`Upon information and belief, Nuplura PH+ is formulated and manufactured to
`
`have reduced endotoxin levels.
`
`37.
`
`Upon information and belief, Nuplura PH+ has a lipopolysaccharide
`
`concentration below that of a reference composition as claimed in claim 9 of the ’941 Patent,
`
`claim 23 of the ’150 Patent, and claim 11 of the ’151 Patent.
`
`38.
`
`Vaxxinova has complied with the notice provision of the Patent Act, 35 U.S.C. §
`
`287, including by listing its SRP® technology patents on Vaxxinova’s website at
`
`https://vaxxinova.us.com/patents/.
`
`COUNT I
`Patent Infringement – U.S. Patent No. 8,282,941
`
`39.
`
`Vaxxinova incorporates by reference the allegations of paragraphs 1-38 above as
`
`if fully set forth herein.
`
`40.
`
` Elanco has made, used, sold, and offered for sale in the United States products
`
`that infringe each and every limitation of the ’941 Patent. Specifically, as set forth above,
`
`Elanco’s Nuplura PH product satisfies every limitation of at least Claim 9 of the ’941 Patent.
`
`Additionally, upon information and belief, as set forth above, Elanco’s Nuplura PH+ product
`
`satisfies every limitation of at least Claim 9 of the ’941 Patent.
`
`41.
`
`In particular, as set forth above and upon information and belief, Nuplura PH and
`
`Nuplura PH+ comprise: at least two SRPs, at least two porins, and an LPS concentration below
`
`that of the claimed reference composition.
`
`12
`
`

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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 13 of 17 PageID #: 13
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`42.
`
`Elanco has had actual knowledge of the ’941 Patent since at least as early as
`
`December 23, 2020, when Vaxxinova contacted Elanco concerning its infringing products,
`
`thereby putting Elanco on notice of infringement pursuant to 35 U.S.C. § 287.
`
`43.
`
`Upon information and belief, Elanco had actual knowledge of the ’941 Patent
`
`prior to December 23, 2020. In particular, Vaxxinova believes that Elanco is and has been aware
`
`of Vaxxinova’s SRP® technology and has been, or reasonably should have been, aware of
`
`Vaxxinova’s patents covering its SRP® technology, including the ’941 Patent.
`
`44.
`
`Upon information and belief, Elanco had actual or constructive knowledge of the
`
`’941 Patent family and Vaxxinova’s patented SRP® technology dating back to at least about
`
`2008, based on Vaxxinova’s discussion of its SRP® technology and related patent portfolio
`
`(including the ’941 Patent) with Elanco and Elanco’s predecessor in interest, Novartis Animal
`
`Health. Additionally, based on these prior disclosures, Elanco should reasonably have been
`
`aware of the ’150 Patent upon its issuance in 2012.
`
`45.
`
`Vaxxinova has been damaged, and will continue to be damaged, by Elanco’s
`
`infringement of the ’941 Patent.
`
`46.
`
`Vaxxinova has suffered, and will continue to suffer, irreparable harm, unless
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`Elanco is enjoined from infringing the ’941 Patent.
`
`COUNT II
`Patent Infringement – U.S. Patent No. 7,943,150
`
`47.
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`Vaxxinova incorporates by reference the allegations of paragraphs 1-46 above as
`
`if fully set forth herein.
`
`48.
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`Elanco has made, used, sold, and offered for sale in the United States products
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`that infringe each and every limitation of the ’150 Patent. Specifically, as set forth above,
`
`Elanco’s Nuplura PH product satisfies every limitation of at least Claim 23 of the ’150 Patent.
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 14 of 17 PageID #: 14
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`Additionally, upon information and belief, as set forth above, Elanco’s Nuplura PH+ product
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`satisfies every limitation of at least Claim 23 of the ’150 Patent.
`
`49.
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`In particular, as set forth above and upon information and belief, Nuplura PH and
`
`Nuplura PH+ comprise: at least two SRPs, at least two porins, and an LPS concentration below
`
`that of the claimed reference composition.
`
`50.
`
`Elanco has had actual knowledge of the ’150 Patent since at least as early as
`
`December 23, 2020, when Vaxxinova contacted Elanco concerning its infringing products,
`
`thereby putting Elanco on notice of infringement pursuant to 35 U.S.C. § 287.
`
`51.
`
`Upon information and belief, Elanco had actual knowledge of the ’150 Patent
`
`prior to December 23, 2020. In particular, Vaxxinova believes that Elanco is and has been aware
`
`of Vaxxinova’s SRP® technology and has been, or reasonably should have been, aware of
`
`Vaxxinova’s patents covering its SRP® technology, including the ’150 Patent.
`
`52.
`
`Upon information and belief, Elanco had actual or constructive knowledge of the
`
`’150 Patent family and Vaxxinova’s patented SRP® technology dating back to at least about
`
`2008, based on Vaxxinova’s discussion of its SRP® technology and related patent portfolio
`
`(including the ’150 Patent) with Elanco and Elanco’s predecessor in interest, Novartis Animal
`
`Health. Additionally, based on these prior disclosures, Elanco should reasonably have been
`
`aware of the ’150 Patent upon its issuance in 2009.
