The most recent chapter in 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 extend the phrase of the patent, but did so only just before the patent expired. This is well beyond the usual deadline, and so Lundbeck had to seek an extension of energy in order for the application for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired but before the application extending time in which to submit an application for an extension of term was considered. Given that they launched at a time when Lundbeck had no patent rights, Sandoz argued which 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 actually a racemic mixture of these two enantiomers, the ( ) enantiomer and also the (-) enantiomer. Lundbeck held Inventhelp Corporate Headquarters 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 in the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter in this particular saga, it had been established the applying for extension of term needs to have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, rather than on the registration of 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 applying for extension of term was based on the ARTG registration for CIPRAMIL. This is associated with an application for extension of time (considering that the application needs to have been made within 6 months of the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for that extension of term to become approved. A delegate of Commissioner held that this extension of energy was allowable because the original deadline for producing the applying 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 right after the expiry of Inventhelp Invention News, and merely 3 days right after 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 inside the Federal Court of Australia on 26 June 2014.
Mind the Gap. In this particular case the Federal Court held that a decision concerning the extension of the term of the patent could be delivered following expiry of the patent, and also the effect of the delivery is retrospective. Although the application for extension of term was filed out of time, this managed to be rectified by using to extend the deadline because the failure to file in time was as a result of an “error or omission” on the portion 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 considering that the patent never ceased nor should be restored.
This may be contrasted with all the situation where How To Patent An Idea is restored when, for instance, a renewal fee pays out of time. Within these circumstances, because the patent did temporarily cease, steps taken by another party to exploit the patented invention inside the “gap” period is not going to open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to produce immediately after the expiry of any patent should take note from the possibility that an application for an extension of term can be made with a late date in Australia if some error or omission frfuaj to this particular not being done in the prescribed time. Such extensions of patent terms may have retrospective effect if granted following the expiry in the patent. It really is understood that the decision is under appeal.