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

Your Decision. Lundbeck sought to extend the phrase of the patent, but did so only just before the patent expired. It was well beyond 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 following the patent expired but before the application extending the time where you can submit an application for an extension of term was considered. Given that they launched at a time when Lundbeck had no patent rights, Sandoz argued which they should have been shielded from patent infringement once rights were restored. However, the Court held that this extension of term should be retrospective., and so Sandoz infringed the patent.

Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is really a racemic mixture of the two enantiomers, the ( ) enantiomer as well as the (-) enantiomer. Lundbeck held Technology within 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). Inside an earlier chapter within this saga, it was established the applying for extension of term should have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains the ( ) enantiomer, rather than on the registration of the ( ) enantiomer (LEXAPRO) on the ARTG .

Lundbeck made 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. It was combined with an application for extension of energy (considering that the application should have been made within half a year from the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for your extension of term to become approved. A delegate of Commissioner held that this extension of time was allowable because the original deadline to make the application form for extension of term was missed because of a genuine misunderstanding in the law on the area of the patentee.

Sandoz released their generic product towards the market on 15 June 2009, just two days following the expiry of Inventor Ideas, and just 72 hours following the application for extension of term was created. 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 Gap. Within this case the Federal Court held that the decision with regards to the extension of the term of a patent might be delivered following expiry of the patent, and the effect of this delivery is retrospective. Even though the application for extension of term was filed away from time, this managed to be rectified by using to increase the deadline since the failure to file in time was due to an “error or omission” on the part of the patentee. Although Sandoz launched their product at the same time when it seemed Lundbeck had no patent rights, there is no gap in protection since the patent never ceased nor should be restored.

This may be contrasted using the situation where How To Start An Invention Idea is restored when, for example, a renewal fee is paid out of time. During these circumstances, considering that the patent did temporarily cease, steps taken by another party to exploit the patented invention within 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 of the possibility that the application to have an extension of term can be made in a late date within australia if some error or omission frfuaj to this not done inside the prescribed time. Such extensions of patent terms could have retrospective effect if granted following the expiry in the patent. It is understood that this decision is under appeal.

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