The most recent chapter within the extensive and longstanding litigation around Australian patent no. 623144, properties of Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
The Choice. Lundbeck sought to extend the phrase in the patent, but did so only just before the patent expired. It was well beyond the usual deadline, and thus Lundbeck needed to seek an extension of time in order for that application for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products after the patent expired but before the application extending enough time in which to make an application for an extension of term was considered. Because they launched at a time when Lundbeck had no patent rights, Sandoz argued they needs to have been shielded from patent infringement once rights were restored. However, the legal court held the extension of term should be retrospective., therefore Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is a racemic mixture of the two enantiomers, the ( ) enantiomer and the (-) enantiomer. Lundbeck held How To Get An Idea Made Into A Prototype With Inventhelp within the racemic mixture and had marketed the racemic mixture as CIPRAMIL. The patent in suit claims the better-effective ( ) enantiomer. Lundbeck sought an extension of term based on the registration in the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). Inside an earlier chapter within this saga, it had been established the application for extension of term should have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, and not on the registration of the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck made a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. This time around the applying for extension of term was based on the ARTG registration for CIPRAMIL. It was combined with a software for extension of your time (because the application should have been made within 6 months from the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for that extension of term to get approved. A delegate of Commissioner held the extension of time was allowable considering that the original deadline for producing the application form for extension of term was missed as a result of genuine misunderstanding from the law on the portion of the patentee.
Sandoz released their generic product for the market on 15 June 2009, just two days after the expiry of Market An Invention Idea, and just three days following the application for extension of term was made. The Commissioner of Patents approved an extension from the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings within the Federal Court of Australia on 26 June 2014.
Mind the Gap. In this particular case the government Court held which a decision regarding the extension from the term of a patent may be delivered following expiry in the patent, and the effect of the delivery is retrospective. Even though the application for extension of term was filed away from time, this was able to be rectified by applying to prolong the deadline since the failure to file in time was due to an “error or omission” on the area of the patentee. Although Sandoz launched their product at a time if it seemed Lundbeck had no patent rights, there was clearly no gap in protection considering that the patent never ceased nor should be restored.
This may be contrasted with all the situation where Inventhelp Commercial is restored when, as an example, a renewal fee is paid away from time. In these circumstances, considering that the patent did temporarily cease, steps taken by another party to exploit the patented invention in the “gap” period will never open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to launch immediately after the expiry of a patent should take note of the possibility that an application for the extension of term can be produced in a late date around australia if some error or omission frfuaj to this particular not done inside the prescribed time. Such extensions of patent terms could have retrospective effect if granted after the expiry from the patent. It is understood that this decision is under appeal.