DCT

1:12-cv-02650

Ferring BV v. Allergan Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:12-cv-02650, S.D.N.Y., 04/05/2012
  • Venue Allegations: Venue is alleged to be proper based on Defendants residing, maintaining places of business, and/or transacting business within the Southern District of New York.
  • Core Dispute: Plaintiff alleges that its former employees/consultants misappropriated its inventions related to low-dosage desmopressin formulations, improperly obtained patents on those inventions in their own names, and seeks correction of inventorship and transfer of patent ownership.
  • Technical Context: The technology concerns low-dosage formulations of desmopressin, a synthetic hormone used to treat conditions like nocturia (frequent nighttime urination), aiming to provide clinical efficacy while reducing the risk of side effects such as hyponatremia.
  • Key Procedural History: The complaint alleges that the individual defendants, former Ferring employees or consultants, used confidential Ferring research to file patent applications that copied "almost verbatim" from a Ferring application. These patents were later assigned to Defendant Allergan as part of a commercialization deal for an investigational drug (SER-120) for an upfront payment of $43 million, with potential future payments. The complaint also notes parallel patent entitlement proceedings between the parties in the District Court of The Hague, Netherlands.

Case Timeline

Date Event
1999-01-01 Ferring scientist Dr. Norgaard presents research on effective antidiuresis at low desmopressin plasma levels.
2001-08-01 Defendant Nardi executes a new Employment Agreement with Ferring, expanding his responsibilities.
2002-05-07 Ferring files Great Britain patent application GB 0210397.6 (Earliest Priority Date for all Patents-in-Suit).
2002-09-30 Defendant Nardi's employment with Ferring ends.
2002-11-06 Defendant Nardi and Ferring execute a Severance Agreement.
2002-11-07 Defendant Fein is formally terminated from Ferring.
2003-05-06 Defendant Fein files a PCT application allegedly copying Ferring’s specification and claiming priority to Ferring’s GB application.
2008-07-29 U.S. Patent No. 7,405,203 is issued.
2009-08-25 U.S. Patent No. 7,579,321 is issued.
2010-04-01 Reprise and Serenity enter a global agreement with Allergan for the development of SER-120.
2010-05-19 The ’203 and ’321 patents are assigned from Reprise to Allergan.
2010-09-21 U.S. Patent No. 7,799,761 is issued.
2012-01-11 Defendants allegedly file confidential Ferring documents in Dutch court proceedings.
2012-04-05 Complaint is filed.

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,405,203 - "Pharmaceutical Compositions Including Low Dosages of Desmopressin"

  • Patent Identification: U.S. Patent No. 7,405,203, "Pharmaceutical Compositions Including Low Dosages of Desmopressin," issued July 29, 2008.

The Invention Explained

  • Problem Addressed: The patent background describes that while existing formulations of desmopressin are effective for conditions like central diabetes insipidus and primary nocturnal enuresis (PNE), standard dosages can lead to undesirable side effects, including hyponatremia (low blood sodium levels) ('203 Patent, col. 2:16-19).
  • The Patented Solution: The invention is directed to methods of treatment using low dosages of desmopressin sufficient to achieve a specific, low peak plasma concentration (no greater than 10 pg/ml) that is maintained for a controlled duration (e.g., four to six hours) ('203 Patent, col. 27:8-16). This approach claims to provide the necessary antidiuretic effect while mitigating the risk of side effects associated with higher standard doses ('203 Patent, col. 2:19-22). The specification provides clinical data, illustrated in figures such as Figure 1, showing the effect of low doses on urine osmolality, a measure of urine concentration ('203 Patent, col. 3:5-8).
  • Technical Importance: This low-dose titration approach represents a strategy to optimize the therapeutic window for desmopressin, potentially making the drug safer for chronic use in sensitive patient populations, such as adults with nocturia ('203 Patent, col. 16:25-30).

Key Claims at a Glance

  • The complaint alleges that the discoveries of its scientists cover the claims of the ’203 Patent, referencing the core concepts of independent claim 1 (Compl. ¶¶125, 128).
  • Independent Claim 1 includes the following essential elements:
    • A method of treating nocturia, primary nocturnal enuresis, or incontinence, or for inducing voiding postponement;
    • administering a pharmaceutical composition comprising a dose of desmopressin;
    • sufficient to achieve a maximum plasma/serum concentration no greater than 10 pg/ml;
    • and maintaining the concentration within the range of about 0.5 pg/ml and 10 pg/ml for about four to six hours.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 7,579,321 - "Pharmaceutical Compositions Including Low Dosages of Desmopressin"

  • Patent Identification: U.S. Patent No. 7,579,321, "Pharmaceutical Compositions Including Low Dosages of Desmopressin," issued August 25, 2009.

