DCT
1:15-cv-40075
Athena Diagnostics, Inc. v Mayo Collaborative Services,
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Athena Diagnostics, Inc. (Delaware); Isis Innovation Limited (England); Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V. (Germany)
- Defendant: Mayo Collaborative Services, LLC d/b/a Mayo Medical Laboratories and Mayo Clinic (Minnesota)
- Plaintiff’s Counsel: Robins Kaplan LLP
- Case Identification: 4:15-cv-40075, D. Mass., 07/08/2016
- Venue Allegations: Venue is alleged to be proper in the District of Massachusetts because Defendant Mayo Medical Laboratories maintains a physical facility in Andover, Massachusetts, and Defendant Mayo Clinic is a founding partner of a research center in Cambridge, Massachusetts, with both entities allegedly subject to personal jurisdiction in the district.
- Core Dispute: Plaintiffs allege that Defendants' diagnostic testing services for Myasthenia Gravis infringe a patent related to methods for detecting autoantibodies to the MuSK protein.
- Technical Context: The technology concerns diagnostic methods for a specific subgroup of patients with Myasthenia Gravis, an autoimmune disorder that causes muscle weakness.
- Key Procedural History: The operative complaint is the Third Amended Complaint. Plaintiff Athena Diagnostics, Inc. is identified as the exclusive licensee of the patent-in-suit.
Case Timeline
| Date | Event |
|---|---|
| 2000-06-16 | ’820 Patent Priority Date |
| 2007-09-11 | ’820 Patent Issue Date |
| c. 2015-05-19 | Accused Mayo tests become available (inferred) |
| 2016-07-08 | Third Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 7,267,820, "Neurotransmission Disorders," issued September 11, 2007 (’820 Patent).
The Invention Explained
- Problem Addressed: The patent’s background section describes the challenge of diagnosing Myasthenia Gravis (MG), a chronic autoimmune disorder, in the approximately 20% of patients who are "sero-negative" (’820 Patent, col. 1:36-44). These patients exhibit symptoms of MG but test negative for the most common autoantibody associated with the disease, the anti-acetylcholine receptor (AChR) antibody, making their diagnosis difficult (’820 Patent, col. 1:12-24, 36-44).
- The Patented Solution: The patent discloses the discovery that many of these sero-negative patients possess a different type of autoantibody, one directed against the muscle-specific tyrosine kinase (MuSK) protein found at the neuromuscular junction (’820 Patent, col. 2:56-65). The invention is a method for diagnosing these neurotransmission disorders by detecting the presence of these anti-MuSK autoantibodies in a patient's bodily fluid, such as blood plasma or serum (’820 Patent, Abstract; col. 2:61-65).
- Technical Importance: The identification of this new biomarker provided a basis for the "more accurate and speedy diagnosis" of a previously difficult-to-diagnose sub-population of MG patients (’820 Patent, col. 3:5-8).
Key Claims at a Glance
- The complaint asserts claims 8 and 9, which are dependent on claim 7, which is in turn dependent on independent claim 1 (Compl. ¶24).
- The essential elements of the root independent claim are:
- A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal
- comprising the step of detecting
- in a bodily fluid of said mammal
- autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK)
- Asserted dependent claim 8 adds the limitation that detection uses a "radioactive label," and claim 9 further specifies the label is "¹²⁵I" (’820 Patent, col. 13:5-9).
III. The Accused Instrumentality
- Product Identification: The complaint identifies two accused services offered by Defendants: the "Muscle-Specific Kinase (MuSK) Autoantibody, Serum" test (MUSK) and the "Myasthenia Gravis Evaluation with MuSK Reflex, Serum" test (MGRM) (Compl. ¶18).
- Functionality and Market Context: The accused instrumentalities are laboratory diagnostic tests that evaluate a patient's serum for the presence of antibodies to the MuSK protein (Compl. ¶16, ¶18). The complaint alleges that Defendants developed these tests as an alternative to a licensed test previously offered by Plaintiff Athena, positioning the accused services as direct competitors (Compl. ¶19-20). The complaint alleges these tests "employ methods that practice each and every step of one or more claims of the ’820 patent" (Compl. ¶18). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
- Claim Chart Summary: The complaint pleads infringement without providing a detailed element-by-element mapping. The following table synthesizes the allegations against the root independent claim.
’820 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal | Defendants offer the MUSK and MGRM tests to the public for the purpose of diagnosing Myasthenia Gravis, a neurotransmission disorder. | ¶1, ¶18, ¶24 | col. 12:30-32 |
| comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK). | Defendants' MUSK and MGRM tests allegedly involve detecting autoantibodies to MuSK in patient serum. | ¶18 | col. 12:32-36 |
- Identified Points of Contention:
- Legal Question: The patent claims are directed to a diagnostic method based on the discovery of a natural correlation between MuSK autoantibodies and a disease state. This raises the question of whether the claims are patent-eligible under 35 U.S.C. § 101 or if they may be construed as impermissibly claiming a law of nature coupled with conventional activity.
- Technical Question: The complaint asserts dependent claims 8 and 9, which explicitly require the use of a "radioactive label" and specifically "¹²⁵I". What evidence does the complaint provide that Defendants' MUSK and MGRM tests utilize a radioimmunoassay with a ¹²⁵I label? The complaint does not contain factual allegations detailing the specific laboratory techniques used in the accused tests.
V. Key Claim Terms for Construction
- The Term: "detecting"
- Context and Importance: This term is the central active step of the method claim. Its scope is critical because the asserted dependent claims (8 and 9) recite a very specific detection method (a radioimmunoassay). The construction of "detecting" in independent claim 1 will determine whether the claim’s scope is limited to the specific assay disclosed in the patent or covers a wider range of known immunological techniques.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification suggests that the invention is not limited to a single technique, stating that "Examples of suitable techniques include ELISA, radioimmunoassays and the like" (’820 Patent, col. 4:35-36). This language may support a construction where "detecting" encompasses any conventional method for identifying antibodies in a sample.
- Evidence for a Narrower Interpretation: The detailed examples in the patent focus heavily on a specific radioimmunoprecipitation assay (’820 Patent, col. 10:50-65). A party could argue that this represents the core of the actual invention and that "detecting" should be construed more narrowly in light of these specific embodiments.
VI. Other Allegations
- Indirect Infringement: The complaint makes a conclusory allegation of direct or indirect infringement (Compl. ¶24). It does not, however, plead specific facts to support the knowledge and specific intent required for a claim of induced infringement or facts to support a claim of contributory infringement.
- Willful Infringement: Willfulness is alleged based on Defendants’ purported "specific knowledge of the ’820 patent" and their alleged conduct in "surreptitiously and purposefully design[ing] an alternate test to avoid paying Athena" (Compl. ¶20, ¶25). These allegations suggest a claim of deliberate infringement based on pre-suit knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- Patent Eligibility: A central issue for the court will be one of patentable subject matter: are the claims, which are directed to a method of diagnosis based on observing a natural biological correlation, patent-eligible under 35 U.S.C. § 101 in the wake of prevailing Supreme Court precedent on the matter?
- Evidentiary Sufficiency: A key factual question will be one of proof of infringement: can Plaintiffs produce evidence in discovery to demonstrate that Defendants’ accused tests practice the specific limitations of asserted dependent claims 8 and 9, namely the use of a radioisotope label, a fact not alleged in the complaint?
- Claim Scope: Should the case proceed, a key question for claim construction will be the scope of the claim term “detecting”: does the term encompass any immunological assay, as Plaintiffs may argue, or is its scope informed by the specific radioimmunoassay embodiments detailed in the patent’s examples, as Defendants may argue?