Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 1 of 89 PageID #: 296
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`
`Plaintiffs,
`
`v.
`
`C.A. No. 23-cv-13-TSK
`
`Defendants.
`
`
`VIATRIS INC. and
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`
`
`
`VIATRIS INC. AND MYLAN PHARMACEUTICALS INC.’S
`ANSWER, SEPARATE DEFENSES, AND COUNTERCLAIMS TO COMPLAINT
`
`Viatris Inc. (“Viatris”) and Mylan Pharmaceuticals Inc. (“MPI”) (collectively,
`
`“Defendants”), by their undersigned attorneys, answer and respond to the Complaint of plaintiffs
`
`Novo Nordisk Inc. (“NNI”) and Novo Nordisk A/S (“NNAS”) (collectively, “Plaintiffs”), as
`
`follows:
`
`THE PARTIES
`
`Plaintiff Novo Nordisk Inc. (“NNI”) is a corporation organized and existing under
`1.
`the laws of the State of Delaware, having its principal place of business at 800 Scudders Mill Road,
`Plainsboro, New Jersey 08536.
`
` Defendants are without knowledge or information sufficient to form a belief as to
`
`the allegations set forth in Paragraph 1 and, therefore, deny those allegations.
`
`Plaintiff Novo Nordisk A/S (“NNAS”) is an entity organized and existing under the
`2.
`laws of the Kingdom of Denmark, having its principal place of business at Novo Allé, 2880
`Bagsvaerd Denmark. NNI is an indirect, wholly-owned subsidiary of NNAS.
`
` Defendants are without knowledge or information sufficient to form a belief as to
`
`the allegations set forth in Paragraph 2 and, therefore, deny those allegations.
`
`
`
`1
`
`

`

`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 2 of 89 PageID #: 297
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`
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`On information and belief, Viatris is a corporation organized and existing under the
`3.
`laws of Delaware, having a principal place of business at 1000 Mylan Blvd., Canonsburg,
`Pennsylvania, 15317. On information and belief, acting in concert with MPI, Viatris is in the
`business of making and selling generic pharmaceutical products, which they distribute in the State
`of West Virginia and throughout the United States.
`
` Viatris admits that it is a corporation organized and existing under the laws of
`
`Delaware, having its principal place of business at 1000 Mylan Boulevard, Canonsburg,
`
`Pennsylvania 15317. Viatris denies the remaining allegations set forth in Paragraph 3.
`
`On information and belief, MPI is a corporation organized and existing under the
`4.
`laws of the State of West Virginia with a place of business at 3711 Collins Ferry Road,
`Morgantown, West Virginia 26505. On information and belief, acting in concert with Viatris, MPI
`is in the business of making and selling generic pharmaceutical products, which they distribute in
`the State of West Virginia and throughout the United States. On information and belief, MPI is an
`agent, affiliate, wholly owned subsidiary and/or alter ego of Viatris and subsumed within Viatris.
`
` MPI admits that it is a corporation organized and existing under the laws of the
`
`State of West Virginia, having its principal place of business at 3711 Collins Ferry Road,
`
`Morgantown, West Virginia 26505. MPI admits that it develops and manufactures pharmaceutical
`
`products. MPI denies the remaining allegations set forth in Paragraph 4.
`
`On information and belief, Defendants collaborate to develop, manufacture, seek
`5.
`regulatory approval for, import, market, distribute, and sell generic pharmaceutical products in the
`State of West Virginia and throughout the United States.
`
` Paragraph 5 contains a legal conclusion to which no answer is required. To the
`
`extent an answer is required, Defendants deny the allegations set forth in Paragraph 5.
`
`On information and belief, MPI is an agent of Viatris, with Viatris exercising
`6.
`considerable control over MPI with respect to generic pharmaceutical products, and approves
`significant decisions of MPI such as allowing MPI to act as its agent in connection with the
`preparation, submission, approval and maintenance of ANDAs, including ANDAs as submitted
`and amendments thereto. Viatris’s 2021 10-K report defines Viatris as “the Company” and
`identifies MPI as a “wholly owned subsidiary.” See Viatris Inc. Form 10-K (Mar. 1, 2021),
`https://www.sec.gov/ix?doc=/Archives/edgar/data/0001792044/000179204422000010/vtrs-
`20211231.htm (last visited Jan. 19, 2023).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`
`
`2
`
`

