The most recent 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.
The Decision. Lundbeck sought to prolong the word of the patent, but did so only just before the patent expired. It was well past the usual deadline, therefore How To Patent An Idea had to seek an extension of energy in order for the application for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products following the patent expired before the applying extending enough time where you can make an application for an extension of term was considered. Since they launched at the same time when Lundbeck had no patent rights, Sandoz argued they must have been protected from patent infringement once rights were restored. However, the legal court held the extension of term needs to be retrospective., therefore Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is a racemic mixture of the two enantiomers, the ( ) enantiomer and 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 in the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). Inside an earlier chapter in 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, your day before patent no. 623144 expired. This time the application form for extension of term was based on the ARTG registration for Product Ideas. This was associated with an application for extension of energy (because the application needs to have been made within 6 months of the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which had to be successful for that extension of term to be approved. A delegate of Commissioner held that the extension of energy was allowable since the original deadline for producing the applying for extension of term was missed because of a genuine misunderstanding from the law on the part of the patentee.
Sandoz released their generic product towards the market on 15 June 2009, just two days after the expiry of Lundbeck’s patent, and just 72 hours right after the application for extension of term was developed. 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 cases like this the Federal Court held that the decision with regards to the extension from the term of a patent could be delivered following expiry of the patent, as well as 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 prolong the deadline because the failure to file in time was because of an “error or omission” on the portion of the patentee. Although Sandoz launched their product at the same time if it seemed Getting A Patent had no patent rights, there was clearly no gap in protection since the patent never ceased nor needed to be restored.
This may be contrasted with all the situation when a patent is restored when, as an example, a renewal fee is paid out of time. Within these circumstances, because the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention within the “gap” period is not going to open the party to infringement proceedings.
The influence on generics. Generic manufacturers who aim to launch soon after the expiry of any patent should take note of the possibility an application for an extension of term can be created at a late date in Australia if some error or omission result in this not being done inside the prescribed time. Such extensions of patent terms could have retrospective effect if granted right after the expiry of the patent. It really is understood the decision is under appeal.