The latest chapter in 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 term of the patent, but did so only just before the patent expired. This was well beyond the usual deadline, and so Lundbeck needed to seek an extension of your time in order for the application for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products after the patent expired but before the applying extending the time where you can apply for an extension of term was considered. Since they launched at the same time when Lundbeck had no patent rights, Sandoz argued which they needs to have been protected against patent infringement once rights were restored. However, the Court held that this extension of term ought to be retrospective., and thus Sandoz infringed the patent.
Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is a racemic mixture of these two enantiomers, the ( ) enantiomer and also the (-) enantiomer. Lundbeck held Inventhelp Commercials covering the racemic mixture along with marketed the racemic mixture as CIPRAMIL. The patent in suit claims the more-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 had been established the application form for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, rather than on the registration from the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck produced a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. This time around the application for extension of term was based on the ARTG registration for CIPRAMIL. This is associated with an application for extension of energy (considering that the application should have been made within six months from the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which had to be successful for that extension of term to become approved. A delegate of Commissioner held the extension of energy was allowable because the original deadline for making the application for extension of term was missed as a result of genuine misunderstanding from the law on the area of the patentee.
Sandoz released their generic product towards the market on 15 June 2009, just two days right after the expiry of Inventhelp Invention Prototype, and only 3 days following the application for extension of term was made. The Commissioner of Patents approved an extension of the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings inside the Federal Court of Australia on 26 June 2014.
Mind the Gap. In this particular case the Federal Court held that a decision with regards to the extension from the term of any patent might be delivered following expiry in the patent, and the effect of this delivery is retrospective. Although the application for extension of term was filed out of time, this managed to be rectified by making use of to increase 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 in the event 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 using the situation where Idea Help is restored when, for example, a renewal fee pays from time. During these circumstances, because the patent did temporarily cease, steps taken by another party to exploit the patented invention inside the “gap” period will not open the party to infringement proceedings.
The influence on generics. Generic manufacturers who seek to produce soon after the expiry of a patent should take note in the possibility that an application for the extension of term can be produced with a late date within australia if some error or omission frfuaj to this not being done inside the prescribed time. Such extensions of patent terms will have retrospective effect if granted right after the expiry in the patent. It is understood the decision is under appeal.