DCT
1:17-cv-00509
Baxalta Inc v. Genentech Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Baxalta Incorporated (Delaware) and Baxalta GmbH (Switzerland)
- Defendant: Genentech, Inc. (Delaware) and Chugai Pharmaceutical Co., Ltd. (Japan)
- Plaintiff’s Counsel: Morgan, Lewis & Bockius LLP
- Case Identification: 1:17-cv-00509, D. Del., 07/18/2018
- Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendants' business contacts within the state and Genentech's incorporation in Delaware.
- Core Dispute: Plaintiff alleges that Defendants’ antibody therapeutic, emicizumab (marketed as Hemlibra), infringes a patent related to antibodies that treat hemophilia A by mimicking the function of the blood coagulation protein Factor VIII.
- Technical Context: The lawsuit concerns biologic therapies for hemophilia, a genetic bleeding disorder, a market characterized by high-value treatments for orphan diseases.
- Key Procedural History: This is an amended complaint. The complaint alleges that Defendants were aware of the patent-in-suit and its potential relevance to their product at least two years prior to this filing, citing a third-party report and Defendants’ assertion of work product privilege. The complaint also references a related litigation proceeding in Japan.
Case Timeline
| Date | Event |
|---|---|
| 1999-09-14 | ’590 Patent Priority Date |
| 2006-04-25 | ’590 Patent Issue Date |
| 2014-05-01 | Chugai allegedly began research and development of emicizumab |
| 2015-06-04 | Chugai filed U.S. trademark application for "HEMLIBRA" |
| 2015-09-01 | Genentech allegedly began collaboration with Chugai on emicizumab |
| 2015-09-01 | FDA granted emicizumab breakthrough therapy designation |
| 2016-05-01 | Defendants allegedly became aware of the ’590 Patent |
| 2016-12-22 | Roche announced completion of Phase III clinical trials |
| 2017-02-17 | Date from which Genentech allegedly asserted work product privilege |
| 2018-07-18 | Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,033,590 - “Factor IX/Factor IXa Activating Antibodies and Antibody Derivatives” (issued Apr. 25, 2006)
The Invention Explained
- Problem Addressed: The patent addresses the treatment of hemophilia A, a bleeding disorder caused by a deficiency of blood coagulation Factor VIII (FVIII) (Compl. ¶20). A key part of the normal blood clotting cascade involves Factor VIIIa helping activated Factor IX (Factor IXa) to convert Factor X into its active form (Compl. ¶19). While FVIII replacement therapy exists, a significant percentage of patients develop inhibitory antibodies that neutralize the treatment, rendering it ineffective ('590 Patent, col. 2:27-34).
- The Patented Solution: The invention is an antibody (or a fragment of an antibody) that binds to Factor IX or Factor IXa and functionally replaces or mimics the cofactor activity of FVIIIa ('590 Patent, Abstract; col. 2:20-26). By directly increasing the procoagulant (clot-promoting) activity of Factor IXa, the antibody allows the coagulation cascade to proceed even in the absence of functional FVIII, thus providing a therapeutic option for patients with FVIII inhibitors ('590 Patent, col. 2:35-43).
- Technical Importance: This approach provided a novel therapeutic strategy to bypass the need for FVIII in hemophilia A treatment, offering a potential solution for the difficult-to-treat patient population that has developed inhibitors to standard therapies ('590 Patent, col. 2:35-43).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 4, 15, 17, and 19 (Compl. ¶47).
- Independent Claim 1:
- An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa
- and increases the procoagulant activity of Factor IXa.
- The complaint does not explicitly reserve the right to assert other claims but focuses on this set.
III. The Accused Instrumentality
Product Identification
- The accused product is Defendants' drug emicizumab, also known as ACE910 and marketed under the brand name HEMLIBRA (Compl. ¶1, ¶34).
Functionality and Market Context
- Emicizumab is described in the complaint as a "humanized bispecific antibody that binds Factor IX/IXa and Factor X to treat hemophilia A" (Compl. ¶1). Its alleged function is to bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa, thereby serving as a treatment for hemophilia A (Compl. ¶23). The FDA granted it breakthrough therapy designation for prophylactic treatment, including for patients with FVIII inhibitors, suggesting its clinical significance (Compl. ¶26). Defendants are alleged to have begun manufacturing and preparing for commercial sale in the U.S. in advance of an expected Q4 2017 launch (Compl. ¶28, ¶30).