`

`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 3 of 89 PageID #: 298
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`
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`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 6.
`
`On information and belief, Viatris attributes FDA submissions and approvals of
`7.
`ANDAs submitted by MPI as Viatris’s FDA ANDA submissions and approvals. See, e.g., Viatris:
`Complex Injectable Pipeline Opportunities Worth at Least $1bn, GENERICS BULLETIN,
`Pharma
`Intelligence
`(Nov. 8, 2022), https://generics.pharmaintelligence.informa.com/
`GB152279/Viatris-Complex-Injectable-Pipeline-Opportunities-Worth-At-Least-$1bn (last visited
`Jan. 19, 2023) (“A generic version of Novo Nordisk’s GLP-1 receptor against Wegovy
`(semaglutide) treatment for obesity is among seven complex generic injectables for which Viatris
`is claiming first-to-file status, as it looks to growth in 2024 and beyond.”); Mylan Launches First
`Generic Restasis. (RX/Generic Drugs), CHAIN DRUG REV. at 31 (Feb. 21, 2022),
`https://mydigitalpublication.com/publication/?i=738336&article_id=4212714&view=articleBro
`wser (last visited Jan. 19, 2023) (“Rajiv Malik, president of [Mylan Pharmaceuticals Inc.’s] parent
`company, Viatris Inc., said: ‘I am pleased that Viatris has received the first FDA approval for
`generic Restasis . . . .’” and “Viatris Developed Markets President Tony Mauro said: ‘The approval
`of generic Restasis reinforces our ongoing commitment to deliver innovative solutions . . . . We
`look forward to quickly bringing this important product to millions of Americans’”); Viatris Inc.
`Announces Receipt of the First FDA Approval for Generic Version of Symbicort® Inhalation
`Aerosol, BreynaTM (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), in
`Partnership with Kindeva (Mar. 16, 2022), https://newsroom.viatris.com/2022-03-16-Viatris-Inc-
`Announces-Receipt-of-the-First-FDA-Approval-for-Generic-Version-of-Symbicort-RInhalation-
`Aerosol,-Breyna-TM-Budesonide-and-Formoterol-Fumarate-Dihydrate-Inhalation-Aerosol-,-in-
`Partnership-with-Kindeva (last visited Jan. 19, 2023) (“Viatris President Rajiv Malik added: ‘The
`momentous FDA final approval of Breyna is further evidence of our well-established development
`expertise and proven ability to move up the value chain with more complex products by leveraging
`our robust scientific capabilities to target gaps in healthcare and patient needs. This approval also
`builds on our past successes of bringing other complex products first to market and demonstrates
`the continued delivery of our strong pipeline.’”).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 7.
`
`On information and belief, MPI acts as an agent for Viatris for purposes including,
`8.
`but not limited to, corresponding with the United States Food and Drug Administration (“FDA”).
`On information and belief, products identified by FDA as products of “Mylan Pharmaceuticals
`Inc.” or “Mylan Pharmaceuticals Inc., a Viatris Company” are identified on Viatris’s website as
`Viatris products. E.g., compare, FDA Listing of Authorized Generics as of December 15, 2022,
`https://www.fda.gov/media/77725/download (last visited Jan. 19, 2023) with Viatris Inc.’s
`Product Catalog, https://www.viatris.com/en-us/lm/countryhome/us-products/productcatalog/
`(last visited Jan. 19, 2023).
`
`
`
`3
`
`

