DCT

1:15-cv-02197

McNeil PPC Inc v. Watson Laboratories Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:15-cv-02197, D.N.J., 03/27/2015
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant’s principal place of business in New Jersey, its systematic and continuous business contacts including marketing and sales of generic drugs within the district, and its intent to market the accused products to residents of the district.
  • Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Rogaine® topical aerosol foam constitutes an act of infringement of a patent covering a specific pharmaceutical formulation.
  • Technical Context: The technology relates to high-concentration topical foam formulations of minoxidil, an active ingredient used for stimulating hair growth, designed to be more effective and cosmetically elegant than prior art solutions.
  • Key Procedural History: This action was triggered by Defendant Watson’s submission of ANDA No. 208-092 and its associated Paragraph IV certification letter to the Plaintiffs, asserting that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by its proposed generic product. The complaint was filed within the 45-day window provided by the Hatch-Waxman Act.

Case Timeline

Date Event
1998-04-22 '120 Patent Priority Date
2005-03-23 NDA filed for Men's Rogaine® (5% minoxidil) Topical Aerosol Foam
2005-09-20 U.S. Patent No. 6,946,120 Issues
2006-01-20 FDA approves NDA for Men's Rogaine®
2013-04-26 sNDA submitted for Women's Rogaine® (5% minoxidil) Topical Aerosol
2014-02-28 FDA approves sNDA for Women's Rogaine®
2015-02-13 Watson sends Paragraph IV Letter regarding its ANDA
2015-03-27 Complaint Filed

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

U.S. Patent No. 6,946,120 - PHARMACEUTICAL COMPOSITION

The Invention Explained

  • Problem Addressed: The patent addresses the poor solubility of minoxidil, a hair growth stimulant. Prior formulations required very high concentrations (e.g., 30-50%) of propylene glycol to achieve a 5% or greater minoxidil concentration. These high-glycol formulations were described as being viscous and tacky, making them "not pharmaceutically or cosmetically elegant" and potentially causing scalp irritation ('120 Patent, col. 1:19-39).
  • The Patented Solution: The invention is a pharmaceutical composition that enables a high concentration of minoxidil (at least 5%) while minimizing or excluding propylene glycol. The key is using an acid to significantly increase the solubility of minoxidil in a solvent system composed of water and a lower alcohol ('120 Patent, col. 1:53-56, col. 1:65-col. 2:3). This allows for a formulation with less than 10% propylene glycol, which can be delivered as a more consumer-friendly foam or mousse ('120 Patent, col. 1:57-64).
  • Technical Importance: This formulation technology allowed for the creation of a high-strength minoxidil product that avoided the negative cosmetic properties and potential irritation associated with the high levels of propylene glycol used in earlier products ('120 Patent, col. 1:30-39).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-3, 5-11, and 13-21 ('Compl. ¶24). Independent claim 1 is representative:
  • A homogeneous aerosol formulation, said homogeneous aerosol formulation consisting essentially of:
    • approximately 5% or greater by weight of minoxidil or a pharmaceutically acceptable salt thereof;
    • an acid in an amount effective to solubilize the minoxidil;
    • a solvent of water and a lower alcohol wherein the ratio of water to alcohol is in a range of approximately 9:1 to 1:9 by volume;
    • a co-solvent of a polyhydric alcohol...at less than approximately 10% by weight;
    • wherein the final product of the homogeneous aerosol formulation is foam or a mousse.
  • The complaint does not specifically identify which dependent claims it intends to assert beyond the listed ranges.

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed "Minoxidil Topical Aerosol 5% (foam)," which is the subject of ANDA No. 208-092 (Compl. ¶21).

Functionality and Market Context

  • The complaint alleges that Watson’s product is a generic version of Plaintiffs’ commercially available Men's Rogaine® and Women's Rogaine® (5% minoxidil) topical aerosol foam products (Compl. ¶21). As a generic drug submitted via an ANDA, the accused product is intended to be bioequivalent to the branded Rogaine® foam.
  • The complaint alleges that Watson seeks approval to engage in the commercial manufacture, use, and sale of its product before the expiration of the ’120 Patent, which is listed in the FDA's Orange Book as covering the branded Rogaine® foam products (Compl. ¶14, ¶20, ¶21).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not provide a detailed infringement analysis or a claim chart. The infringement allegation is a statutory one under 35 U.S.C. § 271(e)(2)(A), where the filing of an ANDA seeking approval to market a drug claimed in a patent before its expiration is a technical act of infringement (Compl. ¶27). The complaint notes that Defendant’s Paragraph IV letter "does not deny infringement of claims 1-3, 5-11 and 13-21 of the '120 Patent separate and apart from asserting invalidity" (Compl. ¶24). The following chart outlines the infringement theory implied by the allegation that the Watson product is a generic version of the patented Rogaine® foam.

