Microbiome and IP Issues in the Microbiome

Not All Types of IP Are Created Equal When It Comes to Patent Protection

Protecting intellectual property (IP) is a priority for companies in the life sciences industry due to the significant revenue potential. But not all types of IP are created equal when it comes to patent protection. To be patentable, a product must meet certain criteria, including being novel (not already in existence). When it comes to substances that occur in nature, the requirement to be a novel invention can create complications.

But as a naturally-occurring substance, microbiomes are difficult to patent. As such, companies conducting microbiome research are having to get creative.

What Are Microbiomes?

Microbiomes are essentially communities of bacteria, viruses, and fungi with a greater complexity than the human genome itself. We know that microbes help us make cheese, yogurts, and breads. We know there are good bugs in our guts. Research has shown that we can actually improve our health if we “help” these good bugs function as effectively as possible. Health science companies are discovering how to patent formulas that create the environments needed to foster the right microbes. Dietary supplement companies can market microbes as probiotics but cannot make therapeutic health claims.

In recent years there has been an increase in our understanding of the human microbiome. Researchers have found there is an estimated 100 trillion microbes, weighing more than 2 kg, and most of them live in our gut. Interest has spiked just as much as understanding because the microbiome represents a new frontier in health and disease. In addition to the potential to help a lot of people improve their overall health and wellbeing, microbiomes also have the potential to generate substantial revenue for drug companies. The human microbiome market can be broadly segmented by application into therapeutics (including therapeutic and medical foods) and diagnostics, which the therapeutics market is by far the dominant application.

Disruptions in the human microbiome can produce inflammation, release toxic substances, create immune system problems, and other diseases. Some health problems in the GI tract, dental caries, and bacterial vaginosis can be treated with microbiome therapies.

Selective Therapeutic Areas of Research

Researchers are conducting microbiome experiments in different areas. These areas include animal health, sustainable crops & farming, livestock productivity, and of course human health. Some companies will focus on how to stimulate the good bugs to increase their effect by, for example, stimulating release of therapeutically effective agents. Some research how to do good bug transplants from healthy people into sick people hoping that the transplant will be therapeutic. Others are using new genetically modified microbiome to produce proteins to combat toxins or destroy bad enzymes released by the unhealthy bugs. A major focus is on engineering the microbiome to produce anti-inflammatory agents because inflammation is thought to cause many cancers.

IP Issues in the Microbiome

Microbiome inventions present a unique challenge for patentability. Whether or not they are eligible for patent protection is not entirely clear. The laws around patent subject matter eligibility are constantly evolving, and this is one of the grey areas.

Furthermore, due to their inherent complexity and the lack of historic research, microbiome patentability requires different considerations than are typical with traditional pharmaceuticals.

To be patentable, an invention must be:

  • Useful—It must possess a function that meets a specific need.
  • Novel—It cannot already exist, at least not in the public sphere.
  • Non-obvious—It must not be entirely derived from an existing teaching or product.

Notwithstanding the potential patent issues related to the microbiome, companies are obtaining patent protection on various aspects of the microbiome. For example, we see issued patents related to:

  • A method of treating pediatric autoimmune disorders by using Streptococcus oralis 89a
  • A method of weight loss by using Lactobacillus rhamnosus CNCM I-4096
  • A method of treating certain diseases by using a purified mixture of certain bacterial strains
  • A method treating GI disease by using a population of germinable bacterial spores and where the spores germinate certain bacteria that have RNA corresponding to certain nucleic acid sequences
  • A method of treating pregnant women by exposing pregnant women to certain bovine manure compositions that contain certain bacterial strains [in other words, expose pregnant women over the pregnancy to farm manure so that the baby has better immunities]

Alternatives to Traditional Patent Protection

In an effort to continue researching and patenting microbiome products, drug companies and life science companies are engaging in creative alternatives to the patent process.

  • Non-natural section—Companies are creating formulae that combine naturally-occurring microbes with synthetic microbes, and/or bacteria with which don’t normally mix. They are also creating microbe-based formulas using methods that do not occur in nature.
  • Keeping it secret—Some drug manufacturers are opting to not include certain aspects of their microbiome research process in patent filings.
  • Protecting the application process—Instead of protecting the microbes themselves, some drug companies are patenting certain aspects of their research. This method is often seen when patent protection is sought in gene therapies.

Contact Upadhye Tang LLP Today

At Upadhye Tang LLP, we are focused on developing IP protection strategies for companies involved in human health and wellbeing, animal health, plants, and agriculture. We will help you determine if your invention is patentable and discuss alternative methods of protection if complications exist. Our experienced IP lawyers will utilize our deep network of industry contacts to ensure that any legal strategy aligns with your goals and objectives.

Contact Shashank Upadhye at 312-327-3326 or shashank@ipfdalaw.com for more information or visit our website at www.ipfdalaw.com.

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