The most recent chapter in the extensive and longstanding litigation around Australian patent no. 623144, belonging to Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
Your Decision. Lundbeck sought to prolong the phrase in the patent, but did so only right before the patent expired. This was well past the usual deadline, therefore Inventhelp Inventions Store needed to seek an extension of energy to ensure the application form for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired but before the application extending the time where you can apply for an extension of term was considered. Because they launched at any given time when Lundbeck had no patent rights, Sandoz argued that 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., therefore Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is actually a racemic mixture of these two enantiomers, the ( ) enantiomer as well as the (-) enantiomer. Lundbeck held patents covering 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). Within an earlier chapter within this saga, it had been established the application for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) provides the ( ) enantiomer, and never on the registration of 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. This time the applying for extension of term was based on the ARTG registration for How Do I Patent An Idea. It was combined with an application for extension of time (because the application should have been made within six months from the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which had to be successful for the extension of term to be approved. A delegate of Commissioner held that this extension of energy was allowable because the original deadline for producing the application for extension of term was missed because of a genuine misunderstanding from the law on the portion of the patentee.
Sandoz released their generic product to the market on 15 June 2009, just two days after the expiry of Lundbeck’s patent, and merely 72 hours following the application for extension of term was created. The Commissioner of Patents approved an extension in the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings inside the Federal Court of Australia on 26 June 2014.
Mind the space. In this case the Federal Court held that a decision concerning the extension from the term of a patent could be delivered following expiry from the patent, and also the effect of the delivery is retrospective. Even though application for extension of term was filed away from time, this could be rectified by applying to prolong the deadline as the failure to submit over time was due to an “error or omission” on the part of the patentee. Although Sandoz launched their product at a time if it seemed How Do I Patent An Idea had no patent rights, there was no gap in protection since the patent never ceased nor should be restored.
This may be contrasted with all the situation in which a patent is restored when, for example, a renewal fee pays out of time. In these circumstances, considering that the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention within the “gap” period will never open the party to infringement proceedings.
The effect on generics. Generic manufacturers who aim to launch soon after the expiry of a patent should pay attention to the possibility that the 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 after the expiry in the patent. It is understood that the decision is under appeal.