Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders satisfied with the Federal Circuit decision in Vanda may be relieved to see that the Solicitor General urges the Supreme Court to deny certiorari in this case. Unpacking the arguments supporting that recommendation shed light on the government’s position on the Court’s recent patent eligibility decisions, and how they impact diagnostic and personalized method of treatment claims in particular.

The Federal Circuit Decision in Vanda

As noted in this article on the Federal Circuit decision in Vanda, a divided panel of the Federal Circuit upheld the validity of personalized method of treatment claims against a patent eligibility challenge. The majority (Judge Lourie and Judge Hughes) characterized the claims as being “directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” Thus, the majority found that the claims recite “a new way of using an existing drug” that satisfies the patent eligibility requirement of 35 USC § 101.

Chief Judge Prost dissented, unable to distinguish the claims from those invalidated by the Supreme Court in Mayo.

Hikma petitioned the Supreme Court to grant certiorari and review the majority decision.

The Amicus Brief for the United States

The United States’ amicus brief characterizes the question presented as “Whether methods of using drugs to treat medical conditions are patent-eligible processes under Section 101.”

The brief makes five main points, unpacked in more detail below:

1. The Supreme Court decisions in Bilski and Mayo departed from long-standing Supreme Court patent eligibility jurisprudence.

2. Notwithstanding Mayo’s expansion of the “law of nature” exception to eligibility, language in Mayo “indicates that the Court did not intend to overturn the well-settled understanding that method-of-medical treatment claims typically are patent-eligible.”

3. The majority decision of Federal Circuit correctly determined that Vanda’s method of treatment claims satisfy § 101.

4. The Supreme Court decisions in Bilski. Mayo, and Alice have created “confusion” and “uncertainty” as to patent-eligibility.

5. The Supreme Court should review its recent patent eligibility decisions and clarify the state of the law, particularly with regard to diagnostic method claims, but Vanda is “not an optimal vehicle to address the confusion” because Vanda follows “the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible.”

The Departure From Long-Standing Patent Eligibility Jurisprudence

The Solicitor General characterizes pre-Bilski/Mayo patent eligibility jurisprudence as being keyed to the statutory language of § 101, and assessing, for example, whether the claims at issue were directed to a “process” as that term is used in the statute (“[w]hoever invents or discovers any new and useful process … may obtain a patent therefor ….”). However, first in Bilski and then in Mayo, the Court grounded its patent eligibility decisions on judicially-created exceptions to § 101 that “are not required by the statutory text.” That is, in Bilski and then in Mayo, the Court referred to the now-familiar exceptions of “laws of nature, physical phenomena, and abstract ideas.” The Solicitor General notes that it was only subsequently, in Alice, that the Supreme Court explained its approach in Mayo as the now-familiar two-step inquiry: (1) whether the claim is directed to a judicial exception; and (2) whether any additional elements in the claims transform the nature of the claim into a patent-eligible application of the judicial exception.

With regard to the “law of nature” exception, the amicus brief emphasizes that “the Mayo Court concluded for the first time that a phenomenon can be a law of nature even if it exists because of, not apart from, human invention.” The brief contrasts Mayo to earlier Supreme Court decisions such as Diamond v. Diehr (1981) which “had viewed as patent-eligible” “processes that depend on natural phenomena but also involve human intervention—for example, a process of curing rubber that relies on inherent chemical properties of a substance extracted from rubber trees.” The brief explains that Mayo “departed from that prior usage by describing as ‘laws of nature’ biological responses of the human body to conditions that arise solely from human intervention.” In particular, even though “[t]he thiopurine drugs involved in Mayo do not exist in nature, and the administration of such drugs to a patient likewise requires ‘a human action,’” the Court found that “‘the relation’ between a patient’s metabolite levels and the recommended thiopurine-drug dosage for that patient … is ‘a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes.” The amicus brief also finds Mayo to be a departure from Diamond v. Chakrabarty (1980), which drew a line “between products of nature and human-made inventions.”

According to the amicus brief, Mayo took this departure even further when it “defined the natural law … at an extremely high level of specificity.” Where Chakrabarty had identified, e.g., “Newton’s ‘law of gravity’ as a law of nature, Mayo identified a “highly particularized relationship” as such (e.g., blood levels of 6–TG exceeding about 400 pmol per 8×10⁸  red blood cells being likely to produce toxic side effects).” As the brief explains, “[w]hen highly specific relationships of that sort are treated as laws of nature, it becomes more difficult for a patent applicant to show that its invention goes substantially beyond an instruction to ‘apply the law.’”

Language in Mayo Supports Eligibility of Method of Treatment Claims

The United States’ amicus brief  highlights language in Mayo where the Supreme Court contrasted the claims at issue in that case with “a typical patent on a new drug or a new way of using an existing drug.” The amicus brief reads this language as being “[c]onsistent with the settled understanding” that method of treatment claims are patent-eligible and as signaling that the Supreme Court “appeared to take as its premise that methods of medical treatment are patent-eligible.”

