Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 1 of 92
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`RIGSHOSPITALET,
`
`Plaintiff,
`
`v.
`SHIRE-NPS PHARMACEUTICALS,
`INC.
`and
`TAKEDA PHARMACEUTICALS
`U.S.A., INC.,
`
`Case No. 21cv11602
`JURY TRIAL DEMANDED
`
`Defendants.
`
`COMPLAINT
`
`Plaintiff Rigshospitalet, a hospital located in Denmark that is affiliated with the
`
`University of Copenhagen, by and through its undersigned counsel, files this Complaint against
`
`Shire-NPS Pharmaceuticals, Inc. (“Shire-NPS”) and Takeda Pharmaceuticals U.S.A., Inc.
`
`(“Takeda USA”; collectively with Shire-NPS, “Defendants”), and alleges as follows:
`
`NATURE OF THE SUIT
`
`1.
`
`Rigshospitalet brings this action to remedy Defendants’ theft of inventions
`
`relating to the revolutionary treatment of short bowel syndrome (“SBS”) in patients with colon-
`
`in-continuity using GLP-2 receptor agonists. By misappropriating Rigshospitalet’s inventions,
`
`Defendants have earned more than $2 billion in revenue on sales of Gattex® without paying any
`
`royalties to Rigshospitalet — a revenue stream that Rigshospitalet could have re-invested in
`
`researching and developing other groundbreaking medical treatments.
`
`2.
`
`The revolutionary inventions that Defendants stole were developed by Dr. Per
`
`Brøbech Mortensen and Dr. Palle Bekker Jeppesen at Rigshospitalet — a hospital located in
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 2 of 92
`
`Denmark that is affiliated with the University of Copenhagen. Dr. Mortensen is Chief Physician
`
`and Head of the Department of Medicine, Gastroenterology Section at Rigshospitalet.
`
`Dr. Jeppesen is Head of Research in the Department of Medicine, Gastroenterology Section at
`
`Rigshospitalet.
`
`3.
`
`Drs. Mortensen and Jeppesen invented the treatment of SBS patients with colon-
`
`in-continuity using GLP-2 receptor agonists at Rigshospitalet as part of clinical trials involving
`
`the treatment of SBS patients with teduglutide, a dipeptidyl peptidase IV resistant GLP-2
`
`receptor agonist (“Teduglutide Study”). The Teduglutide Study was sponsored by Shire-NPS’s
`
`then wholly-owned subsidiary NPS Allelix Corporation (“NPS Allelix”).
`
`4.
`
`Shire-NPS (by and through NPS Allelix), Rigshospitalet, and Dr. Mortensen
`
`struck a clear and unequivocal agreement regarding intellectual property resulting from the
`
`Teduglutide Study. They agreed that Rigshospitalet owned any intellectual property (including
`
`patents) resulting from the Teduglutide Study provided that Shire-NPS had a one-year option to
`
`obtain a worldwide, royalty-bearing, exclusive license to any such patents.
`
`5.
`
`As they worked on the Teduglutide Study, Drs. Mortensen and Jeppesen
`
`discovered that GLP-2 receptor agonists could be used to effectively treat SBS patients with
`
`colon-in-continuity — a discovery that was surprising and contrary to the conventional belief
`
`that such patients could not be helped using GLP-2 receptor agonists. Drs. Mortensen and
`
`Jeppesen reported their findings in a manuscript that was published in the scientific journal Gut
`
`in August 2005: Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like
`
`peptide 2 analogue, improves intestinal function in short bowel syndrome patients (“GLP-2 SBS
`
`Article”).
`
`2
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 3 of 92
`
`6.
`
`But unbeknownst to Drs. Mortensen and Jeppesen, just before submitting the
`
`manuscript to Gut journal, Shire-NPS submitted a near-final draft of the GLP-2 SBS Article as
`
`Provisional Patent Application No. 60/623,233 (“’233 Application”) to the United States Patent
`
`and Trademark Office (“Patent Office”). Shire-NPS did not name Drs. Mortensen and Jeppesen
`
`as inventors. Shire-NPS did not tell Drs. Mortensen and Jeppesen or Rigshospitalet, and
`
`concealed from them, that Shire-NPS had filed the ’233 Application.
`
`7.
