Earlier this fall, Athena Diagnostics, Inc.; Oxford University Innovation Ltd.; and Max-Planck-Gesellschaft Zur Forderung Der Wissenschaften E.V. ("Athena") filed a petition for a writ of certiorari in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, requesting that the Supreme Court "provide much-needed guidance on the important question of the patent eligibility of medical diagnostic tests."  Athena begins its petition by stating that:

Across eight opinions concurring or dissenting in the denial of rehearing en banc, the Federal Circuit unanimously agreed that the claims to a medical diagnostic method in this case should be patent-eligible.  But the court split 7-5 on whether this Court's precedent foreclosed such a result or whether it was the Federal Circuit's own misinterpretation of that precedent that has denied patent protection to diagnostic tests.  Numerous judges asked this Court to provide guidance.

Athena then sets forth the question presented as:

Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

At issue in the case are claims 6-9 of U.S. Patent No. 7,267,820, which is directed to methods for diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK).  The '820 patent discloses that about 80% of patients with Myasthenia gravis (MG) produce acetylcholine receptor autoantibodies, and that the remaining 20% do not.  The named inventors of the '820 patent discovered that many of the 20% of MG patients without acetylcholine receptor autoantibodies instead generate autoantibodies to MuSK.  The '820 patent contains only one independent claim, which, while not at issue in the case, recites:

1.  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).

Claims 6-9, which are at issue in the case, recite:

6.  A method according to claim 3 whereby the intensity of the signal from the anti-human IgG antibody is indicative of the relative amount of the anti-MuSK autoantibody in the bodily fluid when compared to a positive and negative control reading.

7.  A method according to claim 1, comprising contacting MuSK or an epitope or antigenic determinant thereof having a suitable label thereon, with said bodily fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK epitope or antigenic determinant complex from said bodily fluid and monitoring for said label on any of said antibody/MuSK complex or antibody/MuSK epitope or antigen determinant complex, wherein the presence of said label is indicative of said mammal is suffering from said neurotransmission or developmental disorder related to muscle specific tyrosine kinase (MuSK).

8.  A method according to claim 7 wherein said label is a radioactive label.

9.  A method according to claim 8 wherein said label is 125I.

Athena markets a test called FMUSK that functions by evaluating those antibodies.  After Mayo developed two competing tests, Athena filed suit against Mayo for infringement of the '820 patent, and Mayo moved to dismiss under Rule 12(b)(6), arguing that the asserted claims of the '820 patent were invalid under § 101 for claiming patent ineligible subject matter.  The District Court granted Mayo's motion, and Athena appealed for a determination of whether claims 6-9 are patent eligible under § 101.

In February, a divided Federal Circuit panel affirmed a decision by the District Court, holding claims 6-9 invalid under 35 U.S.C. § 101, and dismissing Athena's complaint for infringement under Fed. R. Civ. P. 12(b)(6).  In the panel opinion, authored by Judge Lourie and joined by Judge Stoll (with Judge Newman dissenting), the panel majority "ultimately agree[d] with Mayo that, under Mayo [Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 70 (2012)], the claims are directed to a natural law," and that in the instant case, the natural law "is the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK related neurological diseases like MG."  However, the majority also explained in a footnote that:

[I]n our view, providing patent protection to novel and non-obvious diagnostic methods would promote the progress of science and useful arts.  But, whether or not we as individual judges might agree or not that these claims only recite a natural law, . . . the Supreme Court has effectively told us in Mayo that correlations between the presence of a biological material and a disease are laws of nature, and "[p]urely 'conventional or obvious' '[pre]-solution activity' is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law," . . . .  Our precedent leaves no room for a different outcome here [citations omitted].

In July, the Federal Circuit issued a per curiam Order in the case, denying Athena's petition for rehearing en banc.  The per curiam Order was accompanied by eight opinions, four concurring in the denial of the petition and four dissenting in the denial of the petition.  The four concurring opinions were authored by Circuit Judges Lourie, Hughes, Dyk, and Chen, with Chief Judge Prost and Circuit Judges Reyna, Taranto, and Hughes joining in one of the concurrences and Circuit Judge Chen joining in one concurrence and several parts of another.  The four dissenting opinions were authored by Circuit Judges Moore, Newman, Stoll, and O'Malley, with Circuit Judges O'Malley and Stoll joining in one of the dissents and Circuit Judge Wallach joining in three of the dissents.

