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Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC

United States District Court, D. Massachusetts

August 25, 2016

ATHENA DIAGONISTICS, INC., ISIS INNOVATION LIMITED, and MAX PLANCK-GESELLSCHAFT ZUR FUNG DER WISSENSCHAFTEN e. V., Plaintiffs,
v.
MAYO COLLABORATIVE SERVICES, LLC, d/b/a MAYO MEDICAL LABORATORIES, and MAYO CLINIC, Defendants.

          MEMORANDUM & ORDER

          Indira Talwani Judge

         Plaintiffs Athena Diagnostics, Inc., Isis Innovation Limited, and Max-Planck-Gesellschaft zur Forderung der Wissenschaften e.V., allege that two tests developed by Defendants Mayo Collaborative Services, LLC, and Mayo Clinic, infringe on Plaintiffs' patent, U.S. Patent No. 7, 267, 820 (“ '820 Patent”). Third Am. Compl. (“Complaint”) [#92]. Defendants move to dismiss Plaintiffs' complaint arguing that the '820 patent is invalid under 35 U.S.C. § 101 because the claimed method applies routine and conventional techniques to a law of nature. Defs.' Rule 12(b)(6) Mot. Dismiss (Defs.' Mot. Dismiss”) [#25]. The motion is DENIED.

         I. Facts

         A. The '820 Patent

         The '820 patent allows for the diagnosis of a form of Myasthenia Gravis, a chronic autoimmune disorder. U.S. Patent No. 7, 267, 820 col. 1 l. 13. Patients with Myasthenia Gravis experience waning muscle strength throughout the day, and symptoms include eye weakness (drooping eyelids, double vision), leg weakness, dysphagia (difficulty swallowing) and slurred or nasal speech. U.S. Patent No. 7, 267, 820 col. 1 l. 15-23. In 1960, it was discovered that in 80% of patients with Myasthenia Gravis, antibodies attack the acetyle choline receptor (AChR) (a neurotransmitter). In those patients, diagnosis is achieved through tests which detect the presence of AChR autoantibodies. U.S. Patent No. 7, 267, 820 col. 1 l. 34-36. Autoantibodies “are naturally occurring antibodies directed to an antigen which an individual's immune response recognizes as foreign even though that antigen actually originated in the individual.” U.S. Patent No. 7, 267, 820 col. 1 l. 42-45. However, 20% of Myasthenia Gravis patients do not have the AChR autoantibodies despite experiencing the same symptoms and responding to the same therapies. U.S. Patent No. 7, 267, 820 col. 1 l. 36-40. For the 20% of Myasthenia Gravis patients who do not have the AChR autoantibodies, the '820 patent inventors discovered that they had IgG antibodies that attack the N-terminal domains of muscle specific tyrosine kinase (“MuSK”), a receptor that is located on the surface of neuromuscular junctions. U.S. Patent No. 7, 267, 820 col. 1 l. 55-61.

         The patent describes the method for a more accurate and speedy diagnosis of these patients. U.S. Patent No. 7, 267, 820 col. 3 l. 4-7. Specifically, the patent describes a method for diagnosing Myasthenia Gravis in which a radioactive label is attached to MuSK (or a fragment thereof) and is then introduced to a sample of bodily fluid. U.S. Patent No. 7, 267, 820 col. 3-4 l. 65-10. The method specifies that 125I be used as the radioactive label. U.S. Patent No. 7, 267, 820 col. 4 l. 10. When 125I-MuSK is introduced into the sample of bodily fluid, the MuSK autoantibodies, if present, attach to the labeled fragment. After the bodily fluid is immunoprecipitated, the presence of the radioactive label on any antibody indicates that the person is suffering from Myasthenia Gravis. U.S. Patent No. 7, 267, 820 col. 4 l. 8-10.

         B. Infringement Allegations

         Athena's test, FMUSK, uses the patented method to diagnose neurotransmission or developmental disorders related to MuSK. Compl. [#92 ¶ 16]; U.S. Patent No. 7, 267, 820, Claim 1. Plaintiffs allege that “Defendants, with specific knowledge of the '820 patent and the method it covers, surreptitiously and purposefully designed an alternate test to avoid paying Athena for Athena's licensed FMUSK test.” Compl. [#92 ¶ 20]. Plaintiffs allege that Defendants availed themselves of the technology disclosed in the '820 patent, and developed two tests for diagnosing Myasthenia Gravis patients. Compl. [#92 ¶ 18]. Plaintiffs argue that Defendants' actions directly or indirectly, and literally or under the doctrine of equivalents, infringe the '820 patent. Compl. [#92 ¶ 24]. The claims at issue are those listed in claims 6-9 of the '820 patent. Pls.' Mem. Opp'n Defs.' Mot. Dismiss. 24 [#37]. Plaintiffs concede that they will not pursue infringement claims against Defendants based on the other claims in the patent. Pls.' Mem. Opp'n Defs.' Mot. Dismiss 8 [#37].

         II. Motion to Dismiss

         Defendants move to dismiss the complaint on the ground that the patent seeks to patent a law of nature, and it uses techniques standard in the art. Defs.' Mem. Supp. Mot. Dismiss 5 [#26]. Plaintiffs argue that the patent is not directed at a law of nature because the patent requires the production and use of 125I-MuSK, a non-naturally occurring protein. Plaintiffs also argue that applying various known types of procedures to a non-naturally occurring protein transforms the claim and makes it patent eligible. Pls.' Mem. Opp'n Defs.' Mot. Dismiss 14 [#37].

         A. Standard of Review under 35 U.S.C. § 101

         In applying § 101 at the pleading stage, the court construes the patent claims in a manner most favorable to the non-moving party. See Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass'n, 776 F.3d 1343, 1349 (Fed. Cir. 2014), cert. denied, 136 S.Ct. 119 (2015). As a threshold requirement for patent protection, the subject matter of a patent must be patentable under § 101; otherwise, the patent is invalid. Section 101 states “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. The Supreme Court has held that this section contains an implicit exception: “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v. CLS Bank Intern., ___ U.S. ___, 134 S.Ct. 2347, 2354 (2014) (quoting Association for Molecular Pathology v. Myriad Genetics, Inc., ___ U.S. ___, 133 S.Ct. 2107, 2116 (2013)). Although “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas, ” these three patent-ineligible exceptions prevent “monopolization” of the “basic tools of scientific and technological work” and the impeding of innovation. Mayo Collaborative Servs. v. Prometheus Labs., Inc., ___ U.S. ___, 132 S.Ct. 1289, 1293 (2012).

         To distinguish between patents that claim laws of nature, natural phenomena, and abstract ideas from patent-eligible inventions, the court must first determine whether the claims at issue are directed to one of those patent-ineligible concepts. Alice, 134 S.Ct. at 2355. If the concept is patent ineligible, the court then considers the elements of each claim both “individually and ‘as an ordered combination' to determine whether the additional elements ‘transform the nature of the claim' into a patent-eligible application.” Alice, 134 S.Ct. at 2355 (quoting Mayo, 132 S.Ct. at 1298, 1297). “We have described step two of this analysis as a search for an ‘inventive concept' - i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.'” Alice, 134 S.Ct. at 2355 (quoting Mayo, 132 S.Ct. at 1294). At step two, more is required than well-understood, routine, conventional activity already engaged in by the scientific community. Rapid Litigation Management, Ltd. v. CellzDirect, Inc., ___ F.3d ___, 2016 WL 3606624, *3 (Fed. Cir. July 5, 2016).

         B. Step One: Are Claims Directed to a Patent ...


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