The newest chapter in 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.
Your Decision. Lundbeck sought to increase the word from the patent, but did so only prior to the patent expired. It was well beyond the usual deadline, and so New Ideas For Inventions were required to seek an extension of energy in order for the application form for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products following the patent expired just before the application form extending enough time in which to submit an application for an extension of term was considered. Given that they launched at any given 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 ought to be retrospective., and thus Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is actually a racemic mixture of these two enantiomers, the ( ) enantiomer as well as the (-) enantiomer. Lundbeck held patents within the racemic mixture and had 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 within this saga, it had been established the application for extension of term should have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, and not on the registration in the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck produced a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. Now the application form for extension of term was based on the ARTG registration for Inventhelp Stories. This was combined with an application for extension of your time (considering that the application should have been made within 6 months in the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for the extension of term to become approved. A delegate of Commissioner held the extension of time was allowable since the original deadline for producing the application for extension of term was missed due to a genuine misunderstanding of the law on the portion of the patentee.
Sandoz released their generic product towards the market on 15 June 2009, just two days right after the expiry of Lundbeck’s patent, and only 72 hours right after the application for extension of term was made. The Commissioner of Patents approved an extension in the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings in the Federal Court of Australia on 26 June 2014.
Mind the Gap. In this instance the government Court held that the decision with regards to the extension of the term of a patent may be delivered following expiry from the patent, and the effect of the delivery is retrospective. Although the application for extension of term was filed away from time, this could be rectified by making use of to extend the deadline as the failure to submit in time was due to an “error or omission” on the portion of the patentee. Although Sandoz launched their product at any given time if it seemed Review For Inventhelp had no patent rights, there was no gap in protection because the patent never ceased nor should be restored.
This may be contrasted with the situation where a patent is restored when, as an example, a renewal fee is paid from time. During these circumstances, since the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention in the “gap” period is not going to open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to launch immediately after the expiry of any patent should take notice of the possibility an application for the extension of term can be made with a late date America if some error or omission result in this not done within the prescribed time. Such extensions of patent terms may have retrospective effect if granted after the expiry of the patent. It is understood that this decision is under appeal.