For Australian Companies Entering the U.S.

U.S. Patent Strategy for Australian Medical Device Companies

Australian device companies typically look offshore early because the home market is modest in size. The U.S. portfolio often ends up being the most valuable part of the patent estate, and it deserves to be planned that way from the first filing.

From IP Australia and the TGA to the USPTO and FDA

Australia has produced device companies with global reach. Cochlear, founded in 1981 and headquartered on the Macquarie University campus in Sydney, develops cochlear, bone conduction, and acoustic implants. The Medical Technology Association of Australia (MTAA) is the industry's peak association, with members ranging from local start-ups to multinational manufacturers. The domestic market is price sensitive and largely government funded. Devices must generally be included in the Australian Register of Therapeutic Goods before supply, and the Therapeutic Goods Administration (TGA) classifies them as Class I, IIa, IIb, or III. Depending on class, the TGA can draw on FDA, CE marking, and MDSAP evidence to abridge its own conformity assessment, and Australia is a participating authority in the Medical Device Single Audit Program alongside the United States.

IP Australia administers patents, and Australia is a PCT contracting state. Section 24 of the Patents Act provides a 12-month grace period for the applicant's own publication or use, but the protection depends on filing a complete application, meaning an Australian standard application or a PCT application designating Australia, within 12 months of the disclosure; a provisional application alone does not satisfy that condition. Australia's second-tier innovation patent is also closing: new applications stopped being accepted from August 26, 2021, with existing innovation patents running out by 2029. Australia does not require a foreign filing license for inventions made there, although the Commissioner of Patents may issue orders prohibiting or restricting publication of information in the interests of defense.

The move to FDA brings a different regulatory vocabulary. FDA uses three classes and three main routes: 510(k) clearance based on a predicate, De Novo classification for novel low-to-moderate-risk devices, and premarket approval for Class III. For implantable and life-sustaining devices on a PMA route, U.S. patent term extension under 35 U.S.C. 156 may restore part of the term consumed by regulatory review; 510(k) and De Novo devices do not qualify.

U.S. rights are territorial. An Australian provisional or standard application supports a U.S. priority claim only if the U.S. or PCT application follows within 12 months, and PCT applications must enter the U.S. national stage within 30 months of priority. A freedom-to-operate review before launch is prudent, because importing an infringing device into the United States infringes and the International Trade Commission can exclude infringing imports. We coordinate with Australian patent attorneys on IP Australia matters and focus on the U.S. portfolio.

Home-country organizations active in this sector include Medical Technology Association of Australia (MTAA). Knechtel Law Group is not affiliated with them.

Patent Strategy Considerations

What matters when Australian device companies enter the U.S.

Treat the grace period as a fallback, not a plan

Australia's 12-month grace period and the U.S. one-year exception can both help after an early disclosure, but Europe allows far less, and the Australian protection depends on a complete application rather than a provisional. Filing before disclosure keeps all options open.

Consider term extension for implantables

For Class III implantable or life-sustaining devices headed for PMA, identify early which U.S. patents claim the approved product or its use, so that a term extension application can be considered promptly after approval.

Plan the U.S. filing sequence with the TGA pathway in mind

Where an Australian company expects to use FDA evidence to support TGA inclusion, U.S. clinical work and publications may come early. Patent filings should be in place before trial designs, abstracts, or investor materials describe the invention.

How Engagements Work

Senior counsel, directly — wherever the company is.

Knechtel Law Group is based in Carefree, Arizona, and advises on U.S. patent strategy. Questions of Australian or European law are for your home-country counsel; the work here is coordinated with them so priority claims, filings and deadlines line up. Consultations are scheduled across time zones.

Request a Confidential Consultation

Patent portfolio review and strategy aligned to the product roadmap
Freedom-to-operate and competitor landscape review before launch
Claim alignment with FDA pathway, indications, and product changes
IP diligence readiness for investors, acquirers, and licensees
U.S. market entry for companies based abroad

Common Questions

Australian device companies ask.

Does an Australian provisional application protect our U.S. position?

It can establish a priority date for a U.S. or PCT application filed within 12 months. It does not create U.S. rights on its own, and the U.S. claims must be supported by what the provisional actually disclosed.

Do we need permission to file in the United States first?

Australia does not impose a general foreign filing license requirement, though defense-related prohibition orders are possible. If any part of the invention was made in the United States, a U.S. foreign filing license may be needed before filing in Australia.

Discuss Your Portfolio

Patent strategy built around your device and your market.

Schedule a confidential consultation to discuss your technology, your existing portfolio, and your plans.

Request a Confidential Consultation