Industry Insight. Obesity Treatment using. Neurostimulation. Technology Evolution & Patent Landscape. Deeper Insight.

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1 Industry Insight Obesity Treatment using Neurostimulation Technology Evolution & Patent Landscape R Deeper Insight. Better Outcomes

2 Introduction Neurostimulation for Obesity Treatment The incidence of obesity has more than doubled in the last 5 years, now affecting around % of adult population in the United States according to the Centers for Disease Control & Prevention (CDC). The The concept of neurostimulation to affect functioning of organs has been extensively used in medical practice to treat various disorders such as Parkinson's disease, multiple sclerosis, epilepsy, chronic pain, etc. World Health Organization (WHO) predicts that obesity may soon replace more traditional public health concerns such as under-nutrition and infectious diseases, as the most significant cause of poor health. The healthcare cost of obesity in the United States (US) The use of neurostimulation for obesity treatment was first suggested in the early 990s. Ever since, there has been a steady growth in Intellectual Property investments in this domain, especially in the US (Figure). is estimated to be $47 billion annually (equivalent to 9.% of total medical spending) []. The principal treatments currently available for obesity include diet modification and exercise, pharmaceutical therapies and surgical procedures like gastric bypass and vertical banded gastroplasty. Besides these, the industry has witnessed a flurry of activities around the idea of using neurostimulation for treatment of obesity. The market size for treatments related to obesity is also expected to grow significantly over the next decade Number of patent applications Year Figure : Patent filing trend in the US (Figure ). $ 7000 $ 6000 $ 5000 Obesity Pharmaceutical Sales ($millions) Bariatric Surgical Device Sales ($millions) The key players in this field include: Medtronics Inc Cyberonics Inc Advanced Neuromodulation Systems (now a part of St. Jude Medical) $ millions $ 4000 $ 000 $ 000 Biocontrol Medical Ltd Leptos Biomedical Inc Enteromedics $ 000 $ Year Figure : Bariatric Surgical Devices and Pharmaceuticals in Obesity, Worldwide Sales [] [] Annual Medical Spending Attributable To Obesity: Payer-And Service-Specific Estimates by Eric A. Finkelstein, Justin G. Trogdon, Joel W. Cohen and William Dietz. Health Affairs, 8, no. 5 (009):w8-w8 [] Medmarket Diligence Report #S85 Worldwide Market for the Clinical Management of Obesity, 007

3 Intellectual Property in Neurostimulation Intellectual Property (IP) investments and the patents granted in this domain can be classified into three broad categories (Figure ) Neurostimulators Stimulation methods Stimulator peripherals Identifying anatomical locations for stimulation has been the most prominent patenting field. The industry has also seen significant IP investments, especially in patents related to stimulators for autonomous nerve or more specifically Vagus nerve. However, not many patents are present in the field of neurostimulators specific for Splanchnic nerves. Most of the patents related to neurostimulators belong to Advanced Neurostimulation Systems and Biocontrol Medical. Cyberonics dominates the field of stimulation methods while Medtronics has made considerable investments in stimulator peripherals. Stimulation of Vagus nerve has received extensive focus from these industry leaders resulting in significant patenting activity in this domain. This article presents a detailed analysis of the evolution of Vagus nerve stimulation technology. Further, it provides insight on related technology areas that offer scope for innovation and an investment opportunity for IP protection. Level Level Level Neurostimulators 89 Vagus Nerve 7 Splanchnic Nerve 5 Deep Brain 40 Spinal Cord Autonomous Nerve 87 Other Nerves 87 Miscellaneous 7 Neurostimulation for Obesity Treatment 85 Stimulation methods 8 Stimulating Location Monitoring Method Other medical methods Stimulator peripherals 6 Signal Modulator 0 Communication Facilitator Control System Testing & monitoring system 6 Miscellaneous 9 Figure : Patent Classification

