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.
The Decision. Lundbeck sought to increase the term from the patent, but did so only just before the patent expired. It was well beyond the usual deadline, and so Lundbeck were required to seek an extension of energy 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 form extending enough time in which to make 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 that they should have been shielded from patent infringement once rights were restored. However, a legal court held the extension of term should be retrospective., and thus Sandoz infringed the patent.
Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is actually a racemic mixture of the two enantiomers, the ( ) enantiomer as well as the (-) enantiomer. Lundbeck held I Have An Invention covering the racemic mixture along with 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 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 form for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains the ( ) enantiomer, rather than on the registration from 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. This time the applying for extension of term was based on the ARTG registration for CIPRAMIL. This was accompanied by an application for extension of energy (because the application must have been made within half a year from 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 get approved. A delegate of Commissioner held the extension of your time was allowable since the original deadline for making the application form for extension of term was missed as a result of genuine misunderstanding of the law on the part of the patentee.
Sandoz released their generic product to the market on 15 June 2009, just two days following the expiry of Product Idea, and just 72 hours after 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 inside the Federal Court of Australia on 26 June 2014.
Mind the Gap. In this particular case the Federal Court held that the decision with regards to the extension from the term of a patent might be delivered following expiry in the patent, and the effect of that delivery is retrospective. Although the application for extension of term was filed from time, this was able to be rectified by applying to increase the deadline since the failure to file in 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 was clearly no gap in protection since the patent never ceased nor should be restored.
This may be contrasted with the situation where How To Get An Idea Patented is restored when, for example, a renewal fee is paid away from time. During these circumstances, considering that the patent did temporarily cease, steps taken by another party to exploit the patented invention in the “gap” period is not going to open the party to infringement proceedings.
The impact on generics. Generic manufacturers who seek to produce immediately after the expiry of any patent should take note of the possibility an application to have an extension of term can be made with a late date within australia if some error or omission frfuaj to this particular not done in the prescribed time. Such extensions of patent terms may have retrospective effect if granted following the expiry of the patent. It is actually understood that the decision is under appeal.