So you want to develop your own implant?

Paul Roberts

Paul Roberts is a recently retired Consultant hip and knee arthroplasty surgeon. For most of his consultant career he was based at the Royal Gwent Hospital, Newport. He has a long-standing interest in the design and development of orthopaedic implants and instruments, and held numerous UK and foreign patents.

Where do I start?

So, you have a concept of an orthopaedic implant you would like to develop. The essential questions to ask yourself are:

1. Is it novel? Implant companies are perfectly able to develop, produce and market ‘me to’ products without the involvement of surgeons.

2. Is there likely to be continuing demand for it, taking into account the time it will take to bring it to market? Fashions change quickly in the orthopaedic implant world e.g. the rapid demise of metal-on metal hip replacements.

3. Will it be attractive to an implant company? Essentially, will they be able to make enough profit to justify the very high upfront costs of development, production, regulatory approval and marketing, and satisfy their shareholders?

If after answering these questions you wish to proceed, the issue that must be at the forefront of your mind is protection of your (embryonic) intellectual property (IP). Do not discuss your invention with anyone you cannot trust. Once an invention is in the public domain it cannot be patented, and any confidentiality agreement relating to it would be difficult to enforce. The public domain is wide, and would include for instance, a presentation at a local orthopaedic meeting. So be careful.

Do not use NHS facilities or time for any aspect of the development of your invention. This could leave you open to a claim by the NHS on your IP in the future. Likewise, if you hold a University appointment, clarify with the relevant authorities what claim, if any, they may have on your IP.

Involving industry

To bring an orthopaedic implant to market you will inevitably have to involve the implant industry. The cost and expertise required for development, manufacture, regulatory approval and marketing are simply too great for an individual. For example, a PMA (pre-market approval) submission to the FDA in the USA is likely to cost upwards of $3 million and take at least five years to complete. So, the pertinent question is: when do you begin to interact with industry?

Clearly, your intellectual property is best protected with a patent. However, as discussed in the section on patents later, it is difficult and time consuming to patent an orthopaedic implant. Consequently, it is likely that you will need to approach an implant company relatively early in the pathway, as we did in our first project.

So, how do you choose which company to go to?

Firstly, you should choose a company which has a track record of interest in the type of implant you have invented, but also has a relevant gap in their portfolio. In my experience, small companies are most likely to be receptive to working with a single or small group of surgeons, and be interested in niche markets, but their resources may limit their development and marketing capabilities. The large multi-national implant companies have huge resources but can be difficult to work with if you are not on their ‘surgeons panel’. In particular, over the last 20 years it has become apparent that these companies, particularly the US based ones, are reluctant to work with individual surgeons in developing an implant, as they had done historically, but instead prefer to develop implants with a large ‘panel’ of surgeons, who can subsequently act as product champions and market influencers.

Whatever company you choose, do not discuss any details of your invention without them having signed a Confidentiality Agreement. These are easily and cheaply obtained on the internet, but may need some modification to meet your specific requirements. There are many anecdotes of surgeons having their invention rejected by an implant company, only for a very similar design to appear in the company’s portfolio some years later. A Confidentiality Agreement will provide a reasonable level of protection if well written, but obviously you must be prepared to take legal action if it is breached.

The more detail of the design features and applicability of your implant you are able to provide at the initial meetings, the greater is the chance that it will be taken up. At the very least you should be able to provide a detailed summary of the design rationale and key design features, supported by good quality design drawings, all of which should be signed and dated by you. It may be worthwhile, as discussed earlier, to have some experimental data to support your claims at this stage, but this is not essential.

If the company decides to proceed with the project, the next phase is the preparation and signing of a contract that will define at least the company’s obligations to you, including financial compensation, your obligations to the company, and terms of termination. This contract will normally be drawn up by the company based on their own template, but there is no reason why you should not have a contract prepared independently. Whichever you choose, I would strongly recommend using a specialist life sciences attorney to prepare or check the contract and carry out further negotiations if necessary. Such lawyers do not come cheaply (£400-£500 per hour), but will be well versed in the tactics of the ‘David v Goliath’ situation you are effectively in. Money spent at this stage is likely to be money well spent. Contract disputes further down the line can be toxic, and difficult and costly to remedy. Only after the contract is agreed and signed should the development phase begin.

Patent applications

Patents are probably the most complex and least well understood aspect of intellectual property protection for the non-expert. If you are considering making a patent application, the following section will be relevant.

Background

The patent system exists to protect inventions and products; you cannot patent an idea per se. However, if you are able to develop your concept into an invention, you may be able to obtain patent protection.

To qualify as an invention in the patent process, three criteria must be met:

i) It must be novel. You cannot patent anything which is already in the public domain.

ii) It must demonstrate inventiveness. You cannot patent anything which would be obvious to a person well informed and experienced in the field. Likewise, it cannot be just a minor modification of an existing invention.

iii) It must have a practical, industrial application

Because of criteria (i) and (ii), in most cases it is unlikely that an orthopaedic implant will be patentable: it is unlikely to be novel, and it is likely to be considered a minor modification of an existing implant or previously patented, (although not necessarily marketed), design.

Whilst the whole implant may not be patentable, certain aspects of its design might be. For example, in 2012 we were able to obtain UK and European patents for a monobloc, chrome-cobalt acetabular component with transarticular screw fixation to be used in metal-on-metal hip resurfacing. Although the acetabular component itself was obviously not novel, the UK and European Examiners did consider that the design of the trans-articular screw fixation, with its ability to block transmission of fluid pressure waves and resist backing out, was novel and represented more than a minor modification of existing implants. Interestingly, although this implant was never brought to the orthopaedic market for a variety of reasons, following the publication of the patent we did receive numerous enquiries about the screw design from the marine engineering industry, with offers of collaboration.

