Mallinckrodt filed a certiorari petition with the Supreme Court last week, over the Federal Circuit panel decision (by Chief Judge Prost joined by Judge Dyk; Judge Newman dissented on the issue before the Court in this petition) affirming dismissal of a suit by Mallinckrodt's subsidiary, iNO Pharmaceuticals, in iNO Therapeutics LLC v. Praxair Distribution Inc. From the first sentence, the petition frames the issue as one of lower court confusion with the Supreme Court's subject matter eligibility jurisprudence:
In the years since this Court's decision in Mayo Collaborative Services LLC v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), the lower courts have struggled to apply the judicially-created exceptions to the subject matter that Congress declared eligible for patent protection in 35 U.S.C. § 101.
In addition to painting the Federal Circuit with a brush both familiar to and consistent with the Court's view on its appellate junior, the petition makes the characterization that "[t]here is no more pressing issue in patent law than resolving the uncertainty that has surrounded the judicial exceptions to §101." To be honest, however, following these exhortations with a reiteration of the situation at the Federal Circuit, including the almost cri de coeur nature of the concurrences and dissents by Federal Circuit judges in Athena Diagnostics Inc. v. Mayo Collaborative Services LLC is likely to fall on deaf ears, having already done so when the Court denied Athena's cert petition. The petition is perhaps on firmer ground when adding a reminder of the Government's views, from the Solicitor General in Hikma Pharm. USA Inc. v. Vanda Pharma. Inc. (see "Solicitor General Recommends That Supreme Court Deny Certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals"), because there the SG urged the Court to revisit its subject matter eligibility jurisprudence just not in that case (specifically stating (and quoted in this petition) that "further guidance from this Court is amply warranted" and should be provided "in a case where the current confusion has a material effect on the outcome of the Section 101 analysis). This gives this petition the opportunity to affirmatively state that "[t]his is just such a case."
As a reminder, the case involved methods (and devices) for treating infants with inhaled nitric oxide gas; perhaps more accurately, the claims recited methods to identifying infants in respiratory distress who should not be administered the conventional iNO treatment, due inter alia to their having a congenital defect, left ventricular hypertrophy, which predisposed such infants to pulmonary edema. Illustrative claims of the patents-in-suit* include:
Claim 1 of U.S. Patent No. 8,795,741:
1. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising:
(a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;
(b) determining that a first patient of the plurality does not have left ventricular dysfunction;
(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;
(d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and
(e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.
Claim 1 of U.S. Patent No. 8,776,794:
1. A gas delivery device comprising:
a gas source to provide therapy gas comprising nitric oxide;
a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve to allow the gas through the valve to a control module that delivers the therapy gas comprising nitric oxide in an amount effective to treat or prevent hypoxic respiratory failure; and
a circuit including:
a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and
a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to the control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired.
(where the italicized limitations are relevant to the Federal Circuit's decision).
The District Court held/found that the claims of the HF patents (vide infra) were directed to patent-ineligible subject matter, and a divided panel of the Federal Circuit affirmed; the Court refused to rehear the decision en banc.
The petition terms method-of-treatment claims as "the one island of stability" in subject matter eligibility jurisprudence, which the decision below has disrupted by "extend[ing] the judicially created exceptions to the plain text of 35 U.S.C. §101 far beyond anything envisioned by this Court," characterizing the case as an opportunity for the Supreme Court to "rein in the Federal Circuit's runaway jurisprudence" on § 101 that "threatens innovation at the forefront of medical science." The petition asserts three reasons why the Court should grant certiorari. First, the decision below "heightens confusion" because it is contradictory to the "traditional understanding" (not upset by the Court's decision in Mayo) that method-of-treatment claims are eligible for patenting. The petition illustrates this confusion by returning to statements made by most of the Federal Circuit judges in concurrences and dissents in Athena, as well as additional similar statements in Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1348 (Fed. Cir. 2018) by Judge Plager; Berkheimer v. HP Inc., 890 F.3d 1369, 1374 (Fed. Cir. 2018) by Judges Lourie and Newman; Smart Sys. Innovations, LLC v. Chicago Transit Auth., 873 F.3d 1364, 1377 (Fed. Cir. 2017) by Judge Linn; and Ariosa Diagnostic, Inc. v. Sequenom Inc., 788 F.3d 1371, 1381 (Fed. Cir. 2015) by Judge Linn; (where the combination of such citations may be effective to further illustrate this confusion). The petition terms this an "extraordinary" "collective and consistent cry for help from the Federal Circuit" with evident justification. The petition also cites such luminaries as former Chief Judge Paul Michel, in testimony before the Senate Subcommittee on Intellectual Property last June (see "Senate Subcommittee on Intellectual Property Holds Hearings on Proposed Revisions to 35 U.S.C. § 101"), public statements by current PTO Director Andrei Iancu and former Director David Kappos, testimony by practitioners and patent law groups (Including the American Bar Association and American Intellectual Property Lawyers Association), and legal scholars (including Mark Lemley and Christopher Holman), all asserting that the uncertainty created by inconsistent decisions by the Federal Circuit and district courts are harmful to innovation and the patent system.
