DCT

2:16-cv-00044

Prostrakan Inc v. Actavis Laboratories Ut Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:16-cv-00044, E.D. Tex., 01/13/2016
  • Venue Allegations: Venue is asserted based on Defendants’ regular business in Texas, including holding state licenses to distribute pharmaceuticals, maintaining contracts with Texas-based wholesalers and retailers, and deriving substantial revenue from sales within the judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiffs’ SANCUSO® transdermal patch constitutes an act of patent infringement under the Hatch-Waxman Act.
  • Technical Context: The technology involves a transdermal patch for delivering granisetron, an anti-emetic drug used to prevent nausea and vomiting, particularly those induced by chemotherapy.
  • Key Procedural History: The lawsuit was precipitated by a Notice Letter dated December 1, 2015, in which Defendant Actavis Labs informed Plaintiffs of its ANDA filing containing a Paragraph IV certification. This certification alleges that U.S. Patent No. 7,608,282 is invalid, unenforceable, and/or will not be infringed by the proposed generic product. The patent is listed in the FDA's "Orange Book" as covering the SANCUSO® product. This complaint was filed within the 45-day window provided by statute, which typically triggers a 30-month stay of FDA approval for the generic.

Case Timeline

Date Event
2003-02-05 '282 Patent Priority Date
2009-10-27 '282 Patent Issued
2015-12-01 Defendants' ANDA Notice Letter Sent
2016-01-13 Complaint Filing Date

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

U.S. Patent No. 7,608,282, "Transdermal Granisetron", Issued October 27, 2009

The Invention Explained

  • Problem Addressed: The patent describes the significant challenge of administering anti-nausea medication to cancer patients. It notes that intravenous delivery is uncomfortable and requires medical supervision, while oral delivery is difficult for patients already suffering from nausea. ('282 Patent, col. 1:4-12, 2:27-41). Existing transdermal systems were often large, bulky, or required potentially irritating permeation-enhancing chemicals to achieve a therapeutic effect. ('282 Patent, col. 2:49-60).
  • The Patented Solution: The invention is a transdermal patch that delivers granisetron using a specific adhesive formulation. The key is an acrylic adhesive that contains "non-acidic hydroxyl moieties." The patent asserts that, contrary to conventional wisdom which taught against such reactive groups, this specific chemical environment substantially increases the flux of granisetron through the skin. ('282 Patent, Abstract; col. 4:32-41). This innovation allows for a smaller, more cosmetically acceptable, and effective patch that does not require additional permeation enhancers. ('282 Patent, col. 4:35-37).
  • Technical Importance: The technology provides a method for steady, non-invasive, multi-day drug delivery, improving patient comfort and compliance for a critical supportive therapy in cancer treatment. ('282 Patent, col. 1:46-50, col. 2:1-6).

Key Claims at a Glance

  • The complaint alleges infringement of at least one claim without specifying which. Independent claim 1 is representative of the core invention.
  • Independent Claim 1 elements:
    • An adhesive patch suitable for the transdermal administration of granisetron.
    • The patch comprises an acrylic adhesive consisting essentially of:
      • 50 to 98% by weight of a primary acrylate monomer (either 2-ethylhexyl acrylate or butyl acrylate).
      • 0.5 to 20% by weight of a monomer containing non-acidic hydroxyl moieties.
    • The adhesive is loaded with a physiologically effective amount of granisetron.
    • The granisetron content remains substantially unchanged when stored at 25° C. for six weeks.
  • The complaint does not explicitly reserve the right to assert dependent claims, though such a right is standard practice.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "proposed generic granisetron extended release transdermal film product, 3.1 mg/24 hr," as described in Defendant Actavis Labs’ ANDA No. 208726. (Compl. ¶18, 44).

Functionality and Market Context

The accused product is a generic equivalent to Plaintiffs' SANCUSO® product, a transdermal patch indicated for the prevention of chemotherapy-induced nausea and vomiting. (Compl. ¶39, 42). The lawsuit is based on the technical act of infringement under 35 U.S.C. § 271(e)(2), which occurs when an entity files an ANDA seeking approval to market a generic version of a patented drug prior to patent expiration. (Compl. ¶44). The commercial importance of the product lies in its potential to offer a lower-cost alternative to the branded SANCUSO® patch upon receiving FDA approval. (Compl. ¶39).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint, filed in response to an ANDA submission, does not provide a detailed claim chart or specific factual allegations mapping the formulation of the accused generic product to the patent claims. The infringement allegation is predicated on the assertion that the product described in the confidential ANDA No. 208726, if manufactured and sold, would meet all limitations of at least one claim of the '282 Patent. (Compl. ¶37, 45). The central theory is that, as a proposed bioequivalent generic of SANCUSO®, the accused product will necessarily use the same or an equivalent adhesive formulation covered by the '282 Patent, which is listed in the FDA's Orange Book as protecting SANCUSO®. (Compl. ¶36).