4 Vagus Nerve Stimulation: Evolution of Technology The idea of stimulating the Vagus nerve to treat obesity companies like DuoCure, Beta Stim which work in the There are technology areas related to Vagus nerve understanding the protection provided by them. Apart was conceived and patented in the year 99 by domain of Vagus nerve stimulation. stimulation that have not witnessed significant from this, claim-wise mapping also throws some light on Cyberonics. Thereafter, many players have adapted patenting activity till date. These areas include the possibility of overlap among the patents in question. and actively entered the field of Vagus nerve The players in the field of Vagus nerve stimulation have Stimulation signal patterns, Neurostimulators designs stimulation (Figure 4). focused their research resources on few specific areas. along with Gastric bands with electrodes, and To illustrate this, a detailed claim-wise overlap analysis For instance, Medtronic entered this field in 00, and Transcutaneous neurostimulation. of patents in Screening & Monitoring methods is The technology evolution tree shows the entry and developed its footprint in the area of Screening & explained in the next section. activity of key players in the domain in the last 0 years. It can be observed that Cyberonics entered the field first, followed by Neuro & Cardiac Technologies. Biocontrol Medical Method. entered the domain in the Monitoring Methods for Vagus nerve stimulation. Similarly, Enteromedics and Biocontrol Medical have many patents on Use of Control Unit, while Neuro & Cardiac Technologies has focused on development of There are significant number of patents related to Screening & Monitoring Methods, New Stimulation locations and Communication facilitation & other peripherals. Screening & Monitoring Methods: Claim-wise Map year 00. Biocontrol was started by an entrepreneur named Yossi Gross who also founded Communication facilitation & other peripherals. In technology areas that have higher number of patents, claim-wise mapping of the patents may help in A significant number of patents that deal with Vagus nerve stimulation discuss Screening & Monitoring methods. Many companies have ventured into this technology area and filed for patents with Medtronic Vagus nerve stimulation for obesity treatment Communication Facilitation & Other Peripherals Use of Control Unit Stimulation Signal Patterns Screening and Monitoring Methods New Stimulation Effects and Cyberonics leading the pack. Figure 5 shows the claim-wise overlap analysis of the patents in this area. The analysis helps in identifying the key players and their focus areas. Medtronic is the major assignee in this sub-domain with 5 patent applications. These patents are related to modulating the stimulating signal based on the feedback received from the patient. Cyberonics also has a significant presence in this sub-domain, with 4 patent applications. The applications relate to giving stimuli prior to the induction of therapeutic stimulating signal. The claim wise overlap analysis further helps in Assignees Biocontrol Medical Ltd. Cyberonics Enteromedics 5 4 Gastric Band with Electrodes Neurostimulator Designs identifying the features that are extensively covered by the existing patents and applications. For example, features like determining stimulating parameters, modulating the signal based on feedback and stimulating after feedback have been covered in Medtronics Neuro & Cardiac Technologies Others The number inside the circle denotes the number of US patents / applications Transcutaneous Neurostimulation New Stimulation Locations various patents and applications. On the other hand, features like detecting condition of the nerve, redelivery of signals after temporary signal halting and using imaging techniques for monitoring are present in just one patent / application each Figure 4: Technology Evolution Tree 4 5

Priority Date Feb-0 Oct-0 Oct-0 Oct-0 Mar-0 Oct-0 Jul-04 Sep-04 Oct-05 Oct-05 Nov-05 Jan-06 Jan-06 Jul-06 May-07 Company Jeffrey Hargrove S.E.Karashurov Duocure, Medtronic, Inc. Medtronic, Inc. Cyberonics, Inc.

5 Priority Date Feb-0 Oct-0 Oct-0 Oct-0 Mar-0 Oct-0 Jul-04 Sep-04 Oct-05 Oct-05 Nov-05 Jan-06 Jan-06 Jul-06 May-07 Company Jeffrey Hargrove S.E.Karashurov Duocure, Medtronic, Inc. Medtronic, Inc. Cyberonics, Inc. Electrocore Cyberonics, Inc. Inc Electrocore Pacesetter, Inc. Patent Applications US A US A US7498 US A US A US7940 US A US A US A US A US A US A US A US A US A Determining stimulating parameters Receiving feedback for the stimulation Detecting neurological events Detecting physiological parameters Detecting condition of the nerve Detecting biochemicals of nerve tissues Modulating the signal based on the feedback Redelivery of signals after temporary signal halting Prediction of stimulation result using statistical data Blanking/blocking the signal Sending non-therapeutic stimulus before the therapeutic stimulating signal Using imaging technique for monitoring Stimulating after feedback Monitoring plurality of nerves Simulataneous stimualtion of plurality of electrodes with different signals Conclusion Figure 4: Claim-wise Mapping The concept of neurostimulation for treatment of obesity has gained momentum in the past decade. There has been substantial patenting activity related to Vagus nerve stimulation. However, there are ample opportunities in the field of Splanchnic nerve stimulation for the new players who wish to venture into obesity treatment using neurostimulation. For those interested in Vagus nerve stimulation, there is scope for innovation around design of neurostimulators and understanding the signal patterns and their application. On the other hand, screening and monitoring methods used in Vagus nerve stimulation have been extensively patented. For the players that wish to develop products related to screening and monitoring methods used in Vagus nerve stimulation, it would be beneficial to perform a detailed FTO, especially if they are planning to include features like modulating the signal based on feedback and stimulating after feedback. On the other hand, innovation and product development around detecting condition of the nerve, redelivery of signals after temporary signal halting and using imaging techniques for monitoring can be less risky. 6

6 About irunway irunway helps corporations and law firms unlock and protect the value of patents. We combine deep technology expertise with practical business insight to monetize patent portfolios and profoundly improve litigation outcomes. Our in-depth analysis has contributed to significant courtroom victories and favorable settlements for our clients. Fourth-largest patent jury verdict in the U.S. in 009 A strategic cross-licensing deal with a Fortune 00 technology company Favorable settlement with a medical systems company in a copyright case Our service offerings are designed around our expertise in domains such as biomedical devices, IT, telecom, software, semiconductor, networking and web technologies. Our services include- Landscape analysis, freedom-to-operate analysis, infringement identification, prior art searches, patentability search and more Technology analysis services for litigation including invalidity search, claim charts, source code review, document review, amending PICs and more COMPASS SM Patent Portfolio Analysis Service Technology evaluation services for M&A due diligence Client Testimonials "Case after case, project after project, irunway has shown an amazing ability to seamlessly integrate into our teams and add tremendous value to high profile litigation and other legal projects. Our outside lawyers love the quality and reliability, our technical experts appreciate the support, and I am thrilled with the cost savings and results." "McKool Smith handles significant and challenging matters that move at a very fast pace. When we look outside our firm for support, we need people who understand our business and can bring the same level of focus and expertise that we demand of ourselves. irunway does that." Lance Jones Senior Vice President & General Counsel Trilogy Scott Cole Principal McKool Smith

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