Medical devices are very useful and non-obvious. However, individuals must meet some certain criteria to apply for a medical patent, proving their medical device invention is new and useful or improves upon a process or object in the medical field.
You can apply for a medical patent yourself using the Government website and go through the steps, or use a professional patent lawyer such as Kilburn & Strode to help you prepare the documents and put them forward to obtain your patenting license.
Making a Medical Patent Application
If you are wanting to be granted a medical patent, your idea and invention needs to be truly unique. Here are 6 steps to take you through each part of the application process:
Preparing a Medical Patent Specification
A patent specification is a document where the individual applying describes their invention, like a medical device, for which a medical patent is sought and setting out the scope of the protection of the medical patent. To ensure your application is successful, you should include a detailed description in the specification that are several pages long. This will include a description of different versions of the medical invention and should also include multiple drawings showing the medical invention.
It is important to be aware that depending on the market and subject matter, the style and content varies. For example, more pages of description and drawings are needed for chemical processes and complicated machinery, in comparison to a straightforward idea.
Furthermore, a patent specification should include commercial claims as well. The claims identify the scope of the protection granted by the patent and describes the idea in legal and technical terms, clearly identifying and defining what will infringe the patent.
A good specification should provide a number of ways in which the examiner’s objections can be overcome. If your specification is poorly drafted, it may be impossible to amend the specification to meet the requirements of the UK Patents Act so make sure to perfect it before sending it off!
Request for Grant of a Medical Patent
When you have finished step 1 and your application is ready to be sent off, you should mail it to the Intellectual Property Office. This is for all applications, whether you are applying for a UK, European or International patent.
Preliminary Examination and Search
Once you have sent off your application and it has been received, a preliminary examination is carried out to ensure the application meets the formal legal requirements of the laws governing patents. This does take longer than wanted, taking around 6 months.
During this time, the examiner reads through the application thoroughly to decide whether the invention, such as a device, medical equipment, vaccine or medication, is unique, and undertakes research. Such documents may have been published anywhere in the world and may include published patent applications and technical journals. The outcome of this search is a report detailing a list of the all the documents found, accompanied by a cover letter explaining the search.
If the application is successful, and any formal objections outlined are overcome, it is published shortly after 18 months from the date you filed the application. At this point, all correspondence between the Intellectual Property Office will be open to the public unless you have asked for it to be treated in confidence. This can only be done in limited instances and strict terms which can be found on the website of the Intellectual Property Office. Because of the limited instances where it is kept in confidence, we advise you to not include the information.
The application will then be published in an electronic version, and a notice will be placed in the Patents Journal on the UK website. This means you invention is now searchable, and anyone is entitled to comment on whether they believe the invention should be patented or not. If you are granted your patent, your published application may stop someone from making a similar product or using a similar process.
Request a ‘Substantive Examination’ within 6 months from Publication
A substantive examination is a process carried out to compare the detailed contents of a medical patent application against prior information to determine whether a medical patent can be granted. You want to prevent your application from being terminated once it has been published and is the second-to-last step to your medical patent being granted.
If your application does meet the requirements outline, you will receive a letter that explains when your medical patent will be granted. This normally occurs after 3 months, allowing people a chance to make comments.
Your Medical Patent is Granted
If your application meets the requirements of the Patents Act 1977 and Patents Rules 2007; the Intellectual Property Office will grant your patent, and publish your application in its final form. You will then receive a certificate.
A UK patent gives the owner rights of an invention for up to 20 years. This is only if the patent is kept in force by paying renewal fees year on year. When the fees are not paid, the patent will end.
The 20-year patent protection period may be broken down into two different periods, with one being the initial 5 years and the other being the other 15 to allow you to be better understanding how patents are granted.
Once you’ve applied for a patent, you or your company are provided with an exclusive license to work on a new invention, starting from the date you filed your application.
After the first 5 years, you will need to apply annually to renew the patent protection and this continues for the next 15 years. Patent rights and protection provide complete monopoly over a market for a sufficient time for inventors to reap the benefits of their efforts to the maximum.
How to Make a Successful Patent Application
Preparing, researching and filing a patent does not guarantees you will receive a patent for your invention. The process is complicated and difficult, so here are some key pieces of advice to help you make a successful application to ensure you receive a patent.
A patent application can be the first to global success, and new ideas are being patented all the time. However, patience is needed when it comes to standard patent applications. Before you start, it is important to make understand that the protection the patent offers your idea would prevent any copying in the markets you are active in.
To avoid wasting money and time on existing technology, do a deep and accurate search on databases, internet and sales brochures. This means putting in enough time to make the initial application as strong as possible. Having a well-drafted patent application from the outset puts you in the best position to deal with issues that arise during discovery rather than being rejected because of them. One way to do this is through pre-filling searches as this can give you an idea of what others have done before and how new your invention truly is.
By conducting research, you are strengthening the validity of your initial patent application or identify potential problems that are likely to arise during the review. If you do not have the budget to allow for a thorough pre-application search, give your patent attorney as full a picture as possible of what led to the development of the invention, how it differs from the competition, and all the ways in which the invention will be exploited commercially. This will ensure they take these factors into account when drafting your patent application.
Carrying out regular intellectual property (IP) searches related to your business will enable you to keep an eye on your competitor activity by flagging up possible future problems relating to infringement. Regular research can reveal potentially useful technology, such as patents which are no longer in force or are about to expire. Having a detailed knowledge of the emerging technology in your field will help you with your research. It can also identify opportunities for co-operation with the owners of complementary technology.
Finding Support from a Patent Solicitor (Lawyer)
The basis of a UK patent is a legal document called a ‘specification’. The content in this does not only decide whether a patent is granted but also the rights when receiving a patent.
Even if you are not required to appoint a legal practitioner, it is useful to consult one. Your chances of obtaining a patent is much higher if you use an IP professional. The Chartered Institute of Patent Attorneys can help you locate an attorney close to your location. Additionally, the Institute offers free IP clinics in cities around the UK to provide basic advice to unrepresented innovators.
With help from someone else, they are likely to be able to cover a range of products and processes in the field, for example:
- Surgical Instruments
- Drug Delivery Devices
- Respiratory Apparatus
- Drug Delivery Devices
- Wound Care
- Implantable Devices
- Patient Monitoring
- Manufacturing Technology
- Diagnostics and Sensors
Understanding Medical Patent Variability
If patenting a medical invention internationally, be aware that significant differences exist within the execution of IP law around the globe. Some patents are inherently stronger than others in different jurisdictions.
To ensure that you have the strongest possible medical patent portfolio, you will need to establish a considered international IP strategy, and invest in the subtle adaptation of international applications, by adapting the medical patent applications to complement the local variations of IP law to enhance the prospects of gaining the strongest possible protection under the sometimes-conflicting laws of each respective country. Unfortunately, there are no guarantees with patenting and taking the above steps will not guarantee that your patent is not attacked. They will, however, reduce the risks to your business and put your medical patent portfolio on the strongest possible footing should you need to defend it.