"To achieve maximum competitiveness, medical device companies should review their intellectual property on a regular basis." European Medical Device Technology discuss with David Segal and Pippa Tolfts, Coller IP.
Intellectual property (IP) refers to a range of creations of the mind for which specific legal protection may be available. Common types of protection include patents, trademarks, registered design rights and copyright.
Medical device technology is a developing area and ripe for IP protection. In IP terms, a novel medical device is a device that has not been publicly disclosed before the date of the patent application filing. Such devices are part of the creator's IP and can form part of a coherent IP strategy going forward. A good strategy includes a clear understanding of the inherent value of the IP in the invention, full legal protection in the jurisdictions in which the invention is to be marketed and an understanding of how to commercialise the IP in the future.
In our article, we addressed potential IP issues associated with the growing area of medical devices, with particular attention focused on the wider patent landscape around them.
Inventions in medical devices can include:
- materials, namely metals, polymers and ceramics with specific properties such as mechanical strength and hardness;
- the formation of surface coatings for applications such as drug-release devices;
- the design of electronic circuits for data collection and analysis related to patient management;
- power supplies for medical devices;
- the functional design of the devices themselves.
In our view, R&D staff need to be fully aware of the implications of disclosing their inventions in advance of a patent application. Simply by disclosing their contributions in external discussions or by publishing in journals or conference papers, R&D employees potentially are making their company's technology available to the public. From that point onwards, if no patent application has already been filed, the invention may no longer be considered to be novel or inventive, and it will become difficult to obtain a commercially valuable patent to protect it.
We strongly recommend that prior to any external disclosure whatsoever, organisations take professional advice on precisely when they should patent their inventions and how they should go about it. Otherwise, there is a serious risk of giving away ideas or inventions for free.
Another area to consider is where a new device may include components from other organisations. This is a complicated legal area, and if such a device is contemplated, we strongly recommend obtaining a professional opinion before the device is fully commercialised.
Many organisations use components already built and tested in their products as it leads to faster and more cost-effective development cycles. Such components can be considered as IP assets, and as such, their use should be optimised and protected, whether developed internally or by a third party. Rather than purchasing the component outright, the R&D team may acquire a license to use the component for a specific purpose, or negotiate a contract where a royalty is paid for each shipped product in which the component is integrated. Both commercial judgment (the cost-effectiveness and viability of the chosen model) and IP skills are required, the latter to ensure that contracts between an organisation and any third-party supplier are watertight and do not lead to problems further down the line.
Table I: Studies of patent literature highlight many active players from the medical device industry.
This table shows some of the most active players and the number of patent families.
The following questions are pertinent to the discussion of IP in the field of medical devices:
- Who are the major patent holders and what are their activities?
- Which players occupy niche technology areas?
- Is this a growing or shrinking field of technical activity?
- Are there core technologies common to the product offerings of patent holders?
- How is the technical field changing over time?
- Are my activities novel or are they used by my competitors?
- Who are my nearest competitors in terms of technology?
- Will my activities result in infringement of third-party patents?
- How valuable is my IP?
Databases of published patent information are publicly available through patent offices: the United States Patent and Trademark Office, the UK Intellectual Property Office, the European Patent Office and the World Intellectual Property Organisation, for example. Commercially available software that simplifies the searching process for these databases is available.
Patent searches on medical devices identify nearly 13,000 patent families that have been filed over the past 20 years. Analysis of the patent filing dates shows that medical devices is one area of growing activity (Figure 1). Studies of patent literature highlight the many active players, as shown in Table I.
Figure 1: Filing rate for medical device patents. The figures for 2011/2012 are not yet fully published (output from Thomson Innovation).
The patent landscape provides an indication of where competitors might be active and there are specific features of the landscape that can affect the success of product offerings for medical devices. In a patent landscape as crowded as the medical device field (Figure 2), there is always a possibility of a new entrant infringing patents belonging to a third party. Anyone coming into this complex field, as well as existing players, should ensure that they have professional advisors who can help to steer them through this maze and review their IP on a regular basis. Some of the patents on the landscape will be of significant value, and understanding the relative position of the new development to existing patents is important for business decisions that may relate to investment in an enterprise, development of a product or the complete sale of a business.
Figure 2: Patent landscape for 13,000 families of medical devices (output from Thomson Innovation).
Anyone who has business interests in the field of medical devices will want to know who their nearest competitors are and what patents they hold. The landscape for the set of 13,000 patent families used for Figure 2 is generated through an analysis of the most frequent words and phrases (referred to as themes) in the set of documents and allows us to see the active parties in a specific area of development.
In general, topics that lie close together on the landscape can be considered to be related technically, and the snow-covered peaks are around subject areas of high patenting activity.
Figure 2 has been annotated to show the location of specific technical areas within the landscape. We have also shown in Figure 2 the position of some patent family holders in the landscape. In some cases, patents for a particular player are dispersed across the landscape activity in various technical areas. Where patents are clustered for a player in a specific region of the landscape, there is an indication that that player has focused on a specific technology or application for the technology, for example an emphasis on spinal implants.
In summary, the medical device area has seen growing patent activity over the last 20 years. Assessment of the wider patent landscape reveals the intellectual property held by both existing players and new entrants in the medical device market, essential information in today's world of business. A full understanding of where a new invention lies on the patent landscape is vital, as is ensuring that all contracts with third-party suppliers are watertight. An IP audit, review or health check should be undertaken on a regular basis to ensure the organisation is aligning its business strategy with its IP—the so-called crown jewels of a company—to achieve maximum competitiveness going forward.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
