Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 1 of 46 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
` ELECTRONICALLY
` FILED
`Jan 27 2023
` U.S. DISTRICT COURT
` Northern District of WV
`
`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
` Plaintiffs,
`
`v.
`
`VIATRIS INC. and MYLAN
`PHARMACEUTICALS INC.,
`
` Defendants.
`
`1:23-CV-13 (Kleeh)
`Civil Action No. ________
`
`COMPLAINT
`
`Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”) for
`
`their Complaint against Defendants Viatris Inc. (“Viatris”) and Mylan Pharmaceuticals Inc.
`
`(“MPI”) (collectively, “Defendants”) allege as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiff Novo Nordisk Inc. (“NNI”) is a corporation organized and existing under
`
`the laws of the State of Delaware, having its principal place of business at 800 Scudders Mill Road,
`
`Plainsboro, New Jersey 08536.
`
`2.
`
`Plaintiff Novo Nordisk A/S (“NNAS”) is an entity organized and existing under the
`
`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.
`
`3.
`
`On information and belief, Viatris is a corporation organized and existing under the
`
`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
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 2 of 46 PageID #: 2
`
`
`
`business of making and selling generic pharmaceutical products, which they distribute in the State
`
`of West Virginia and throughout the United States.
`
`4.
`
`On information and belief, MPI is a corporation organized and existing under the
`
`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.
`
`5.
`
`On information and belief, Defendants collaborate to develop, manufacture, seek
`
`regulatory approval for, import, market, distribute, and sell generic pharmaceutical products in the
`
`State of West Virginia and throughout the United States.
`
`6.
`
`On information and belief, MPI is an agent of Viatris, with Viatris exercising
`
`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).
`
`7.
`
`On information and belief, Viatris attributes FDA submissions and approvals of
`
`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),
`
`
`
`2
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 3 of 46 PageID #: 3
`
`
`
`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-R-
`
`Inhalation-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.’”).
`
`
`
`3
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 4 of 46 PageID #: 4
`
`
`
`8.
`
`On information and belief, MPI acts as an agent for Viatris for purposes including,
`
`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).
`
`9.
`
`On information and belief, MPI acts as an agent for Viatris for purposes including,
`
`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
`
`
`
`4
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 5 of 46 PageID #: 5
`
`
`
`with that statement, Viatris’s 2021 10-K report identifies multiple Hatch-Waxman litigations in
`
`which MPI is involved. Id.
`
`10.
`
`On information and belief, since the merger of Mylan N.V., MPI’s former parent
`
`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.
`
`11.
`
`On information and belief, MPI holds itself out to the public, including through
`
`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-
`
`Potential-for-a-Missing-Label-in-the-Batch
`
`(last
`
`visited
`
`Jan.
`
`23,
`
`2023;
`
`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).
`
`12.
`
`On information and belief, Viatris’s website states: “Viatris was formed in 2020
`
`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
`
`
`
`5
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 6 of 46 PageID #: 6
`
`
`
`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).
`
`13.
`
`On information and belief, Viatris is transitioning the Viatris brand around the
`
`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-
`
`purchased-by-west-virginia-university-for-1-with-plans-to-house-business/article_5af8d6d0-
`
`b9f8-11ec-9574-6b3dce9aba75.html (last visited Jan. 19, 2023).
`
`14.
`
`On information and belief, upon the creation of Viatris, the former executive
`
`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
`
`
`
`6
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 7 of 46 PageID #: 7
`
`
`
`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.
`
`15.
`
`On information and belief, one or more of MPI’s corporate officers and employees
`
`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.
`
`16.
`
`On information and belief, MPI’s shared or subsumed officers maintain their
`
`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/
`
`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.
`
`17.
`
`On information and belief, upon formation, Viatris assumed various agreements
`
`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).
`
`18.
`
`On information and belief, attempts to access the website for all Mylan entities,
`
`including MPI, mylan.com, result in a pop-up window, which redirects access to Viatris, along
`
`
`
`7
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 8 of 46 PageID #: 8
`
`
`
`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.
