Latest Federal Circuit Ruling on 101 Strikes Down Mallinckrodt Method of Treatment Claims; Newman Dissents

“The majority’s broad pronouncement of ineligibility of medical treatment that relates to human physiology not only contravenes precedent, but contravenes the national interest in achieving new methods of medical treatment with the assistance of the patent incentive.” – Judge Pauline Newman, dissenting

Chief Judge Prost, Federal Circuit.

In the most recent exploration of Section 101 by the Federal Circuit, Chief Judge Sharon Prost authored a non-precedential opinion holding the claims of a patent for a method of administering inhaled nitric oxide (iNO) ineligible for patent protection under the Alice/Mayo framework. The ruling paves the way for industrial gas company Praxair Distribution to move forward with marketing its generic nitric oxide delivery system. Judge Pauline Newman dissented in part, stating that the “method that is described and claimed does not exist in nature” and “was designed by and is administered by humans,” so should be patent eligible.

The Claims

INO Therapeutics LLC, Mallinckrodt Hospital Products Inc., and Mallinckrodt Hospital Products IP Ltd. (“Mallinckrodt”) filed suit against Praxair in the U.S. District Court for the District of Delaware in 2015, alleging infringement of several patents related to methods of administering inhaled nitric oxide and others related to devices and methods for administering gas. The suit was in response to Praxair’s abbreviated new drug application (ANDA) seeking approval to market Noxivent, a generic form of 100 and 800 ppm nitric oxide gas for inhalation. Among the patents Mallinckrodt asserted were:
  • U.S. Patent No. 8282966, titled Method of Reducing the Risk of Occurrence of Pulmonary Edema in Children in Need of Treatment with Inhaled Nitric Oxide. It claims a method of reducing risks for pulmonary edema associated with a treatment by performing echocardiography to identify a child in need of an inhaled nitric oxide treatment, determining that the child has such a risk due to ventricular dysfunction, and then excluding the child from nitric oxide treatment if that treatment would cause pulmonary edema.
  • U.S. Patent No. 8795741, titled Methods for Treating Patients Who are Candidates for Inhaled Nitric Oxide Treatment. It claims a method for treating patients for hypoxic respiratory failure that reduces the risk of increasing pulmonary capillary wedge pressure leading to pulmonary edema in neonatal patients.
  • U.S. Patent No. 8846112, entitled Methods of Distributing a Pharmaceutical Product Comprising Nitric Oxide Gas for Inhalation. It discloses a method of providing pharmaceutically acceptable nitric oxide gas in a cylinder of compressed gas which is also designed to reduce adverse effects or serious adverse effects in patients undergoing nitric oxide treatments.

In 2017, the Delaware court ruled that five of the Mallinckrodt patents were invalid under 35 U.S.C. § 101 and six others were not infringed. The appeal involved 10 of those patents.

The Federal Circuit agreed, holding that representative claim 1 of the ‘741 patent:

does no more than add an instruction to withhold iNO treatment from the identified patients; it does not recite giving any affirmative treatment for the iNO-excluded group, and so it covers a method in which, for the iNO-excluded patients, the body’s natural processes are simply allowed to take place.


Not Vanda

The Court added that the claim’s language instructing physicians not to administer iNO gas to patients with a condition called left ventricular dysfunction (LVD) is not evidence that the claims are not directed to a natural phenomenon, but instead is “simply an instruction not to act. In effect, the claim is directed to detecting the presence of LVD in a patient and then doing nothing but leaving the natural processes taking place in the body alone for the group of LVD patients.”

Mallinckrodt had relied in part on Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International Ltd. to prove the claims eligible, but the Court called the comparison “misplaced.” While in Vanda, “the claims leveraged the natural phenomenon to improve treatment for schizophrenia,” here, the Court said “the invention does not improve treatment of the underlying conditions in question—pulmonary edema and hypoxic respiratory failure—by taking advantage of the body’s natural processes…. the claim language stops well short of an improved treatment method.”

As to the device claims, the court found them not infringed because the plain language of the claims taught that the devices should be used with iNO gas. Mallinckrodt had argued that the “claims were practiced when any iNO cylinder was combined with a circuit storing gas data—even if the data is unrelated to the particular gas in the cylinder.” But the Federal Circuit said that “the ‘gas’ throughout the claim consistently refers to the specific contents of the ‘gas source’ administered to the patient. Thus, ‘gas data’ relates to the actual gas inside the cylinder.” The district court had also found that Praxair’s delivery system (NOxBOXi) did not “verify” the gas and therefore did not infringe claim 15 of the ’794 patent, which is representative of the DSIR patents’ method claims, and the Federal Circuit agreed.

Mallinckrodt was successful, however, in its argument that the district court had erred in ruling on claims that were not asserted before it. In its decision, the district court had found the patents invalid and not infringed in their entirety, instead of specifying the claims at issue. The Court thus remanded to the district court to correct this “clerical error.”

Newman Laments Unpredictability

In her dissent, Judge Newman repeatedly warned about the dangers of finding such patents ineligible. It is worth repeating several excerpts from her opinion in their entirety:

Mallinckrodt’s method of treatment may or may not pass the tests of sections 102 or 103, but this court’s precedent and that of the Supreme Court do not exclude methods of treatment from access to the patent system under section 101. Today’s change of law adds to the inconsistency and unpredictability of this area of patent-supported innovation…..

The majority’s broad pronouncement of ineligibility of medical treatment that relates to human physiology not only contravenes precedent, but contravenes the national interest in achieving new methods of medical treatment with the assistance of the patent incentive….

