Prior to suing an alleged patent infringer, a patent owner must now carefully consider whether the patent’s subject matter is patent-eligible or is directed to an exception to patent-eligibility, such as natural laws, natural phenomena or products, or abstract ideas. This area of patent law continues to evolve rapidly.

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012) (Mayo), the Supreme Court set forth a two-prong test for patent-eligibility. (1) Is the claim directed to an exception to eligibility? If yes, then: (2) Do any element, or combination of elements, amount to significantly more than the exception? To answer yes, the element(s) must be more than “well-understood, routine, conventional activity” engaged in by practitioners in the field.

In Berkenheimer v. HP, Inc., 881 F.3d 1360 (Fed. Cir. 2018) (Berkenheimer), the Federal Circuit clarified when elements are more than “well-understood, routine, conventional activity.” The invention in Berkenheimer related to digitally processing and archiving files in a digital asset management system, which purportedly improves computer functionality by improving system efficiency and reducing storage requirements. On summary judgment, the claims were invalidated as directed to an abstract idea.

The Federal Circuit agreed that some claims were patent-ineligible, because they did not actually capture the purported inventive concepts or improvements; however, for some of the claims, the court reversed summary judgement and remanded for further fact finding, because those claims “contain limitations directed to the arguably unconventional inventive concept described.” The Federal Circuit further explained: “the district court erred in concluding there are no underlying factual questions.” Significantly, the court clarified that “[w]hether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art.”

In view of Berkenheimer, the U.S. Patent and Trademark Office (USPTO) issued a Guidance on April 19, 2018 on how the decision would be applied to patent examination. Examiners were instructed that when rejecting claims for patent-ineligibility, a conclusion that an element is well-understood, routine, and conventional activity must be based on an explicit factual determination in writing. Merely finding an element in the prior art is insufficient. The Guidance also elaborates that this analysis is the same as for whether an element is so well-known that it need not be described in detail to satisfy the written description requirement. Thus, a specification (or a statement made during prosecution) shows that an element is well-understood, routine, and conventional when it describes that element “as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that [it is] sufficiently well-known that the specification does not need to describe the particulars of [it] to satisfy” the written description requirement.

Following the Federal Circuit’s ruling in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018) (Vanda) the USPTO issued additional guidance that suggested that patents for treating disease should usually be patent-eligible, simplifying an otherwise potentially complicated eligibility analysis. Thus, when a patent claims specific methods of treating disease, it can usually avoid patent-eligibility issues that have led to the invalidation of many life sciences patents.

Vanda. held as patent-eligible claims to treat schizophrenia with FANAPT® (iloperidone); in patients having a gene that can cause poor drug metabolism, the drug can disrupt the heart’s rhythm. The patent describes testing to determine whether the patient has the gene and, if they do, administering a lower dosage of the drug. The Federal Circuit held that the claims are patent-eligible, because they are directed to a specific treatment method for schizophrenia at specific doses to make the drug safer. They are not directed to the patent-ineligible natural relationship between the gene and risk of heart rhythm disruption, so there was no need to proceed to ask whether the patent claims “something more” than that natural phenomenon.

Chief Circuit Judge Sharon Prost strongly dissented. She argued that Vanda’s claims were ineligible, because they merely direct doctors to apply a natural law just like Mayo’s claims.

Vanda is the first Federal Circuit decision after Mayo to address methods of using a particular drug or therapy to treat disease. Such methods can often be based on natural relationships involving the human body, which are not patent-eligible and had posed a risk that patents that include them may be found invalid under Mayo. However, by finding the FANAPT® patent to be patent-eligible and emphasizing that patents for treatment methods should be analyzed as a whole, and not just by looking at the parts dealing with natural phenomena, the Federal Circuit and an associated USPTO memo provide useful guidance for how such patents can survive eligibility challenges.

Similarly, Natural Alternatives Int’l v. Creative Compounds, LLC., Slip Op. No. 2018-1295, (Fed. Cir. March 15, 2019), the Federal Circuit recently held treatment claims patent-eligible even when they use a natural product. In that case, the court reversed a district court’s patent ineligibility holding for methods of using a natural compound, namely beta-alanine, in a dietary supplement for “increasing anaerobic working capacity” and “regulating hydronium ion concentrations” in human tissues. According to the court, the claims are “treatment claims; they cover using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages outlined in the patents[,]” and therefore, they are “patent-eligible new ways of using an existing product.” The court emphasized: “Unlike the claims in Mayo, the [claims] at issue are treatment claims.” The court also compared the claims to those in Vanda, and concluded that they went “far beyond merely stating a law of nature, but instead set forth a particular method of treatment.” The claims, like those in Vanda, specify “a patient population to be treated … particular results to be obtained … [and] a compound to be administered” in specified dosages.

To assist both examiners and patent practitioners, the USPTO has issued guidance on several occasions with a large number of examples of patent-eligible and -ineligible claims. But practitioners should be careful and recognize the risk of relying on USPTO guidance that subject matter is patent-eligible. USPTO guidance that subject matter is patent-eligible is no safe harbor from invalidation, if courts disagree with the USPTO’s analysis. That is one message from the recent case Cleveland Clinic Foundation et al. v. True Health Diagnostics LLC, Slip Op. No. 2018-1218 (Fed. Cir. April 1, 2019) (Cleveland Clinic), where the Federal Circuit disagreed with the USPTO.

In Cleveland Clinic, the Federal Circuit invalidated claims for identifying an elevated myeloperoxidase (MPO) concentration in plasma from a human with atherosclerotic cardiovascular disease, because they were drawn to a law of nature. On May 4, 2016, the USPTO issued guidance entitled “Subject Matter Eligibility Examples: Life Sciences” One exemplary patent-eligible claim (Example 29, claim 1) is directed to “a method of detecting JUL-1 [a fictitious protein only found naturally in patients with a fictitious autoimmune disease julitis] in a patient,” is considered patent-eligible. Cleveland Clinic noted the similarity between its claims and this exemplary claim and argued that its claims should be eligible for the same reasons as the claim in the guidanc; the Federal Circuit disagreed, stating that “while we greatly respect the PTO’s expertise … we are not bound by its guidance.”

Clearly, patent-eligibility is an area of patent law that needs clarification from Congress or the Supreme Court or both. There are some signs that some clarity may be forthcoming. On December 27, 2018, a petition to the Supreme Court was filed for a writ of certiorari to review Vanda. Recently, the Supreme Court has asked the Solicitor General of the United States for input on this petition. The Supreme Court is also awaiting the Solicitor General’s input for a request to review Berkenheimer. Thus, the Supreme Court is showing renewed interest in patent-eligibility, and will perhaps provide more clarity to this area of law.