Patents Nominally Directed to Method of Treatment Held Invalid as Claiming Law of Nature - Claims Instructed to Withhold Drug from Patients in whom it was Contraindicated - JD Supra

Posted: 04 Sep 2019 05:33 PM PDT

Most of the Section 101 cases discussed on this blog concern patents in the technology arts, which are commonly challenged on the ground that the claims are invalid because they are directed to an "abstract idea." This post concerns a pharmaceutical case, in which the Section 101 challenge was based on the argument that the claims were directed to a "law of nature."

By way of background, patents claiming methods of treating patients by administering pharmaceuticals have generally survived challenges under Section 101. For example, patents that direct treating patients with lower doses of a particular drug when lab tests show that those patients will be more sensitive than typical—for example because of a specific genetic variation that results in slow metabolism, or impaired renal function that results in slow elimination—were held by the Federal Circuit to claim patent-eligible subject matter. Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117 (Fed. Cir. 2018); Endo Pharm. Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019).

In a recent case, the Federal Circuit held that claims which were written in method-of-treatment format, but instructed to not treat patients with a drug that might cause them harm, were invalid as claiming laws of nature. INO Therapeutics LLC v. Praxair Distribution Inc., No. 2018-1019 (Fed. Cir. Aug. 27, 2019).

This case arose from the defendants' submission of an abbreviated new drug application (ANDA) seeking FDA approval to sell a generic formulation of the plaintiffs' inhaled nitric oxide (iNO) medical gas. For those who don't remember their chemistry, the formula for nitric acid is NO, while that for nitrous oxide (laughing gas) is N₂O. They are distinct compounds with different physiological effects.

Nitric oxide is a vasodilator that can be useful for treatment of pulmonary hypertension, including in certain neonates with respiratory problems. However, giving it to infants with compromised heart function, specifically left ventricular dysfunction, was found to increase the risk of pulmonary edema. The patents at issue were directed to "solving" this problem by withholding iNO from neonates with the heart condition, although some of the claims were drafted more creatively by further reciting the step of administering iNO to those patients without the heart problem. The Federal Circuit quoted this claim as representative:

A method of treating patients who are candidates for inhaled nitric oxide treatment . . . comprising:

(a) identifying a plurality of term or near-term neonatal patients who . . . are candidates for . . . inhaled nitric oxide treatment;

(b) determining that a first patient of the plurality does not have left ventricular dysfunction [LVD];

(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of . . . pulmonary edema upon treatment with inhaled nitric oxide;

(d) administering . . . 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 . . . pulmonary edema upon treatment with inhaled nitric oxide.

U.S. Patent No. 8,795,741 (the '741 patent).

Translated from patentese, the claimed method was to determine which infants with breathing problems had LVD, and only treat infants without LVD with iNO.

Because the use of iNO for breathing problems was conventional, the only potentially inventive feature of the claims was to determine if an infant with respiratory problems also had LVD, and if so to refrain from treating that infant with iNO. This feature is even clearer in claims of some of the other asserted patents, such as this one:

A method of reducing the risk of occurrence of pulmonary edema associated with . . . inhalation of 20 ppm nitric oxide gas, said method comprising: (a) performing echocardiography to identify a child in need of 20 ppm inhaled nitric oxide treatment for pulmonary hypertension . . .; (b) determining that the child . . . has left ventricular dysfunction, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; and (c) excluding the child from inhaled nitric oxide treatment based on the determination that the child has left ventricular dysfunction and so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide.

U.S. Patent No. 8,282,966 (the '966 patent).

The district court held the method claims invalid as being directed to unpatentable subject matter, and the Federal Circuit affirmed in a fully elaborated, but nonprecedential, opinion authored by Chief Judge Prost in which Judge Dyk joined. Judge Newman dissented.

The Federal Circuit opinion repeatedly noted that the claims were not directed to a method of giving a drug to treat a disease, but to an instruction to not give it. For example:

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.

Slip op. at 8-9. The court rejected the patentees' argument that the above-quoted claim of the '741 patent was directed to a "protocol" for "selective administration" of iNO, with the new step of not giving the drug to infants with LVD:

Properly understood, 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.

Id. at 10.

The Federal Circuit distinguished the result of the discovery at issue here—which is to refrain from giving the drug to patients in whom it may do more harm than good—with other method-of-treatment claims that were held to pass muster under Section 101. Specifically, the court explained that in each of the Vanda and Endo cases, the focus of the claims was treating the patient by administering the drug at issue in a different way, which used the law of nature underlying the discoveries "to produce a change in the natural state of the patient to treat a condition." Slip op. at 13.

Similarly, the claims at issue in a case involving nutritional supplements required administering sufficient amounts of a particular compound that was said to promote the endogenous production of creatine, thereby improving the user's athletic performance. Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019). In that case, explained the INO Therapeutics opinion, "the claim used a particular dose of a substance to obtain a specific benefit by altering the subject's natural state."Slip op. at 14 (internal citation omitted).

Although not mentioned by the Federal Circuit, another way to understand the outcome here is to note the similarity between the claims at issue and claims of diagnostic patents held invalid under Section 101. Specifically, while the preamble of the exemplary claim of the '741 patent recited that it was drawn to a "method of treating patients," the discovery behind the claim was associating the presence of LVD with the undesirability of administering iNO, i.e., not administering the identified treatment. Despite the preamble, then, the claim can be characterized as a method of acting on a diagnosis. This is more apparent from the above-quoted claim of the '966 patent, which unlike the exemplary claim of the '741 patent did not even require the step, albeit the conventional step, of administering iNO to infants with breathing problems who were not also diagnosed with LVD.