In its petition for a writ of certiorari, Athena declares that "[a]cross eight separate opinions in which the court divided 7-5 on denying en banc review, the Federal Circuit issued an unprecedented cry for help from this Court to clarify the patent eligibility of medical diagnostic tests."  Athena then requests that the Supreme Court "heed that cry and provide much-needed guidance on the proper application of the judicially-created exceptions to Section 101 of the Patent Act."  Noting that since the Supreme Court's decision in Mayo, "the Federal Circuit has invalidated every diagnostic claim to come before it as ineligible subject matter for patent protection," Athena points out that the Federal Circuit, while denying Athena's petition for rehearing en banc, "agreed with Athena that sufficiently specific diagnostic methods with proven utility like the ones here should be patent-eligible," and that there was broad consensus among the Federal Circuit judges that Supreme Court review was "desperately needed."

Athena provides three reasons for the Supreme Court to grant its petition.  First, Athena suggests that the Court should review the case to clarify the Court's § 101 precedent.  Second, Athena contends that the Federal Circuit's holding threatens to disrupt important medical innovation.  And finally, Athena asserts that the case provides an ideal vehicle to clarify the patent eligibility of diagnostic methods.

With respect to the first reason, Athena argues that:

The Federal Circuit is deeply divided on how to apply this Court's precedent.  Every judge of the en banc court was troubled by the conclusion that Athena's claims are not patent-eligible, despite their use of specific chemical steps and man-made molecules in the first diagnostic test ever developed for a large number of patients with MG.  The disagreement focused on whether this Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) mandates such an unfortunate result, or whether, as five judges argued, the Federal Circuit itself created the problem by misinterpreting this Court's precedent.  Either way, the fractured decisions of the Federal Circuit are a clarion call for this Court to grant certiorari and provide much-needed guidance on the important question of the patent eligibility of medical diagnostic tests.

After pointing to other decisions in which "the Federal Circuit expressed confusion and division on patent eligibility or called for this Court's intervention," Athena states that:

The collective and consistent cry for help from the Federal Circuit, culminating in this case, is extraordinary and emphasizes just how critical this Court's guidance is.  Patent-eligibility is a threshold question of enormous importance to innovation and the economy, and yet the Federal Circuit has badly misinterpreted the judicially-created exceptions to the statute to bar patent protection to inventions that meet all the statutory criteria for patenting, including the requirements that claims be novel and nonobvious.  The judges tasked with hearing all patent appeals in the United States have now told this Court in no uncertain terms that they are confused and need clarification on how to apply those judicial exceptions.  The Court should heed that call.

Athena provides five points of confusion that it contends have emerged "as courts and litigants have struggled to apply—or have misapplied—the judicially-created exceptions to Section 101."  First, Athena contends that "courts have struggled with the tension between the Federal Circuit's striking down a diagnostic method claim that uses novel man-made molecules and this Court's holding that a 'molecule that is not naturally occurring' is 'not a 'product of nature' and is patent eligible under § 101.'"  Second, Athena contends that "courts have struggled to apply the principles articulated in the context of the unusual facts of Mayo to more typical patent claims," arguing that in contrast with the claims at issue in the instant case, "[t]he claim in Mayo was an oddity" because the two actions required by the claim were steps that were already performed by doctors before the patent was issued.  Third, Athena argues that "courts have struggled with the level of abstraction at which to determine whether the steps of a claim 'transform an unpatentable law of nature into a patent eligible application of such a law.'"  Fourth, Athena asserts that "the Federal Circuit's approach gives little consideration to the 'preemptive' scope of a claim, contrary to this Court’s guidance," stating that the Federal Circuit "has transformed the preemption analysis into a one-way ratchet" in which claims that do not prevent others from using a natural law are nevertheless deemed to be patent ineligible.  Finally, Athena argues that "courts have struggled with what it means to review a claim 'as a whole.'"