The practicalities

It is possible to successfully apply for a patent without involving Intellectual Property lawyers. However, orthopaedic implants, and to a lesser extent instruments, are likely to be in the more complex range of the spectrum of patent applications. The work involved in the preliminary searches, and the drafting and filling of the application will be extensive and difficult if you do not have experience in the process. Likewise, responding to formal and detailed reports and questions from the patent examiners is a daunting challenge without expert guidance. It may not be possible to rectify errors made at this stage.

Consequently, if you think your invention is going to be commercially viable, I would recommend using an Intellectual Property lawyer with a track record in life sciences from an early stage in the patent application. Details and advice can be obtained from the Chartered Institute of Patent Attorneys’ website. To minimise the costs, provide your chosen lawyer with the most detailed description and design drawings of your invention that you are able to produce. Likewise, if you have any experimental data to support your claims, a successful outcome is more likely.

The procedure

There is no such thing as a ‘worldwide patent’. Individual applications must be made to each country/jurisdiction in which you want patent protection (commonly UK, Europe and USA). There are two pathways you can follow: (i) individual country/ jurisdiction applications, or (ii) the Patent Cooperation Treaty (PCT) ‘international patent application’, covering most of the major industrialised countries of the world.

It is important to understand that the PCT system does not examine patent applications fully and it does not grant patents. However, once the PCT application is filed, it does provide immediate protection of your invention in the 142 member countries. It will also eventually provide you with information enabling you to judge the likely chance of success in subsequently obtaining patents from individual country/jurisdictions before potentially major costs are incurred.

For either pathway, the first stage is to file the patent application with your national patent office. In the UK this is the UK Intellectual Property Office. This establishes the priority date. This immediately gives you a 12-month period of protection and prevents anyone else in the UK obtaining a patent covering your invention, even if you do not subsequently complete the process.

If you decide to proceed down the individual country/jurisdiction patent route, it is important that the foreign applications are filed within one year of the priority date. In this situation they will be considered to have been filed on the priority date, effectively giving you retrospective protection.

If you choose the PCT route, the application should also be made within one year of the priority date for the same reason. You then enter the International phase, when the application is subject to both search (of relevant prior art) and examination of the design for inventiveness and industrial applicability. Within six months or so you will be provided with an International Search Report (ISR) and the Written Opinion of the International Search Authority (WOISA). If you do not challenge the WOISA, it is subsequently published without change as the International Preliminary Report on Patentability (IPRP), usually within 18 months of the priority date. This is essentially a non-binding opinion on the core patentability requirements: novelty, inventiveness and industrial applicability.

If you choose to continue the patent application process based on the result of the IPRP, you then enter the National phase, when individual applications are made to each country/ jurisdiction in which you want patent protection. Many countries will use the IPRP as the starting point for further examination. However, some countries, including the USA, ignore the IPRP and will conduct their own comprehensive search and examination.

In summary, the advantages of the PCT route compared to early filing of individual foreign patent applications include:

• Lower costs initially.

• The decision to pursue foreign patent protection, with the associated substantial costs, does not have to be made until the end of the International phase, when the IPRP will give you some indication of the likely probability of success.

The disadvantages include:

• Overall costs are higher.

• The process takes longer.

The costs when using an IP lawyer

It is difficult to provide an accurate estimate of the costs of even a UK patent application because of the many variables, including; the complexity of the application, the extent to which it is challenged by the examiner, and not least the fee structure of the IP firm you have chosen. An on-line search will produce wildly different results.

In May 2018, Hutchinson IP carried out a statistical analysis of the cost of their own successful direct UK patent applications (not UK National Phase). They concluded that the range was £3,300 - £10,200, with an average of £5,595.

Accepting that orthopaedic implant applications are likely to be at the expensive end of the range, and factoring in the increase in RPI since May 2018, the cost of a direct UK patent application now would be approximately £13,000, based on Hutchinson’s figures. Foreign applications are likely to be considerably more expensive. The cost of a PCT application currently is approximately £12,500.

For a ‘real world figure’, I have looked at the cost of the patent applications in 2012 mentioned above. We used a Partner in a well-known international IP firm. This turned out to be a complex and lengthy process, requiring multiple responses to questions and disputes with the various examiners. The total cost for applications in the UK (successful), Europe (successful,) and the USA (unsuccessful), taking in to account the increase in RPI, was approximately £40,000. On top of this are the not insubstantial annual renewal fees for each country/jurisdiction.

Key reflections (many of which I did not follow)

1. If possible, work with a trusted friend/ colleague. You can share the costs (and benefits), but more importantly, you can support each other when times are tough, which they certainly will be. There were many times in the dealings with the implant companies that I would have given up if I had been acting alone.

2. Protect your intellectual property at all times. Keep detailed minutes of all meetings, and date, sign and keep any design drawings, however rough, you create at the meetings.

3. Employ the best life sciences attorney you can afford to prepare or check the definitive contract. We did not, and subsequently regretted it.

4. Don’t be overawed by the David v Goliath nature of the relationship with the implant companies. They are aware that you have ‘soft power’ with your influence in the wider orthopaedic community, and they will generally avoid overt confrontation with a surgeon-designer.

5. Learn to say no.

6. Don’t forget your family and friends, however busy or stressed you feel.

7. Enjoy the experience – easy to say in retrospect. Developing an implant is an immense intellectual challenge, which will take you outside your comfort zones on many occasions. In return, the satisfaction in seeing your idea come to fruition and benefit patients is huge.

Read how Paul and his colleague Peter Grigoris developed two implants of their own, a new hip resurfacing system incorporating the Metasul bearing and a monobloc hip resurfacing acetabular component with trans-articular screw fixation, on Orthopaedics Online at www.boa.ac.uk/O2/implants