Full Federal Court Confirms an Application to list on the PBS Prior to Patent Expiry is a non infringing Act
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Late last week, the Full Federal Court of Australia confirmed that the mere act of filing a Pharmaceutical Benefits Scheme (PBS) application for a generic pharmaceutical product is not, of itself, an act of infringement provided that the generic product will not be made available for sale to wholesalers or pharmacists until after the relevant patent has expired: Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58. This decision clears any uncertainty for generics proposing to apply to list on the PBS prior to patent expiry for post patent launch.
Warner Lambert & Pfizer appealed the 2016 decision of Nicholas J, Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 that an application by the respondents for the listing of their generic pregabalin product, (Generic Pregabalin)) on the Australian Pharmaceutical Benefits Scheme (PBS) did not infringe Warner Lambert's patent (Australian standard patent 714980) directed to the use of pregabalin to treat pain (the Patent)).
Full Federal Court – the issue
The present appeal turned on the Full Federal Court considering Nicholas J's characterisation of a patentee’s exclusive rights and the meaning of “exploit” under the Patents Act 1990 (Cth) (the Patents Act).
"Exploit" is defined in the Patent Act to mean:
(a) where the invention is a product–make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or
(b) where the invention is a method or process–use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use.
Full Federal Court – the appellants' case
Warner Lambert & Pfizer claimed Nicholas J was in error in concluding that the respondents' proposed actions fell short of offering to sell or otherwise dispose of the products and therefore did not amount to patent infringement, arguing that:
- The definition of "exploit" in the Patents Act provides that the patentee alone may exploit the invention during the term of the patent; and
- Any act which enables another party to take advantage of the invention for commercial or economic benefit is liable to be found to have exploited the invention; and
- The offer to supply the Generic Pregabilin is made on the making of the PBS application, and therefore applying for a PBS listing during the term of the Patent gives a "a springboard for PBS listing", which is a commercial or economic benefit and therefore amounts to patent infringement.
Full Federal Court – the respondents'…
