Recognising that back pain is the Number 1 cause of healthcare expenditures in the U.S., NuVasive launched in 1997 to address the unmet need for implants, instrumentation and procedures for the minimally disruptive surgical treatment of spine disorders. In 2001, the company launched its first products and achieved approximately $2.1 million in sales. Although a modest start in hindsight, NuVasive quickly emerged as an in-novator and by 2005 it received the "No. 1 Fastest Growing Company in North America" award by Deloitte & Touche. By 2008, it achieved $250 million in sales and is currently among the largest spine companies in the world.

Jonathan Spangler, Esq.
Vice President and Chief Patent Counsel
NuVasive

Summary

Offices

San Diego, California

Personnel

640

Portfolio

Over 200 issued patents; over 550 pending patent applications; over 80 registered trademarks; and over 30 pending trademark applications.

CPA Global Solutions

FoundationIP
Docketing
Patent Searching
Patent Illustration

The bottom line

• NuVasive's swift emergence into a leader in the spinal market has been fully supported by its well-executed IP strategy:
• The organisation strengthened its market position by using CPA Global's solutions to release products faster than its competitors
• NuVasive was able to bring its IP practice in-house under one department successfully streamlining workflows and business processes
• Using CPA Global's expert legal resources and technology allowed NuVasive to adequately scale with its M&A activities without disruption.

To support this high growth and innovation, NuVasive developed a centralised IP management strategy based on using in-house IP counsel to handle substantive IP-related matters. To achieve this in a high quality, efficient and cost effective manner, NuVasive partnered with an expert in legal support services and IP management software solutions.

The Company

While NuVasive's product portfolio is focused primarily on the $4.6 billion U.S. spine implant market, it has also expanded into several other areas: the $1.5 billion global biologics market; the $1.5 billion international spine market; and is developing products for the emerging motion preservation market.

NuVasive's principal product offering involves its innovative "Maximum Access Surgery" (MAS®) platform. The MAS platform combines four categories of products that collectively minimise soft tissue disruption during spine surgery while providing maximum visualisation for safe, easy reproducibility for the surgeon. Having redefined spine surgery with the MAS platform's approach, NuVasive has built an entire spine franchise with nearly 50 products spanning lumbar, thoracic and cervical applications. It has continued to expand and evolve its offering with a relentless focus and dedication to R&D and outstanding service levels supported by a culture of Absolute Responsiveness®.

NuVasive's global IP portfolio includes over 200 issued patents; 550 pending patent applications; 80 registered trademarks; and 30 pending trademark applications.

IP Management Challenges

As a venture-capital backed start-up company, NuVasive initially retained multiple law firms to manage its IP portfolio and to provide strategic IP oversight. This approach proved to be costly, inefficient and a challenge in establishing a cohesive, unified effort. Working with multiple law firms was made worse due to a "revolving door" of associate attrition.

To overcome these drawbacks and support the company's goals of being an innovator and leader in the spine surgery market, NuVasive decided in 2001 to centralise its IP practices in-house under one department and to work strategically with a partner who could foster NuVasive's explosive growth. To set this in motion, NuVasive brought on Jonathan Spangler, Esq., to assess the company's fragmented IP practices and spearhead the necessary changes.

At the core of supporting an in-house IP department was the need for an effective IP management system. Jonathan, now Vice President and Chief Patent Counsel, was aware of the negative impacts of having an inflexible system to support the IP lifecycle. Limited functionality required extensive manual labour and administration of the system which took essential human capital away from more crucial business activities and also ended up being expensive to maintain. Prepared with this knowledge, Jonathan directed his search for a new IP management system that would be more functional, flexible, and reliable.

Additionally, resourcing the company with specialists in such areas as docketing, paralegal, illustrations and searching, was not always easily achieved as staff turnaround could be unpredictable. NuVasive needed to effectively extend the bandwidth of its IP team to quickly and seamlessly respond to workload boosts.

Jonathan was looking for a strategic partner with expert legal outsourcing expertise to support the company with a new IP management system and a wide variety of on-demand administration IP services.

Selecting the Right Strategic Partner

After evaluating several prospective partners, NuVasive selected CPA Global for its flexible web-based IP management software FoundationIP and its expertise in legal support services.

