BONESUPPORT: Products for the medical device industry require a focused patent strategy

The Swedish orthobiologics company BONESUPPORT AB is developing synthetic bone graft substitutes, that are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Depending on regulatory constraints, newness and innovation, the products may have a long path to the market. Orthobiologics is a crowded market, with lots of prior art, which makes it challenging to get patent protection.

Usually, your body can heal a bone void or defect, but in some circumstances it cannot, for example if the void or defect is too large, or if there is an underlying disease that reduces bone healing. This is where BONESUPPORTs CERAMENT® products can help. The CERAMENT family of products are ceramic bone substitutes that promote bone healing.

CERAMENT has a powder component which consists of calcium sulfate and hydroxyapatite, that is mixed with a liquid to form an injectable paste. This paste is injected into a bone void or defect during surgery. BONESUPPORT has obtained patents on both the CERAMENT composition and kit components, for example the combined mixing-injection syringe that ensures a homogenous mix every time.

All of the CERAMENT products are designed to resorb and be replaced by new bone over 6-12 months, and two products contain antibiotics, which elute to protect bone healing in cases where there is a risk of, or confirmed infection.

On behalf of BONESUPPORT, Guardian IP Consulting has written and filed patent applications in several parts of the world, and especially in the European and American markets, BONESUPPORTs products are in use among orthopedic surgeons in the healthcare sector.

– This kind of product must be approved by various regulatory authorities and as it can be difficult to get it approved as a combined medical device – drug (for the products where antibiotic is included), it is not always necessary to have many patent families for products like this, says Lars Pallisgaard Olsen, European Patent Attorney, and partner at Guardian IP Consulting and continues:

– It is an advantage to have a few strong patents to defend while increasing market share. The patent costs in a company like BONESUPPORT need to reflect the products on the market and in the pipeline.

At BONESUPPORT, which is based at Ideon Science Park in Lund, research manager Eva Lidén agrees:

– We try to have as broad patents as possible, but sometimes we must choose what to include because it is not always possible to have patent claims as broad as we wish. It differs between Europe and US what you can patent. A broad strong patent also gives us more freedom to operate and invent modifications and to focus on this one product, while continuing to make improvements, which may be the subject of a new patent.

Eva Lidén, research manager

High professional knowledge is essential in a resource-intensive development area

The development of the BONESUPPORT CERAMENT® product family has taken many years and the company has invested in clinical studies and health economic evidence to get the products approved in different markets. This process is extensive and requires competences and resources and therefore it is important that BONESUPPORT can both attract investors and keep competitors at a distance.

– We operate in an area where there are many players and a risk of being copied. It is not easy to find the areas where you can obtain a patent, but we have done so, thanks to Guardian, says Eva Lidén and highlights Guardian IP Consulting’s professional knowledge as an advantage of the collaboration:

– We have a close collaboration with Guardian, and they handle our applications, monitoring and everything else we need. This requires deep knowledge within chemistry, and I really appreciate that Lars has broad competencies in this challenging area and quickly understands our scope.

In addition to the many requirements and clinical studies that BONESUPPORT’s products must go through, the products´ success also revolves around the company´s abilities on the market within the hospital world.

– The hospital sector is mainly public in Europe, but in other parts of the world the private sector dominates, so it is important that BONESUPPORT is aware of what is in demand amongst orthopedic surgeons, so they can adapt their development and thus also their patent strategy accordingly, says Lars Pallisgaard Olsen.

This means that BONESUPPORT regularly assesses its patent portfolio and competitors´ activities and focuses on the patents that create commercial value and therefore the company continuously adjusts its IP strategy.

Read more: Do you need a patent strategy?

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