DCT

2:18-cv-16521

BTG Intl Ltd v. Qilu Pharmaceutical Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:18-cv-16521, D.N.J., 11/28/2018
  • Venue Allegations: Venue is alleged to be proper over the foreign defendant, Qilu Pharmaceutical Co., Ltd., under the alien venue statute, and over the domestic defendant, Qilu Pharma, Inc., based on its alleged regular and established place of business in New Jersey. The complaint also alleges both defendants have consented to venue in the district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the cancer drug ZYTIGA® constitutes an act of infringement of a patent covering a combination therapy method.
  • Technical Context: The technology relates to methods of treating prostate cancer by co-administering abiraterone acetate, an enzyme inhibitor that blocks testosterone production, with the steroid prednisone.
  • Key Procedural History: The asserted patent has a complex and contentious history. In prior consolidated litigation, the U.S. District Court for the District of New Jersey found the patent invalid for obviousness, though it would be infringed by other generic manufacturers if it were valid. That invalidity judgment is currently on appeal to the Federal Circuit. Separately, the Patent Trial and Appeal Board (PTAB) instituted multiple inter partes review (IPR) proceedings and issued final written decisions finding all claims (1-20) of the patent unpatentable. The complaint states it was filed to preserve Plaintiffs' right to a statutory 30-month stay of FDA approval for the generic product, should the Federal Circuit reverse the district court's invalidity finding.

Case Timeline

Date Event
2006-08-25 '438 Patent Priority Date
2014-09-02 '438 Patent Issue Date
2015-07-31 Plaintiffs file "Lead Action" litigation over '438 Patent
2015-12-04 IPR petition filed against '438 Patent (IPR2016-00286)
2016-05-31 PTAB institutes IPR2016-00286
2016-06-29 IPR petition filed against '438 Patent (IPR2016-01317)
2016-06-30 IPR petition filed against '438 Patent (IPR2016-01332)
2016-08-10 IPR petition filed against '438 Patent (IPR2016-01582)
2018-01-17 PTAB issues Final Written Decisions finding claims 1-20 unpatentable
2018-02-20 USPTO issues Certificate of Correction for inventorship of '438 Patent
2018-07-01 Bench trial held in prior "Lead Action" litigation
2018-10-15 Date of Qilu's ANDA Notice Letter to Plaintiffs
2018-10-26 District Court issues opinion finding '438 Patent invalid for obviousness
2018-10-31 Plaintiffs file Notice of Appeal of the invalidity judgment
2018-11-28 Complaint Filing Date

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

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

The Invention Explained

  • Problem Addressed: The patent describes a need for more effective treatments for hormone-dependent cancers like prostate cancer, particularly for patients whose cancer has become "refractory," meaning it no longer responds to existing therapies ('438 Patent, col. 1:20-66). Such patients are noted to have very few treatment options ('438 Patent, col. 2:1-5).
  • The Patented Solution: The invention is a method of treatment comprising the administration of a 17α-hydroxylase/C17,20-lyase inhibitor, specifically abiraterone acetate, in combination with another therapeutic agent, such as a steroid ('438 Patent, Abstract). The patent explains that this combination can provide an effective treatment for individuals with refractory cancer ('438 Patent, col. 2:17-24). Abiraterone acetate inhibits an enzyme involved in testosterone synthesis, while the co-administered steroid (e.g., prednisone) is a glucocorticoid.
  • Technical Importance: This combination therapy offers a new line of treatment for patients with advanced prostate cancer, including those who have relapsed after or are not responsive to standard hormone ablation therapies ('438 Patent, col. 2:17-24).

Key Claims at a Glance

  • The complaint asserts infringement of claims including independent claim 1 and dependent claims 4, 11, 19, and 20 (Compl. ¶64). The core of the asserted claims is captured in independent claim 1.
  • Independent Claim 1:
    • 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 reserves the right to assert other claims of the ’438 Patent (Compl. ¶64).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Qilu's Abiraterone Acetate Tablets," a proposed generic drug product that is the subject of Abbreviated New Drug Application (ANDA) No. 212462 ("Qilu's ANDA Product") (Compl. ¶36).

