The most recent chapter in 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 Decision. Lundbeck sought to increase the word from the patent, but did so only right before the patent expired. This is well beyond the usual deadline, and thus New Invention Ideas needed to seek an extension of time in order for the applying for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired before the application form extending enough time in which to submit an application for an extension of term was considered. Because they launched at the same time when Lundbeck had no patent rights, Sandoz argued they needs to have been protected from patent infringement once rights were restored. However, a legal court held that the extension of term ought to be retrospective., therefore Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is really a racemic mixture of these two enantiomers, the ( ) enantiomer and also the (-) enantiomer. Lundbeck held patents covering the racemic mixture and had marketed the racemic mixture as CIPRAMIL. The patent in suit claims the greater-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). Within an earlier chapter within this saga, it was established the application form 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 in the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck made a new application for extension of term on 12 June 2009, the morning before patent no. 623144 expired. This time around the application form for extension of term was based on the ARTG registration for Inventhelp Invention News. This is combined with a software for extension of energy (since the application must have been made within 6 months in the date from 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 this extension of energy was allowable since the original deadline for making the application for extension of term was missed because of a genuine misunderstanding of the law on the area of the patentee.
Sandoz released their generic product to the market on 15 June 2009, just two days following the expiry of Lundbeck’s patent, and just 72 hours right after the application for extension of term was created. The Commissioner of Patents approved an extension in the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings in the Federal Court of Australia on 26 June 2014.
Mind the space. In this instance the Federal Court held that the decision with regards to the extension in the term of a patent may be delivered following expiry from the patent, and the effect of this delivery is retrospective. Even though application for extension of term was filed from time, this could be rectified by applying to prolong the deadline since the failure to file soon enough was because of an “error or omission” on the part of the patentee. Although Sandoz launched their product at a time when it seemed Inventhelp Office Locations had no patent rights, there was no gap in protection because the patent never ceased nor must be restored.
This can be contrasted using the situation where a patent is restored when, for instance, a renewal fee pays away from time. Within these circumstances, considering that the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention in the “gap” period will never open the party to infringement proceedings.
The influence on generics. Generic manufacturers who attempt to launch right after the expiry of a patent should take notice of the possibility that the application for an extension of term can be made at a late date America if some error or omission cause this not done in the prescribed time. Such extensions of patent terms may have retrospective effect if granted after the expiry in the patent. It really is understood the decision is under appeal.