Patents are among the most important assets that a technology company can have. Building a patent portfolio involves balancing competing demands. Technical development, cashflow management and attracting investment must all happen against a backdrop of unforgiving patent application deadlines. Getting it right can pave the way to commercial success; but getting it wrong can kill a business before it even starts. Of course, filing patent applications too late can be fatal. But there's also a risk of filing too soon; an applicant can be locked into a spiral of patent fees before it can afford the cost. Drawing on more than thirty years of experience in the IP field, Sean Cummings will help to navigate the patent maze. He will explain how the international patent system works and how to exploit the system to maximise options while minimising outlay. He will give tips for accelerating the process when granted patents are needed quickly and for slowing down the clock when cashflow is tight. And he will identify the ‘sweet spot' for assessing inventions and attracting investment in the early stages when patent costs are still modest.

Background

Vertebral body compression fractures (VCFs) impair quality of life (QOL) and increase patient morbidity and mortality. The international, multicentre, randomised, controlled Fracture Reduction Evaluation (FREE) trial was initiated to compare effectiveness and safety of Balloon kyphoplasty (BKP) to non-surgical management (NSM) for the treatment of acute painful VCFs. We describe the primary endpoint of the ongoing 2-year study.

Purpose: Balloon kyphoplasty (BKP) is a minimally invasive treatment for acute vertebral compression fractures (VCF) that aims both to correct associated vertebral deformity (reduce) and stabilize the fracture by injecting bone cement. We performed the first multicenter randomized trial to assess the effect of BKP.

Method: Patients with 1–3 non-traumatic vertebral compression fractures diagnosed within 3 months were randomly assigned to receive either BKP (N=149) or usual nonsurgical care (NSC) (N=151). Measurements of quality of life, back pain and function, days of disability and bed rest were assessed at baseline, 1, 3, 6 and 12 months.

Results: The primary outcome measure, the difference between groups in change from baseline scores in the physical component summary of the SF-36 questionnaire, improved 3.5 points (95% CI, 1.6 to 5.4; p=0.0004) more in the BKP group when averaged across 12 months of follow-up. Compared with the NSC group, those assigned to BKP also had greater improvement in quality of life and back function throughout 12 months of follow-up as measured by the EuroQol and Roland-Morris scales; a difference of 0.14 points (95% CI, 0.05 to 0.23; p=0.0023) more and 3.2 points (95% CI, 1.7 to 3.8; p< 0.0001) and reported fewer days of limited activity in the previous 2 weeks due to back pain (2.5 fewer days; 95% CI, 1.2 to 3.8; p=0.0001). New radiographically detected vertebral fractures occurred in 41.8% of subjects in the kyphoplasty and 37.8% in the nonsurgical group (4% difference; 95% CI −7.5 to 15.6; p=0.5).

Conclusion: Compared to nonsurgical treatment, balloon kyphoplasty improved multiple measurements of quality of life, back pain and disability that last at least one year after the procedure. No difference is seen between groups in radiographically detected VCF’s (Clinicaltrials.gov number, NCT00211211).