IV. Analysis of Infringement Allegations
The complaint alleges that emicizumab infringes at least claim 1 of the ’590 Patent, both literally and under the doctrine of equivalents (Compl. ¶47). While the complaint references an external claim chart exhibit which is not provided (Compl. ¶47, ¶55), the body of the complaint contains the core allegations mapping the accused product to the claim elements. No probative visual evidence provided in complaint.
’590 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa | Defendants' product emicizumab is an antibody that binds Factor IX or Factor IXa. | ¶23 | col. 6:52-55 |
| and increases the procoagulant activity of Factor IXa. | Defendants' product emicizumab...increases the procoagulant activity of Factor IXa as claimed in Baxalta's '590 Patent. | ¶23 | col. 2:50-53 |
- Identified Points of Contention:
- Scope Questions: The complaint describes emicizumab as a "bispecific" antibody that binds both Factor IX/IXa and Factor X (Compl. ¶1). A central question for the court will be whether such a bispecific, bridging antibody falls within the scope of the claim term "an antibody...that binds Factor IX or Factor IXa." The analysis may focus on whether the claim requires binding only to Factor IX/IXa or if binding to an additional target (Factor X) is permissible within the claim's scope.
- Technical Questions: A related technical question is how the claim limitation "increases the procoagulant activity of Factor IXa" is to be interpreted. Does the accused product's mechanism—physically bridging Factor IXa and its substrate, Factor X—constitute an "increase" in the activity of Factor IXa itself, or does it represent a fundamentally different mechanism of action not contemplated or covered by the patent? The resolution will depend on how the court construes this functional language in light of the patent's specification.
V. Key Claim Terms for Construction
- The Term: "increases the procoagulant activity of Factor IXa"
- Context and Importance: This functional limitation is the core of the invention. Its construction will be dispositive. The key dispute will likely be whether this language is broad enough to cover the alleged "bridging" mechanism of the bispecific emicizumab antibody, which brings Factor IXa and Factor X together, or if it is limited to a more direct enhancement of Factor IXa's enzymatic function as potentially described in the patent's embodiments. Practitioners may focus on this term because the difference between a direct activity enhancement and a scaffolding/bridging mechanism could be a basis for a non-infringement argument.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is result-oriented and does not specify a particular mechanism for achieving the increase in activity. The patent's stated objective is to create a FVIII bypass therapy, which a bridging antibody accomplishes ('590 Patent, col. 2:20-26). A party could argue that any antibody that achieves the claimed functional result infringes, regardless of the precise biological mechanism.
- Evidence for a Narrower Interpretation: A party may argue that the specification and its examples, which describe assays measuring FVIII-like activity ('590 Patent, e.g., Example 5, col. 15:1-15:8), implicitly define "increases the procoagulant activity" in a way that does not include the distinct mechanism of a bispecific antibody physically linking two separate factors. The patent's abstract and summary describe an antibody against Factor IX/IXa that increases its activity, without mentioning an interaction with Factor X, potentially suggesting a narrower scope ('590 Patent, Abstract; col. 2:20-26).
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement and contributory infringement, asserting that Defendants' commercial activities, including manufacturing, marketing, and selling emicizumab, will cause and contribute to infringement by others (e.g., healthcare providers and patients) in the United States (Compl. ¶46).
- Willful Infringement: The complaint includes a specific count for willful infringement (Compl. ¶¶ 60-65). It alleges that Defendants knew of the patent and the risk of infringement since at least May 2016, citing a third-party report in Genentech's possession that stated the "'590 patent seems to be covering ACE910" (Compl. ¶39). The complaint further alleges that Defendants' continued activities despite this knowledge constitute an unreasonable risk of infringement, and that they did nothing to avoid it (Compl. ¶62, ¶65).
VII. Analyst’s Conclusion: Key Questions for the Case
A core issue will be one of claim scope and mechanism of action: Can the claim phrase "increases the procoagulant activity of Factor IXa," as defined by the patent's specification, be construed to cover the alleged "bridging" mechanism of the accused bispecific antibody, which functions by binding and co-localizing both Factor IXa and its substrate, Factor X? Or, is the claim limited to a more direct enhancement of Factor IXa's intrinsic activity?
A second central issue will be willfulness: The complaint alleges Defendants possessed a report explicitly identifying an overlap between the '590 patent and their product. An evidentiary focus will be on what steps, if any, Defendants took in response to this notice. The determination of whether their subsequent commercialization activities were objectively reckless in the face of this alleged knowledge will be critical to the willfulness claim.