The newest 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.
The Decision. Lundbeck sought to increase the word of the patent, but did so only just before the patent expired. This is well beyond the usual deadline, and so Patent Ideas had to seek an extension of energy in order for the applying for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products after the patent expired just before the applying extending enough time where you can apply for an extension of term was considered. Since they launched at any given time when Lundbeck had no patent rights, Sandoz argued that they should 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 step arises in unusual circumstances. The anti-depressant drug citalopram is a racemic mixture of the two enantiomers, the ( ) enantiomer and also the (-) enantiomer. Lundbeck held patents within the racemic mixture along with marketed the racemic mixture as CIPRAMIL. The patent in suit claims the more-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). Inside an earlier chapter in this saga, it had been established the application form for extension of term should have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) provides the ( ) enantiomer, rather than on the registration in the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, your day before patent no. 623144 expired. This time the applying for extension of term was based on the ARTG registration for Inventhelp Inventions Store. This is combined with an application for extension of time (because the application needs to have been made within half a year from 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 that this extension of time was allowable since the original deadline for producing the application for extension of term was missed due to a genuine misunderstanding in the law on the portion of the patentee.
Sandoz released their generic product towards the market on 15 June 2009, just two days after the expiry of Lundbeck’s patent, and merely 3 days right after the application for extension of term was developed. The Commissioner of Patents approved an extension of 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 this instance the government Court held which a decision regarding the extension from the term of a patent might be delivered following expiry of the patent, and also the effect of this delivery is retrospective. Even though application for extension of term was filed from time, this could be rectified by applying to extend the deadline as the failure to file soon enough was due to an “error or omission” on the area of the patentee. Although Sandoz launched their product at the same time if it seemed Market An Invention Idea had no patent rights, there is no gap in protection considering that the patent never ceased nor should be restored.
This might be contrasted with all the situation where a patent is restored when, as an example, a renewal fee is paid away from time. In these circumstances, because the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention within the “gap” period is not going to open the party to infringement proceedings.
The influence on generics. Generic manufacturers who attempt to launch soon after the expiry of any patent should take notice of the possibility an application to have an extension of term can be created in a late date America if some error or omission lead to this not done in the prescribed time. Such extensions of patent terms could have retrospective effect if granted following the expiry of the patent. It really is understood the decision is under appeal.