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Patent Docs: More in patent-ineligibility from the Federal Circuit
January 2020
by Kevin Noonan  |  Email the author
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The Federal Circuit continues to expand the scope of patent-ineligible invention in its recent iNo Therapeutics LLC v. Praxair Distribution Inc. decision, relying on Justice Breyer's exhortation, in his Mayo Collaborative Serv. Inc. v. Prometheus Laboratories opinion, about the need to beware of "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles un­derlying the prohibition against patents for [natural laws].'” Plaintiffs iNO Therapeutics, LLC, Mallinckrodt Hospital Products Inc., and Mallinckrodt Hospital Products IP Inc. asserted five patents U.S. Patent Nos. 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112), collectively the “heart failure patents” or 'HF patents'" against Praxair Distribution Inc. and Praxair Inc.  Plaintiffs asserted another five patents (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," directed to devices for administering nitric oxide gas.  Inhaled nitric oxide (iNO) gas had been used to treat infants experiencing hypoxic respiratory failure since at least the early 1990's, but in certain cases this treatment results in increased pulmonary edema for infants having a congenital defect, left ventricular hypertrophy.  The patents-in-suit were directed to methods and a gas delivery device to ameliorate this side effect.
 
The District Court held the claims of the HF patents to be directed to patent-ineligible subject matter under 35 U.S.C. § 101, and that Praxair did not infringe the claims of the DSIR patents.  The Federal Circuit affirmed-in-part, vacated-in-part, and remanded, in an opinion by Chief Judge Prost joined by Judge Dyk; Judge Newman dissented to that part of the opinion affirming that the claims were not eligible for patenting under § 101, applying the Supreme Court’s Mayo/Alice test.  The majority stated that:
It is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades.  The inventors observed an adverse event that iNO gas causes for certain patients.  The patent claim 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.  Consequently, the claim here is directed to the natural phenomenon.  The claim, apart from the natural phenomenon itself, involves only well-understood, routine, and conventional steps.  For the reasons below, claim 1 of the '741 patent fails to recite eligible subject matter.
 
Majority finds "[a] neonate patient's body will react to iNO gas in a certain way depending on whether or not the patient has a congenital heart condition called LVD," and this is a natural phenomenon. The claims this were directed to an observation of the natural phenomenon, because the exclusion (from treatment) step "merely restates the natural law," wherein
this added step 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.  Accordingly, the claim is directed to the natural phenomenon.
 
“The patented method does not propose a new way of treating LVD patients that leverages this discovery (e.g., by titrating the iNO dose).  Instead, the claim simply requires that the patient not be treated with iNO.  This is significant because a claim not to treat—i.e., not to disturb these naturally-occurring physiological processes within the LVD patient's body—risks monopolizing the natural processes themselves.” And the presence of a treatment step does not resolve these eligibility deficiencies, according to the court, because “the invention is not on a new way of actually treating the underlying condition of hypoxic respiratory failure” (the treatment being conventional) “[n]or does [is] it [] a way of reducing the risk of pulmonary edema while providing some level of treatment to those patients.” The court considers the invention to be a method of screening for those individuals who should not receive conventional treatment, and thus lacks the requisite degree of innovation” to be patent-eligible.
Judge Newman's dissent directed to the eligibility portion of the decision states that, in her view, the inventors observed a natural phenomenon and then developed a treatment method that took advantage of that observation to avoid adverse events.  "The method that is described and claimed does not exist in nature; it was designed by and is administered by humans" in her view. 
 
The Judge believes her colleagues “improperly separate[d] the claim into old and new steps, any by doing so were able to identify the claim to recite a "natural phenomenon" and some steps as "well-understood, routine, and conventional steps," and avoids the requirement that a claimed invention is considered as a whole. She states that the majority contravenes precedent as well as the national interest in achieving new methods of medical treatment with the assistance of the patent incentive.
This decision in narrow and non-precedential but will bring cold comfort to patent-divested patentees. It suggests that (contrary to Justice Breyer’s exhortation in Mayo) that the Federal Circuit is encouraging the “clever draftsman” to develop stratagems for avoiding patent-ineligibility language as a way to avoid decisions such as this one. Another example of this trend can be seen in in In re Roslyn, where Judge Dyk's opinion held patent-ineligible claims to Dolly the sheep because she was, after all, just a sheep (notwithstanding being a sheep unlike any sheep that had ever lived).  But a careful review of that opinion leads ineluctably to the conclusion that, had the draftsman been clever enough (or prescient enough to realize before the fact the quantum and quality of cleverness required) to have claimed a flock of genetically identical sheep, the Court's objections to patent ineligibility would have perforce fallen, because it would be undeniable that flocks of genetically identical sheep do not occur in nature. 
 
This state of affairs is frankly Byzantine and antithetical to Congress's purpose (uniformity and predictability in U.S. patent law) for creating the Federal Circuit, as well as being contrary to the principles of clarity and the creation of "bright line rules" that arguably prompted the Supreme Court to begin its heightened scrutiny of the Court and its opinions (if not philosophy).  The Federal Circuit's current path is contrary to the idea that patent claims should be readily understandable to well-intended business people and frank (or in current parlance, "efficient") infringers alike and also contrary to the Founders' attitudes regarding patenting as a way to encourage disclosure of new inventions for the public good.  Having such a path will give little relief to those who have lost patent rights under the current regime, but at least it provides a way for inventors to obtain patent-eligible claims no matter what other branches of government do in addressing this issue.  Innovation, especially in the diagnostic and life sciences arts, requires no more and is entitled to no less.

Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.
 
Code: E012040

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