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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 4 of 89 PageID #: 299
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`
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` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 8.
`
`On information and belief, MPI acts as an agent for Viatris for purposes including,
`9.
`but not limited to, providing notice of Paragraph IV certifications to patent owners and NDA
`holders in connection with Defendants’ ANDA filings and defending against any subsequent
`infringement claims under 35 U.S.C. § 271(e)(2). Viatris’s 2021 10-K states: “Viatris invests
`significant sums in R&D and in manufacturing capacity. [Viatris] also often incur[s] substantial
`litigation expense as a result of defending or challenging brand patents or exclusivities.” Form 10-
`K
`(Mar.
`1,
`2021),
`https://www.sec.gov/ix?doc=/Archives/edgar/data/0001792044/
`000179204422000010/vtrs-20211231.htm (last visited Jan. 19, 2023). Viatris’s 2021 10-K report
`further states: “The Company is involved in a number of patent litigation lawsuits involving the
`validity and/or infringement of patents held by branded pharmaceutical manufacturers including
`but not limited to the matters described below. The Company uses its business judgement to decide
`to market and sell certain products, in each case based on its belief that the applicable patents are
`invalid and/or that its products do not infringe, notwithstanding the fact that allegations of patent
`infringement(s) or other potential third party rights have not been finally resolved by the courts.”
`Id. In connection with that statement, Viatris’s 2021 10-K report identifies multiple Hatch-
`Waxman litigations in which MPI is involved. Id.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 9.
`
`On information and belief, since the merger of Mylan N.V., MPI’s former parent
`10.
`company, and Upjohn Inc. to create Viatris in November 2020, any corporate separateness that
`may have existed between Viatris and MPI shortly after the formation of Viatris has dissolved,
`and MPI is now no more than an alter ego for Viatris, subsumed within Viatris.
`
` Paragraph 10 contains legal conclusions to which no answer is required. To the
`
`extent an answer is required, Defendants deny the allegations of Paragraph 10.
`
`On information and belief, MPI holds itself out to the public, including through
`11.
`press releases posted to Viatris’s website and communications to FDA, as “Mylan Pharmaceuticals
`Inc., a Viatris company.” See, e.g., https://newsroom.viatris.com/2022-01-18-Mylan-
`Pharmaceuticals-Inc-,-a-Viatris-Company,-Conducting-Voluntary-Recall-of-One-Batch-of-
`Semglee-R-insulin-glargine-injection-,-100-units-mL-U-100-,-3-mL-Prefilled-Pens,-Due-to-the-
`
`
`
`4
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`

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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 5 of 89 PageID #: 300
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`
`
`2023;
`23,
`Jan.
`visited
`(last
`Potential-for-a-Missing-Label-in-the-Batch
`https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-
`viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin (last visited Jan. 23,
`2023).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 11.
`
`On information and belief, Viatris’s website states: “Viatris was formed in 2020
`12.
`through the combination of Mylan and Upjohn . . . . By integrating the strengths of these two
`companies, including our global workforce of ~38,000, we aim to deliver increased access to
`affordable, quality medicines for patients worldwide. Our global portfolio includes best-in-class .
`. . generics, including branded and complex generics; [and] biosimilars . . . . We are domiciled in
`the United States. . . . And we maintain an industry-leading pipeline, composed of numerous
`complex generic, biosimilars and global key brands. . . . As we work to fully transition to the
`Viatris brand commercially and operationally around the world, you may continue to see both the
`Mylan and Upjohn names in certain markets.” See https://www.viatris.my/en-my/about-us/our-
`story#:~:text=Viatris%20was%20formed%20in%202020,quality%20medicines%20for%
`20patients%20worldwide (last visited Jan. 19, 2023); https://newsroom.viatris.com/2020-11-16-
`Viatris-Inc-Launches-as-a-New-Kind-of-Healthcare-Company-Positioned-to-Meet-the-Worlds-
`Evolving-Healthcare-Needs#:~:text=Formed%20in%20November%202020%20through,than%
`20165%20countries%20and%20territories (last visited Jan. 23, 2023).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 12.
`
`On information and belief, Viatris is transitioning the Viatris brand around the
`13.
`world, both commercially and operationally. As part of the transition, Viatris has been divesting
`MPI properties, assuming MPI corporate responsibilities, absorbing MPI employees, commingling
`funds with MPI, and subsuming MPI. For instance, on information and belief, by March 7, 2022,
`Viatris closed MPI’s facility located at 781 Chestnut Ridge Road, Morgantown, West Virginia,
`26505 and auctioned off its equipment. See, e.g., https://www.wboy.com/news/local/monongalia-
`and-preston/former-mylan-viatris-facility-auctions-off-equipment/ (last visited Jan. 19, 2023);
`https://www.hgpauction.com/auctions/110662/viatris-morgantown-2/ (last visited Jan. 19, 2023).
`On information and belief, on March 31, 2022, West Virginia University assumed ownership of
`781 Chestnut Ridge Road, Morgantown, West Virginia, 26505, after purchasing the property for
`$1
`from Viatris. See, e.g., https://www.wvnews.com/news/wvnews/former-mylan-plant-
`
`
`
`5
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`