Method of Treatment Claims Are Patent-Eligible, but …

The United States’ amicus brief explains that “[a] method of treating a medical condition with an existing drug—such as Vanda’s claimed method of using iloperidone to treat schizophrenia—is a patent-eligible process.” In support, the brief cites pre-Bilksi Supreme Court decisions such as Diamond v. Diehr (1981), the language of the statute, the USPTO’s grant of “tens of thousands of patents that included at least one method-of-treatment claim,” and congressional action in enacting “the Hatch-Waxman Act’s generic-drug regime” which refers to method of treatment patents.

Notwithstanding its firm position that the patent-eligibility of method of treatment claims rests on firm footing, the amicus brief explains how Mayo could be interpreted and applied otherwise, as Chief Judge Prost did in her Vanda dissent. The brief acknowledges that it is hard to draw a line between “the metabolizing of a drug, as in Mayo” being an “‘entirely natural process’” and “the biological reactions involved in Vanda’s process.” Turning to step two of the Mayo/Alice framework, the brief points out that “while the process claimed in Vanda’s patent concludes with a concrete treatment step, it is unclear whether that step would render the process patent-eligible under the Court’s reasoning in Mayo, or whether that step would instead be discounted as routine, conventional activity because it is not independently new.”

Going where no Supreme Court of Federal Circuit decision has gone before, the Solicitor General explains how “even a method of treating disease with a newly created drug would be deemed patent-eligible under a mechanical application of Mayo’s two-part test.” At step one, “[t]he proposition that a specified dosage of a new drug has therapeutic benefits for a particular class of patients would seem to constitute a ‘law of nature’ under Mayo’s expansive conception of that term.” At step two, an instruction to administer the drug in the specified dosage to the relevant patients might be viewed as nothing more than routine and conventional activity. The brief rejects this interpretation of Mayo, because “patent-eligibility of such method-of-treatment claims has long been settled, and the Mayo Court did not suggest that it intended such an avulsive effect on established practices.”

The Supreme Court Decisions In Bilski, Mayo and Alice Have Created “Confusion

The United States’ amicus brief notes that “current uncertainty as to the proper application of the Mayo framework has considerable practical consequences for various types of medical innovations,” particularly diagnostic methods such as those invalidated in Ariosa Diagnostics, Inc. v. Sequenom, Inc. The brief quotes statements in the USPTO’s January 2019 Revised Patent Subject Matter Eligibility Guidance noting that difficulty in “[p]roperly applying the Alice/Mayo test in a consistent manner” “has caused uncertainty in this area of the law”; has made it difficult for “inventors, businesses, and other patent stakeholders to reliably and predictably determine what subject matter is patent-eligible”; and “poses unique challenges for the USPTO” itself.

The amicus brief discusses how the Court’s efforts in Alice to explain Mayo exacerbated the problem.

Within a single post-Mayo opinion, the Court variously articulated [the second] step as a query regarding “what else is there in the claims”; an examination of “whether the additional elements transform the nature of the claim into a patent-eligible application”; “a search for an inventive concept”; an inquiry into any “additional features to ensure that the claim is more than a drafting effort designed to monopolize” the abstract idea or natural law; a review of whether the claims do “more than simply stating the abstract idea while adding the words ‘apply it’ ”; an evaluation of whether a patent does more than merely “limit the use of an abstract idea to a particular technological environment”; and a determination whether additional features are “well-understood, routine, conventional activit[ies]” previously known to the industry.

The brief highlights the additional challenges caused by the overlap between the newly articulated “well-understood, routine, conventional” inquiry with “considerations already addressed by the novelty and nonobviousness requirements of Sections 102 and 103. The brief points out that the Alice/Mayo framework violates two long-held principles (internal quotations and citations omitted):

First, the Court had previously emphasized that the “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter. Tying patent-eligibility to novelty and nonobviousness ignores the distinct purposes those statutory requirements have traditionally served. Second, to the extent Mayo’s approach screens out routine activity and considers only those discrete steps that are independently new, it replaces the traditional statutory focus on the invention “as a whole” with a more demanding test. The Court had previously observed that analyzing the claimed invention “as a whole” is particularly important in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.

The Supreme Court Should Clarify Patent Eligibility Law, But Not In Vanda

Against this backdrop, the Solicitor General makes clear that “[t]he confusion created by [the] Court’s recent Section 101 precedents warrants review in an appropriate case,” but emphasizes that Vanda “is not an optimal vehicle” for doing so for two reasons. First and foremost, “because  the court of appeals majority arrived at the correct result.” Additionally, because “reaffirming that Section 101 encompasses methods of medical treatment would have little practical effect in this case. Rather, “[t]he Court instead should provide additional guidance in a case where the current confusion has a material effect on the outcome of the Section 101 analysis,” such as with respect to diagnostic methods.

Will The Supreme Court Follow The Solicitor General’s Advice?

Since the United States’ amicus brief was filed on December 6, 2019, Hikma filed a supplemental brief on December 20 urging the Court to ignore the Solicitor General’s advice and grant certiorari, and Vanda filed a supplemental brief on December 23 urging the Court to follow the Solicitor General’s advice and deny certiorari.  According to the Supreme Court’s docket, Vanda will be discussed in Conference on January 10, 2020.