In the past few years, there has been an increase in innovation in the Medical sector, prompted by the enactment of the Affordable Care Act in the US, and more recently, the COVID pandemic.
Medical patents is a broad field covering medical devices, chemical/pharmaceuticals, health care information technology, surgical methods, regenerative medicine technologies.
While the benefits of better medical care are invaluable to those who need them, the costs associated with development of new devices and methods, as well as bringing them to the market, can be quite high.
This makes intellectual property a cornerstone of companies involved in this sector. The high costs of development are rewarded with a long term monopoly. Medical patents tend to be strong patents covering real, sustainable innovation.
Things to consider when making the decision about IP strategy related to Medical Devices :
- whether to obtain a prior art search
- whether to file a provisional application
- whether to seeking design patent protection
Patent Search
A prior art search helps to evaluate and consider the full picture of the publications, patents and patent applications held by competitors in the relevant medical device field.
Since it is possible for two or more inventors to develop similar products independently, a prior art search can reveal what other products or prototypes are already in existence, and can potentially save significant sums of money, since patent claims can be carefully and thoughtfully drafted to distinguish over any identified prior art.
Conversely, a prior art search could lead a company to wilfully infringing a patent and impose a wide duty of disclosure to the patent office. It is therefore a nuanced question when to conduct a prior art search and there are multiple schools of thought.
It is important to distinguish between a prior art search, meant to identify whether one’s own invention is new and is suitable for patent protection and a freedom to operate search, meant to ascertain if a company is in risk of infringing other people’s patents. Both of these types of searches are common and often essential in the medical space.
Provisional Patent applications for Medical Devices
Provisional Patent application
Medical patents are characterised by an ongoing development and discovery process.
In the United States, there is an option to start the patenting process with a provisional patent application, an application with reduced formal requirement which can be used as a “placeholder” for later applications. Other countries include similar, even if not identical, mechanisms.
It is a common strategy to submit a provisional application every time there is an incremental improvement and eventually bind them all in a single “full” application.
Some advantages of a provisional application are:
- The filing fees of a provisional patent application are significantly lower
- A provisional application gives the applicant up to a year to begin the patent application process in earnest, security the early filing date.
- All the additional data related to the invention can be incorporated into the full, non-provisional application filed after a year from the provisional.
Design Patents for Medical Devices / Utility Models
Sometimes the specific design of a medical device is a very important part of the invention, or can promote proper use or improve user experience.
The particular way that a medical device looks can be protected as Design Patent.
Design patent protection lasts for 15 years from issuance.
Design patents can be a fast and efficient way of protecting important parts of a product quickly and efficiently, without the scrutiny that a utility patent application is subject to.
Some countries (but not the US) offer an IP right falling short of a utility patent but more than a design. These rights are often referred to as “utility models” (albeit they have different names in different countries) and can offer protection for a shorter period of time (e.g. 10 years) but quickly and without having to prove an inventive step.