Athena suggests that "[g]iven the lower courts' widespread confusion about the judicially-created exceptions to patent eligibility, government officials, practitioners, and commentators have all echoed and amplified the need for guidance from this Court."  Athena argues that "[t]he Federal Circuit's wavering hand has only made the PTO's struggle implementing this Court's Section 101 case law more difficult."  Athena therefore contends that the Supreme Court "should grant review to provide the guidance that the Federal Circuit, the PTO, practitioners, and scholars all agree is urgently needed."

Moving on to the second reason for the Supreme Court to grant its petition, Athena contends (citing Judges Moore and Lourie) that the Federal Circuit's decision in this case has effectively shut the door for good for the vast majority of diagnostic claims, "establishing a 'per se rule' that bars 'diagnostic kits and techniques,' . . . insofar as they are deemed to 'consist of routine steps to observe the operation of a natural law,' . . . no matter how novel or useful they are."  Athena declares that "[t]his rule will have devastating consequences," noting that in the month after Mayo was decided, the rejection rate for medical diagnostics applications rose from 7% to 32%, and that by the time that Alice Corp. v. CLS Bank Int'l was decided, the rejection rate increased to 50%, eventually rising to 64%.  According to Athena, "[w]ith the decision below, that rate will climb significantly higher—if inventors even bother to apply for patents for diagnostic methods at all."  Athena argues that such an outcome will be devastating for U.S. healthcare because diagnostics, which account for only 2.3% of national healthcare spending, reduce healthcare costs by allowing doctors to replace expensive late-stage therapies with cost-effective early-stage therapies.

Athena concludes its petition by arguing that this case provides an ideal vehicle to clarify the patent eligibility of diagnostic methods.  In particular, Athena argues that its claims "recite a new and specific method of diagnosing MG through a series of concrete laboratory steps, so that patients can be accurately and expeditiously diagnosed," declaring that "[i]f these claims are patent-ineligible, that is truly the end for most medical diagnostic methods."  Athena then points to several ways in which this case would provide an opportunity to clarify the patent eligibility of medical diagnostic tests.

First, Athena argues that its claims provide an opportunity to clarify the law with respect to the use of novel man-made molecules.  According to Athena, the use of man-made compounds in its claimed methods "makes this an easy case," since "[t]here is no reason in law or logic that a claim that goes even further [than reciting man-made molecules] and limits itself to specific uses of novel man-made compounds should lose its eligibility for patent protection" (emphasis in opinion).

Athena next suggests that its claims provide an opportunity to clarify the law with respect to the recitation of specific chemical steps to achieve a new and useful result.  Arguing that "[t]he patent claims here are a world apart from the claim invalided in Mayo," Athena notes that while the inventors made an undisputedly groundbreaking discovery that 20% of MG patients develop the disorder because they generate autoantibodies to MuSK, "that is not what they claimed."  Instead, Athena argues that the inventors claimed an application of that discovery.

Athena closes its petition by arguing that "the rules the Federal Circuit has relied on to invalidate medical diagnostic claims find no support in the statute," adding that "[t]he language chosen by Congress easily encompasses Athena's claims," and that "[t]his case thus turns entirely on judicially-created exceptions, unsupported by the statutory text."  Athena states that:

This Court, as the creator of those non-textual exceptions, bears a special responsibility to ensure that they are properly interpreted and applied.  The Court has admonished courts to "tread carefully" lest the exceptions "swallow all of patent law."  Alice, 573 U.S. at 217.  But the Federal Circuit has not heeded that admonition, allowing those exceptions to expand ever outward and swallow the field of medical diagnostics.  The legal issues are too fundamental, and the stakes too high, to allow that misapplication of the law to stand.  The Court should grant the petition and reverse.

For additional information regarding this topic, please see:

• "The Proper Role of the Federal Circuit," July 25, 2019
• "Athena Diagnostics v. Mayo Collaborative Services -- The Dissents," July 17, 2019
• "Athena Diagnostics v. Mayo Collaborative Services -- The Concurrences," July 14, 2019
• "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)," July 9, 2019
• "Invitation to Join Amicus Brief in Athena Diagnostics v. Mayo," April 11, 2019
• "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)," February 12, 2019
• "Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (D. Mass. 2017)," August 8, 2017