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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 Decision. Lundbeck sought to extend the word in the patent, but did so only right before the patent expired. It was well past the usual deadline, therefore Inventhelp Success were required to seek an extension of energy to ensure that 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 enough time in order to make an application for an extension of term was considered. Since they launched at a time when Lundbeck had no patent rights, Sandoz argued that they must have been protected from patent infringement once rights were restored. However, the legal court held that 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 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 better-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 absolutely was established the application form 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 in the ( ) enantiomer (LEXAPRO) on the ARTG .

Lundbeck made a new application for extension of term on 12 June 2009, your day before patent no. 623144 expired. Now the application form for extension of term was based on the ARTG registration for Inventhelp Number. This was combined with a software for extension of time (because the application must have been made within six 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 become approved. A delegate of Commissioner held the extension of your time was allowable because the original deadline for producing the applying for extension of term was missed due to 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 Lundbeck’s patent, and only 3 days right after the application for extension of term was developed. 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. In this case the government Court held that a decision concerning the extension in the term of the patent could be delivered following expiry of the patent, and the effect of that delivery is retrospective. Even though application for extension of term was filed from time, this could be rectified by applying 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 any given time when it seemed Inventhelp Company Headquarters had no patent rights, there was no gap in protection since the patent never ceased nor needed to be restored.

This can be contrasted with all the situation when a patent is restored when, for example, a renewal fee pays away from time. During these circumstances, because the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention in the “gap” period will not open the party to infringement proceedings.

The impact on generics. Generic manufacturers who aim to launch immediately after the expiry of the patent should pay attention to the possibility that an application for an extension of term can be produced at a late date America if some error or omission result in this not being done within the prescribed time. Such extensions of patent terms may have retrospective effect if granted right after the expiry of the patent. It is understood that this decision is under appeal.