'120 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A homogeneous aerosol formulation... wherein the final product of the homogeneous aerosol formulation is foam or a mousse. The accused product is described as a "Minoxidil Topical Aerosol 5% (foam)." ¶21 col. 18:38-39
approximately 5% or greater by weight of minoxidil or a pharmaceutically acceptable salt thereof; The accused product is identified as a "5% (foam)" formulation of minoxidil. ¶21 col. 18:21-23
an acid in an amount effective to solubilize the minoxidil or a pharmaceutically acceptable salt thereof... As a generic equivalent, the Watson Generic Product would necessarily include an equivalent mechanism to solubilize the minoxidil as taught by the patent. The complaint lacks specific details on the acid used. ¶21, ¶24 col. 18:24-31
a solvent of water and a lower alcohol wherein the ratio of water to alcohol is in a range of approximately 9:1 to 1:9 by volume; The Watson Generic Product, as an equivalent, is alleged to contain the same or an equivalent solvent system. The complaint does not specify the exact solvent composition. ¶21, ¶24 col. 18:31-33
a co-solvent of a polyhydric alcohol selected from...propylene glycol at less than approximately 10% by weight; To be a generic of the improved Rogaine® foam, the Watson Generic Product is alleged to contain a low concentration of propylene glycol, a key feature of the patented invention. ¶21, ¶24 col. 18:34-37
  • Identified Points of Contention:
    • Scope Questions: A central dispute may involve the transitional phrase "consisting essentially of." The parties may contest whether any additional, unlisted ingredients in Watson's ANDA formulation materially alter the "basic and novel properties" of the claimed invention, such as its solubility characteristics or low-irritation profile.
    • Technical Questions: A key question will be whether the specific formulation detailed in Watson’s confidential ANDA literally meets every limitation of the asserted claims. This will involve a fact-intensive comparison of the exact excipients, their concentrations, and their functions in Watson’s product against the language of the claims. For instance, does the acid in Watson’s product function "to solubilize" the minoxidil in the same manner claimed, or is solubility achieved through other means?

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of" (Claim 1)

    • Context and Importance: This term is critical because it defines the scope of the formulation. It permits the presence of unlisted ingredients so long as they do not materially affect the "basic and novel properties" of the invention. The infringement analysis will depend on what those properties are and whether any additional components in Watson's formulation affect them.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The use of this term, rather than the more restrictive "consisting of," suggests the patentee did not intend to exclude all other components.
      • Evidence for a Narrower Interpretation: The specification emphasizes that a key advance was creating a non-tacky, low-irritation formulation by minimizing propylene glycol ('120 Patent, col. 1:30-39). A court could find that the "basic and novel properties" are tied to this specific cosmetic and solubility profile, thus narrowing the scope of permissible unlisted ingredients.

  • The Term: "an acid in an amount effective to solubilize" (Claim 1)

    • Context and Importance: This is a functional limitation. Its construction will determine the threshold for infringement. The dispute may turn on the degree of solubilization required (e.g., complete vs. substantial) and whether the acid must be the primary agent responsible for it. Practitioners may focus on this term if the accused product achieves solubility through a combination of factors, raising questions about whether the acid itself is "effective" as claimed.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language does not specify a degree of solubilization, potentially covering any amount of acid that contributes to the effect.
      • Evidence for a Narrower Interpretation: The Summary of the Invention states the acid is present "in an amount to substantially completely solubilise" the active ingredient ('120 Patent, col. 1:53-56). This language may be used to argue for a narrower construction requiring a high degree of solubilization attributable to the acid.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Watson’s activities will lead to direct and indirect infringement (Compl. ¶33; Prayer for Relief, A, C). Induced infringement under § 271(b) would be predicated on the product's labeling and instructions for use, which would direct end-users to apply the foam to the scalp, thereby performing the claimed method of use and infringing the composition claims.
  • Willful Infringement: The complaint does not use the word "willful," but it alleges the case is "exceptional under 35 U.S.C. § 285" and seeks attorneys' fees (Prayer for Relief, E, F). The factual basis for this allegation is Defendant's pre-suit knowledge of the patent, demonstrated by its filing of a Paragraph IV certification as part of its ANDA submission (Compl. ¶22-23).

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

  • A core issue will be one of claim scope and interpretation: The outcome will likely depend on the court's construction of the term "consisting essentially of." This will define whether the specific list of ingredients in Watson’s ANDA, which may contain unlisted excipients, falls within the bounds of the patent claims.
  • A second central issue will be the interplay of infringement and validity. This case presents a classic Hatch-Waxman dispute where the defendant's primary defense, as indicated in its Paragraph IV letter, is likely to be patent invalidity (Compl. ¶23). The case will turn on whether Plaintiffs can prove that the specific formulation in the confidential ANDA infringes the patent as construed, and whether Watson can, in turn, prove by clear and convincing evidence that the asserted claims are invalid.
  • A key evidentiary question will be one of functional performance: Does the specific acid used in the accused product, at its specified concentration, actually perform the function of being "effective to solubilize" the minoxidil as required by the claim? Or is the required solubility in the accused product achieved through a mechanism sufficiently different from that disclosed and claimed in the patent?