Functionality and Market Context

  • The Qilu ANDA Product is described as a generic version of Janssen's ZYTIGA® (abiraterone acetate) tablets (Compl. ¶36). The complaint states that ZYTIGA®, when used in combination with prednisone, is indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (Compl. ¶33). The filing of the ANDA itself is the statutory act of infringement, as it seeks FDA approval to market a generic equivalent for the same indications prior to the expiration of the ’438 Patent (Compl. ¶¶ 1, 65).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement theory is based on the future intended use of the defendant's product as will be directed by its FDA-approved labeling. No probative visual evidence provided in complaint.

’438 Patent Infringement Allegations

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 The proposed labeling for Qilu's ANDA Product will direct its use for the treatment of prostate cancer. ¶33, ¶36, ¶67 col. 16:15-16
comprising administering to said human a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof Qilu's ANDA Product contains abiraterone acetate, and its proposed labeling will instruct its administration to patients. ¶36, ¶67 col. 16:17-20
and a therapeutically effective amount of prednisone. The complaint alleges that the proposed labeling for Qilu’s ANDA Product will direct its administration in combination with prednisone, thereby inducing infringement of the complete method. ¶33, ¶67, ¶69 col. 16:20-21

Identified Points of Contention

  • Scope Questions: The primary infringement dispute will likely center on inducement. A central question is whether the specific language of Qilu's proposed product label will actively instruct, encourage, or recommend the co-administration of its abiraterone acetate product with prednisone, as required to meet all elements of the asserted claims.
  • Technical Questions: An underlying question, typical in ANDA litigation, is whether Qilu's product is bioequivalent to ZYTIGA® and whether its proposed label will substantially mirror the branded drug's label, which recommends combination use with prednisone. The complaint's allegation that it is a "generic version" suggests this is the premise of the infringement claim (Compl. ¶36).

V. Key Claim Terms for Construction

  • The Term: "therapeutically effective amount"
  • Context and Importance: This term appears twice in Claim 1, governing the dosage of both abiraterone acetate and prednisone. Its construction is critical because infringement will depend on whether the dosages directed by Qilu's proposed label fall within the scope of the claim. Practitioners may focus on this term to determine if there is a quantitative match between the claim and the accused instructions.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes a very wide range of potential daily dosages for 17α-hydroxylase/C17,20-lyase inhibitors, from "about 0.0001 mg/kg/day to about 1000 mg/kg/day," which could support a broad construction encompassing numerous dosing regimens ('438 Patent, col. 11:39-44).
    • Evidence for a Narrower Interpretation: The patent includes specific dosage amounts in dependent claims, such as "about 1000 mg/day of abiraterone acetate" and "about 10 mg/day of prednisone" (see, e.g., '438 Patent, claim 11). A party might argue that these specific examples should inform or limit the meaning of "therapeutically effective amount" as understood by a person of ordinary skill in the art at the time of the invention.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement (Compl. ¶¶ 66, 69-71). The inducement theory is based on allegations that Qilu's proposed product labeling will instruct physicians and patients to use the generic drug in combination with prednisone, thereby causing them to perform the patented method (Compl. ¶67). The contributory infringement theory alleges that Qilu's product and labeling are "especially made or adapted for use in infringing" the '438 Patent and are not suitable for substantial non-infringing use (Compl. ¶70).
  • Willful Infringement: Willfulness is alleged based on Qilu's knowledge of the '438 Patent at the time it submitted its ANDA (Compl. ¶¶ 40, 73). This knowledge is evidenced by Qilu's Paragraph IV certification and its notice letter to Plaintiffs, which are statutory requirements for an ANDA filer seeking to challenge a patent (Compl. ¶¶ 36, 38).

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

  • A threshold issue, explicitly raised by the complaint's procedural history, is one of patent viability: will the Federal Circuit reverse the prior district court judgment of invalidity and the PTAB's findings of unpatentability? The continuation of this lawsuit is entirely contingent on a favorable outcome for the Plaintiffs on appeal.
  • Assuming the patent is revived, a central question will be one of induced infringement: does the precise language of Qilu's proposed product label go beyond merely mentioning prednisone and instead actively instruct or encourage co-administration in a manner that would lead a physician to directly infringe the combination method claims?
  • A further question may be one of claim scope: can the term "therapeutically effective amount," as used in the claims, be construed to read on the specific dosages of abiraterone acetate and prednisone that will be set forth in the defendant's proposed labeling, or is there a potential mismatch that could support a non-infringement argument?