`
`Shire-NPS continued to file non-provisional patent applications claiming priority
`
`to the ’233 Application (collectively, the “GLP-2 SBS Applications”) and has obtained almost
`
`30 United States and foreign patents claiming priority to that application (collectively, the
`
`“GLP-2 SBS Patents”; collectively with the GLP-2 SBS Applications, the “GLP-2 SBS
`
`Applications and Patents”). Shire-NPS did not name Drs. Mortensen and Jeppesen as inventors
`
`on any of the GLP-2 SBS Applications and they are not therefore named as inventors on any of
`
`the issued GLP-2 SBS Patents. Shire-NPS did not tell Drs. Mortensen and Jeppesen or
`
`Rigshospitalet, and concealed from them, that Shire-NPS had filed the GLP-2 SBS Applications
`
`and obtained the GLP-2 SBS Patents.
`
`8.
`
`In fact, pursuant to their agreement with Shire-NPS, Rigshospitalet owns all
`
`rights, title, and interests in the GLP-2 SBS Applications and Patents. Moreover, Drs.
`
`Mortensen and Jeppesen are inventors of the inventions claimed in the GLP-2 SBS Applications
`
`and Patents.
`
`9.
`
`Rigshospitalet only recently learned about Defendants’ theft of its inventions and
`
`that Defendants have earned billions of dollars on royalty-free sales of Gattex — a parenteral
`
`therapeutic containing GLP-2 receptor agonists indicated for use in the treatment of adult and
`
`pediatric SBS patients, including patients with colon-in-continuity.
`
`3
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 4 of 92
`
`10.
`
`Rigshospitalet brings this action to remedy Defendants’ theft of Drs. Mortensen
`
`and Jeppesen’s inventions, wrongful prosecution of the GLP-2 SBS Applications, and misuse of
`
`the GLP-2 SBS Patents to protect the royalty-free profits that Defendants have illicitly earned by
`
`exploiting Drs. Mortensen and Jeppesen’s inventions.
`
`THE PARTIES
`
`11.
`
`Plaintiff Rigshospitalet is located at Blegdamsvej 9, 2100 Copenhagen Ø,
`
`Denmark. Rigshospitalet is the most specialized hospital in Copenhagen and one of the largest
`
`hospitals in Denmark. Rigshospitalet is the owner of all rights, title, and interests in Drs.
`
`Mortensen and Jeppesen’s inventions described in the ’233 Application and all applications
`
`and patents claiming priority thereto, including the GLP-2 SBS Applications and Patents.
`
`12.
`
`Shire-NPS is a corporation organized and existing under the laws of the state of
`
`Delaware, with its principal place of business at 300 Shire Way, Lexington, Massachusetts.
`
`Shire-NPS is a wholly owned direct or indirect subsidiary of Takeda USA and is held out as “a
`
`Takeda company” on the Gattex website (www.gattex.com). Shire-NPS was formerly known as
`
`NPS Pharmaceuticals, Inc. (“NPS Pharmaceuticals”), then-parent of NPS Allelix. In 2008, NPS
`
`Allelix sold its intellectual property and substantially all of its other assets to its parent NPS
`
`Pharmaceuticals. Shire-NPS, together with Takeda USA, manufactures, distributes, markets,
`
`offers for sale, and sells Gattex in the United States.
`
`13.
`
`Takeda USA is a corporation organized and existing under the laws of the state of
`
`Delaware, with its principal place of business at 95 Hayden Avenue, Lexington, Massachusetts.
`
`Takeda USA wholly owns, directly or indirectly, Shire-NPS and holds Shire-NPS out as “a
`
`Takeda company” on the Gattex website (www.gattex.com). Takeda USA, together with Shire-
`
`NPS, manufactures, distributes, markets, offers for sale, and sells Gattex in the United States.
`
`4
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 5 of 92
`
`JURISDICTION AND VENUE
`
`14.
`
`This Court has subject matter jurisdiction over Rigshospitalet’s claims pursuant
`
`to 28 U.S.C. §§ 1331, 1332(a), 1338, 1367, 2201, and 2202. This Court has subject matter
`
`jurisdiction over Rigshospitalet’s claims for breach of contract, breach of the implied covenant of
`
`good faith and fair dealing, unjust enrichment, fraudulent nondisclosure, conversion, and unfair
`
`and deceptive trade practices, each having a value exceeding $75,000, under 28 U.S.C.
