[guest authors: Jessica Miles* and Anthony D. Sabatelli** ]

The gut microbiome, a collection of microbes living in the gastrointestinal tract, has emerged as an attractive target for pharmaceutical intervention for the treatment of a variety of disorders.  This is the fifth article in a series on advancements in microbiome research and development.  This installment will summarize issued U.S. microbiome-based patents that describe therapies relating to obesity and other metabolic disorders.  It is a follow-up to the fourth part of the series, which reviewed important research and development in this subject area.  The patents reviewed herein are neatly summarized in the table at the end of this installment.  Upcoming articles will continue to review important topics in this technology area, and patents of interest.

The diet and nutrition industry is big business: the industry brings in over $60 billion dollars from the nation's 100 million-plus dieters.  Yet, years of R&D have failed to produce a blockbuster weight loss drug.  Clearly, there is a big incentive to develop new and effective therapies for this area, particularly considering the risks and adverse events that have plagued previous prescription therapies, and companies are looking to the untapped potential of the microbiome for an elusive wonder drug.

The earliest patents issued relating to obesity and the microbiome describe formulations of lactic acid bacteria used to prevent weight gain.  Patent activity in this area started a few years ago with a series of patents obtained by Nestec S.A.  Recently dubbed "Pharma's newest nemesis" for its efforts to create pharmaceutical food products, the four-year-old research and development subsidiary of Nestlé has Patent Nos. 8,318,150; 8,318,151; 8,440,178; 8,454,949; and 8,591,880.  The '150 and '151 patents describe the use of two strains of the same probiotic species, Lactobacillus rhamnosus, for weight loss and treatment of metabolic disorders.  Patent No. 8,440,178 describes the use of two additional L. rhamnosus strains, while Patent No. 8,454,949 relates to the use of a similar probiotic species, L. helveticus.  Patent No. 8,591,880 describes a composition of L. rhamnosus to modulate a patient's microbiome.

After growing steadily, the number of patents granted in this field peaked in 2015.  Patent No. 8,986,675 was issued to Jinis Biopharmaceuticals, a South Korean clinical and commercial life sciences manufacturer for an invention comprising mutagenized L. acidophilus strains.  Later that year, Nestec S.A. obtained another patent (Patent No. 9,101,651) for the use of probiotic L. rhamnosus strains for weight management.  Patent No. 9,113,641 relates to a composition of L. paracasei and a milk product used to regulate fat uptake.  The patent was granted to Arla Foods amba, the largest producer of dairy products in Scandanavia, and Sven Pettersson, a renowned microbiome researcher at Sweden's Karolinska Institute, is one of its listed inventors.

Recently issued patents have focused on modulating the microbiome to diagnose and ameliorate obesity and other metabolic disorders.  MicroBiome Therapeutics LLC obtained Patent No. 9,040,101, which was mentioned in the second installment of this series, which describes a drug being evaluated in clinical trials for the treatment of diarrhea in patients taking metformin, a treatment for type II diabetes.  Patent No. 9,168,233 relates to the inhibition of Trimethylamine (TMA) N-oxide (TMAO), a product of the gut microbiome that is associated with atherosclerosis.  Patent No. 9,173,910, whose inventors include Peter Turnbaugh, relates to the use of bacteria of the phyla Verrucomicrobia to modulate the microbiome for the treatment of a suite of metabolic disorders, including obesity and diabetes.  Seres Therapeutics, which is still riding high on its widely-publicized 2015 IPO, was granted Patent No. 9,180,147, which describes a composition of bacterial spores and probiotic strains as a therapy for metabolic disorders and other diseases.  Patent No. 9,201,064 relates to the use of two microbial metabolites -- phenylacetylglutamine (PAG) and p-cresol sulphate -- as biomarkers in aging adults.

Closing

2015 was the best year yet for patent activity in microbiomics and obesity, with higher numbers and diverse technologies represented among the patent grantees.  These signs indicate that the field will see continued growth and increased commercialization activity in 2016.  However, securing patent protection has become more complicated in the aftermath of the Supreme Court's infamous Mayo and Alice decisions defining more stringent criteria for patent subject matter eligibility under 35 U.S.C. § 101.  Microbiomics inventions, which often utilize living bacteria and other natural products, will be vulnerable to such 101 rejections, and already-issued patents could also be vulnerable in post grant proceedings.  Careful, thoughtful, and creative patent drafting and prosecution will be vital for protecting on-going innovation in this area.

Table 1: Selected Patents in Microbiomics Relating to Obesity and Metabolic Disorders (click on table to expand)

* Jessica Miles is a Technology Specialist at Dilworth IP
** Dr. Sabatelli is a Partner with Dilworth IP

For additional information regarding this topic, please see:

• "The Emergent Microbiome: A Revolution for the Life Sciences – Part IV, Obesity and other Metabolic Disorders," February 18, 2016
• "Jackson Laboratory Hosts Microbiome Symposium Related to Cancer and Immunology," January 19, 2016
• "Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part III, Psychobiotics," October 13, 2015
• "Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part II, 2015 Patent Trends," August 11, 2015
• "Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders," August 10, 2015