According to Jonathan, a primary reason why NuVasive chose FoundationIP was the efficiency and cost-effectiveness its IP department would attain with the new system. FoundationIP's feature-rich capabilities would automate many of the manual tasks as well as reduce data entry errors and streamline NuVasive's docketing practices.

NuVasive would also be able to rely on CPA Global's expert resources to equip the company with on-demand legal resources. The availability of these specialists would relieve the strain on internal resources and effectively expand the bandwidth of the IP team to quickly respond to increased workload. Bracing for future changes and spikes in IP activities, NuVasive felt confident selecting CPA Global to provide the specialised professionals to help the company achieve optimal results.

Cementing its decision to partner with CPA Global was the cost savings NuVasive would realise. As a growing company with financial goals of profitability and attractive investor returns, NuVasive was careful to fully assess the financial impact of administratively supporting its new IP strategy. NuVasive analysed the costs to hire a full time patent administrator or patent paralegal with the skills and experience sufficient to support its growth plans and discovered it was far more expensive than partnering with CPA Global for its IP management system and expert resources. "NuVasive has a high expectation as to where we want to position ourselves in the marketplace. Aligning with CPA Global and using its innovative IP management solutions help us manage these expectations without the growing pains that would otherwise be experienced.

"The bandwidth of CPA Global is unparalleled in the industry; this allows NuVasive to grow as fast as we want without worrying about how to address the administrative challenges of our progress." - Jonathan Spangler, Esq., Vice President and Chief Patent Counsel

Outcomes and Benefits

By partnering with CPA Global, Jonathan was able to transfer the entire IP portfolio in-house and progressively build and grow NuVasive's IP team as the business and product portfolio expanded. By using FoundationIP as the core system for managing their IP portfolio, and CPA Global's ondemand legal resources, NuVasive's IP team is able to focus on supporting the organisation in its pursuit of innovation and leadership in spinal surgery technology. "We have an IP department to fuel and support NuVasive's growth because we can rely on FoundationIP and CPA Global's on-demand expert administrative legal resources. This gives us more time to focus on substantive activities, such as protecting our innovation and managing freedom-to-operate (FTO) risk, which are vital in supporting and growing our business," says Jonathan.

As a keystone of NuVasive's IP management strategy, CPA Global has helped NuVasive realise these benefits:

Reliable and responsive partnership

NuVasive's growth plans demanded a partner that could evolve with its business objectives. CPA Global has 40 years of providing best-in-class legal and IP management services along with innovative software solutions. With offices across the globe, CPA Global is well positioned to support and respond to NuVasive's diverse IP needs. "CPA Global is a responsive and reliable partner with comprehensive products and services that are instrumental in our ability to manage our dynamic business needs," says Jonathan.

Comprehensive insight into portfolio

In addition to technological advancement and financial discipline, NuVasive's success is attributable to its commitment to measuring and assessing results in all areas of the business. Leveraging FoundationIP's functionality and powerful reporting capabilities is helping NuVasive track and measure metrics associated with its IP portfolio. FoundationIP also provides the ability to make better forecasts and effectively prioritise the company's IP assets. "It's more than just patents and patentability. It's about being able to have access to, and report on, critical data to drive strategic decision-making and assess our results," Jonathan adds.

FoundationIP also facilitates insight into the portfolio in terms of its ease of access. NuVasive can directly manage all IP-related information and activities through the system's secure online environment. The web-based system houses all of NuVasive's IP information including case history, documents, scanned copies of office actions, drafts, and invention disclosures - all which are available from one easyto- use interface. In addition, having remote access is advantageous for the IP team to access the portfolio regardless of their geographic location.

NuVasive also finds it advantageous in facilitating due diligence investigations of NuVasive's IP portfolio by third parties, such as investors during its venture-backed stage and underwriters before its IPO in 2004. "The entire third-party due diligence of our IP portfolio was conducted remotely by granting them access to FoundationIP, which avoided the need to have their teams camp out at our facility with the associated disruption that oftentimes occurs in those situations," explains Jonathan.

Better protection of portfolio

Having a strong IP portfolio can be a critical factor in obtaining funding from investors, particularly for startup companies looking for venture capital. By using the FoundationIP system to automate its docketing procedures, NuVasive's IP team is able to concentrate on patent prosecution to protect its ground-breaking spinal innovations. For example, the standard forms and process automation available through the FoundationIP system reduces human-related errors and missed dates which are critical in upholding IP assets.

