DCT

1:17-cv-01029

Bristol Myers Squibb Co v. EMD Serono Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-01029, D. Del., 07/26/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendants are incorporated in Delaware, transact business in the state, derive substantial revenue from sales in the state, and have otherwise purposefully availed themselves of the jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants’ cancer immunotherapy drug, BAVENCIO® (avelumab), infringes a patent directed to methods of treating cancer by administering an anti-PD-L1 antibody that blocks a specific immune checkpoint pathway.
  • Technical Context: The technology lies in the field of cancer immunotherapy, which seeks to harness a patient's own immune system to recognize and destroy cancerous cells by disabling natural "brakes" on immune T-cells.
  • Key Procedural History: The complaint alleges that Defendants had pre-suit knowledge of the patent family, citing an International Search Report from June 2013 that identified a European counterpart to the patent-in-suit as a relevant document.

Case Timeline

Date Event
2002-07-03 Priority Date for U.S. Patent No. 9,402,899
2013-06-06 International Search Report allegedly put Defendants on notice of patent family
2016-08-02 U.S. Patent No. 9,402,899 Issued
2017-03-23 FDA approved BAVENCIO® for metastatic Merkel cell carcinoma
2017-05-09 FDA approved BAVENCIO® for locally advanced or metastatic urothelial carcinoma
2017-07-26 Complaint Filed

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

U.S. Patent No. 9,402,899 - “Immunopotentiative Composition”

  • Patent Identification: U.S. Patent No. 9,402,899, “Immunopotentiative Composition,” issued August 2, 2016.

The Invention Explained

  • Problem Addressed: The patent describes that the immune system possesses natural "off switches" or checkpoints to prevent over-activation, involving molecules like PD-1 found on T-cells. It suggests that certain tumors and viruses can exploit these checkpoints by expressing a corresponding ligand (like PD-L1), which binds to PD-1 and suppresses the T-cell response, allowing the cancer or virus to evade the immune system (’899 Patent, col. 2:48-55).
  • The Patented Solution: The invention provides a method for activating the immune system by administering a substance that inhibits the immunosuppressive signal generated by the PD-1/PD-L1 interaction. Specifically, the patent discloses using agents like an anti-PD-L1 antibody to block the ligand (PD-L1) from binding to its receptor (PD-1), thereby "releasing the brakes" on the T-cells and enabling them to attack cancer cells (’899 Patent, Abstract; col. 3:1-10). Experimental data in the patent shows that this approach can suppress tumor growth and metastasis in animal models (’899 Patent, col. 32:45-67).
  • Technical Importance: This technology provided a therapeutic strategy for cancer treatment based on blocking the PD-1/PD-L1 immune checkpoint, a pathway that has since become a major focus in the field of oncology. (Compl. ¶¶2, 5).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and a number of dependent claims (2-6, 16, 17, 19-23, 33, 34, 36-38, 43-51) (Compl. ¶56).
  • The essential elements of independent claim 1 are:
    • A method of treating a tumor in a human patient in need thereof
    • comprising administering to the human an effective amount of an anti-PD-L1 monoclonal antibody
    • that inhibits an interaction between PD-1 and PD-L1,
    • wherein the anti-PD-L1 monoclonal antibody treats the tumor in the patient.

III. The Accused Instrumentality

Product Identification

The accused product is Defendants’ antibody product BAVENCIO®, the active ingredient of which is avelumab (Compl. ¶¶11, 31).

