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.
Your Decision. Lundbeck sought to increase the phrase of the patent, but did so only just before the patent expired. It was well past the usual deadline, therefore Patent An Invention had to seek an extension of time in order for the application form for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products after the patent expired but before the application extending time in which to apply for an extension of term was considered. Because they launched at any given time when Lundbeck had no patent rights, Sandoz argued that they must have been protected from patent infringement once rights were restored. However, a legal court held the extension of term needs to be retrospective., therefore Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is actually a racemic mixture of these two enantiomers, the ( ) enantiomer as well as the (-) enantiomer. Lundbeck held patents within the racemic mixture along with 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). Inside an earlier chapter in this saga, it absolutely was established the application for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains the ( ) enantiomer, and never on the registration of 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 the applying for extension of term was based on the ARTG registration for How To Patent Ideas. It was combined with an application for extension of energy (because the application must have been made within half a year of the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for the extension of term to get approved. A delegate of Commissioner held the extension of energy was allowable since the original deadline for making the applying for extension of term was missed as a result of 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 right after the expiry of Lundbeck’s patent, and just 3 days after the application for extension of term was developed. 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 cases like this the government Court held that a decision regarding the extension in the term of any patent may be delivered following expiry from the patent, and also the effect of this delivery is retrospective. Even though application for extension of term was filed from time, this was able to be rectified by making use of to extend the deadline as the failure to submit in time was because of an “error or omission” on the area of the patentee. Although Sandoz launched their product at a time if it seemed Tech had no patent rights, there was clearly no gap in protection since the patent never ceased nor needed to be restored.
This can be contrasted with the situation in which a patent is restored when, for instance, a renewal fee pays out of time. In these circumstances, considering that the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention in the “gap” period is not going to open the party to infringement proceedings.
The influence on generics. Generic manufacturers who seek to launch immediately after the expiry of the patent should take note of the possibility that an application for an extension of term can be produced at a late date around australia if some error or omission cause this not being done within the prescribed time. Such extensions of patent terms could have retrospective effect if granted following the expiry from the patent. It is understood that the decision is under appeal.