DCT

2:18-cv-02372

BTG Intl Ltd v. MSN Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-02372, D.N.J., 02/20/2018
  • Venue Allegations: Venue is alleged to be proper based on Defendant MSN Pharmaceuticals Inc.'s principal place of business in New Jersey and both Defendants' explicit consent to jurisdiction and venue in the district for the purposes of this action.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA to market a generic version of the prostate cancer drug ZYTIGA® (abiraterone acetate) constitutes an act of infringement of a patent covering a method of treatment using that drug in combination with prednisone.
  • Technical Context: The patent relates to combination therapies for treating hormone-dependent cancers, specifically castration-resistant prostate cancer, a significant and challenging stage of the disease.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Defendants' Paragraph IV certification asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed. The complaint discloses that one month prior to its filing, the Patent Trial and Appeal Board (PTAB) issued final written decisions in several inter partes review (IPR) proceedings, finding all claims of the patent-in-suit unpatentable. At the time of filing, Plaintiffs stated their intent to appeal these decisions.

Case Timeline

Date Event
2006-08-25 ’438 Patent Priority Date
2014-09-02 ’438 Patent Issue Date
2017-01-24 Court orders correction of inventorship for the '438 Patent
2018-01-09 Defendant MSN sends Paragraph IV Notice Letter to Plaintiffs
2018-01-17 PTAB issues Final Written Decisions in IPRs finding claims 1-20 of '438 Patent unpatentable
2018-02-20 Complaint Filed

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

U.S. Patent No. 8,822,438 - "Methods and Compositions for Treating Cancer"

  • Patent Identification: U.S. Patent No. 8,822,438, "Methods and Compositions for Treating Cancer," issued September 2, 2014. (Compl. ¶10).

The Invention Explained

  • Problem Addressed: The patent describes a need for more effective treatments for hormone-dependent cancers, such as prostate cancer, particularly for patients whose cancer has become "refractory," meaning it no longer responds to standard hormone therapies. (Compl. ¶1; ’438 Patent, col. 1:18-24, col. 2:1-5).
  • The Patented Solution: The invention is a method of treating cancer that combines a 17α-hydroxylase/C17,20-lyase inhibitor, specifically abiraterone acetate, with at least one other therapeutic agent, such as the steroid prednisone. (’438 Patent, Abstract; col. 2:8-18). This combination therapy is presented as a way to effectively treat patients, including those with refractory cancer.
  • Technical Importance: This method provides a treatment regimen for patients with advanced prostate cancer who have limited options after their disease progresses despite initial hormone therapy. (’438 Patent, col. 2:20-24).

Key Claims at a Glance

  • The complaint asserts dependent claims 4, 11, 19, and 20, all of which ultimately depend on independent Claim 1. (Compl. ¶45).
  • The essential elements of independent Claim 1 are:
    • A method for the treatment of a prostate cancer in a human
    • comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof
    • and a therapeutically effective amount of prednisone.
  • The complaint notes infringement of claims "including but not limited to" the specifically enumerated dependent claims, thereby reserving the right to assert others. (Compl. ¶45).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic "250 mg Abiraterone Acetate Tablets," which are the subject of ANDA No. 210686 filed with the FDA. (Compl. ¶19).