`
`§§ 1332(a) and 1367. This Court has subject matter jurisdiction over Rigshospitalet’s claim to
`
`quiet title to the GLP-2 SBS Applications and Patents, which has a value exceeding $75,000,
`
`pursuant to 28 U.S.C. §§ 1332(a), 1367, 2201, and 2202. This Court has subject matter
`
`jurisdiction over Rigshospitalet’s claim for correction of inventorship pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202. This Court has jurisdiction over Rigshospitalet’s claims for
`
`patent infringement pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`15.
`
`This Court has personal jurisdiction over Shire-NPS because Shire-NPS
`
`maintains its principal place of business in the Commonwealth of Massachusetts; is licensed to
`
`do business in Massachusetts; and regularly, systematically, and continuously transacts business
`
`within Massachusetts. Shire-NPS has also committed the wrongful acts alleged herein, and
`
`benefited from those acts, within Massachusetts. Those wrongful acts include filing and
`
`prosecuting the GLP-2 SBS Applications despite the fact that Shire-NPS does not own the
`
`inventions claimed therein; deliberately misrepresenting the inventors on the GLP-2 SBS
`
`Applications and Patents; wrongfully recording in the Patent Office Shire-NPS’s alleged
`
`ownership of all rights, title, and interests in the GLP-2 SBS Applications and Patents;
`
`wrongfully listing the GLP-2 SBS Patents in the Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (“Orange Book”) which misrepresented that Shire-NPS owns and/or is
`
`5
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 6 of 92
`
`the exclusive licensee to the GLP-2 SBS Patents; and infringing the GLP-2 SBS Patents by its
`
`unauthorized marketing, distribution, offer for sale, and sale of Gattex in Massachusetts and
`
`elsewhere in the United States. Shire-NPS took, directed, and oversaw those wrongful acts from
`
`its Massachusetts headquarters and has reaped the benefits of royalty-free revenues on sales of
`
`Gattex at that headquarters.
`
`16.
`
`This Court has personal jurisdiction over Takeda USA because Takeda USA
`
`maintains its principal place of business in the Commonwealth of Massachusetts; is licensed to
`
`do business in Massachusetts; and regularly, systematically, and continuously transacts business
`
`within Massachusetts. Takeda USA has also committed wrongful acts giving rise to this action,
`
`and benefited from those acts, within Massachusetts. Those wrongful acts include overseeing
`
`Shire-NPS’s filing and prosecution of the GLP-2 SBS Applications despite the fact that Shire-
`
`NPS does not own the inventions; knowingly supporting Shire-NPS’s deliberate
`
`misrepresentation of the inventors on the GLP-2 SBS Applications; wrongfully coordinating
`
`with Shire-NPS to list the pediatric extensions to the GLP-2 SBS Patents in the Orange Book,
`
`which listings misrepresent that Shire-NPS owns and/or is the exclusive licensee to the GLP-2
`
`SBS Patents; and infringing the GLP-2 SBS Patents by its unauthorized marketing, distribution,
`
`offer for sale, and sale of Gattex in Massachusetts and elsewhere in the United States. Takeda
`
`USA took, directed, and oversaw all of those wrongful acts from its Massachusetts headquarters
`
`and has reaped the benefits of royalty-free revenues on sales of Gattex at that headquarters.
`
`17.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`
`
`
`
`
`
`6
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 7 of 92
`
`FACTUAL BACKGROUND
`
`A.
`
`18.
`
`Drs. Mortensen and Jeppesen Are Experts in the Treatment of SBS Patients
`and Oversee an Internationally Recognized Practice at Rigshospitalet
`
`Rigshospitalet is one of the largest hospitals in Denmark and the most highly
`
`specialized hospital in Copenhagen. Rigshospitalet is affiliated with the University of
`
`Copenhagen and part of the framework organization Copenhagen University Hospital.
`
`19.
`
`Dr. Mortensen, M.D., D.M.Sc., is Chief Physician and Head of the Department of
`
`Medicine, Section of Gastroenterology at Rigshospitalet.
`
`20.