Patents provide the economic incentive for medical scientists and industries to devise new treatments to serve the afflicted public. My colleagues’ holding that such inventions are broadly ineligible for patenting, will simply add disincentive to medical advance. From my colleagues’ holding that this improved method of treatment of neonates having left ventricular dysfunction is ineligible under section 101, I respectfully dissent.

In a statement issued August 27, Mallinckrodt said it is disappointed by the decision, but “confident its well-established presence and INOmax Total Care, its comprehensive product and service offering, are highly valued by customers. The company believes that the prospects for a newcomer succeeding in this market are by no means a foregone conclusion.”

According to Bloomberg, Mallinckrodt fell 13% to $3.66 at 12:03 p.m on August 27.

In an email sent to IPWatchdog, attorneys for Praxair called the decision a “victory.”

Seth Waxman of WilmerHale argued for Mallinckrodt at the Federal Circuit, while Morgan Lewis partners Mike Abernathy, William Peterson, Sanjay Murthy, and Jason White led the appellate team representing Praxair, with assistance from associate Julie Goldemberg.




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Join the Discussion

4 comments so far.

  • [Avatar for Dmitry Karshtedt]
    Dmitry Karshtedt
    August 31, 2019 01:34 pm

    I’m not seeing how this opinion is consistent with Vanda. In both cases, the claim is basically directed to determining a patient characteristic (here, a preexisting heart issue; in Vanda, a specific genetic marker) and pursuing a course of treatment accordingly. The majority seizes upon the “excluding” step, but if it wasn’t in the claim, would the patentee then have won (an odd result to be sure, but one that is suggested by the majority’s “ironic[]” focus that the exclusion “instruction that directs the claims to the particular natural phenomenon” )? Or perhaps if the claim said “lower the dosage to zero” for neonates with a left ventricular dysfunction, that would have been ok? I think there’s a reason why this case went non-precedential.

  • [Avatar for TFCFM]
    August 30, 2019 10:43 am

    The decision is straight-forward once the technology is understood:

    Therapeutic agent iNO has been administered to infants with condition X for a long time. Some infants with X are so treated, some aren’t. A portion of infants treated with iNO develop adverse effect Z. Pediatric doctors have tried to treat X with iNO without provoking Z, but it was difficult to do this because it wasn’t clear which infants will exhibit Z.

    The ‘new’ technology relates to recognition that infants with symptom A are more likely to exhibit Z when treated with iNO. (Therefore, folks should avoid treating infants that exhibit A with iNO).

    The claims are directed, in various ways, to trying to monopolize this decision process. Basically, see if an infant exhibits A and, if so, don’t administer iNO to that infant.

    However, symptom A is merely a natural phenomenon, as is the association between A and development of Z upon administration of iNO. The inventors named on the patent merely recognized this pre-existing relationship. The claims are directed merely to “applying” this now-recognized relationship.

    If this technology were patentable, then every incremental medical observation made henceforth could be tied up for decades, effectively paralyzing the practice of medicine and holding otherwise-savable-lives hostage to royalty payments.

    That outcome seems to me pretty unlikely “to promote the progress of science and useful arts.” (“Doctor, before you give the patient your diagnosis and treatment plan, please give me two-to-four weeks to prepare a freedom-to-operate opinion and negotiate all the necessary IP licenses…“)

    It seems to me that advocates of broader patent eligibility would be wise to steer clear of using this case in their arguments.

  • [Avatar for Night Writer]
    Night Writer
    August 29, 2019 06:22 pm

    It is becoming urgent to disband the CAFC. The only way forward for patents in the USA is for legislation to cancel out the Scotus and to dissolve the CAFC. Trump could reform it the next day and appoint qualified people. I would include wiping out all the precedential opinions since the “staking” of Obama. Wipe all out all precedents going back to 2008.

  • [Avatar for Paul Cole]
    Paul Cole
    August 29, 2019 05:10 pm

    A very brief search in esp@cenet for some of the patents in issue reveals one granted European patent with an apparatus claim and a bunch of abandoned European applications with method claims. Reasons for abandonment would take too long to determine, but there seems to be pertinent prior art.

    It pays to look at the decision and the claims in issue. The representative method claim reads:

    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.

    The approach adopted by the panel majority is summarised by Judge Prost in the following terms:

    “To analyze whether a claim involves eligible subject matter, we apply a two-step test. First, we evaluate whether the claims are “directed to” a patent-ineligible concept, such as a natural phenomenon. Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 749
    (Fed. Cir. 2019) (quoting Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014)). If so, we ask whether the limitations of the claim, considered individually and as an ordered combination, “‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 566 U.S. at 78).”

    The erroneous and inadequate nature of this test should be immediately apparent to any student of patent law. The omitted first step is evaluation of positive compliance of the claims with one of the four eligible categories of 35 USC 101, this being the normal and ordinary manner for evaluating compliance with a provision enacted by Congress. The fact that the Supreme Court omitted or made little mention of this first step in recent decisions (presumably as a short cut) is no authority for the proposition that the step should as a matter of law be eliminated or down-graded.

    However, substantive compliance with the “process” category is not self-evident. There is nothing transformative about the treatment of the first patient because the administration of NO is admitted prior art and there is no difference in the way that patent is treated compared to the pre-invention treatment. It is not clear that the exclusion of the second patient is transformative either because in the outcome there is no therapeutic treatment. While I defer to US colleagues (including Anon) who no more about the law that I do, I would be EXTREMELY interested to see an analysis of the claim for positive compliance on the basis of what is said in the relevant section of MPEP and the decisions cited in it.

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