`
`19.
`
`On information and belief, MPI employees presently identify as employees of
`
`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.
`
`20.
`
`On information and belief, present MPI job listings indicate employment is with
`
`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).
`
`21.
`
`On information and belief, Viatris and certain lenders entered into a $4.0 billion
`
`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-
`
`
`
`8
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 9 of 46 PageID #: 9
`
`
`
`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.
`
`22.
`
`On information and belief, Viatris entered into a $400 million “Receivables
`
`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
`
`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.
`
`23.
`
`On information and belief, Viatris’s 2021 10-K report to the SEC states that
`
`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
`
`
`
`9
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 10 of 46 PageID #: 10
`
`
`
`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.
`
`24.
`
`On information and belief, to resolve class action cases pending in the U.S. District
`
`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
`
`demonstrates a commingling of funds between Viatris and its subsidiaries, including MPI, a lack
`
`of corporate separateness, and Viatris subsuming Mylan subsidiaries, including MPI.
`
`NATURE OF THE ACTION
`
`25.
`
`This action arises under the patent laws of the United States, Title 35, United States
`
`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.
`10
`
`
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 11 of 46 PageID #: 11
`
`
`
`26.
`
`27.
`
`NNAS is the owner of all rights, title, and interest in the Asserted Patents.
`
`NNI is the holder of New Drug Application (“NDA”) No. 215256 for WEGOVY®
`
`(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.
`
`28.
`
`The Asserted Patents are listed in FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) in connection
`
`with WEGOVY ® and the related NDA.
`
`NOVO NORDISK’S WEGOVY®
`
`29.
`
`The WEGOVY® Label states that “WEGOVY® is indicated as an adjunct to a
`
`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).”
`
`30. WEGOVY® is to be administered once weekly by subcutaneous injection.
`
`31.
`
`The WEGOVY® Label provides limitations of use, instructing that WEGOVY®
`
`should not be used in combination with other semaglutide-containing products or any other GLP-
`
`1 receptor agonist.
`
`32.
`
`The WEGOVY® Label further instructs to administer WEGOVY® once weekly
`
`according to a dose escalation schedule that includes an initiating dosage at 0.25 mg of semaglutide
`
`for four weeks, 0.5 mg for the next four weeks, and 1 mg for the next four weeks after that.
`
`33.
`
`The active ingredient in WEGOVY® is semaglutide and its structure is:
`
`
`
`11
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 12 of 46 PageID #: 12
`
`
`
`
`34. WEGOVY® is an aqueous solution. Each 0.5 mL single-dose pen (i.e., prefilled
`
`syringe with needle) contains a solution of WEGOVY® containing 0.25 mg, 0.5 mg or 1 mg of
`
`semaglutide; and each 0.75 mL single-dose pen contains a solution of WEGOVY® containing 1.7
`
`or 2.4 mg semaglutide. Thus, each 1 mL of WEGOVY® contains 0.5 mg, 1 mg or 2 mg, or 2.3
`
`mg or 3.2 mg depending on the dosage.
`
`35.
`
`Each 1 mL of WEGOVY® contains the following inactive ingredients: 1.42 mg
`
`disodium phosphate dihydrate (also known as disodium hydrogen phosphate dihydrate), 8.25 mg
`
`sodium chloride, and water for injection. WEGOVY® has a pH of approximately 7.4.
`
`Hydrochloric acid or sodium hydroxide may be added to adjust pH.
`
`DEFENDANTS’ ANDA AND PARAGRAPH IV CERTIFICATION
`
`36.
`
`On information and belief, Defendants submitted Defendants’ ANDA under Section 505(j)
`
`of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), i.e., 21 U.S.C. § 355(j), seeking approval to
`
`commercially manufacture, use and/or sell Defendants’ ANDA Product.
`
`37.