`
`Dr. Jeppesen, M.D., Ph.D. is Head of Research at the Department of
`
`Gastroenterology of Rigshospitalet.
`
`21.
`
`Drs. Mortensen and Jeppesen are experts in conducting metabolic balance studies
`
`and have worked for years with SBS patients. SBS is a malabsorption disorder caused by a lack
`
`of functional small intestine. There are two distinct subgroups of SBS patients: those with no
`
`functional colon and those with colon-in-continuity with their remnant small intestine. Patients
`
`with no functional colon have low basal GLP-2 levels and limited meal-stimulated GLP-2
`
`secretions, which significantly impedes the intestinal absorption of nutrients. By contrast,
`
`patients with colon-in-continuity have elevated basal endogenous GLP-2 levels.
`
`22.
`
`Drs. Mortensen and Jeppesen worked for years exploring the efficacy of treating
`
`SBS patients using GLP-2 receptor agonists. GLP-2 is of interest for SBS patients because it
`
`acts to slow gastric emptying, reduce gastric secretions, increase intestinal blood flow, and
`
`stimulate growth of the small and large intestines. By July 1999, Drs. Mortensen and Jeppesen
`
`had prepared a formulation for the first human GLP-2 study in eight SBS patients with no colon.
`
`23.
`
`Drs. Mortensen and Jeppesen also shared their research and development
`
`regarding the treatment of SBS patients by publishing their research findings in several well-
`
`7
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 8 of 92
`
`known medical journals in the field of gastroenterology, including Gut, Journal of Parenteral
`
`and Enteral Nutrition, The Journal of Nutrition, and Gastroenterology. For example, in April
`
`1999, Drs. Mortensen and Jeppesen published their research regarding postprandial endogenous
`
`GLP-2 secretion in SBS patients with no functional colon in Gut. In 2001, Drs. Mortensen and
`
`Jeppesen published an article describing the positive benefits of GLP-2 in SBS patients with no
`
`functional colon in Gastroenterology.
`
`B.
`
`24.
`
`Shire-NPS Recruited Drs. Mortensen and Jeppesen to Oversee Clinical
`Trials Investigating the Treatment of SBS Patients at Rigshospitalet
`
`In light of their expertise in this area, and Rigshospitalet’s access to patients with
`
`rare SBS conditions, Drs. Mortensen and Jeppesen were recruited by Shire-NPS to oversee a
`
`clinical study of teduglutide at Rigshospitalet. Teduglutide is a type of GLP-2 receptor agonist
`
`that can help stimulate GLP-2 secretions in SBS patients.
`
`25.
`
`The Teduglutide Study was conducted in accordance with the Clinical Research
`
`Protocol titled “Open-Label Multicenter, Dose-Ranging, Pilot Study to Examine the Safety,
`
`Tolerability and Efficacy of a 21 Day, Ascending, Multidose Subcutaneous Treatment with
`
`ALX-0600 in Patients with Short Bowel Syndrome” (“Clinical Study Protocol”).
`
`26.
`
`Rigshospitalet, Dr. Mortensen, and NPS Allelix on behalf of itself and its
`
`affiliates (including Shire-NPS), also entered into a Clinical Study Agreement, dated April 1,
`
`2000 (“Clinical Study Agreement”). The Clinical Study Agreement provided that Rigshospitalet
`
`owns any intellectual property resulting from the Teduglutide Study subject to Shire-NPS’s
`
`option to license any patents.
`
`27.
`
`The Clinical Study Agreement provided, inter alia, that “[Rigshospitalet] shall
`
`own its medical records, research notebooks and related documentation and any intellectual
`
`8
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 9 of 92
`
`property resulting from the [Teduglutide] Study subject to the option granted to [Shire-NPS] to
`
`license Inventions described below.” (Section 8, Clinical Study Agreement.)
`
`28.
`
`The Clinical Study Agreement further provided that Shire-NPS would notify
`
`Rigshospitalet (and Dr. Mortensen) if Shire-NPS believed that any proposed publication
`
`concerning their work on the Teduglutide Study disclosed any invention for which a patent
`
`application should be filed:
`
`The Investigator shall furnish Sponsor with a copy of any proposed publication
`for review and comment at least thirty (30) days prior to submission for
`publication. At the expiration of such thirty (30) day period, Investigator may
`proceed with the submission for publication provided, however, that upon notice
`by Sponsor that Sponsor reasonably believes a patent application claiming an
`Invention (such as the term is defined in Section 8 below) should be filed, such
`publication shall be delayed for an additional ninety (90) days or until any patent
`application or applications have been filed.
