On Friday the Solicitor General filed amicus briefs requested by the Supreme Court in two patent cases, Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc. and HP Inc. v. Berkheimer. In both cases, the Solicitor General recommended that the Court deny review. A closer examination of the briefs, however, shows the Solicitor General supporting a reexamination of substantive, if not not procedural, patent eligibility law, at least as expressed by the Supreme Court since Bilski v. Kappos in 2010, and in particular in the currently-pending case Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC.
In Hikma, the question presented in the petition is “whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.” In March, the Court requested the Solicitor General file a brief expressing the views of the United States. On Friday, the Solicitor General recommended the Court deny the petition.
Notably, the brief describes the history of patent eligibility law in two distinct time periods, prior to and starting with the Court’s decision in Bilski v. Kappos in 2010. According to the brief, “[u]ntil 2010, the Court’s decisions recognizing that [certain] discoveries are not patent-eligible were best understood as interpreting the specific terms . . . contained in Section 101’s list of patent-eligible inventions, based in part on history and statutory context.” In one important example, the brief characterizes the Court has having “interpreted ‘process’ in Section 101 based on traditional usage of that term and its precursor (‘art’) in the patent context,” and in particular as having taken “as its touchstone ‘[i]ndustrial processes’ of ‘the types which have historically been eligible to receive the protection of our patent laws.'” (quoting Diamond v. Diehr, 450 U.S. 175, 184 (1981). The brief goes on to explain that “[t]he Court’s recent decisions, however, have applied a different approach.”
After telling this history, the Solicitor General comes down on the side of the Federal Circuit on the merits of this case. The brief explains that the Federal Circuit “correctly held that the relevant claims of Vanda’s patent constitute patent-eligible subject matter under 35 U.S.C. 101” because “[t]hose claims encompass methods of medical treatment” that “[h]istorically . . . were well understood to be patent-eligible.”
The Solicitor General, however, also admits the uncertainty the Court’s recent cases have generated. The brief highlights that while “[l]anguage in [Mayo Collaborative Services v. Prometheus Laboratories, Inc.] indicates that the Court did not intend to overturn the well-settled understanding that method-of-medical-treatment claims typically are patent-eligible . . . . the decision’s logic arguably implies the opposite.” More generally, however, the brief recognizes that “[t]he Court’s reconceptualization in Bilski v. Kappos of inherent, long-recognized limitations on Section 101’s affirmative scope as freestanding, atextual ‘exceptions’ has given rise to an array of difficult questions.”
Having highlighting the confusion the Court’s cases have generated, the brief hits its most important point: “The confusion created by this Court’s recent Section 101 precedents warrants review in an appropriate case.” According to the government, this case is not the “optimal vehicle for bringing greater clarity because the court of appeals majority arrived at the correct result.” Rather, the optimal vehicle is likely one of the “cases involving medical-diagnostic methods,” such as the currently-pending case Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC.
As a result, while the conclusion of the Solicitor General’s brief first states that the “petition . . . should be denied,” it also goes on to explain that, “[i]n the alternative, if the Court grants the petition for a writ of certiorari in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 19-430 (filed Oct. 1, 2019), the petition in this case should be held pending the Court’s decision in Athena and then disposed of as appropriate.”
The Solicitor General’s brief is a shining example of the good that his office can do in helping to correct the Supreme Court’s recent error in the area of patent eligibility law. The brief’s strategy, too, seems particularly wise: Blame Justice Kennedy, who wrote Bilski and, helpfully, is no longer on the Court. This approach differs from other prior scholarship, including my own, which focuses on the later cases of either Mayo (and, as a result, its author, Justice Breyer, who of course is still on the Court) or Alice Corp. v. CLS Bank International (and, as a result, its author, Justice Thomas, who of course also is still on the Court). As I explained in my recent Senate testimony, however, I have essentially lost faith in the Supreme Court’s interest or ability to resolve the confusion the Solicitor General’s brief showcases. Perhaps despite my lack of faith the Court will grant review in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC and backtrack to its precedent prior to 2010. In the meantime, I will continue to support legislative reform efforts, a topic notably omitted from the Solicitor General’s brief.
In HP, the question presented in the petition is “whether patent eligibility is a question of law for the court based on the scope of the claims or a question of fact for the jury based on the state of the art at the time of the patent.” The Court way back in January requested the views of the United States. On Friday, the Solicitor General presented the recommendation of the United States that the Court deny review.
The first thing to note about the Solicitor General’s brief is that it presents the same historical discussion used in the brief in Hikma to focus attention on the change in patent eligibility law beginning with the Court’s Bilski decision.
The second thing to note is that it recommends the Court focusing on correct the substantive approach to patent eligibility before concerning itself with the procedural approach. In the words of the brief, “[r]esolution of the question presented in the petition logically depends on the substantive standard for assessing patent-eligibility under Section 101” and “review to address the logically subsequent, procedural question presented in the petition here is premature.” The Solicitor General then takes the opportunity to stress that “[t]he Court should grant review in an appropriate case to clarify the substantive Section 101 standards” before “address[ing] any ancillary issues that remain.” As a result, the brief’s conclusion is the same in HP as in Hikma: “The petition . . . should be denied,” but, “[i]n the alternative, if the Court grants the petition for a writ of certiorari in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 19-430 (filed Oct. 1, 2019), the petition in this case should be held pending the Court’s decision in Athena and then disposed of as appropriate.”
Finally, the third thing to note is that the brief never takes a position on the question presented, whether patent eligibility is a question of law for the court or a question of fact for the jury. Moreover, the brief never really even discusses the merits of the two positions.
In short, the Solicitor General’s message is clear: This case is not important until the underlying test for patent eligibility is reconsidered, hopefully soon, in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC. That case has not yet seen the filing of the reply in support of the petition. But once the reply brief is filed, given the Solicitor General’s brief in this case, it may not be necessary for the Supreme Court to ask the Solicitor General’s view on whether that petition should be granted before making that decision.
We will keep track of events in all of these cases and report on developments.