Functionality and Market Context

  • The product is a generic version of Plaintiffs' ZYTIGA® drug product. (Compl. ¶19). The infringement alleged is statutory under 35 U.S.C. § 271(e)(2), which makes the submission of an ANDA an act of infringement if the proposed generic drug would infringe a valid patent. The complaint alleges that the proposed labeling for Defendants' product will direct its use in a manner that infringes the ’438 Patent, specifically by instructing co-administration with prednisone for the treatment of metastatic castration-resistant prostate cancer. (Compl. ¶¶1, 16, 48).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint does not contain a claim chart. The infringement theory is that the proposed labeling for MSN’s ANDA product will instruct medical professionals and patients to perform the steps of the patented method.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the treatment of a prostate cancer in a human Defendants' ANDA seeks approval to market their abiraterone acetate product for the treatment of patients with metastatic castration-resistant prostate cancer. ¶16 col. 1:25-27
comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof Defendants' ANDA product is a 250 mg tablet of abiraterone acetate, and the proposed labeling will direct its administration in a therapeutically effective amount. ¶19 col. 6:49-54
and a therapeutically effective amount of prednisone. The proposed labeling for Defendants' ANDA product will direct its use in combination with prednisone, mirroring the approved indication for the brand-name drug ZYTIGA®. ¶16, ¶48 col. 10:15-25
  • Identified Points of Contention:
    • Validity Questions: The complaint itself raises the primary point of contention by disclosing that the PTAB found all claims of the '438 Patent unpatentable in IPR proceedings. (Compl. ¶14). While this case may proceed pending appeal of that decision, the ultimate validity of the patent is the central issue.
    • Technical Questions: Assuming the patent is ultimately found valid, a question may arise as to whether the instructions in MSN's proposed label require co-administration with prednisone for all indicated uses, or if a substantial non-infringing use exists. The complaint preemptively addresses this by alleging the product and its label are "especially made or adapted for use in infringing the '438 patent" and are "not suitable for substantial noninfringing use." (Compl. ¶51).

V. Key Claim Terms for Construction

  • The Term: "therapeutically effective amount"

  • Context and Importance: This term appears twice in Claim 1, applying to both abiraterone acetate and prednisone. Its construction is critical because infringement depends on whether the dosage directed by the accused product's label falls within the scope of a "therapeutically effective amount." Practitioners may focus on this term because asserted dependent claims recite specific dosages (e.g., 1000 mg/day of abiraterone acetate and 10 mg/day of prednisone), which could influence the interpretation of the broader term in the independent claim. (e.g., ’438 Patent, Claim 11).

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification discloses very wide dosage ranges, such as "about 0.01 mg/day to about 500 mg/day of a glucocorticoid" like prednisone, which could support a broad construction. (’438 Patent, col. 13:9-12).
    • Evidence for a Narrower Interpretation: Defendants may argue that the specific dosages recited in dependent claims (e.g., Claim 11) and those likely used in the underlying clinical trials should inform a narrower construction of what constitutes a "therapeutically effective amount." (’438 Patent, col. 16:51-56).

  • The Term: "refractory prostate cancer"

  • Context and Importance: This term appears in dependent claim 12, which is a basis for asserted claims 19 and 20. Defining when a cancer is "refractory" is key to determining infringement of these specific claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent provides a broad functional definition: ""refractory cancer," means cancer that is not responding to an anti-cancer treatment or cancer that is not responding sufficiently to an anti-cancer treatment." (’438 Patent, col. 3:23-27).
    • Evidence for a Narrower Interpretation: A party could argue that the context of the patent, including its discussion of specific prior treatments, implies a more limited definition, such as a cancer that has failed a particular line of therapy (e.g., docetaxel, as recited in claim 17). (’438 Patent, col. 17:1-2).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement, stating that MSN intends to cause infringement through its proposed product labeling, which will instruct users to perform the patented method. (Compl. ¶¶48, 50). It also alleges contributory infringement, asserting that MSN's product and label are especially adapted for infringing use and are not suitable for substantial non-infringing use. (Compl. ¶51).
  • Willful Infringement: The complaint alleges that MSN had knowledge of the ’438 patent when it submitted its ANDA and is "knowingly and willfully infringing." (Compl. ¶¶23, 53). It further alleges MSN "acted without a reasonable basis for believing that it would not be liable." (Compl. ¶54).

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

  • A determinative threshold issue will be one of patent validity: will the U.S. Court of Appeals for the Federal Circuit affirm or reverse the PTAB’s final written decisions that found all asserted claims of the ’438 patent unpatentable, a development which could render the entire infringement action moot?
  • A key evidentiary question will be one of induced infringement: assuming the patent survives appeal, does the content of MSN’s proposed product label contain instructions that would inevitably lead physicians and patients to practice the patented method of co-administering abiraterone acetate with prednisone, or does the label allow for substantial, commercially significant non-infringing uses?