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’203 Patent: the need for desmopressin treatments that are effective but minimize side effects like hyponatremia ('321 Patent, col. 2:17-20).
  • The Patented Solution: This patent claims methods for inducing voiding postponement while explicitly "reducing the risk that the patient develops hyponatremia" ('321 Patent, col. 29:1-3). The claimed solution involves delivering a very small amount of desmopressin (e.g., no more than about 2 ng/kg) via specific administration routes (e.g., intranasal, transmucosal) to produce an antidiuretic effect lasting for a limited duration of about four to six hours ('321 Patent, col. 29:1-10). The detailed description explains that this controlled, limited duration is key to avoiding over-hydration and the resulting hyponatremia ('321 Patent, col. 16:36-45).
  • Technical Importance: By claiming a method that explicitly links a low-dose administration protocol to the reduction of a specific, serious side effect, the invention provides a targeted therapeutic strategy for safely managing conditions that require antidiuresis.

Key Claims at a Glance

  • The complaint alleges that the work of its scientists corresponds to the claims of the ’321 patent, referencing the concepts of independent claims 1 and 8 (Compl. ¶¶138-143).
  • Independent Claim 1 includes the following essential elements:
    • A method for inducing voiding postponement while reducing the risk of hyponatremia;
    • delivering to the bloodstream an amount of desmopressin of no more than about 2 ng/kg;
    • by intranasal, transdermal, intradermal, transmucosal, or conjunctival administration;
    • with the amount being therapeutically effective to produce an antidiuretic effect lasting for no more than between about 4 and about 6 hours.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 7,799,761 - "Pharmaceutical Compositions Including Low Dosages of Desmopressin"

  • Patent Identification: U.S. Patent No. 7,799,761, "Pharmaceutical Compositions Including Low Dosages of Desmopressin," issued September 21, 2010.
  • Technology Synopsis: This patent is directed to pharmaceutical compositions rather than methods of treatment. It claims specific dosage forms (e.g., adapted for intranasal or transdermal administration) containing a low amount of desmopressin (e.g., 0.5 ng to 1 µg) that, when administered, establish a low steady-state plasma concentration to achieve a safe and effective antidiuretic effect.
  • Asserted Claims: The complaint alleges its scientists' inventions cover the subject matter of independent claims 1 and 9 (Compl. ¶¶153, 156-159).
  • Accused Features: The complaint alleges that the claimed compositions cover subject matter invented by Ferring's scientists, specifically the concept that low doses of desmopressin can be clinically effective and avoid side effects (Compl. ¶¶159-160).

III. The Accused Instrumentality

The dispute does not center on a traditional "accused instrumentality" in an infringement context. Instead, the subject of the lawsuit is the ownership of the patents-in-suit themselves: the ’203, ’321, and ’761 patents (Compl. ¶1).

The commercial embodiment of the disputed patented technology is identified in the complaint as SER-120, a "Phase III investigational drug comprising a desmopressin formulation for intranasal administration" (Compl. ¶106). The complaint alleges that on April 1, 2010, Defendants Reprise and Serenity entered into a "global agreement with Allergan for the development and commercialization of SER-120." As part of this agreement, the patents-in-suit were assigned to Allergan in exchange for an "up-front payment of $43 million... with potential milestone payments of up to $122 million" (Compl. ¶106). The commercial value and strategic importance of SER-120 provide the context for the dispute over the rightful ownership of the underlying intellectual property.

IV. Analysis of Infringement Allegations

The complaint does not allege patent infringement. The core allegation is a dispute over inventorship and ownership, brought under 35 U.S.C. § 256 for correction of inventorship (Compl. ¶1). Plaintiff Ferring's central theory is that its scientists, Jens Peter Norgaard and Thomas Senderovitz, are the true inventors of the subject matter claimed in the patents-in-suit, and that Defendant Seymour Fein, the sole listed inventor, misappropriated their work.

Narrative Summary of Inventorship Allegations

  • ’203 Patent: Ferring alleges that Norgaard and Senderovitz conducted extensive analysis which "revealed the efficacy of low doses of desmopressin" (Compl. ¶128). Their work allegedly determined that doses resulting in plasma concentrations "well below 10 pg/ml, including below 5 pg/ml, can provide an antidiuretic effect" for an "appropriate period... such as 6 hours or less" (Compl. ¶128). The complaint asserts that these specific discoveries "correspond to and cover the '203 patent claims" and that Defendant Fein "did not contribute to any of this work" (Compl. ¶128-129). Ferring seeks to have Norgaard and Senderovitz added as inventors and Fein removed (Compl. ¶¶133-134).

