Medical device patents

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.

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.

What medical devices are patentable?

Medical devices, methods of medical treatment and software are all patentable in Australia.

Benefits and challenges of filing medical device patents

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.

Examples of granted medical device patent applications

Tissue engineering
AU Patent # 2015220781
FGF-18 in graft transplantation and tissue engineering procedures

Merck Patent GmBH

Prosthetics
AU Patent # 2018204135
Prosthetic capsular devices, systems, and methods

Omega Ophthalmics LLC

Diagnostics
AU Patent # 2017200853
MiRNA and its diagnostic therapeutic uses in diseases or conditions associated with melanoma, or in diseases or conditions associated with activated BRAF pathway

InteRNA Technologies BV; Koninklijke Nederlandse Akademie van Wetenschappen

Monitoring
AU Patent # 2018200163
Methods of therapeutic monitoring of phenylacetic acid prodrugs

Horizon Therapeutics LLC

Laboratory
AU Patent # 2013402428
A device for washing, disinfecting and/or sterilizing medical, dental, laboratory and/or pharmaceutical goods and methods and program products for use therein

Getinge Sterilization AB

Therapeutic device
AU Patent # 2016202644
Device for use in endoluminal vacuum therapy

Kleiner, Daniel Eduard

Implants
AU Patent # 2016252274
Absorbable implants for plastic surgery

Tepha, Inc.

Surgery
AU Patent # 2015401598
Argon beam coagulation flex probe for laparoscopic surgery

Conmed Corporation

General healthcare systems
AU Patent # 2016216665
Home medical device systems and methods for therapy prescription and tracking, servicing and inventory

Baxter Healthcare SA; Baxter International Inc