Ferring B.V. v. Allergan, Inc.

932 F. Supp. 2d 493, 2013 WL 1144878, 2013 U.S. Dist. LEXIS 37993
CourtDistrict Court, S.D. New York
DecidedMarch 19, 2013
DocketNo. 12 Civ. 2650
StatusPublished
Cited by15 cases

This text of 932 F. Supp. 2d 493 (Ferring B.V. v. Allergan, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ferring B.V. v. Allergan, Inc., 932 F. Supp. 2d 493, 2013 WL 1144878, 2013 U.S. Dist. LEXIS 37993 (S.D.N.Y. 2013).

Opinion

OPINION

SWEET, District Judge.

Defendants Allergan, Inc.; Allergan USA, Inc.; and Allergan Sales, LLC (collectively, “Allergan”); Serenity Pharmaceuticals Corporation, Serenity Pharmaceuticals, LLC (collectively, “Serenity”), Reprise Biopharmaceutics, LLC (“Reprise”), Dr. Seymour H. Fein (“Fein”) and Dr. Ronald V. Nardi (“Nardi”) (collectively, the “Defendants”) have moved pursuant to Rules 8, 9(b), and 12(b)(6) of Federal Rules of Civil Procedure to dismiss the complaint § the “Complaint”) of plaintiffs Ferring B.V., Ferring International, Center S.A., and Ferring Pharmaceuticals Inc. (collectively, “Ferring” or the “Plaintiffs”) alleging seventeen causes of action arising out of the obtaining and use of certain patents by the Defendants.

Based upon the conclusions set forth below, the Defendants’ motion is granted as to Counts 4-17 and denied as to counts 1-3.

I. The Facts & Prior Proceedings

Desmopressin is a synthetic hormone used to treat a variety of disorders related to excessive urine production. (See Compl. ¶¶ 27-28).

Ferring developed the world’s first pharmaceutical desmopressin products, launching desmopressin in Denmark in 1972 as a treatment for central diabetes insipidus. (Id. ¶ 29). Over the past several decades, Ferring almost single-handedly built the' current desmopressin market by leading the industry in developing novel formulations and obtaining regulatory approval to treat an increasing number of disorders. (Id. ¶¶ 29-^14). Given its efficacy, safety profile, and worldwide commercial success, Ferring markets various desmopressin products today under the Minirin® tradename and continues to conduct research and development (“R & D”) on desmopressin. (Id. ¶¶ 29, 30).

‘ Given desmopressin’s success in treating central diabetes insipidus, a Ferring affiliate in 1984 awarded Dr. Jens Peter Norgaard (“Norgaard”), then a medical doctor in Denmark, a grant to investigate the possibility of effectively treating nocturnal enuresis. (Id. ¶ 31). Norgaard’s work established that desmopressin successfully treated children suffering from this disorder, enabling Ferring to obtain regulatory approval and launch desmopressin for this purpose. (Id.) After becoming an employee with a Ferring affiliate, Norgaard also led the effort to gain regulatory approval for desmopressin as a treatment for nocturia, further expanding the reach of desmopressin therapy and Ferring’s Minirin® products. (Id. ¶¶32, 33). During the 1990s, Norgaard also investigated an adverse side effect associated with desmopressin, hyponatremia, in which excessive water retention causes an imbalance in [498]*498blood sodium levels. (Id. f 33). His research into dosage levels led him to recognize that higher doses, rather than generating a stronger antidiuretic effect, simply extend desmopressin’s duration of action. (Id. ¶¶ 34, 35).

Dr. Thomas Senderovitz (“Senderovitz”) joined Ferring soon thereafter to build a pharmacokinetics department and began collaborating with Norgaard. (Id. ¶ 35). Senderovitz began pooling data both from in and outside of Ferring to generate comprehensive analyses of desmopressin’s properties, known internally as the EMF study. (Id. ¶¶ 35, 37). Norgaard and Senderovitz confirmed that desmopressin was far more potent than previously understood and that even low doses may yield maximum antidiuretic effect, while higher doses merely extend duration of action. (Id. ¶¶ 35, 36). Given these findings and the understanding that higher dosages may increase the risk of hyponatremia, Norgaard and Senderovitz proposed dosages designed to achieve maximum plasma levels of approximately 6-7 pg/ml or lower, yielding a duration of six hours or less. (Id.) Their studies later served as a basis for Ferring clinical studies targeted at further evaluating the efficacy of low doses of desmopressin. (Id. ¶ 38).

On August 30, 2001, Ferring decided to proceed with an orodispersible formulation project, and Senderovitz and his pharmacokinetics group developed study protocols in support of this endeavor, (Id. at ¶44.) Consistent with previous development plans considered in the 1990s, these protocols specified using the orodispersible formulation as a sublingual tablet. (Id.)

Fein and Nardi worked together in Fer-ring’s former Tarrytown, New York office beginning in the 1990s. (Id. ¶46). An “Employment Agreement” executed in connection with the promotion allegedly manifests Nardi’s “agree[ment] to assign his ownership rights to any invention (or any improvement upon or addition to an invention) applicable to the business then being carried on by Ferring that Nardi made, discovered, or participated in the discovery of’ during the course of his employment. (Id. ¶ 48).

When Nardi joined Ferring, he began working with Fein, then a consultant for Ferring. (Id. ¶ 52.) In 1997, Fein became an employee at Ferring with the position of Executive Director, Clinical Research and Medical Affairs. (Id. ¶ 53.) He was an employee for just one year, however, and then resumed his consulting role. (See id. ¶¶ 54-56.) In 2001, while Fein was a consultant, his “duties and responsibilities ... expanded to include assisting with developing (and potentially patenting) a desmopressin formulation.” (Id. ¶ 56.) Fein “continued to hold himself out as Medical Director” during that period. (Id. ¶ 59). For most of their tenure, neither Nardi or Fein nor that office had any involvement in desmopressin R & D. (Id. ¶ 50). After Nardi became Executive Vice President, Research and Development and Chief Scientific Officer on August 1, 2001, his responsibilities expanded to include Ferring’s development of the new orodispersible desmopressin formulation. (Id. ¶ 47, 50). His performance objectives and bonus criteria for 2001/2002 depended in part on obtaining patent protection for this formulation. (Id. ¶ 50).

Fein became a senior management member of - Ferring’s high-level Research Development Marketing committee (“RMDC”) (Id. ¶ 57) and began travelling to Copenhagen to attend various meetings concerning Ferring’s global research and development. (Id.) Fein also later served as the sponsor on several Ferring clinical studies, signing on Ferring’s behalf and holding himself out as Medical Director, Ferring Research and Development. (Id. [499]*499¶ 58). Fein was one of the most highly compensated employees at Ferring in 2001 and 2002. (Id. ¶ 60).

As of December 2001, Nardi was unaware of the status of the orodispersible study, internally designated CS004. (Id. ¶ 51.) When he inquired about its status, Senderovitz informed him that the protocol, specifying sublingual delivery and naming Senderovitz as study sponsor, had been completed. (Id.) Fein similarly did not participate in any desmopressin meetings until 2002. (Id. ¶ 57).

Ferring filed a patent application on an orodispersible desmopressin formulation in Great Britain on May 7, 2002, without identifying any inventors, and then filed a Patent Cooperation Treaty (“PCT”) application on September 20, 2002, identifying an initial set of six inventors, (Id.

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Bluebook (online)
932 F. Supp. 2d 493, 2013 WL 1144878, 2013 U.S. Dist. LEXIS 37993, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ferring-bv-v-allergan-inc-nysd-2013.