`
`(Section 7, Clinical Study Agreement.)
`
`
`29.
`
`The Clinical Study Agreement also provided that Shire-NPS would notify
`
`Rigshospitalet if it believed that a patent application relating to inventions resulting from
`
`Rigshospitalet’s (and Dr. Mortensen’s) work on the Teduglutide Study should be filed:
`
`Within sixty (60) days of such disclosure, [Shire-NPS] shall notify institution in
`writing if it wishes Institution to file a patent application claiming the Invention at
`[Shire-NPS’s] expense. For one (1) year after Institution’s disclosure of each
`Invention, [Shire-NPS] shall have the option to obtain a worldwide, royalty-
`bearing exclusive license to [Rigshospitalet’s] rights under any such patent
`application and any patent that issues on it.
`
` (Section 8, Clinical Study Agreement.)
`
`
`30.
`
`The Clinical Study Agreement also provided that the terms of any such license by
`
`Rigshospitalet to Shire-NPS for any issued patents would be negotiated in good faith:
`
`The terms of such license shall be negotiated in good faith, and shall include
`terms standard for agreements between academic research institutions and
`industry including, without limitation, clauses providing for reasonable royalties
`and/or other payments to [Rigshospitalet], objective time-limited due diligence
`
`9
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 10 of 92
`
`provisions and product liability indemnification and insurance requirements
`which are acceptable to [Rigshospitalet’s] liability insurance carrier.
`
`
`(Section 8, Clinical Study Agreement.)
`
`
`31.
`
`Drs. Mortensen and Jeppesen were Principal Investigators on the Teduglutide
`
`Study. Drs. Mortensen and Jeppesen enrolled the first Danish SBS patients in the Teduglutide
`
`Study in October 2000.
`
`32.
`
`Per the Clinical Study Protocol, the Teduglutide Study initially included only
`
`patients with no functional colon. Drs. Mortensen and Jeppesen analyzed the data for the
`
`Teduglutide Study in real time and recognized a beneficial effect in SBS patients with no
`
`functional colon. As they continued analyzing the results, Drs. Mortensen and Jeppesen
`
`conceived that GLP-2 receptor agonists should also have a beneficial effect in SBS patients with
`
`colon-in-continuity. This was contrary to the then widely held belief that GLP-2 receptor
`
`agonists would not help SBS patients with colon-in-continuity. In fact, the potential benefit of
`
`teduglutide in patients with colon-in-continuity had never before been studied.
`
`33.
`
`After conceiving of the idea of treating SBS patients with colon-in-continuity
`
`with GLP-2 receptor agonists, Drs. Mortensen and Jeppesen began recruiting and treating such
`
`patients as part of the Teduglutide Study. Drs. Mortensen and Jeppesen’s analysis of the data
`
`confirmed their hypothesis that treating SBS patients with colon-in-continuity using GLP-2
`
`receptor agonists provided significant benefits.
`
`34.
`
`Drs. Mortensen and Jeppesen drafted an article describing the positive impacts
`
`associated with treating SBS patients with colon-in-continuity using GLP-2 receptor agonists.
`
`Drs. Mortensen and Jeppesen provided the first draft for comment to Shire-NPS by early 2004.
`
`Drs. Mortensen and Jeppesen continued to work to finalize the GLP-2 SBS Article throughout
`
`the year, in connection with their ongoing work on the Teduglutide Study.
`
`10
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 11 of 92
`
`35.
`
`In September 2004, Shire-NPS solicited final approvals of the draft article before
`
`submitting it for publication and asked that the co-authors “join me in thanking Palle [Jeppesen]
`
`and Per [Mortensen] for the work they did on preparing the core of this manuscript.” Shire-NPS
`
`did not reveal that it intended to submit the final manuscript (or any draft) to the Patent Office as
`
`a provisional patent application or otherwise seek patent protection of the inventions described
`
`in the GLP-2 SBS Article. Shire-NPS did not notify Rigshospitalet that the GLP-2 SBS Article
`
`included any invention for which a patent application should be filed.
