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27 October 2022FeaturesBiotechnologyRosie McDowell

Patenting livestock microbiome tech: trends and takeaways

Attempts at reducing antibiotic use in livestock farming have driven an increase in inventive activity in the microbiome technology space over the past decade.

This involves the modulation of the animal’s microbiome to prevent bacterial infection, reducing the need for antibiotics and increasing welfare standards as well as product yield.

Patent landscape summary

In areas of growing innovation, we expect to see an increase in patent filing activity. So, to explore patent filing trends in this space, we searched applications filed between 2011 and 2021, having claims directed to the manipulation of the livestock microbiome, and analysed the results using Patently.

Filing activity seems to have peaked globally in 2017, but has since been in decline; although filing activity at the European Patent Office has remained stable since 2018.

The majority of recent filings globally have been made in China; although looking back to rights from similar applicants which were published three to five years ago, few of these gave rise to subsequent international applications.

Therefore, it would be fair to predict that many of the resulting monopolies from these rights will also be specific to China. For applicants in Europe, such applications represent a significant body of prior art, which could be relevant to patentability. Conscientious applicants in Europe and elsewhere would do well to perform additional prior art searching of Chinese language publications.

Outside of China, the most prominent owner of patent rights in this category is Novozymes,  a biotech headquartered in Denmark, which holds a diverse portfolio directed to probiotic animal feeds; and a range of antibiotic alternatives. These include Bacillus strains, which have activity against Lawsonia intracellularis infection (WO2019152791); methods of decreasing pathogenic bacteria in poultry hatcheries using Bacillus and Lactobacillus strains (WO2017132230); and methods of treating salmonella in chickens with B. Subtilis (WO2021055474).

Bar chart prepared using Patently

Patenting livestock microbiome technologies at the EPO

Many technologies in this space are readily patentable in Europe; examples of the type of subject matter we see being awarded patent protection are:

  • New isolated microorganisms or compositions of microorganisms
  • Probiotics for use in treating or preventing infections
  • Methods of increasing product yield using probiotics
  • Animal feeds containing pre- or pro- biotics
  • Methods of culturing or preserving microorganisms
  • Microbiome swab test kits for agricultural use

Relevant to microbiome innovators, there are some special requirements for patentability at the EPO that applicants should be aware of, and which are summarised below.

Veterinary therapeutic and diagnostic methods

In Europe, methods of treating animals (or humans) and diagnostic methods performed on the animal’s body are excluded from patentability.

This exclusion avoids obstructing the work of vets and medical practitioners. In practice, there will usually be subject matter in a therapy invention which is patentable. For example, it is possible to protect a probiotic for use in treatment (a so-called EPC2000 medical use claim), which protects the product itself, when marketed or intended for the claimed use rather than the steps performed by the vet or agricultural worker.

Further, a new therapeutic use for a known probiotic could be patentable; this is known as a ‘second medical use claim’.  An example of what such a claim might look like is found in DuPont Nutrition Biosci APS EP application EP 3762000 (below), which states that:

“A composition for preventing and/or treating an E. coli-based infection in an animal wherein said composition a Bacillus- ased direct-fed microbial component comprising Bacillus subtilis strain 3BP5 (NRRL B-50510); Bacillus amyloliquefaciens strains 918 (NRRL B-50508), and 15AP4 (PTA-6507) either alone or in combination with a culture supernatant derived from these strains.”

It is also worth noting that methods of increasing livestock output using probiotics could potentially be caught by the method of treatment exclusion; for example, if the increase in output could arise due to suppression of some pathogenic process.

It is worth considering if this could be the case, and as a precaution including language which frames the invention in terms of a product-for-use format.

In Europe, probiotics for use in the treatment of livestock are held to the same standards of evidence as any other pharmaceutical product, and the EPO increasingly requires evidence that a technical effect is plausible for uses which fall within the scope of protection.

This requirement means that if a probiotic can be used to treat a range of animals or infections, but the application only renders certain uses credible, the EPO may require that the protection is limited to only certain conditions.

Innovators are encouraged to test their products widely and, where possible, arm themselves with a range of examples showing improvement of a variety of conditions or a mechanistic connection between the conditions before filing a patent application.

Filing microorganism deposit receipts

If a new useful microbial strain has been discovered it will always be desirable to protect that strain in its own right or as part of a composition, and not only in the context of an agricultural treatment.  An example of what such a claim might look like is found in Novozymes EP application EP3745876 A1 (below), which states that:

“A composition comprising one or more Bacillus strains and calcium carbonate, wherein the Bacillus strains are selected from the group consisting of:

Bacillus licheniformis strain O42AH3 having deposit accession number DSM 32559 or a strain having all the identifying characteristics of Bacillus licheniformis strain DSM 32559, Bacillus subtilis strain O52Y J6 having deposit accession number DSM 32560 or a strain having all the identifying characteristics of Bacillus subtilis strain DSM 32560, Bacillus amyloliquefaciens strain O52YYT having deposit accession number DSM 32561 or a strain having all the identifying characteristics of Bacillus amyloliquefaciens strain DSM 32561, Bacillus pumilus strain O72NR7 having deposit accession number DSM 32563 or a strain having all the identifying characteristics of Bacillus pumilus strain DSM 32563, and any combination thereof.”

Patents relying on new strains or combinations of strains need to include a microorganism deposit receipt at the priority date; when relying on a specific strain for patentability, a key consideration in Europe is that a sample of the strain is deposited at a deposit institute in accordance with the rules of the ‘ Budapest Treaty’.

In the above claim, the strains deposit numbers are prefixed by ‘DSM’ indicating they were deposited in the DSMZ-German Collection of Microorganisms and Cell Cultures GmbH; although a deposit institute will be available in most countries. A list of Institutes and their requirements can be found at  here.

Importantly, there are specific requirements which must be met in Europe by the date 16-months from the earliest filing, and failure to take these actions cannot be remedied upon entry into the European regional phase.

Therefore, non-EU applicants who will eventually seek protection in Europe, should obtain the advice of a European patent attorney, or ensure that their patent attorney/agent is aware of and can attend to the European requirements, to avoid refusal of the European application under Article 83 EPC (Sufficiency). A.83 EPC requires that a skilled person is able to perform the invention, and for inventions dependent on a particular strain, this is dependent on the ability to obtain the strain from a public source.

Microbiome inventions including algorithms

If the invention relies on a new algorithm for inventive step, such as in the processing of samples to optimise livestock diet or supplementation protocols; care needs to be taken to ensure that the application includes inventive features which have technical character.

If the new aspect of the invention comes down to the algorithm which is used to select a diet or supplementation protocol, some patent offices may consider that this is not sufficiently ‘technical’.  For such an invention it is important to identify if there are inventive features which are technical in nature; for example, if there is anything remarkable about the kit used to collect the sample, or if parts of the assay machinery, eg, cartridges have been adapted for agricultural use.

Rosie McDowell is a UK and European patent attorney at EIP. She can be contacted at: rmcdowell@eip.com


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More on this story

Biotechnology
23 August 2022   Protecting new and inventive innovations in this increasingly crowded area is essential, explains Ine Vanderleyden of Mewburn Ellis.
Big Pharma
11 May 2020   IP firm HGF has appointed two patent attorneys to partner, increasing the partner group to 63 partners.