  • ’321 Patent: The complaint makes similar allegations regarding the ’321 Patent. It states that Norgaard and Senderovitz's analyses on the efficacy of low doses, the resulting plasma concentrations, the appropriate duration of antidiuretic effect (6 hours or less), and consideration of standard advice to restrict fluid intake "correspond to and cover the '321 patent claims" (Compl. ¶143). As with the '203 patent, the complaint alleges that Fein "did not contribute to any of this work" (Compl. ¶143) and therefore should be removed as an inventor in favor of Norgaard and Senderovitz (Compl. ¶¶148-149).

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

While this is not an infringement case, the scope of the claims is central to determining who invented the claimed subject matter. Practitioners may focus on the construction of terms that define the core technical discovery.

  • The Term: "achieve a maximum desmopressin plasma/serum concentration no greater than 10 pg/ml" ('203 Patent, claim 1)

  • Context and Importance: This term quantifies the "low dose" concept at the heart of the patents and the inventorship dispute. The central question of fact is who first conceived of and demonstrated clinical utility at this specific, low plasma concentration. Ferring alleges its scientists presented data on effective treatment with plasma levels as low as 3 pg/ml in 1999 (Compl. ¶34).

    • Intrinsic Evidence for a Broader Interpretation: The claim language "achieve" is broad and not tied to a specific dosage form. This could support an interpretation where the inventive act was the discovery of the target plasma level itself, regardless of how it is achieved.
    • Intrinsic Evidence for a Narrower Interpretation: The specification discusses specific formulations, such as orodispersible tablets, as enabling the invention ('203 Patent, col. 3:55-61). A party could argue the inventive concept was not merely the target concentration but a practical method or formulation for reliably achieving it.

  • The Term: "antidiuretic effect lasting for no more than between about 4 and about 6 hours" ('321 Patent, claim 1)

  • Context and Importance: This limitation defines the duration of the drug's action, a critical factor for balancing efficacy with the risk of hyponatremia. The inventorship dispute may turn on who first conceived of targeting this specific, limited duration. Ferring alleges its scientist proposed dosages designed to yield an antidiuretic effect of "approximately 6 hours or less" (Compl. ¶36).

    • Intrinsic Evidence for a Broader Interpretation: The patent defines "antidiuretic effect" in its examples by measuring both urine osmolality and urine output, suggesting the term is not limited to a single metric ('203 Patent, Example 8).
    • Intrinsic Evidence for a Narrower Interpretation: A party might argue that the "effect" must meet specific quantitative thresholds shown in the patent’s clinical data, such as the mean nadir urine output levels or peak osmolality levels depicted in Figures 7-9 ('203 Patent, col. 22:35-40).

VI. Other Allegations

  • Willful Infringement: The complaint alleges conduct that suggests willful and deliberate misappropriation rather than infringement. It asserts that Defendants Fein and Nardi, as former Ferring personnel, had access to confidential research, trade secrets, and proprietary information (Compl. ¶¶86, 111). The complaint alleges that Fein's patent application "copied almost verbatim the specification from Ferring's PCT and Great Britain patent applications" (Compl. ¶74). It further alleges that Defendants wrongfully used Ferring's confidential clinical study reports and other internal documents to obtain and commercialize the patents-in-suit (Compl. ¶¶109, 119). These allegations form the basis for claims of fraudulent concealment and unjust enrichment, and support an inference of knowing and willful misconduct (Compl. ¶¶193, 205, 214).

VII. Analyst’s Conclusion: Key Questions for the Case

This case is not a standard infringement action but a dispute over inventorship and ownership rooted in allegations of misappropriation by former employees and consultants. The central questions for the court appear to be:

  • A fundamental question of inventive contribution: Who conceived of the core technical advance claimed in the patents—specifically, the therapeutic efficacy of maintaining a peak desmopressin plasma concentration below 10 pg/ml for a controlled duration of approximately 4-6 hours to balance antidiuresis with hyponatremia risk? The case will likely require a detailed factual inquiry into the respective contributions of Ferring’s scientists versus those of the named inventor, Defendant Fein.

  • A dispositive issue of ownership and duty: Even if Defendant Fein made some inventive contribution, did he do so by misappropriating Ferring’s confidential information and trade secrets in breach of his contractual and common law duties? The resolution of this question may determine whether inventorship must be corrected and ownership of the patents transferred to Ferring, regardless of Fein’s role in the inventive process.