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 Choice. Lundbeck sought to prolong the word from the patent, but did so only just before the patent expired. This was well past the usual deadline, therefore 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 after the patent expired but before the application extending time in order to apply for an extension of term was considered. Because they launched at any given 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 ought to be retrospective., and so 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 as well as the (-) enantiomer. Lundbeck held How Do I Patent An Idea 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 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 application form for extension of term needs to 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 made a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. Now the application form for extension of term was based on the ARTG registration for CIPRAMIL. This is associated with an application for extension of energy (since the application needs to have been made within six months in the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for your extension of term to get approved. A delegate of Commissioner held that this extension of energy was allowable since the original deadline for making the application form 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 for the market on 15 June 2009, just two days following the expiry of Invention Companies, and just 72 hours following the application for extension of term was made. The Commissioner of Patents approved an extension from 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 this case the Federal Court held that a decision with regards to the extension of the term of any patent could be delivered following expiry in the patent, as well as the effect of that delivery is retrospective. Even though the application for extension of term was filed out of time, this managed to be rectified by making use of to extend the deadline since the failure to file over time was due to an “error or omission” on the part of the patentee. Although Sandoz launched their product at a time in the event 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 the situation where I Have An Idea For An Invention is restored when, as an example, a renewal fee is paid from time. In 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 influence on generics. Generic manufacturers who seek to produce right after the expiry of any patent should take note in the possibility that the application for the extension of term can be made with a late date around 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 right after the expiry of the patent. It is actually understood that the decision is under appeal.