The world of biomaterials science is gathering pace as some of the early research work into new materials for use in biomedical applications that has been undertaken over the past decade or so comes to fruition. There is also some excitement surrounding potential new methods of using biomaterials involving the use of 3D printing. However, this area of research is notoriously challenging and potentially costly, not least because of the requirement to obtain regulatory approval for any material that is going to be used in a biological or medical application. In this tightly-controlled area of research science, there is always the risk that a new biomaterial might prove itself during initial research, only to fall at one of the clinical trials hurdles.
Among the factors driving interest in biomaterials science is the potentially rich rewards available for inventions that make it to market, helping to solve long-standing medical problems for potentially large numbers of people. There are also many more Universities in the UK offering degrees in biomaterials science today compared to 20 years ago, some of which have become hotbeds of technology transfer and spawned some successful spin-outs. Obtaining patent protection for inventions in this sector helps businesses protect their significant investment in research, development and clinical testing work.
One such spin-out from Oxford University is Orthox Ltd., the company behind the discovery of a recently-patented biomaterial called FibroFix, which can be used for orthopaedic applications. The company’s scientists have found a way of taking a naturally-occurring component of silk known as fibroin and spinning it in the same way as a spider spins its web. In doing so, a material with exceptional strength and resilience is created, which can then be processed to produce something akin to human cartilage. The company already has a number of published patent applications in place to protecting its innovation, including patent applications relating to the preparation of regenerated fibroin solution to enable the production of the material in sufficient quantities for use in medical applications. Orthox have also filed patent applications directed to implantable devices made from silk fibroin. Confident of significant demand for its inventions based on forecasts that demand for knee replacements in the US is expected to increase fivefold by 2030, the company is soon to embark on a series of clinical trials.
This is a classic example of biomaterials research science in action and is indicative of some of the quality innovations now nearing market readiness. To reach this stage, it is likely that the innovator will have filed a number of patent applications during the incubation phase, giving them a minimum 18 months’ leeway for development work before publication of the patent applications and the opportunity for rivals to encroach on their work.
Another biomaterial that is gaining traction in the medical arena currently is Cerament, developed by Bone Support AG, which is involved in the production and marketing of injectable bone substitutes. Cerament G, a product containing the company’s patented Cerament technology, aids the sustained release of antibiotics, helping to manage infection and support bone healing. This product has successfully crossed the regulatory hurdles and boasts that it is the first CE-marked injectable ceramic bone graft substitute.
The fact that new technologies now exist, which are capable of facilitating the application of biomaterials is driving interest among research scientists and investors. For example, 3D printing technology has recently been used to produce personalized implants from a synthetic biomaterial to treat young patients with tracheobronchomalacia, an incurable disorder that causes the airway to collapse. The implant is designed to expand as the child grows and the printed splints are made from polycaprolactone, a polymer that harmlessly dissolves in the body. While these personalized implants are still regarded as high-risk and they have not yet received US regulatory approval, the science has attracted a significant amount of public interest and we might assume that bringing this to market will only be a question of time.
While the hurdles to achieving regulatory approval are considerable, the current interest in biomaterials science is set to continue and opportunities for research-led companies abound in the UK and around the world. To make the most of any opportunities, however, research scientists need to protect their innovation every step of the way.
Ben Dempster and Jennifer Unsworth are patent attorneys and materials science specialists at Withers & Rogers, a leading intellectual property firm.