  • Identified Points of Contention:
    • Scope Questions: A central question will be whether the specific formulation of the accused generic patch, as described in its confidential ANDA, falls within the scope of the claims. The dispute will likely focus on whether the adhesive in the generic product is an "acrylic adhesive consisting essentially of" the two claimed monomer types in the specified ratios. Defendants’ non-infringement argument, referenced in the complaint, may be that their formulation uses different components or ratios that fall outside the claim scope. (Compl. ¶39-40).
    • Technical Questions: The primary technical question is one of chemical composition. What are the precise ingredients and their proportions in the adhesive of the generic patch? The discovery process, which provides access to the confidential ANDA, will be critical to resolving this evidentiary question.

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of"

    • Context and Importance: This transitional phrase is narrower than "comprising" and is critical for defining the scope of the claimed adhesive. It limits the adhesive to the specified monomers (primary acrylate and hydroxyl-containing monomer) and any other unlisted components that do not materially affect the basic and novel properties of the invention—namely, the enhanced transdermal flux of granisetron. Practitioners may focus on this term because if the accused product contains additional ingredients, the case could turn on whether those ingredients materially alter this core property.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue that the term permits the presence of standard, inert manufacturing aids or stabilizers that have no material effect on the drug delivery characteristics of the patch.
      • Evidence for a Narrower Interpretation: The patent emphasizes that the patches are effective "without having to incorporate any plasticisers or permeation enhancers." ('282 Patent, col. 4:35-37). This statement could be used to argue that the "basic and novel" property is the ability to achieve high flux without such agents, suggesting a very narrow construction that excludes almost any other active or flux-affecting ingredient.

  • The Term: "non-acidic hydroxyl moieties"

    • Context and Importance: This term defines the invention's key functional group, which the patent credits with unexpectedly enhancing drug flux. The patent explicitly contrasts these moieties with problematic "electronegative groups, such as COOH groups." ('282 Patent, col. 4:32-34). The construction of this term will be vital if the accused product uses a hydroxyl-containing monomer that differs from the patent's specific examples (e.g., hydroxyethylacrylate). ('282 Patent, col. 4:62-63).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a non-exhaustive list of suitable monomers, suggesting the term is not limited to only those examples. ('282 Patent, col. 4:60-65). A broader reading might encompass any monomer with a hydroxyl group that is not part of a formal acid, like a carboxylic or sulfonic acid.
      • Evidence for a Narrower Interpretation: The patent states a preference "that the OH group not be part of any COOH, NCOH and the like groups." ('282 Patent, col. 4:1-3). A defendant could argue this language narrows the term to exclude any monomer where the hydroxyl group exhibits even weak acidic properties due to its surrounding chemical structure.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement upon FDA approval. The basis for this claim is that Defendants' product labeling and instructions will direct physicians and patients to apply the patch to the skin, thereby performing the steps of the patented method of drug delivery. (Compl. ¶46, 57).
  • Willful Infringement: While the term "willful" is not used, the complaint alleges facts that could support such a claim. It pleads that Defendants had knowledge of the '282 Patent at least since filing their ANDA, which contained a required certification regarding the patent. (Compl. ¶41, 58). It further alleges that Defendants' legal and factual bases for non-infringement and invalidity, as stated in their notice letter, are "devoid of any objective good-faith basis." (Compl. ¶48).

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

This case appears poised to turn on the resolution of two main issues:

  1. A central evidentiary and chemical question: Does the adhesive formulation in Defendants' proposed generic product, as disclosed in the confidential ANDA filing, contain the specific monomer components in the ratios required by Claim 1 of the '282 Patent? The infringement analysis will depend entirely on the facts revealed from that confidential filing.
  2. A key claim construction dispute: How should the term "consisting essentially of" be interpreted in the context of the claimed adhesive? The viability of Defendants' non-infringement defense may depend on whether any additional ingredients in their formulation are found to "materially affect" the patented invention's novel property of enhanced granisetron flux.