Understood in this manner, the claims at issue here are not too different for Section 101 purposes from those held invalid in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, 915 F.3d 742 (Fed. Cir. 2019), which concerned a method of diagnosing certain neurological diseases by detecting in the blood specific antibodies associated with them. In that case, the Federal Circuit distinguished Vanda by noting that Vanda concerned claims to a method of treatment:

Claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself [Athena]. But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law [Vanda].

Athena, 915 F.3d at 752-53.

More simply, perhaps, the INO Therapeutics decision can also be understood as standing for the unremarkable proposition that applicants cannot rely merely on clever drafting—such as including the step of treating patients without LVD with the standard dose of iNO—to satisfy the demands of Section 101. Had the inventors' come up with an unconventional way of using iNO in patients with LVD, such as giving a reduced dose of iNO or coadministering it another drug that avoided the risk of pulmonary edema while preserving the benefits of iNO, claims directed to such methods would likely have fit comfortably within the Vanda/Endo line of cases holding that methods of treatment that change the body's natural state do not impermissibly claim a law of nature.

BioNews' PH Forum Fosters Community and Raises Awareness - Pulmonary Hypertension News

Posted: 04 Sep 2019 05:00 AM PDT

Online forums have markedly altered how patients, caregivers, and healthcare professionals communicate and connect. Even when miles apart, people can establish supportive relationships, share experiences and information, and sometimes simply vent.

BioNews Services, a leading online health, science, and research publication company, has been rolling out its own forums, including one for pulmonary hypertension (PH), a rare disease relating to the lungs. Moderated by patients and caregivers — nearly all of them BioNews columnists — the forums complement the company's news and information websites, such as Pulmonary Hypertension News.

It's that synergy of science and personal experience that sets BioNews' forums apart.

"Patient forums are certainly not a new concept, but BioNews has something unique to offer our communities," said Chris Comish, BioNews founder and CEO. "No other company has the ability to deliver such relevant content to our readers and use that as a starting point for driving conversation and discourse. We've had some really touching conversations occur, and have seen patients, particularly those newly diagnosed, find sources of hope and inspiration. It's touched everyone involved."

The company has introduced nine forums since last January — PH started last March — with more launching by year's end. The plan is eventually to have a forum, customized by moderators, for each of BioNews' 60-plus rare disease sites. In addition, BioNews is working to add multimedia to each forum, including podcasts and YouTube videos. Every forum requires registration and moderator approval, and offers features such as private messaging.

Join our PH forums: an online community especially for patients with Pulmonary Hypertension.

Within each forum are categories, known as subforums. In Awareness and Advocacy, for example, patients can discuss ways to raise visibility of the disorder, and how to advocate for themselves and others. Topics include educating others about PH and how to prepare for a care team appointment. Another subforum, Community Events, is a space for sharing upcoming conferences, support groups, and other events.

The subforum Dating and Relationships is for discussions related to intimacy, platonic or otherwise. For instance, there is a post about sharing living spaces with a chronically ill person, and online dating. Diagnosis Information and General Questions is for the newly diagnosed and their parents or caregivers. Members may ask and answer questions, and help one another through the first stage.

In the Diet and Nutrition subforum, patients can discuss healthful eating strategies and goals with peers, caregivers, and healthcare professionals. There are recipes and posts about, for example, body weight and image.

Exercising with PH is a platform for sharing fitness goals and challenges, particularly since disease symptoms can make exercise and routine tasks difficult. And in Mental Health, members can validate one another's bad times, and offer support and encouragement.

There is also a subforum about Lung Transplant, where people can learn more about the process, and connect with patients and caregivers who are experiencing it. Topics include post-transplant pain and debunking transplantation myths.

Oxygen Users is for those on supplemental oxygen. Participants in this subforum may ask questions and offer tips about living more comfortably and independently on oxygen.

The subforum Pediatric PH is a space where parents of children with pulmonary hypertension can discuss concerns, get answers, and share experiences such as living with PH and autism. Because PH is sometimes caused by a disorder, or can influence onset of another disease, the forum offers PH and Co-Existing Conditions, which includes topics such as living with PH and kidney disease.

There's also Side Effects and Symptoms, where patients can discuss conditions such as dehydration, blue feet, hair loss, and fatigue, as well as treatment side effects. There's a subforum on Treating PH, where members can discuss approved therapies such as Adempas (Riociguat) and Treprostinil (Tyvaso/Remodulin).

Though not possible for some, many PH patients are able to work. Working with PH is a space for sharing success stories and information about workplace accommodations.

In another subforum, Upcoming Procedures, patients can post supportive messages or give updates about surgeries.

Some forums also have offshoots — public and private groups. Pulmonary Hypertension has four: Teens and Young Adults with PH, Research and Development, PH Caregivers, Family Members & Spouses, and the private group Pulmonary Hypertension Patients.

To help generate conversation, moderators — at least two for each forum — regularly post topics within subforums. Sometimes the topic is based on a new column. Other times, it's something about day-to-day life. Moderators, including Brittany Foster, also post about their own lives, for instance sharing about movies they've seen or their vacation photos.

"It's been emotional to discuss my experiences with PH," said forum co-moderator Colleen Steele, whose son was misdiagnosed for two years but, at 14, is celebrating five years since undergoing a heart and double lung transplant. "But it's also been rewarding, especially when helping new patients."

The forums' framework was developed by Kevin Schaefer, with help from the social media team at BioNews. Schaefer is the company's community development manager, and an SMA forum moderator. He's excited about the forums, and their growth and potential.

"It's just really cool to see a community evolving in each of them," said Schaefer, who has SMA type 2. "They are as much about fostering community as they are about providing information. We want to do everything we can to engage with our members."

Author Details

Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d'Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled "Belle of the Concours."

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