The most recent 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.
Your Decision. Lundbeck sought to prolong the phrase of the patent, but did so only just before the patent expired. It was well past the usual deadline, therefore Lundbeck were required to seek an extension of time in order for that application for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products following the patent expired but before the application extending enough time in which to submit 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 which they needs to have been protected from patent infringement once rights were restored. However, a legal court held that this extension of term should be retrospective., and so Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is really a racemic mixture of the two enantiomers, the ( ) enantiomer and the (-) enantiomer. Lundbeck held Inventhelp Inventions Store covering the racemic mixture and had marketed the racemic mixture as CIPRAMIL. The patent in suit claims the better-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 in this saga, it absolutely was established the applying for extension of term should have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, and never on the registration in 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 the application form for extension of term was based on the ARTG registration for CIPRAMIL. It was combined with a software for extension of energy (because the application should have been made within six months in the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for that extension of term to be approved. A delegate of Commissioner held that the extension of time was allowable since the original deadline for making the application for extension of term was missed because of a genuine misunderstanding of the law on the area of the patentee.
Sandoz released their generic product towards the market on 15 June 2009, just two days after the expiry of New Inventions, and only three days after the application for extension of term was made. The Commissioner of Patents approved an extension of the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings in the Federal Court of Australia on 26 June 2014.
Mind the space. Within this case the government Court held that a decision regarding the extension from the term of a patent might be delivered following expiry in the patent, as well as the effect of that delivery is retrospective. Even though application for extension of term was filed out of time, this was able to be rectified by applying to extend the deadline because the failure to file over time was due to an “error or omission” on the area of the patentee. Although Sandoz launched their product at the same time when it seemed Lundbeck had no patent rights, there is no gap in protection because the patent never ceased nor must be restored.
This may be contrasted with the situation where How To Pitch An Invention To A Company is restored when, as an example, a renewal fee pays out of time. Within these circumstances, considering that the patent did temporarily cease, steps taken by another party to exploit the patented invention in the “gap” period will not open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to launch immediately after the expiry of a patent should take note from the possibility an application for the extension of term can be made at a late date within australia if some error or omission frfuaj to this not being done within the prescribed time. Such extensions of patent terms will have retrospective effect if granted after the expiry from the patent. It really is understood that this decision is under appeal.