One of the most game-changing patents ever awarded in the field of medical devices, was for the revolutionary cardiac pacemaker (US Pat No. 3,057,356). This patent was issued in October 1962 to Wilson Greatbatch. Medical devices are defined as any instrument or material that is intended for use in the diagnosis, prevention, monitoring, treatment, and alleviation of disease or injury in humans, or in investigating, replacing and modifying the human body or a certain bodily process.
In 2018, medical technology is the largest patent source in Australia for Australian patents. According to a report released in 2017, Australia’s medical patent landscape has been dominated by diagnostic instruments, and comprised approximately 22% of Australian PCT applications in the medical devices field, followed by syringes, catheters and other probes (13%), prostheses (12%) and respiratory care (12%). Other hotspot areas for medical device patents included: diagnostic imaging and therapy; surgical instruments, biocompatible materials and sterilisation; patient transport and care apparatus; physical therapy apparatus; eye and ear care; dental apparatus; dressings and first aid; life-saving equipment; laboratory equipment; veterinary procedures and apparatus and anaesthetics.
The top filers, ResMed and Cochlear, own about 20% of the total filed inventions in the medical devices field. Most applications have been filed by single parties; among collaborators, the most prolific filers in the field are CSIRO and universities such as University of Technology, Sydney, University of Sydney, University of Queensland, Monash University and University of Melbourne.
Medical devices, methods of medical treatment and medical software are all patentable in Australia.
For any type of medical device, IP protection is essential to protect profit margins and to justify the investment in medical technology development. In the medical devices industry as in other industries, patent literature can be used as indicators of R&D performance and can reflect the current state of science and technology. In addition, medical device patents serve as insurance for investors aiming to commercialise ideas for devices that can potentially revolutionise the medical field.
Having patent protection means that the first person to file a patent application claiming the rights to a certain innovative medical device can sell or license the technology to another party to be able to immediately regain a portion of the funding that went into the development of the product. This is a possible route for parties lacking the means or interest in progressing the innovation to commercialisation.
Invasive medical devices typically need to undergo significant testing to gain regulatory approval before they can be brought to market due to the inherent risk associated with such devices. In the most recent amendment to the patent act, the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, provisions for an exemption to infringement of non-pharmaceutical patents for gaining regulatory approval and conducting research were established. This allows researchers to conduct genuine scientific inquiry without the risk of infringing patents.
| Tissue engineering |
Merck Patent GmBH |
|---|---|
| Prosthetics |
Omega Ophthalmics LLC |
| Diagnostics |
InteRNA Technologies BV; Koninklijke Nederlandse Akademie van Wetenschappen |
| Monitoring |
Horizon Therapeutics LLC |
| Laboratory |
Getinge Sterilization AB |
| Therapeutic device |
Kleiner, Daniel Eduard |
| Implants |
Tepha, Inc. |
| Surgery |
Conmed Corporation |
| General healthcare systems |
Baxter Healthcare SA; Baxter International Inc |
The medical devices experts at Baxter IP are more than just patent attorneys. They are focused on marketable medical product features – clients need more than just proficiency in drafting and preparing patent applications.
A patent attorney with an extensive knowhow of the subject matter can see beyond these requirements and go the extra mile to derive the maximum gain for the client by designing a carefully considered patent strategy that can take the client from filing to commercialisation of the product. In addition, our patent attorneys have backgrounds in engineering and the medical sciences, enabling them to understand the most complex of medical devices and processes and present these concepts in a way that is coherent and easily understandable. In addition, our attorneys are experienced in prosecuting patents and knowledgeable about court proceedings, which may help in forecasting the possible enforcement requirements involving the medical device.
Depending on specific circumstances, however, other strategies may be more appropriate. It is important to discuss your particular situation with a qualified attorney to determine the best strategy in each case.
Mike Biagio discusses the case of Vald Performance vs Kangatech, which demonstrates the outcome of a license that is not done properly and why you need an IP solictor’s advice in drafting exclusive licenses.
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