The petition then turns to the potential for harm this decision poses, in disrupting the "island of stability" of patent eligibility for method-of-treatment claims, citing Natural Alternatives Int'l. Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019), and Endo Pharma. Inc. v. Teva Pharm. USA Inc., 919 F.3d 1347 (Fed. Cir. 2019), as well as Vanda. This case "breaches that firewall" by holding for the first time that a method-of-treatment claim is patent ineligible. The petition characterizes as the Federal Circuit "finess[ing] the point" by considering the claims to instruct inaction, which Petitioner counters by interpreting Mallinckrodt's claims as being directed to "an integrated treatment protocol" involving "selective action" (anticipating at least some of the argument Respondent can be expected to make). And the evils this decision could occasion are not limited to such selective treatment claims, the petition asserting that this principle "could reach . . . manufacturing processes in which testing and predefined criteria are used to determine whether a step previously performed on all batches can be skipped in some instances, increasing efficiency . . .," this argument taking the issue outside the realm of diagnostics and illustrating the potential scope of the problem.
The petition next makes the bald assertion that "the Federal Circuit's decision is wrong." And the basis for the statement is, first, that Congress spoke expansively in drafting Section 101 and the implicit judicial exceptions recognized by the Court are not as expansive as the Federal Circuit's decision below makes them. The petition characterizes (properly) the claims in Mayo as being "an oddity" and accordingly, readily distinguishable from Mallinckrodt's claims (most easily by noting that the Mayo claims did not require any action on the part of a physician who had practiced the claimed method to determine whether the amount of administered drug was in the therapeutic range). The Federal Circuit's mistake here was in disregarding this distinction and in failing to heed the Court's prescription that claims must be considered as a whole, citing (of course) Diamond v. Diehr, 450 U.S. 175, 188 (1981). The petition also criticizes the decision below for attempting to distinguish the Vanda decision (noting that the author of this opinion dissented in that one), the deficiency in the attempt being crafting an "arbitrary distinction" between "treating and not treating" steps neither found or required by the statute or the Court's eligibility decisions (and further noting that the scope of the Vanda claims were even broader, wherein was claimed all dosages of the drug at 12 mg/day or less, while the claims here recited a "single, specific course of action," the petition reciting unclaimed, potential alternatives that reduced the scope of preemption).
The final reason the petition asserts supporting the Court's grant is the threat to personalized medicine, which Petitioner calls "the next frontier of medical research." While compelling writing, such paeans to the coming beneficent future and the threat subject matter eligibility restrictions pose to it have become commonplace (due, at least in part, to the truth of these assertions), but frankly the Court has shown no tendency to be persuaded by them. Perhaps this is due to the expected salvo of amicus briefing and legal and popular literature to the contrary, that patenting is a tax and an impediment to innovation, and perhaps it reflects the individual Justice's views on the proper place for patents involving medicine. No matter how well written or how cogent the arguments made (here, by Seth Waxman, a preeminent Supreme Court advocate), it is hard to place much hope in any change of heart in this regard by the Court in this case.
Mylan will have an opportunity to file a responsive brief in due course, and the Court should it grant certiorari can be expected to hear argument in the Fall term (COVID-19 willing).
* The full list of claims asserted by iNO and Mallinckrodt include U.S. Patent Nos. 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112, collectively termed the "heart failure patents" or "HF patents," and U.S. Patent Nos. 8,573,209; 8,776,794; 8,776,795; 9,265,911; and 9,295,802, collectively termed the "delivery system infrared patents" or "DSIR patents."
