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The most recent chapter in the extensive and longstanding litigation around Australian patent no. 623144, owned by Danish pharmaceutical company H. Lundbeck A/S [1], highlights a practical difficulty for generic manufacturers.

Your Decision. Lundbeck sought to extend the word from the patent, but did so only just before the patent expired. This was well past the usual deadline, and thus Lundbeck were required to seek an extension of time in order for your application for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired but before the application extending the time in which to apply for an extension of term was considered. Because they launched at a time when Lundbeck had no patent rights, Sandoz argued which they must have been protected against patent infringement once rights were restored. However, a legal court held that this extension of term needs 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 Invention Website 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 of the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter in this saga, it had been established the applying for extension of term needs to have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains 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 form for extension of term was based on the ARTG registration for CIPRAMIL. It was associated with a software for extension of your time (considering that the application must have been made within half a year from the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for the extension of term to get approved. A delegate of Commissioner held that this extension of time was allowable because the original deadline for producing the application for extension of term was missed due to a genuine misunderstanding from 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 Inventhelp, and merely 72 hours following the application for extension of term was made. The Commissioner of Patents approved an extension from the patent term on 25 June 2014 [3]. Lundbeck filed patent infringement proceedings inside the Federal Court of Australia on 26 June 2014.

Mind the space. In this particular case the Federal Court held that a decision with regards to the extension of the term of the patent may be delivered following expiry in the patent, as well as the effect of that delivery is retrospective. Although the application for extension of term was filed out of time, this was able to be rectified by applying to extend the deadline since the failure to file over time was as a result of an “error or omission” on the portion of the patentee. Although Sandoz launched their product at the same time when it seemed Lundbeck had no patent rights, there was clearly no gap in protection since the patent never ceased nor should be restored.

This may be contrasted with the situation where How To Start An Invention Idea is restored when, for example, a renewal fee is paid from time. During these circumstances, considering that the patent did temporarily cease, steps taken by another party to exploit the patented invention inside the “gap” period is not going to open the party to infringement proceedings.

The impact on generics. Generic manufacturers who seek to launch right after the expiry of the patent should take note from the possibility that an application for an extension of term can be produced in a late date in Australia if some error or omission frfuaj to this not done within the prescribed time. Such extensions of patent terms will have retrospective effect if granted after the expiry in the patent. It is actually understood that this decision is under appeal.

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