The latest chapter within the extensive and longstanding litigation around Australian patent no. 623144, properties of Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
The Choice. Lundbeck sought to increase the phrase from the patent, but did so only just before the patent expired. This is well beyond the usual deadline, and thus Lundbeck needed 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 applying extending time in order to submit an application for an extension of term was considered. Because they launched at any given time when Lundbeck had no patent rights, Sandoz argued which they must have been protected against patent infringement once rights were restored. However, the legal court held that the extension of term needs to be retrospective., and thus Sandoz infringed the patent.
Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is a racemic mixture of the two enantiomers, the ( ) enantiomer and the (-) enantiomer. Lundbeck held How To Patent within the racemic mixture and had 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 from 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 for extension of term needs to 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 made a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. Now the applying for extension of term was based on the ARTG registration for CIPRAMIL. This was associated with an application for extension of energy (since the application needs to have been made within 6 months in the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for your extension of term to be approved. A delegate of Commissioner held that this extension of your time was allowable because the original deadline for producing 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 I Have An Invention Idea Now What, and just 72 hours following 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 within the Federal Court of Australia on 26 June 2014.
Mind the space. In this case the government Court held which a decision with regards to the extension in the term of any patent may be delivered following expiry in the patent, and the effect of the delivery is retrospective. Even though the application for extension of term was filed away from time, this was able to be rectified by making use of to prolong the deadline as the failure to file in time was because of an “error or omission” on the part of the patentee. Although Sandoz launched their product at a time when it seemed Lundbeck had no patent rights, there was no gap in protection considering that the patent never ceased nor should be restored.
This may be contrasted with all the situation where Product Idea is restored when, as an example, a renewal fee is paid from time. In 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 soon after the expiry of the patent should take note in the possibility that the application to have an extension of term can be made at a late date within australia if some error or omission frfuaj for this not being done inside the prescribed time. Such extensions of patent terms may have retrospective effect if granted after the expiry from the patent. It is actually understood the decision is under appeal.