More Bad Legal News for Athena Diagnostics: Don’t Mess with Mayo

We have been reporting for more than a year about the case of Williams v. Quest Diagnostics (the parent company of Athena Diagnostics), in which the plaintiff has sued Athena and Quest for causing the death of her son by misclassifying a genetic variant when testing the boy’s DNA. That case is now on hold in a South Carolina federal court until the state’s Supreme Court resolves the question of whether a genetic testing lab is a licensed health care provider under South Carolina law. If it is, then the case will be governed by the state’s malpractice statute of limitations and will probably be dismissed as having been filed too late. If it’s not, then the ordinary negligence statute of limitations will apply and the case will probably be allowed to proceed.

But now Athena faces an adverse ruling from another court—a Massachusetts federal district court—in a patent infringement suit that Athena and two co-plaintiffs brought against Mayo Collaborative Services and the Mayo Clinic: Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC. In an Aug. 4, 2017 decision, Judge Indira Talwani invalidated Athena’s patent on a method for diagnosing myasthenia gravis (MG), an autoimmune disease that depletes muscle strength. Previous tests detected what are called AChR autoantibodies (antibodies that attack antigens originating in the patient’s own body as if they were foreign substances) to diagnose MG.

But 20% of MG patients don’t have AChR autoantibodies, so the earlier tests yield false negatives. The inventors of the Athena patent discovered that the 20% do have another kind of autoantibody that attacks a neuromuscular protein receptor called MuSK. The patented method calls for making a version of MuSK with a radioactive label (125I-MuSK) and then introducing the 125I-MuSK to a bodily fluid (blood) sample from the patient. If MuSK autoantibodies are detected, the patient is diagnosed with MG.

Athena and its co-plaintiffs alleged that an alternative test developed by Mayo (irony alert—see below) infringed multiple claims (claims 6-9) of their U.S. Patent No. 7,267,820. A patent infringement defendant can win by proving—by clear and convincing evidence—that the U.S. Patent and Trademark Office should not have issued the patent in the first place. The effect of asserting the invalidity defense is that the court goes back and second-guesses all aspects of the USPTO’s decision under the applicable legal standards. The defendant’s burden of proof is difficult but the reward is great: the patent is invalidated and the plaintiff’s technology enters the public domain.

Mayo based its argument on—what else?—the Supreme Court’s 2012 decision in Mayo v. Prometheus. In that case, Mayo, also as an infringement defendant, succeeded in invalidating a Prometheus patent on a method for measuring the level of a drug in the body and then adjusting the dose. The Supreme Court held that the patent failed the patentable subject matter test of section 101 of the Patent Act because it claimed nothing more than a routine, conventional application of a law of nature (the relationship between the level of the drug in the body and the correct next dose). Two other highly publicized Supreme Court decisions, AMP v. Myriad Genetics (2013) and Alice Corp. v. CLS Bank (2014) invalidated patents for claiming, respectively, a product of nature (Myriad: an isolated gene) and an abstract idea (Alice: using a computerized third-party intermediary in a financial transaction). 

Mayo/Myriad/Alice prescribes a two-part test for determining validity. First, decide whether the claims “are directed to a patent ineligible concept”—a law of nature, a product of nature, or an abstract idea. In the Athena case, the Massachusetts court saw a clear factual analogy to Mayo:

In Mayo, a man-made substance was administered to a person, and the by-product of the metabolization of that man-made substance was observed. . . . Here, a man-made substance (125I-MuSK) is administered to a sample of bodily fluid, and the by-product (125I-MuSK autoantibodies) is observed.

Both patents, in other words, depend on observing the results of natural bodily reactions, which are themselves manifestations of laws of nature.

Athena countered that the method should not be construed as dependent on a law of nature, since the critical substance used in the test—125I-MuSK, with its radioactive label—is man-made. The court rejected this argument: despite the use of a man-made substance, “[t]he focus of the claims of the invention is the interaction of the 125I-MuSK and the bodily fluid, an interaction which is naturally occurring.” The patent claims a method for detecting autoantibodies, not a method for creating 125I-MuSK.

Having determined that the claims were directed to a law of nature, the court went on to the second part of the test: whether the particular method adds an “inventive concept” to the law of nature, or whether the application is simply “a well-understood, routine, conventional activity already engaged in by the scientific community.” The court found—citing the plaintiffs’ own statement in their patent—that the claimed use of 125I-MuSK is based on “standard techniques in the art.” The patent thus failed both steps of the Mayo patentable subject matter test.

I would expect that Athena will appeal this decision to the U.S. Court of Appeals for the Federal Circuit, which hears all patent appeals.

Some Implications of the Decision

1. The anti-life sciences patent trend continues. Despite a few exceptions, the trend in the USPTO, the federal district courts and the Federal Circuit is hostile to life sciences patents, especially those claiming diagnostic methods. The most extreme example of this trend is the Federal Circuit’s 2015 decision in Ariosa Diagnostics v. Sequenom, which invalidated a patent on an apparently innovative method of using cell-free fetal DNA in maternal blood plasma to determine paternity. The USPTO and the courts seem to be finding laws of nature, products of nature, and abstract ideas everywhere, and it is proving virtually impossible to demonstrate enough of an inventive concept to save the patent. Life sciences patent advocates are mounting organized resistance to this trend, with the American Bar Association and the American Intellectual Property Association, among others, urging Congress to amend the Patent Act to undo the effects of Mayo/Myriad/Alice. This is theoretically doable, since those cases are merely interpreting the patentable subject matter standard of section 101 of the Patent Act, which Congress can change. But the likelihood of the current Congress dealing with such a complicated issue seems remote. Moreover, having seen no evidence thus far, I personally doubt that the anti-patent trend is having any material economic impact on the life sciences industry. More on this below.

2. Be careful when you file a patent infringement suit. When you file a patent infringement suit against a defendant with money, you invite that defendant to challenge the patent’s validity. (I emphasize with money, since patent litigation is extremely expensive, and impecunious defendants may just roll over.) In fact, if the patent is vulnerable in any way, the challenge is a virtual certainty. If you lose, the patent is gone forever. Given this, I always advise clients to think long and hard before suing.

3. Will anyone ever sue Mayo again? Mayo has been sued in two major patent infringement cases, and has successfully proved invalidity both times. They’re good at this. On one of the patent blogs I read regularly, a commenter called Mayo “the serial accused infringer that started all this nonsense.” Maybe so, but don’t mess with Mayo.

4. Where does the law go from here? There is no reason to think that it won’t continue in the same direction. As I said above, I wouldn’t bet on Congressional action any time soon. Absent a major change of heart at the Federal Circuit, decisions like this one will remain the norm. For those who want to compete with established, patent-heavy life sciences companies, this is good news. For the former companies, of course, the news is more ominous. The big question in my mind is what effect this legal trend will have on innovative start-ups. Will the squeeze on potential patents scare off venture capitalists? Or will the declining patent threat and resulting increased freedom to operate make innovation even more attractive? We shall see.