`

`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 6 of 89 PageID #: 301
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`
`
`purchased-by-west-virginia-university-for-1-with-plans-to-house-usiness/article_5af8d6d0-b9f8-
`11ec-9574-6b3dce9aba75.html (last visited Jan. 19, 2023).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 13.
`
`On information and belief, upon the creation of Viatris, the former executive
`14.
`chairman of Mylan N.V., Robert J. Coury, became Viatris’s executive chairman. See, e.g.,
`https://www.viatris.com/en/about-us/our-leaders/robert-j-coury (last visited on January 19, 2023).
`On information and belief, Mr. Coury “leads the [Viatris] board of directors, oversees the strategic
`direction of the company in collaboration with executive management, and advises the
`management team as they execute on the company’s strategy to drive value creation . . .” Id.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 14.
`
`On information and belief, one or more of MPI’s corporate officers and employees
`15.
`are shared with or have been subsumed by Viatris. See, e.g., https://www.fiercepharma.com/
`pharma/mylan-crowns-former-ceo-coury-as-executive-chairman-as-upjohn-merger-deal-faces-
`delays (last visited Jan. 19, 2023); https://www.viatris.com/en/about-us/our-leaders (last visited
`January 19, 2023); https://www.wsj.com/market-data/quotes/VTRS/company-people/executive-
`profile/268055
`(last
`visited
`Jan.
`19,
`2023);
`https://www.sec.gov/Archives/edgar/data/1792044/000119312521313437/d163117ddef14a.htm
`(last visited Jan. 19, 2023)). On information and belief, the shared and subsumed corporate officers
`and employees demonstrates that MPI is subsumed within, and an alter ego of, Viatris.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 15.
`
`On information and belief, MPI’s shared or subsumed officers maintain their
`16.
`offices at Viatris’s principal place of business at 1000 Mylan Blvd., Canonsburg, Pennsylvania,
`15317. See, e.g., https://www.sec.gov/Archives/edgar/data/1792044/000119312521313437/
`
`
`
`6
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`

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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 7 of 89 PageID #: 302
`
`
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`d163117ddef14a.htm (last visited Jan. 19, 2023). On information and belief, Defendants’ use of
`the same office or business location demonstrates that MPI is subsumed within, and an alter ego
`of, Viatris.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 16.
`
`On information and belief, upon formation, Viatris assumed various agreements
`17.
`between MPI and certain MPI officers, including retention agreements and retirement benefit
`agreements. See, e.g., https://www.sec.gov/Archives/edgar/data/1792044/000119312521313437/
`d163117ddef14a.htm (last visited Jan. 19, 2023).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 17.
`
`On information and belief, attempts to access the website for all Mylan entities,
`18.
`including MPI, mylan.com, result in a pop-up window, which redirects access to Viatris, along
`with a statement that: “Mylan is now part of Viatris, a new global healthcare company committed
`to empowering people to live healthier at every stage of life.” See https://www.mylan.com (last
`visited Jan. 19, 2023). On information and belief, the LinkedIn website for Mylan entities,
`including MPI,
`states:
`“Follow
`us
`on
`our
`new
`journey
`as Viatris.
`www.linkedin.com/company/viatris” and “We have combined with Upjohn, a legacy division of
`Pfizer, and are now Viatris. Follow along on our new journey as we empower people worldwide
`to
`live healthier at every
`stage of
`life. www.linkedin.com/company/viatris.” See
`https://www.linkedin.com/company/mylan/ (last visited Jan. 19, 2023). On information and belief,
`MPI’s holding itself out as Viatris and the redirection from mylan.com to the website of Viatris
`demonstrates that MPI is subsumed within, and an alter ego of, Viatris.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 18.
`
`
`
`7
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`

`

`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 8 of 89 PageID #: 303
`
`
`
`On information and belief, MPI employees presently identify as employees of
`19.
`Viatris. See, e.g., https://www.linkedin.com/in/brandon-mcmahon-2754a263/ (last visited Jan. 19,
`2023). On information and belief, MPI employees presently identifying as employees of Viatris
`demonstrates that MPI is subsumed within, and an alter ego of, Viatris.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 19.
`
`On information and belief, present MPI job listings indicate employment is with
`20.
`Viatris, demonstrating that MPI is subsumed within, and an alter ego of, Viatris. See, e.g.,
`https://www.indeed.com/jobs?q=Mylan%20Pharmaceuticals%20Inc.&l=Morgantown%2C%20
`WV&from=mobRdr&utm_source=%2Fm%2F&utm_medium=redir&utm_campaign=dt&vjk=8
`203d5b1e393f80f (last visited Jan. 19, 2023).
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 20.
`
`On information and belief, Viatris and certain lenders entered into a $4.0 billion
`21.
`revolving facility agreement with (the “2021 Revolving Facility”) on July 1, 2021, to which MPI
`has
`or
`has
`had
`access.
`See Viatris
`Inc. Form
`10-K
`(Mar.
`1,
`2021)
`https://www.sec.gov/ix?doc=/Archives/edgar/data/0001792044/000179204421000009/vtrs-
`20201231.htm (last visited Jan. 19, 2023). On information and belief, Viatris and MPI operate as
`a single entity with the ability to borrow funds from certain lenders with whom Viatris has
`instituted revolving loan accounts.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 21.
`
`On information and belief, Viatris entered into a $400 million “Receivables
`22.
`Facility” agreement in 2020 for a period of two-years, which expired in April 2022. Id. MPI “has
`access to $400 million under the Receivables Facility.” Id. On information and belief, MPI,
`operating as a single entity with Viatris, is able to sell MPI’s accounts receivables to Mylan
`
`
`
`8
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`