"CPA Global has been instrumental in defining the right IP processes to help us generate and protect our robust IP portfolio. This is a key consideration for potential investors who will look at how solid and enforceable our portfolio is." - Jonathan Spangler, Esq., Vice President and Chief Patent Counsel

Extending capabilities

NuVasive needed to manage and expand its IP portfolio while controlling resources, costs, and without sacrificing quality. CPA Global has invested in state-of-the-art facilities and talent unsurpassed in the industry and offers cost-effective solutions in the areas of docketing, maintenance and annuity fee management, along with on-demand IP services that have been critical in extending NuVasive's internal capabilities. The company currently benefits from the following CPA Global solutions:

Docketing:

NuVasive relies exclusively on CPA Global's experts to handle the intake and administration of its IP docket into the FoundationIP system. "Having FoundationIP's expert docketing professionals in our corner provides essential administrative support that wouldn't otherwise be achievable without unacceptable cost, particularly in a highly competitive region for in-house docketing talent such as Southern California where NuVasive is based. Moreover, it eliminates the risk of disruption that can happen if internal docketing talent moves on. With CPA Global, I have confidence that I will always receive high-quality, dependable docketing in a cost-effective manner," adds Jonathan.

Illustration:

For active projects, NuVasive typically relies upon its engineers to provide the illustrations for the associated patent applications in that they are already generating those illustrations for modelling and prototyping purposes. For advanced projects or non-commercial IP, however, NuVasive looks to CPA Global to provide on-demand illustration services. "Importantly, this allows our engineers to remain focused on immediate product development and releases to fulfil our aggressive product launch schedule, as opposed to taking time to generate drawings for these longer term projects. It's all about efficiency and quality," says Jonathan.

Searching:

NuVasive's explosive growth has been fuelled by organic development as well as by strategic acquisitions. To help support these business development efforts, NuVasive has turned to CPA Global for on-demand patent searching services. This adds efficiency to the process by allowing the IP team to focus on assessing the search results, as well as keeping up with the ongoing patent prosecution matters, while leaving the experts at CPA Global to conduct the actual search. According to Jonathan, "Having the added bandwidth on the searching front enables the IP team to stay true to our corporate commitment to Absolute Responsiveness by absorbing workload spikes associated with IP due diligence."

Faster product marketability

With the flexibility and reliability of FoundationIP together with the skilled specialists readily available, NuVasive's IP team is better positioned to support product development and drive products to market faster. FoundationIP automates many of the administrative and manual tasks, which reduces the time the IP team spends managing the administrative aspects of the company's patent portfolio. Add-on services such as illustrations are drafted by CPA Global quickly and with the highest quality. CPA Global's searching service provides reliable results and eliminates the exhaustive commitment that would have been required of the IP department.

"NuVasive's confidence in CPA Global allows us to focus on substantive IP matters and thus gives us more time to stay close to all aspects of the business, which is imperative to ensure our IP strategy is intimately aligned with our marketing and development strategy.

This, we believe, represents a significant advantage in allowing NuVasive to develop and release products faster than our competitors." - Jonathan Spangler, Esq., Vice President and Chief Patent Counsel

Risk mitigation

Having the right technology and resources in place prevents NuVasive from jeopardizing its IP assets. The risks associated with abandonment or failure to respond to docketing deadlines could result in loss of patents and also permit competitors to copy NuVasive's products, which could translate into loss of revenue and distinction in the marketplace. "NuVasive does not want negative impacts on our IP portfolio due to administrative failures and potential lapse of IP rights. This is why NuVasive partners with reliable experts like CPA Global who offer high-quality resources and dependable, robust technology solutions," says Jonathan.

The partnership with CPA Global helps NuVasive to be more efficient as an organization. "An ineffective partner and IP management system cost organisations time, money and human resources. Some companies learn this the hard way and suffer irretrievable IP rights. NuVasive selected strategic partners like CPA Global to avoid this because of its comprehensive, innovative and dependable legal outsourcing solutions," explains Jonathan.

The benefits from this efficiency allow NuVasive to focus more on critical IP and business development activities, deliver products to the market faster, better protect and strengthen its IP assets, and manage the risks and costs associated with a growing product portfolio. "We couldn't do what we do without CPA Global," concludes Jonathan.

NuVasive Interview