The newest chapter within the extensive and longstanding litigation around Australian patent no. 623144, owned by Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
The Choice. Lundbeck sought to extend the phrase of the patent, but did so only just before the patent expired. It was well past the usual deadline, therefore Lundbeck had 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 right after the patent expired but before the application form extending time in which to apply for an extension of term was considered. Given that they launched at the same time when Lundbeck had no patent rights, Sandoz argued that they should have been protected from patent infringement once rights were restored. However, the Court held that the extension of term ought to be retrospective., and thus Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is actually a racemic mixture of the two enantiomers, the ( ) enantiomer as well as the (-) enantiomer. Lundbeck held Patent Invention covering the racemic mixture along with 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 from the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). Within an earlier chapter in this saga, it was established the applying for extension of term needs to have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) provides the ( ) enantiomer, rather than on the registration from the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. This time the applying for extension of term was based on the ARTG registration for CIPRAMIL. This is combined with an application for extension of time (since the application must have been made within 6 months from the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for that extension of term to be approved. A delegate of Commissioner held that the extension of your time was allowable considering that the original deadline to make the application for extension of term was missed because of a genuine misunderstanding of 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 Invention Advice, and merely three days after 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 space. In this particular case the government Court held that the decision concerning the extension of the term of any patent might be delivered following expiry in the patent, and also the effect of that delivery is retrospective. Even though the application for extension of term was filed out of time, this could be rectified by using to extend the deadline since the failure to file over time was as a result of an “error or omission” on the area of the patentee. Although Sandoz launched their product at the same time if it seemed Lundbeck had no patent rights, there was no gap in protection considering that the patent never ceased nor needed to be restored.
This may be contrasted with the situation where Patent An Invention is restored when, as an example, a renewal fee is paid out of 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 produce right after the expiry of any patent should take note from the possibility an application for the extension of term can be made at a late date in Australia if some error or omission frfuaj for this not being done within the prescribed time. Such extensions of patent terms will have retrospective effect if granted right after the expiry in the patent. It is actually understood the decision is under appeal.