Introduction

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the U.S. Food and Drug Administration (the FDA) include therapeutics, cosmetics, and foods. Each category of product is regulated by the FDA, but at different levels of oversight.

Food is a broad category that encompasses traditional foods (e.g., yogurt), dietary supplements, and medical foods. While traditional foods (yogurt) and dietary supplements that contain microbes have broad public awareness, an underappreciated and potential area for growth is the medical food market.

Medical Foods

In the U.S., medical foods are those foods which meet the following requirements:

1. Specifically formulated and processed, as medical foods are not a naturally occurring food used in its natural state;
2. Intended:
   1. to be consumed or administered enterally—e.g., by oral intake or through a feeding tube (a topical formulation is not a medical food);
   2. for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by a medical evaluation;
3. Consumed by or administered to a patient:
   1. under physician supervision;
   2. receiving active and ongoing medical care; and
4. Provides unique nutritional support specifically for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation.

As stated in the FDA's 2016 guidance, the FDA "considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food …" This is because, as described above, medical foods are specially formulated and processed, to be used under the supervision of a physician, and are intended for a patient who "requires use of the product as a major component of a disease or condition's specific dietary management."

Medical Food Claims and Scientific Substantiation

It is worth pointing out that a medical food may, but need not be, formulated in a capsule or tablet, or otherwise appear to be in the form of a medicine. Also, per the FDA's 2016 guidance, medical foods may not bear the symbol "Rx only"—which is reserved for prescription drugs. However, the FDA indicates it will not object to the use of language used to communicate the requirement that the medical food "must be used under the supervision of a physician."

Importantly, unlike traditional foods, health claims can be made for a medical food without prior FDA review or approval. Such claims can include therapeutic nutritional management for a medical condition. These health claims, also referred to as "disease management" claims, must be truthful and non-misleading. Furthermore, health claims for a medical food must be scientifically substantiated, and a company planning to market a medical food must initially determine how it will substantiate its health claim(s). Expert opinion alone is less likely to meet the substantiation requirement. On the other hand, prospective, randomized, placebo-controlled clinical trial(s) using the medical food—as it is intended to be marketed—could meet the substantiation requirement. Some have suggested that meta-analyses and systematic reviews of "high quality" clinical trial results may also suffice.

Pulmocare® is an example of a commercially available medical food. The indication for Pulmocare reads as follows: "PULMOCARE is designed for people with chronic obstructive pulmonary disease (COPD), cystic fibrosis, or respiratory failure who may benefit from a high-calorie, modified carbohydrate and fat enteral formula that may help reduce diet-induced carbon dioxide production. For tube or oral feeding. For supplemental or sole-source nutrition. Use under medical supervision."

It is instructive to compare the Pulmocare indication for use with an approved drug intended to treat the same disease—in this case the drug Symbicort®: "SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: Treatment of asthma in patients 6 years of age and older. Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. Important limitations: Not indicated for the relief of acute bronchospasm."

Symbicort is specifically indicated for "maintenance treatment of airflow obstruction" and further specifies the indicated patent population—"patients with chronic obstructive pulmonary disease including chronic bronchitis and emphysema." The drug claim is a treatment claim, and names specific patient populations to be treated.

In contrast, Pulmocare (a medical food) is intended for "people with chronic obstructive pulmonary disease (COPD), cystic fibrosis, or respiratory failure," the same medical condition and patient population indicated for Symbicort. The medical food claim also recites: "Use under medical supervision."

Other Medical Food Requirements

Medical foods have labeling requirements that arise under the Federal Food Drug & Cosmetic Act and the Fair Packaging and Labeling Act of 1966. Additionally, medical foods must contain ingredients that are Generally Recognized as Safe (GRAS), or be approved as food additives that are the subject of exemptions for investigational use. Medical foods must also comply with Current Good Manufacturing Practices, or CGMPs.

Individual medical food products need not be registered with the FDA. However. manufacturing facilities, processing facilities, and packing and holding facilities involved in making and supplying medical foods must register with the FDA. Medical foods are "reportable food," that can be subject of Class I recalls. The FDA has a compliance program for medical foods. And, adverse event reporting associated with medical foods is voluntary.

Patenting

Because medical foods are not approved or licensed by the FDA, medical foods are not entitled to FDA market exclusivities. Thus, patents are the primary mechanism for preserving medical food market exclusivity. In light of the ongoing evolution of patent subject matter eligibility law, and that medical foods may contain products found in nature, special consideration should be given to generating patentable, commercially valuable claims that will robustly protect a medical food franchise.

Commercial Potential

The medical food market is projected to reach $29.54 billion by 2026. And the microbiome market, which may include medical foods, is projected to reach $1.73 billion by 2027. There is significant commercial potential for medical foods, including those containing microbes.

Conclusion

Microbes, and the microbiome, are taking on increasing importance as ingredients in dietary supplements, cosmetics, and therapeutics. An area that is receiving increased interest is the use of microbes in medical foods. Medical foods offer an attractive and fast pathway to market, allow for drug-like claims without prior FDA review and approval, and may also result in broader product market uptake than, for example, a pharmaceutical. Patents are central to building a commercially viable and robust medical food franchise.

For questions regarding medical foods, or any patent or FDA related question, please contact Vern Norviel, Matthew Bresnahan, David Hoffmeister, Georgia Ravitz, James Ravitz, or any member of the Patents and Innovation Strategies or FDA Regulatory, Healthcare and Consumer Products Compliance practices.

Charles Andres contributed to the preparation of this WSGR alert.