Trond Erik Vee Aune, C.E.O. of Vectron Biosolutions, explains in an article published last month in Pharma‘s Almanac how Vectron’s unique strain development processes can enable patenting of the resulting production strain. Fully owning the rights to their production strain results in added protection for thecustomer on several levels.

Several reasons to patent

A typical patent protects the newly created strain for 20 years. Whether it covers a strain enabling the production of a challenging protein or the achievement of high-titers for an easier protein, a patent would protect both the production process (e.g. the specific modalities of the vector) and the product itself when it has been uniquely engineered to fit in that process.

Another indirect advantage is that an additional patent for the production strain can extendmarket exclusivity for the customer’s proprietary product. This is especially valuable when the original patent of the product is due to expire in the near future.

Patenting possibilities

Because Vectron creates novel production strains specially fitted to each protein brought to us by our clients, it can be possible to protect the fruit of our efforts and innovations through patenting. This must be assessed at the beginning of each new project to ensure that the result of our work will respect the criteria to be eligible for patenting and to agree with the customer on the scope of a potential patent.

Such a patent covers the sequences of the specific expression vector and chromosomic alterations that are engineered by Vectron in order to produce the client’s protein at the documented quantity and quality. The objective is to protect the unique combination of changes designed and introduced by Vectron into the client’s production strain.

The patents offered by Vectron are narrow and cover solely the specific aspects of the strains related to the protein being produced for the customer. Nevertheless, they represent an additional layer of intellectual property protection that most of our competitors, relying on pre-defined, limited sets of vectors, cannot offer.

Patenting biological features

Patenting the living and all that is related to biology in general is strictly regulated. What makes it possible in the projects with Vectron Biosolutions is the design, implementation and use of unique solutions, combined in a highly specific and original way.

Our three technologies, VB Expression, Evolution and Secretion, comprise the most sophisticated technology platform for the production of proteins in E.coli and each can result in the creation of a patentable production strain. The more unique alterations are made, the stronger the patent will be.

VB Expression takes advantage of the positively regulated XylS/Pm system, induced by inexpensive benzoic acid that can enter the cell without active transport. Through the years, Vectron has built large libraries for eachkey-feature in protein expression and production, such has copy number regulators, signal peptides, promoter strengths, … The wide variety of elements to choose from makes it possible to build uniquely tailored vectors for each protein. The final combination is expertly fine-tuned to give the best results, resulting in a potentially patentable production vector.

VB Evolution mimics the natural evolution process. Vectron introduces a defined number of random point mutations into a selected production strain, thereby creating a library of several millions mutated vectors. The ultra-high-throughput screening method that we implemented then enables us to select within a couple of days a few of these newly created vectors for their enhanced production of the target protein. Because these mutations occur in a unique pattern, the chosen production vector can be a candidate for patenting.

VB Secretion aims at producing the target protein directly in the medium, in order to facilitate its purification. Originally developed by Pr. K. Hughes (University of Utah) and T3S Technologies for Salmonella, Vectron has since then transferred the technology to E. coli and is currently working on increasing the secretion rate and ensuring that the solution is versatile enough to accommodate most proteins. This highly innovative challenge has brought to us to understand with evermore depths the complexity of the secretion process in this system, which will in the future enable us to tailor to some extent our secretion solution to each specific protein. The final vector as well as the bacterial chromosome are specifically engineered in each project and can therefore be protected by a patent.

In brief, in addition to an exclusive license agreement, Vectron’s clients could soon also have their own proprietary production strain. Any exclusively developed solution by Vectron for our clients can, in theory, be patented.

Read the original article on Pharma’s Almanac here.