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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 9 of 89 PageID #: 304
`
`
`
`Securitization LLC, a Viatris subsidiary, under Viatris’s Receivables Facility agreement for the
`purpose of accessing instant funds from outstanding unpaid invoices. Id. On information and
`belief, MPI is thereby funded through Viatris’s subsidiary Mylan Securitization LLC. On
`information and belief, Viatris and MPI’s joint use of the 2021 Revolving Facility and 2020
`Receivables Facility demonstrates the commingling of funds and that MPI is subsumed within,
`and is an alter ego of, Viatris.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 22.
`
`On information and belief, Viatris’s 2021 10-K report to the SEC states that
`23.
`references to “Viatris” within the 10-K refer to “Viatris Inc. and its subsidiaries.” See Viatris Inc.
`Form 10-K (Mar. 1, 2021), https://www.sec.gov/ix?doc=/Archives/edgar/data/0001792044/
`000179204422000010/vtrs-20211231.htm (last visited Jan. 19, 2023). MPI is identified in the
`Viatris 2021 10-K report as a Viatris subsidiary, and references the “Viatris Charter.” Id. Upon
`information and belief, the “Viatris Charter” is the “amended and restated certificate of
`incorporation of Viatris Inc.” According to Viatris’s 2021 10-K report, Delaware is designated by
`the “Viatris Charter” “as the sole and exclusive forum for certain types of actions and proceedings
`that may be initiated by Viatris’s stockholders, which could discourage lawsuits against Viatris
`and its directors and officers . . . . To the fullest extent permitted by law, this exclusive forum
`provision will apply to state and federal law claims, including claims under the federal securities
`laws . . . . This exclusive forum provision may limit the ability of Viatris’s stockholders to bring a
`claim in a judicial forum that such stockholders find favorable for disputes with Viatris or its
`directors or officers, which may discourage such lawsuits against Viatris or its directors or
`officers.” Id.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited document
`
`speaks for itself. Defendants deny the remaining allegations of Paragraph 23.
`
`On information and belief, to resolve class action cases pending in the U.S. District
`24.
`Court for the District of Kansas, Viatris agreed to pay settlement fees of $264 million on behalf of
`defendants,
`including MPI. See Viatris
`Inc. Form 10-Q, dated May 9, 2022,
`https://www.sec.gov/ix?doc=/Archives/edgar/data/0001792044/000179204422000017/vtrs-
`20220331.htm (last visited Jan. 19, 2023); In Re: EpiPen (Epinephrine Injection, USP) Marketing,
`Sales Practices and Antitrust Litigation, MDL No. 2785, 17-md-2785-DDC-TJJ (D. Kan. March
`11, 2022). On information and belief, the payment of debt incurred by Viatris and its subsidiaries
`
`
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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 10 of 89 PageID #: 305
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`
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`demonstrates a commingling of funds between Viatris and its subsidiaries, including MPI, a lack
`of corporate separateness, and Viatris subsuming Mylan subsidiaries, including MPI.
`
` The allegations in this Paragraph relate solely to issues of venue and jurisdiction.
`
`Defendants do not dispute venue and jurisdiction for purposes of this litigation only, and therefore,
`
`no answer is required. To the extent an answer is required, Defendants state that the cited
`
`documents speak for themselves. Defendants deny the remaining allegations of Paragraph 24.
`
`NATURE OF THE ACTION
`
`This action arises under the patent laws of the United States, Title 35, United States
`25.
`Code, § 100 et seq., including 35 U.S.C. §§ 271(a), (b), (c), (e), and (f), arising from Defendants’
`submission of an Abbreviated New Drug Application (“ANDA”) No. 217705 (the “Defendants’
`ANDA”) to the United States Food and Drug Administration (“FDA”), by which Defendants seek
`approval of a generic version of Novo Nordisk’s pharmaceutical product WEGOVY®
`(semaglutide) injection prior to the expiration of United States Patent Nos. 8,129,343 (the “’343
`Patent”), 8,536,122 (the “’122 Patent”), 9,764,003 (the “’003 Patent”), 10,888,605 (the “’605