`
`36.
`
`The manuscript was submitted for publication to Gut on November 22, 2004, and
`
`accepted for publication on March 31, 2005. The GLP-2 SBS Article was published in the
`
`August 2005 issue of Gut.
`
`C.
`
`37.
`
`Shire-NPS Stole Drs. Mortensen and Jeppesen’s Invention and Built a
`Substantial Patent Portfolio Based on Their Invention
`
`Just days before submitting the GLP-2 SBS Article for publication, and
`
`unbeknownst to Drs. Mortensen and Jeppesen or Rigshospitalet, Shire-NPS filed a near-final
`
`draft of the GLP-2 SBS Article with the Patent Office as the ’233 Application. The ’233
`
`Application included the data and results from Drs. Mortensen and Jeppesen’s study reflecting
`
`the effective treatment of SBS patients with colon-in-continuity using GLP-2 receptor agonists.
`
`Shire-NPS did not name Drs. Mortensen and Jeppesen as inventors. Instead, Shire-NPS named
`
`one of its own employees as the sole inventor. Shire-NPS did not tell Drs. Mortensen and
`
`Jeppesen or Rigshospitalet, and concealed from them, that Shire-NPS had filed the
`
`’233 Application.
`
`38.
`
`In November 2005, Shire-NPS, by and through its wholly owned subsidiary
`
`NPS-Allelix, filed a non-provisional application claiming priority to the ’233 Application: U.S.
`
`Patent Application No. 11/262,980 (the “’980 Application”). The ’980 Application was a near
`
`11
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 12 of 92
`
`copy of the ’233 Application, i.e., a near-final draft of the GLP-2 SBS Article. The ’980
`
`Application again included the data and results from Drs. Mortensen and Jeppesen’s study
`
`reflecting the effective treatment of SBS patients with colon-in-continuity using GLP-2 receptor
`
`agonists. Shire-NPS did not name Drs. Mortensen and Jeppesen as inventors on the ’980
`
`Application. Instead, Shire-NPS named four of its own employees. Shire-NPS did not tell
`
`Drs. Mortensen and Jeppesen or Rigshospitalet, and concealed from them, that Shire-NPS had
`
`filed the ’980 Application.
`
`39.
`
`Shire-NPS kept Drs. Mortensen and Jeppesen and Rigshospitalet in the dark as it
`
`filed and prosecuted the GLP-2 SBS Applications and Patents, even as Drs. Mortensen and
`
`Jeppesen steadfastly continued their work on the Teduglutide Study — work that Shire-NPS
`
`later used to obtain marketing approval for Gattex.
`
`40.
`
`Shire-NPS continued to file additional non-provisional patent applications
`
`claiming priority to the ’233 Application. These GLP-2 SBS Applications were near copies of
`
`the ’233 Application, i.e., near-final drafts of the GLP-2 SBS Article. The GLP-2 SBS
`
`Applications included the data and results from Drs. Mortensen and Jeppesen’s study reflecting
`
`the effective treatment of SBS patients with colon-in-continuity using GLP-2 receptor agonists.
`
`Shire-NPS did not tell Drs. Mortensen and Jeppesen or Rigshospitalet, and concealed from
`
`them, that Shire-NPS was continuing to file and prosecute the GLP-2 SBS Applications
`
`claiming priority to the ’233 Application. Shire-NPS’s prosecution of the GLP-2 SBS
`
`Applications led to the issuance of numerous United States and foreign patents claiming priority
`
`to the original ’233 Application.
`
`41.
`
`The first GLP-2 SBS Patent that issued was U.S. Patent No. 7,847,061 (the
`
`“’061 Patent”). The ’061 Patent issued on December 7, 2010 from the ’980 Application, and
`
`12
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 13 of 92
`
`was titled “Treatment Of Short Bowel Syndrome Patients With Colon-In-Continuity.” The
`
`’061 Patent specification was a near copy of the ’233 Application, i.e., a near-final draft of the
`
`GLP-2 SBS Article. The ’061 Patent included the data and results from Drs. Mortensen and
`
`Jeppesen’s study reflecting the effective treatment of SBS patients with colon-in-continuity
`
`using GLP-2 receptor agonists. The ’061 Patent claimed methods for treating patients with SBS
`
`with colon-in-continuity using GLP-2 receptor agonists.