`
`On
`
`information and belief, Defendants’ ANDA refers and relies upon
`
`WEGOVY®’s NDA and contains data that, according to Defendants, demonstrate the
`
`bioequivalence of Defendants’ ANDA Product and WEGOVY®.
`
`38.
`
`On information and belief, Defendants made and included in Defendants’ ANDA
`
`a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Paragraph IV Certification”) that, in their
`
`
`
`12
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 13 of 46 PageID #: 13
`
`
`
`opinion and to the best of their knowledge, the Asserted Patents are invalid.
`
`39.
`
`Novo Nordisk received written notice of Defendants’ ANDA and Paragraph IV
`
`Certification as to the Asserted Patents (“Notice Letter”), which was dated December 16, 2022,
`
`along with an enclosed statement that is required to state all the factual and legal bases for stating
`
`that the commercial manufacture, use, or sale of Defendants’ ANDA Product allegedly will not
`
`infringe any valid claim of the Asserted Patents, and/or that the claims of the Asserted Patents
`
`allegedly are invalid and/or unenforceable (the “Detailed Statement”).
`
`40.
`
`Defendants’ Detailed Statement does not allege or provide any separate factual
`
`bases for stating that the Asserted Patents will not be infringed by Defendants’ ANDA Product
`
`apart from arguing that the Asserted Patents are invalid.
`
`41.
`
`Defendants’ Detailed Statement does not allege or provide any separate factual
`
`bases to assert that the Asserted Patents are unenforceable.
`
`42.
`
`43.
`
`This action is being commenced within 45 days of receipt of the Notice Letter.
`
`Defendants have infringed one or more claims of the Asserted Patents under 35
`
`U.S.C. § 271(e)(2)(A) by filing Defendants’ ANDA with a Paragraph IV Certification and seeking
`
`FDA approval of Defendants’ ANDA before the expiration of the Asserted Patents or any
`
`extensions thereof.
`
`44.
`
`Defendants have infringed one or more claims of the Asserted Patents under 35
`
`U.S.C. § 271(e)(2)(A) by the submission of Defendants’ ANDA, including any amendments or
`
`supplements thereof, seeking FDA approval to commercially manufacture, use, offer for sale, sell,
`
`distribute in, or import into the United States of Defendants’ ANDA Product before the expiration
`
`of the Asserted Patents or any extensions thereof.
`
`45.
`
`Defendants will infringe one or more claims of the Asserted Patents under 35
`
`
`
`13
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 14 of 46 PageID #: 14
`
`
`
`U.S.C. § 271(a), (b), (c) or (f) should they engage in, induce, or contribute to the commercial
`
`manufacture, use, offer for sale, sale, distribution in, or importation into the United States of
`
`Defendants’ ANDA Product before the expiration of the Asserted Patents or any extensions
`
`thereof.
`
`46.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`JURISDICTION
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`47.
`
`This Court has personal jurisdiction over Defendants because, on information and
`
`belief, Defendants, with MPI acting as an agent of Viatris, have committed and/or have aided,
`
`abetted, contributed to, or participated in the commission of tortious acts of patent infringement in
`
`preparing and submitting Defendants’ ANDA with a certification pursuant to 21 U.S.C. §
`
`355(j)(2)(A)(vii)(IV), including its amendments, which acts have led to foreseeable harm and
`
`injury to NNI, a Delaware corporation
`
`48.
`
`On information and belief, Defendants, with MPI acting as an agent of Viatris, have
`
`submitted Defendants’ ANDA, including amendments seeking FDA approval to engage in the
`
`commercial manufacture, use, sale, offer for sale, and/or importation of Defendants’ ANDA
`
`Product in or into the United States, including West Virginia, prior to the expiration of the Asserted
`
`Patents.
`
`49.
