The newest chapter within the extensive and longstanding litigation around Australian patent no. 623144, belonging to Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
Your Decision. Lundbeck sought to increase the word of the patent, but did so only just before the patent expired. This was well beyond the usual deadline, and thus New Ideas For Inventions needed to seek an extension of time in order for the application form for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired before the application form extending the time in order to make an application for an extension of term was considered. Because they launched at the same time when Lundbeck had no patent rights, Sandoz argued that they needs to have been protected against patent infringement once rights were restored. However, a legal court held that 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 the two enantiomers, the ( ) enantiomer and also the (-) enantiomer. Lundbeck held patents covering 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 from the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter within this saga, it absolutely was 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, and never on the registration from the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. This time around the application for extension of term was based on the ARTG registration for Inventhelp Successful Inventions. This was associated with a software for extension of energy (considering that the application must have been made within 6 months in the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for that extension of term to get approved. A delegate of Commissioner held the extension of energy was allowable considering that the original deadline to make the application form for extension of term was missed as a result of genuine misunderstanding in the law on the part of the patentee.
Sandoz released their generic product to the market on 15 June 2009, just two days right after the expiry of Lundbeck’s patent, and merely 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 . Lundbeck filed patent infringement proceedings within the Federal Court of Australia on 26 June 2014.
Mind the space. In cases like this the government Court held which a decision with regards to the extension from the term of any patent may be delivered following expiry of the patent, and the effect of this delivery is retrospective. Even though application for extension of term was filed out of time, this managed to be rectified by making use of to prolong the deadline since the failure to file soon enough was due to an “error or omission” on the part of the patentee. Although Sandoz launched their product at the same time in the event it seemed Inventhelp Commercial had no patent rights, there was clearly no gap in protection because the patent never ceased nor must be restored.
This may be contrasted with the situation where a patent is restored when, as an example, a renewal fee pays out of time. During 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 influence on generics. Generic manufacturers who attempt to launch immediately after the expiry of a patent should pay attention to the possibility an application for the extension of term can be created at 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 right after the expiry in the patent. It is actually understood the decision is under appeal.