`
`42.
`
`Since the issuance of the ’061 Patent, Shire-NPS has obtained almost thirty
`
`United States and foreign patents claiming priority to the ’233 Application. The specifications
`
`of these GLP-2 SBS Patents are all near copies of the ’233 Application, i.e., a near-final draft of
`
`the GLP-2 SBS Article. The GLP-2 SBS Patents all include the data and results from
`
`Drs. Mortensen and Jeppesen’s study reflecting the effective treatment of SBS patients with
`
`colon-in-continuity using GLP-2 receptor agonists. The GLP-2 SBS Patents claim methods for
`
`treating patients with SBS with colon-in-continuity using GLP-2 receptor agonists. Shire-NPS
`
`did not tell Drs. Mortensen and Jeppesen or Rigshospitalet, and concealed from them, that its
`
`prosecution of the GLP-2 SBS Applications led to the issuance of the GLP-2 SBS Patents.
`
`43.
`
`The GLP-2 SBS Patents include the following issued United States patents:
`
`7,847,061; 9,060,992; 9,545,434; 9,981,014; 9,987,334; 9,993,528; 9,974,835; 9,974,836;
`
`9,545,435; 9,968,655; 9,539,310; 9,572,867; 9,592,273; 9,592,274; 9,555,079; 9,981,015;
`
`9,968,656; 9,974,837; 9,987,335; 9,974,838; 9,999,656; 9,981,016; 9,968,657; and 9,968,658.
`
`Copies of these patents are attached hereto as Exhibits A through X, respectively. The GLP-2
`
`SBS Patents also include the following foreign counterparts: CA 258542; JP 5197012; EP
`
`1809318; and HK 1107026.
`
`13
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 14 of 92
`
`44.
`
`Even today, Shire-NPS, at the direction and under the control of parent Takeda
`
`USA, is continuing to prosecute patent applications claiming priority to the ’233 Application
`
`and is misrepresenting to the Patent Office the inventors and ownership of the inventions
`
`claimed therein. Shire-NPS has six such pending patent applications in the United States alone.
`
`As with the other GLP-2 SBS Applications, the pending applications are near copies of the ’233
`
`Application, i.e., a near-final draft of the GLP-2 SBS Article. The pending applications include
`
`the data and results from Drs. Mortensen and Jeppesen’s study reflecting the effective treatment
`
`of SBS patients with colon-in-continuity using GLP-2 receptor agonists. Shire-NPS did not tell
`
`Drs. Mortensen and Jeppesen or Rigshospitalet, and concealed from them, that Shire-NPS had
`
`filed these applications and that it is continuing to prosecute them.
`
`45.
`
`The GLP-2 SBS Applications that are currently pending include the following
`
`United States patent applications: 16/732,545; 16/992,751; 17/206,513; 17/213,534;
`
`17/215,036; and 17/224,761.
`
`46.
`
`Rigshospitalet owns all rights, title, and interests in the GLP-2 SBS Applications
`
`and Patents. Moreover, Drs. Mortensen and Jeppesen are inventors of the inventions claimed in
`
`the GLP-2 SBS Applications and Patents.
`
`D.
`
`47.
`
`Shire-NPS Launches Gattex and Earns Billions of Dollars of Royalty-Free
`Revenues
`
`In 2012, Shire-NPS obtained marketing approval from the United States Food
`
`and Drug Administration (“FDA”) for its subcutaneous teduglutide treatment for SBS patients.
`
`48.
`
`By 2013, Shire-NPS launched the approved product in the United States as
`
`Gattex (teduglutide), indicated for the treatment of adults with SBS who are dependent on
`
`parenteral support, including SBS patients with colon-in-continuity. The administration of
`
`Gattex to SBS patients was the first significant long-term treatment for SBS in nearly 40 years.
`
`14
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 15 of 92
`
`49.
`
`In 2015, Shire plc acquired NPS Pharmaceuticals in a stock acquisition for total
`
`consideration of approximately $5.2 billion. At that time, Gattex was NPS Pharmaceuticals’
`
`only approved therapeutic. Shire plc subsequently changed the name of NPS Pharmaceuticals
`
`Inc. to Shire-NPS.