Functionality and Market Context

  • The complaint, citing BAVENCIO's prescribing information, describes avelumab as a human IgG1 monoclonal antibody that binds to human PD-L1, which in turn inhibits the interaction between PD-L1 and the PD-1 receptor (Compl. ¶34). This mechanism is alleged to release the immune response's inhibition, activating an anti-tumor response (Compl. ¶34).
  • BAVENCIO is administered intravenously and is FDA-approved for treating patients with metastatic Merkel cell carcinoma (MCC) and locally advanced or metastatic urothelial carcinoma (UC) (Compl. ¶¶32, 33). The complaint positions Plaintiffs and Defendants as direct competitors in the immunotherapy market (Compl. ¶10).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'899 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a tumor in a human patient in need thereof BAVENCIO is prescribed and used for the treatment of cancer in human patients, as indicated by its FDA approvals for Merkel cell carcinoma and urothelial carcinoma. ¶32, ¶36 col. 3:13-17
comprising administering to the human an effective amount of an anti-PD-L1 monoclonal antibody BAVENCIO's active ingredient, avelumab, is an anti-PD-L1 monoclonal antibody. It is administered in an effective dose, such as 10 mg/kg every two weeks. ¶33, ¶34, ¶36 col. 5:21-24
that inhibits an interaction between PD-1 and PD-L1, The BAVENCIO prescribing information is alleged to state that avelumab binds to PD-L1, "thereby inhibiting the interaction of PD-L1 with PD-1." ¶34 col. 3:1-6
wherein the anti-PD-L1 monoclonal antibody treats the tumor in the patient. The administration of BAVENCIO to a patient with a tumor, pursuant to its FDA-approved indications, is alleged to treat the tumor. ¶32, ¶36 col. 20:26-29

Identified Points of Contention

  • Scope Questions: The complaint's infringement theory appears to map the accused product’s label directly onto the claim language. A potential point of contention, however, may surround the scope of the term "treats the tumor." The parties may dispute the level of clinical efficacy required to satisfy this limitation—for example, whether it encompasses stabilizing disease, slowing progression, or requires a more substantial tumor response.
  • Technical Questions: While the product label provides strong evidence for the plaintiff, a technical question for the court could be whether the evidence, upon full discovery, confirms that the sole or primary mechanism by which avelumab "treats the tumor" is through the claimed inhibition of the PD-1/PD-L1 interaction, as opposed to other potential biological effects.

V. Key Claim Terms for Construction

The Term: "treats the tumor"

Context and Importance: This term appears in the final "wherein" clause of claim 1 and defines the required outcome of the method. Its construction is critical because it sets the evidentiary standard for infringement. A narrow definition could require proof of a specific level of clinical efficacy (e.g., tumor shrinkage), while a broader one might be satisfied by evidence of slowed growth or increased patient survival.

Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent specification describes a range of anti-cancer effects beyond complete eradication. It discloses compositions for "cancer treatment" generally (’899 Patent, col. 3:14) and methods for "suppressing cancer metastasis" (’899 Patent, col. 3:16). The experimental examples demonstrate effects such as suppressed "carcinoma cell growth" and a "clear survival effect" in animal models, supporting a construction that includes slowing disease progression or improving survival rates (’899 Patent, col. 20:26-29).
  • Evidence for a Narrower Interpretation: A party seeking a narrower construction might argue that the term implies a direct, measurable, and clinically significant effect on the tumor itself, such as regression. However, the intrinsic evidence in the patent does not appear to explicitly limit the term to such a high standard, instead referring more broadly to treatment and suppression of growth.

VI. Other Allegations

Indirect Infringement

The complaint alleges both induced and contributory infringement (Compl. ¶56). Inducement is based on allegations that Defendants market BAVENCIO with prescribing information and instructions that encourage and guide medical professionals to perform the patented method (Compl. ¶45). Contributory infringement is based on the allegation that BAVENCIO is especially made for this infringing use and has no substantial non-infringing uses (Compl. ¶54).

Willful Infringement

Willfulness is alleged based on Defendants' knowledge of the '899 patent since at least its issue date in August 2016 (Compl. ¶52, ¶57). The complaint further alleges that Defendants knew or should have known of the patent family as early as June 2013, due to an International Search Report for a related application that cited a European counterpart to the '899 patent as particularly relevant prior art (Compl. ¶53).

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

  • A central issue for the court will likely be one of patent validity and pre-suit knowledge. The complaint's specific allegation that Defendants were aware of the patent family as early as 2013 raises the stakes for both validity challenges (based on the state of the art at the time of invention) and a potential finding of willful infringement. The case may therefore turn on what was publicly known about the PD-1/PD-L1 pathway prior to the patent's priority date and what Defendants knew about Plaintiffs' patenting activities.
  • A second key question will be one of claim scope and damages. Assuming the patent is found valid and infringed, the interpretation of the "treats the tumor" limitation will influence the scope of infringing acts. The ultimate financial exposure will depend not just on the volume of BAVENCIO sales but also on the court's assessment of willfulness and the appropriate reasonable royalty for a foundational therapy in the highly competitive and lucrative cancer immunotherapy market.