The newest chapter within the extensive and longstanding litigation around Australian patent no. 623144, owned by Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
The Choice. Lundbeck sought to increase the phrase in the patent, but did so only prior to the patent expired. It was well past the usual deadline, therefore Inventhelp Intromark needed to seek an extension of time in order for the application form for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products following the patent expired before the application extending enough time where you can apply for an extension of term was considered. Since they launched at the same time when Lundbeck had no patent rights, Sandoz argued they needs to have been protected against patent infringement once rights were restored. However, a legal court held that this extension of term should be retrospective., therefore 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 as well as the (-) enantiomer. Lundbeck held patents within 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 in the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter in this saga, it had been established the application form for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has 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 morning before patent no. 623144 expired. This time around the applying for extension of term was based on the ARTG registration for Inventhelp Reviews. It was combined with a software for extension of your time (since the application must have been made within half a year of the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which had to be successful for that extension of term to become approved. A delegate of Commissioner held that the extension of time was allowable considering that the original deadline for making the application 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 72 hours after the application for extension of term was created. 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 Federal Court held that the decision regarding the extension in the term of any patent might be delivered following expiry from the patent, as well as the effect of the delivery is retrospective. Although the application for extension of term was filed away from time, this managed to be rectified by making use of to extend the deadline since the failure to file in time was because of an “error or omission” on the portion of the patentee. Although Sandoz launched their product at a time if it seemed Inventhelp Successful Inventions had no patent rights, there was clearly no gap in protection because the patent never ceased nor should be restored.
This might be contrasted with all the situation when a patent is restored when, for instance, a renewal fee is paid from time. In these circumstances, because the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention inside the “gap” period is not going to open the party to infringement proceedings.
The effect on generics. Generic manufacturers who aim to launch soon after the expiry of a patent should take note of the possibility that an application to have an extension of term can be created in a late date the USA if some error or omission cause this not being done inside the prescribed time. Such extensions of patent terms will have retrospective effect if granted following the expiry of the patent. It is understood that the decision is under appeal.