`
`50.
`
`On January 8, 2019, Takeda USA acquired Shire plc in a stock acquisition worth
`
`approximately $62 billion. On information and belief, Takeda USA reviewed the Clinical Study
`
`Agreement and knew before closing on the acquisition about all of the GLP-2 SBS Applications
`
`and Patents; that Rigshospitalet (not Shire-NPS) owned the GLP-2 SBS Applications and
`
`Patents; that Drs. Mortensen and Jeppesen should have been but were not named as inventors on
`
`the GLP-2 SBS Applications and Patents; that Shire-NPS had been misrepresenting the
`
`inventorship and ownership on the GLP-2 SBS Applications and Patents; and that Shire-NPS
`
`had been wrongfully listing the GLP-2 SBS Patents in the Orange Book and wrongfully
`
`asserting the GLP-2 SBS Patents against generics in litigation to protect its multi-billion dollar
`
`revenue stream.
`
`51.
`
`In May 2019, the FDA approved extending the indication of Gattex to pediatric
`
`patients one year and older with SBS who are dependent on parenteral support, including
`
`pediatric SBS patients with colon-in-continuity.
`
`52.
`
`Defendants have earned more than $2 billion in revenue on sales of Gattex in the
`
`United States so far — including more than $500 million in revenue last year alone. Defendants
`
`have earned these billions of dollars in royalty-free revenues on the backs of Drs. Mortensen and
`
`Jeppesen’s pioneering inventions at Rigshospitalet.
`
`53.
`
`Shire-NPS has also protected its royalty-free profits and discouraged competitors
`
`from entering the market by listing the GLP-2 SBS Patents for Gattex in the Orange Book.
`
`15
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 16 of 92
`
`Nineteen of the twenty patents listed for Gattex in the Orange Book are GLP-2 SBS Patents —
`
`the only other listed patent is a patent on the active ingredient set to expire in 2023. Shire-NPS
`
`listed these GLP-2 SBS Patents in the Orange Book despite knowing that it does not own those
`
`patents and is not licensed to use the inventions claimed therein.
`
`54.
`
`Shire-NPS has also filed suit against competitors to block their entry into the
`
`market by asserting GLP-2 SBS Patents against them, despite the fact that Shire-NPS does not
`
`own and is not licensed to use those patents. For example, in April 2017, Shire-NPS filed suit
`
`against Par Pharmaceuticals to block entry of a generic teduglutide treatment into the market.
`
`Shire-NPS alleged, inter alia, that Par Pharmaceuticals’ generic teduglutide treatment would
`
`infringe twenty different GLP-2 SBS Patents. Shire-NPS and Par Pharmaceuticals ultimately
`
`resolved the suit pursuant to a stipulation by which Par Pharmaceuticals was permanently
`
`enjoined from manufacturing, marketing, distributing, and selling generic teduglutide until the
`
`patent on the active ingredient (U.S. Patent No. 7,056,886) expires. That patent is set to expire
`
`in early 2023 at the conclusion of a pediatric extension.
`
`55.
`
`The entire time that Defendants earned billions of dollars in royalty-free profits
`
`and used the GLP-2 SBS Applications and Patents to keep competitors out of the market, they
`
`continued to knowingly, intentionally, and willfully keep Drs. Mortensen and Jeppesen and
`
`Rigshospitalet in the dark.
`
`56.
`
`Drs. Mortensen and Jeppesen and Rigshospitalet did not know, and in the
`
`exercise of reasonable diligence could not have known, of Defendants’ wrongful conduct or the
`
`factual basis for the claims asserted herein. Drs. Mortensen and Jeppesen and Rigshospitalet
`
`also did not have enough information to suggest that they had suffered any injury based on
`
`Defendants’ misconduct described herein and giving rise to those claims.
`
`16
`
`

`

`Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 17 of 92
`
`57.
`
`For example, Drs. Mortensen and Jeppesen and Rigshospitalet did not know that
`
`Shire-NPS submitted the GLP-2 SBS Article to the Patent Office, filed any of the GLP-2 SBS
`
`Applications, or obtained any of the GLP-2 SBS Patents.
`
`5