28.01.15
Developing a healthcare product
Guest blog by consultant patent attorney Kate Lees, who has some advice for entrepreneurial clinicians.
General practitioners are not usually thought of as inventors, but they are often the best-placed people to assess the type of equipment or instruments that may assist in the care of their patients.
This, coupled with a doctor’s thirst to solve problems, has led many GPs to come up with some great ideas. Doctors naturally want to be able to carry out a procedure or treatment faster, less invasively and with improved outcomes. The constant financial pressure on GP surgeries also means that alternative cheaper options to treatments are desirable. As a result, it is not uncommon to find a GP crossing over into the world of inventions and commercial product development. Kate Lees, Consultant Patent Attorney at leading law firm Harrison Clark Rickerbys offers some sound advice to all entrepreneurial practitioners.
So what should you do if you believe that you have invented a new product?
It is important to keep details of the idea confidential until you have spoken with a patent attorney. The attorney can advise whether it may be possible to protect the invention via a patent or other intellectual property right and can inform you of the necessary actions that need to be taken.
The grant of a patent provides a monopoly for a limited time period (generally 20 years) in exchange for the publication of details of the invention so that this information is readily available and can be freely used following expiry of the monopoly. If no patent or other intellectual property right is in place, the invention may be freely used once it is in the public domain, leaving the inventor with no means of obtaining a financial return on his or her creation. Patents and other forms of intellectual property rights enable the invention to be exploited for the Patentee’s benefit, for example by selling the invention to the exclusion of others, by licensing the technology to a third party or by assignment of the patent.
The healthcare profession represents a huge source of potential inventions, but can they all be protected by a patent?
A wide range of inventions are patentable provided they meet certain criteria. The invention must be novel (that is, the invention has not been made available to the public by any means anywhere in the world), involve an inventive step (i.e. it is not an obvious modification of something that has been done before) and be capable of industrial application. Products, such as orthopaedic devices, surgical instruments, dosage regimes and compositions may be patentable, as may improved processes for manufacturing a product, novel uses for a known product (such as a drug) and kits containing several items that may be used together.
However, there are some types of invention that are excluded from patentability. The most relevant exclusions to the healthcare industry are as follows:
- Essentially biological processes for the production of plants or animals (although this provision does not apply to microbiological processes or the products thereof)
- Methods for the treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body
Whilst methods of treatment may be excluded, the products, in particular substances or compositions, for use in any of these methods, are not. Although, at first sight this appears to severely limit the ability to obtain a patent in this technical field, this is not in fact the case. While a method for surgically joining two organs together may be excluded, the surgical instrumentation (for example, stapling apparatus) for implementing that procedure may be patentable providing that it is found to be new and non-obvious. Similarly, a method of treating a wound may not be patentable, but a composition for application to the wound may well be.
The boundaries set by the above exclusions are not clear and require interpretation using available guidelines, directives and case law. Thus, it is always appropriate to seek professional advice as to whether a new product, composition, process, kit or method may fall within the exceptions to patentability.
For example, European patent law has held that methods of surgery which were ‘neither clearly suitable nor potentially suitable for maintaining or restoring the health, the physical integrity, or the physical well-being of human beings or animals’ fell outside the above exclusion.
This has led to a number of ‘cosmetic’ surgeries being considered patentable, such as an application that related to ‘methods for hair-removal using optical radiation’ (wherein optical radiation is applied to a selected wavelength to damage the hairs and follicles without causing significant damage to the skin). While the invention involved ‘a non-intentional physical intervention which [was] to be regarded as a surgical operation’, it was not ‘potentially suitable for maintaining or restoring the health, physical integrity, or physical well-being of a person or animal’.
Similarly, tattooing and piercing, whose only possible object was to beautify the human or animal body, would not fall foul of the exclusion. In contrast, methods relating to breast enlargement or nose reconstructions, which were meant to restore the physical integrity of the body following, for example, breast cancer or a car accident, were held to be non-patentable.
So the invention may be patentable, what then? As mentioned, it is crucial that the invention remains secret until after the filing of a patent application in order to obtain a valid patent. It is important to seek professional advice early in the development of an invention prior to any public disclosure, including before any testing of the device or publication in a trade journal. A full and frank disclosure of the invention should also be provided to your professional representative to ensure any patent application covers all envisaged variations of the invention and to enhance any searching that may be carried out prior to filing to assess the novelty of the invention.
A patent application can be filed in the inventor’s home territory, which will provide provisional protection for a twelve month priority period. Once filed, details of the invention can be disclosed to others, enabling its commercial potential to be explored further without detriment to the grant of a patent. The pending application is generally subject to a search and examination procedure over a number of years prior to any patent being granted. If protection is required outside of the inventor’s home territory, it is necessary to submit separate national applications before the expiry of the priority period. Some regional patent systems do exist and it is possible to file an international application to delay the expense of filing in numerous separate territories until thirty months from the original filing date.
It is important to seek professional advice early in the development of an invention prior to any public disclosure.
Kate Lees is consultant patent attorney at Harrison Clark Rickerbys, specialising in the healthcare industry. She is happy to talk you through the first steps of protecting an idea during a free initial consultation. Contact Kate via email on [email protected].