`
`53.
`
`Vaxxinova has been damaged, and will continue to be damaged, by Elanco’s
`
`infringement of the ’150 Patent.
`
`54.
`
`Vaxxinova has suffered, and will continue to suffer, irreparable harm, unless
`
`Elanco is enjoined from infringing the ’150 Patent.
`
`14
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 15 of 17 PageID #: 15
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`COUNT III
`Patent Infringement – U.S. Patent No. 7,943,151
`
`55.
`
`Vaxxinova incorporates by reference the allegations of paragraphs 1-54 above as
`
`if fully set forth herein.
`
`56.
`
`Elanco has made, used, sold, and offered for sale in the United States products
`
`that infringe each and every limitation of the ’151 Patent. Specifically, as set forth above,
`
`Elanco’s Nuplura PH product satisfies every limitation of Claim 11 of the ’151 Patent.
`
`Additionally, upon information and belief, as set forth above, Elanco’s Nuplura PH+ product
`
`satisfies every limitation of Claim 11 of the ’151 Patent.
`
`57.
`
`In particular, as set forth above and upon information and belief, Nuplura PH and
`
`Nuplura PH+ comprise: at least two SRPs, at least two porins, and an LPS concentration below
`
`that of the claimed reference composition
`
`58.
`
`Elanco has had actual knowledge of the ’151 Patent since at least as early as
`
`December 23, 2020, when Vaxxinova contacted Elanco concerning its infringing products,
`
`thereby putting Elanco on notice of infringement pursuant to 35 U.S.C. § 287.
`
`59.
`
`Upon information and belief, Elanco had actual knowledge of the ’151 Patent
`
`prior to December 23, 2020. In particular, Vaxxinova believes that Elanco is and has been aware
`
`of Vaxxinova’s SRP® technology and has been, or reasonably should have been, aware of
`
`Vaxxinova’s patents covering its SRP® technology, including the ’151 Patent.
`
`60.
`
`Upon information and belief, Elanco had actual or constructive knowledge of the
`
`’151 Patent family and Vaxxinova’s patented SRP® technology dating back to at least about
`
`2008, based on Vaxxinova’s discussion of its SRP® technology and related patent portfolio
`
`(including the ’151 Patent) with Elanco and Elanco’s predecessor in interest, Novartis Animal
`
`15
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`

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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 16 of 17 PageID #: 16
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`Health. Additionally, based on these prior disclosures, Elanco should reasonably have been
`
`aware of the ’151 Patent upon its issuance in 2011.
`
`61.
`
`Vaxxinova has been damaged, and will continue to be damaged, by Elanco’s
`
`infringement of the ’151 Patent.
`
`62.
`
`Vaxxinova has suffered, and will continue to suffer, irreparable harm, unless
`
`Elanco is enjoined from infringing the ’151 Patent.
`
`Prayer for Relief
`
`
`
`WHEREFORE, Vaxxinova prays for the following relief:
`
`A.
`
`A judgment that Elanco has directly infringed U.S. Patent Nos. 8,282,941,
`
`7,943,150, and 7,943,151;
`
`B.
`
`A preliminary and permanent injunction enjoining and restraining Elanco, its
`
`officers, directors, agents, employees, attorneys and all others acting under or through them,
`
`directly or indirectly, from infringing U.S. Patent Nos. 8,282,941, 7,943,150, and 7,943,151;
`
`C.
`
`A judgment and order requiring Elanco to pay damages to Vaxxinova under 35
`
`U.S.C. § 284, including treble damages for willful infringement, with interest;
`
`D.
`
`A judgment and order directing Elanco to pay the costs of this action (including
`
`all disbursements) and attorney fees as provided by 35 U.S.C. § 285, with interest; and,
`
`E.
`
`Such other and further relief as this Court may deem just and equitable.
`
`Demand for Jury Trial
`
`Plaintiffs hereby demand a jury trial on all issues so triable.
`
`
`
`
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`Case 1:21-cv-00712-SEB-MPB Document 1 Filed 03/24/21 Page 17 of 17 PageID #: 17
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`Dated: March 24, 2021
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`Respectfully submitted,
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`FISHERBROYLES, LLP
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`/s Alastair J. Warr
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`Alastair J. Warr
`203 North LaSalle Street, Suite 2100
`Chicago, IL 60601
`Tel: 317-407-5260
`Email: alastair.warr@fisherbroyles.com
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`Attorneys for Plaintiff
`Epitopix, LLC d/b/a Vaxxinova US
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`Of Counsel:
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`Christopher R. Kinkade
`FISHERBROYLES, LLP
`100 Overlook Center, 2nd Floor
`Princeton, NJ 08540
`Tel: 609-415-0101
`Email: christopher.kinkade@fisherbroyles.com
`
`Andrew K Gonsalves
`FISHERBROYLES, LLP
`445 Park Avenue, 9th Floor
`New York, NY 10022
`Tel: 585-545-4249
`Email: andrew.gonsalves@fisherbroyles.com
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`17
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