`Patent”), and 11,318,191 (the “’191 Patent”) (collectively, the “Asserted Patents”), which cover,
`inter alia, WEGOVY® (semaglutide) injection and/or its use.
`
` Paragraph 25 states a legal conclusion to which no answer is required. To the extent
`
`an answer is required, Defendants admit that Plaintiffs’ complaint purports to bring an action for
`
`patent infringement under the patent laws of the United States, 35 U.S.C. § 100 et seq. To the
`
`extent any further answer is required, MPI admits it submitted an Abbreviated New Drug
`
`Application (“ANDA”) seeking approval by the United States Food and Drug Administration
`
`(“FDA”) for semaglutide injection, 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75
`
`mL, and 2.4 mg/0.75 mL single-dose prefilled pens. MPI admits its ANDA was filed with a
`
`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’343 patent, the ’122
`
`patent, the ’003 patent, the ’605 patent, and the ’191 patent. Defendants are without knowledge or
`
`information sufficient to form a belief as to any remaining allegations set forth in Paragraph 25
`
`and, therefore, deny those allegations.
`
`26.
`
`NNAS is the owner of all rights, title, and interest in the Asserted Patents.
`
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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 11 of 89 PageID #: 306
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` Defendants are without knowledge or information sufficient to form a belief as to
`
`the allegations set forth in Paragraph 26 and, therefore, deny those allegations.
`
`NNI is the holder of New Drug Application (“NDA”) No. 215256 for WEGOVY®
`27.
`(semaglutide) injection, for subcutaneous use, administered with 0.25 mg/0.5 mL, 0.5 mg/0.5 mL,
`1 mg/0.5 mL, 1.7 mg/0.75 mL and 2.4 mg/0.75 mL Pre-filled Single-dose Pens, which NNI sells
`under the trade name WEGOVY®. NNI holds the exclusive right to sell, distribute, and market
`WEGOVY® (semaglutide) injection in the United States.
`
` Defendants state that the Orange Book maintained by FDA lists Novo Nordisk Inc.
`
`as the holder of NDA 215256 for Wegovy® (semaglutide) injection, for subcutaneous use, 0.25
`
`mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL and 2.4 mg/0.75 mL Pre-filled Single-
`
`dose Pen. Defendants are without knowledge or information sufficient to form a belief as to the
`
`remaining allegations set forth in Paragraph 27 and, therefore, deny those allegations.
`
`The Asserted Patents are listed in FDA’s Approved Drug Products with
`28.
`Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) in connection
`with WEGOVY ® and the related NDA.
`
` Defendants state that the Orange Book maintained by FDA currently lists U.S.
`
`Patent Nos. 8,129,343 (“’343 patent”); 8,536,122 (“’122 patent”); 9,764,003 (“’003 patent”);
`
`10,888,605 (“’605 patent”); and 11,318,191 (“’191 patent”) in conjunction with NDA 215256 for
`
`Wegovy® (semaglutide) injection, for subcutaneous use, 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1
`
`mg/0.5 mL, 1.7 mg/0.75 mL and 2.4 mg/0.75 mL Pre-filled Single-dose Pen.
`
`NOVO NORDISK’S WEGOVY®
`
`The WEGOVY® Label states that “WEGOVY® is indicated as an adjunct to a
`29.
`reduced calorie diet and increased physical activity for chronic weight management in adults
`with an initial body mass index (BMI) of []:
`
`•
`•
`
`30 kg/m2 or greater (obesity) or
`27 kg/m2 or greater (overweight) in the presence of at least one weight-related
`comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).”
`
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`Case 1:23-cv-00013-TSK Document 25 Filed 03/31/23 Page 12 of 89 PageID #: 307
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` Defendants admit that the following text appears in the Full Prescribing Information
`
`for Wegovy® (semaglutide) injection, for subcutaneous use, revised 12/2022, under Section 1
`
`(Indications and Usage):
`
`“WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity
`for chronic weight management in:
`
`• adult patients with an initial body mass index (BMI) of [see Dosage and Administration
`(2.1)]:
`o 30 kg/m2 or greater (obesity) or
`o 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid
`condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
`
`• pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater
`standardized for age a