`
`On information and belief, Defendants, with MPI acting as an agent of Viatris, have
`
`committed an act of infringement by submitting Defendants’ ANDA in this district, including
`
`amendments, with the intent to make, use, sell, offer for sale, and/or import Defendants’ ANDA
`
`Product in or into this judicial district, prior to the expiration of the Asserted Patents, an act of
`
`infringement that has led and will lead to foreseeable harm and injury to Novo Nordisk.
`
`50.
`
`On information and belief, Viatris has attributed MPI’s submission of Defendants’
`14
`
`
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 15 of 46 PageID #: 15
`
`
`
`ANDA as to Wegovy as Viatris’s ANDA filing: “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.” See 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).
`
`51.
`
`This Court has personal jurisdiction over Defendants because, on information and
`
`belief, Defendants, with MPI acting as an agent of Viatris, upon approval of Defendants’ ANDA,
`
`will commit or will aid, abet, contribute to, or participate in future tortious acts of patent
`
`infringement permitted under Defendants’ ANDA that will be purposefully directed at West
`
`Virginia, including the marketing of Defendants’ ANDA Product in West Virginia, prior to the
`
`expiration of the Asserted Patents.
`
`52.
`
`On information and belief, MPI acted as an agent of Viatris in the preparation and
`
`submission of Defendants’ ANDA, including amendments, and, if Defendants’ ANDA is
`
`approved, MPI will continue to act as an agent of Viatris to engage in the commercial manufacture,
`
`use, sale, offer for sale, and/or importation of Defendants’ ANDA Product in or into the United
`
`States, including West Virginia, prior to the expiration of the Asserted Patents.
`
`53.
`
`On information and belief, Defendants, with MPI acting as an agent of Viatris, have
`
`taken the costly, significant step of applying to the FDA for approval, including submission of
`
`Defendants’ ANDA and amendments thereto, to engage in future activities, including the
`
`marketing of Defendants’ ANDA Product, that will be purposefully directed at West Virginia and
`
`elsewhere.
`
`
`
`15
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 16 of 46 PageID #: 16
`
`
`
`54.
`
`On information and belief, MPI, acting as an agent of Viatris, has systematic and
`
`continuous contacts with West Virginia; has established distribution channels for drug products in
`
`West Virginia; regularly and continuously conducts business in West Virginia, including by selling
`
`drug products in West Virginia, either directly or indirectly through its subsidiaries, agents, or
`
`affiliates; has purposefully availed itself of the privilege of doing business in West Virginia; and
`
`derives substantial revenue from the sale of drug products in West Virgina.
`
`55.
`
`On information and belief, Viatris has systematic and continuous contacts with
`
`West Virginia; has established distribution channels for drug products in West Virginia; regularly
`
`and continuously conducts business in West Virginia, including by selling drug products in West
`
`Virginia, either directly or indirectly through its subsidiaries, agents, or affiliates; has purposefully
`
`availed itself of the privilege of doing business in West Virginia; and derives substantial revenue
`
`from the sale of drug products in West Virginia.
`
`56.
`
`This Court has personal jurisdiction over Defendants because, on information and
`
`belief, Defendants, acting in concert, with MPI and Viatris acting as a single enterprise, have
`
`committed and/or have aided, abetted, contributed to, or participated in the commission of tortious
`
`acts of patent infringement in preparing and submitting Defendants’ ANDA with a certification
`
`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), including their amendments, which acts have led to
`
`foreseeable harm and injury to NNI.
`
`57.
`
`On information and belief, MPI acting as an alter ego of Viatris, develops,
`
`manufactures, distributes, sells and/or imports drug products for the entire United States market
`
`and does business in every state including West Virginia, either directly or indirectly.
`
`58.
`
`On information and belief, including, based on, inter alia, Defendants’ website,
`
`public SEC filings, and public press releases, Defendants hold themselves out as a unitary entity
`
`
`
`16
`
`

`

`
`Case 1:23-cv-00013-TSK Document 1 Filed 01/27/23 Page 17 of 46 PageID #: 17
`
`
`
`and operate as a single integrated business with respect to the regulat