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 extend the phrase from the patent, but did so only just before the patent expired. This is well past the usual deadline, and so Inventions were required to seek an extension of your time to ensure that the application form for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired but before the applying extending time in order to make an application for an extension of term was considered. Given that they launched at the same time when Lundbeck had no patent rights, Sandoz argued that they needs to have been protected from patent infringement once rights were restored. However, the legal court held the extension of term needs to be retrospective., therefore Sandoz infringed the patent.
Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is really a racemic mixture of these 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). Within an earlier chapter in this saga, it had been established the applying for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains the ( ) enantiomer, and not 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 Office Locations. It was combined with an application for extension of time (because the application needs to have been made within six months of 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 get approved. A delegate of Commissioner held that the extension of energy was allowable because the original deadline for making the applying for extension of term was missed as a result of genuine misunderstanding from the law on the part of the patentee.
Sandoz released their generic product for the market on 15 June 2009, just two days right after the expiry of Lundbeck’s patent, and just 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 inside the Federal Court of Australia on 26 June 2014.
Mind the space. In this case the Federal Court held that a decision concerning the extension in the term of the patent could be delivered following expiry from the patent, and the effect of that delivery is retrospective. Although the application for extension of term was filed away from time, this could be rectified by using to increase the deadline as 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 any given time when it seemed How To Get A Patent On An Idea had no patent rights, there is no gap in protection since the patent never ceased nor must be restored.
This might be contrasted with the situation where a patent is restored when, for instance, a renewal fee is paid out of 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 any patent should take note of the possibility that the application for the extension of term can be created in a late date America if some error or omission cause this not being done in the prescribed time. Such extensions of patent terms could have retrospective effect if granted after the expiry of the patent. It is understood the decision is under appeal.