This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
Last week I wrote here about renewed interest in natural products, spurring development of novel antibiotics, cancer and diabetes therapies inspired by environmental biomes. In tandem, scientists have gained insights into important health benefits of microscopic human flora known as the microbiome. These bacterial biofilms in and even around the human body may prove extraordinarily important to development of novel diagnostics and therapies.
In 2008, the U.S. National Institute of Health (NIH) launched the Human Microbiome Project to characterize microbial species, analyze the role of biofilms, and encourage translational research. Other public and privately funded research estimated at over $500 million over the last decade improved basic understanding of the importance of the microbiome for human health. In fact, we are just beginning to get to know our own microbes – we have studied only a small percentage of the millions of non-human genes.
What have we learned so far? We are outnumbered – each of us hosts 100 trillion bacterial, fungal or otherwise non-human cells, as compared to an estimated 30 trillion human cells. Due to their small size biofilms represent only 1 – 3% of body mass. (So no, your microbes are not making you look fat, though lack of intestinal bacterial diversity may contribute to weight gain.)
These microbial fellow-travelers lost their ability to live outside of the human body somewhere along the line, much to our benefit. Intestinal bacteria, for example: “help us harness energy and nutrients from our food,” make large amounts of vitamins, regulate our insulin levels, boost our immune systems, and supply substances that help us fight stress and anxiety. And they selfishly help us fight off uninvited, disease-causing microbes. In the words of Stanford University microbiologist Justin Sonnenburg, “[T]he microbiome is little drug factory,” – albeit one that needing substantial commercial investment.
Large and small companies alike are investing in ongoing R&D to translate what we have learned into useful products, based on the expectation of patent exclusivity to ensure return on investment.
For example, Pfizer partnered with start-up Second Genome in mid-2004 on a major observational study of the role of bacterial biofilms in metabolic disorders. This year Nestle Health Sciences invested $65 Million in the US-based start-up Seres on new approaches to restore healthy gut bacteria. (In June, Seres Therapeutics became the first microbiomics company to go public, with a $134 million IPO.) MicroBiome Therapeutics is also developing pharmaceutical products to enhance diversity of GI bacteria, reporting data for microbiome modulators with clinical effectiveness against metabolic disease.
Now bacterial oncology peptides are also coming on line. As noted by biotech pioneer Ananda M. Chakrbarty, Ph.D., we have a great deal to learn from “bacteria with 3 billion years of evolutionary wisdom … to keep cancers in check.” (Full disclosure – I co-founded Amrita Therapeutics with Ananda Chakrabarty to commercialize novel bacterial peptides with p53 tumor suppressor and anti-metastatic properties.) Cancer immunotherapy provides yet another compelling example of how bacteria may jumpstart the patient’s immune system. Nearly 150 years ago, physicians observed that acute bacterial infections could shrink cancer tumors, often contributing to complete remission. The recent resurgence of interest in modern immunotherapies has created important new approaches to cancer treatment, using modified bacteria and bacterial products to cure cancer.
Unfortunately this ongoing innovative research now may be undercut by new hurdles to patentability of microbiomics. Over the last two years, the US PTO has rejected patent applications for technologies including new microbial genes, bacterial enzymes, and fermentation products, among others. These heightened non-statutory hurdles to patentability for microbiomic inventions are upending reasonable expectations around patentability of novel life forms. Start-up companies have long understood that they won’t be able to attract capital without effective patent protection; nor will large companies continue to invest in R&D in the absence of exclusivity. Now more than ever, full patentability of novel bacteria / life forms is essential to deliver on the promise of the microbiome for translation of basic science into real-life solutions for human health.
About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues in the US and globally. She also is CEO and Managing Director of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India commercializing oncology peptides. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.
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