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The most recent chapter in 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.


The Choice. Lundbeck sought to extend the phrase of the patent, but did so only prior to the patent expired. This is well beyond the usual deadline, therefore How To Pitch An Idea To A Company had to seek an extension of time to ensure that the application form for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products right after the patent expired before the application extending time in which to apply 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 legal court held the extension of term should be retrospective., therefore 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 as well as the (-) enantiomer. Lundbeck held patents covering 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 of the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). Within an earlier chapter in this particular saga, it absolutely was 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 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. Now the application form for extension of term was based on the ARTG registration for Invention. This is accompanied by an application for extension of energy (considering that the application must 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 be approved. A delegate of Commissioner held that the extension of energy was allowable because the original deadline to make the applying for extension of term was missed due to a genuine misunderstanding from the law on the portion of the patentee.

Sandoz released their generic product for the market on 15 June 2009, just two days after the expiry of Lundbeck’s patent, 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 within the Federal Court of Australia on 26 June 2014.

Mind the space. In this instance the government Court held that the decision concerning the extension of the term of the patent could be delivered following expiry from the patent, and the effect of this delivery is retrospective. Even though application for extension of term was filed out of time, this was able to be rectified by using to extend the deadline because the failure to submit soon enough was as a result of an “error or omission” on the portion of the patentee. Although Sandoz launched their product at a time if it seemed Inventhelp Success had no patent rights, there was clearly no gap in protection because the patent never ceased nor needed to be restored.

This may be contrasted with the situation when a patent is restored when, as an example, a renewal fee pays from time. In these circumstances, since 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 impact on generics. Generic manufacturers who attempt to launch soon after the expiry of any patent should pay attention to the possibility that the application to have an extension of term can be made with a late date America if some error or omission lead to this not done in the prescribed time. Such extensions of patent terms will have retrospective effect if granted following the expiry from the patent. It is understood the decision is under appeal.