The most recent chapter within 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.
The Decision. Lundbeck sought to extend the phrase from the patent, but did so only prior to the patent expired. This was well beyond the usual deadline, and so Inventhelp Tv Commercial were required to seek an extension of energy to ensure the applying for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products after the patent expired before the application extending the time in which to make an application for an extension of term was considered. Given that they launched at a time when Lundbeck had no patent rights, Sandoz argued they needs to have been shielded from patent infringement once rights were restored. However, the legal court held that this extension of term needs to be retrospective., and so Sandoz infringed the patent.
Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is really a racemic mixture of these two enantiomers, the ( ) enantiomer and the (-) enantiomer. Lundbeck held patents covering the racemic mixture and had 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 in this particular saga, it had been established the applying for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains the ( ) enantiomer, and never on the registration from the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck made a new application for extension of term on 12 June 2009, your day before patent no. 623144 expired. This time around the applying for extension of term was based on the ARTG registration for Patent My Idea. This is accompanied by an application for extension of time (considering that the application needs to have been made within 6 months of the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for your extension of term to become approved. A delegate of Commissioner held that the extension of energy was allowable considering that the original deadline to make the applying for extension of term was missed because of a genuine misunderstanding in 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 just 72 hours following the application for extension of term was made. The Commissioner of Patents approved an extension of the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings within the Federal Court of Australia on 26 June 2014.
Mind the space. In cases like this the Federal Court held that the decision regarding the extension of the term of the patent may 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 using to prolong the deadline since the failure to submit in time was as a result of an “error or omission” on the part of the patentee. Although Sandoz launched their product at the same time in the event it seemed Inventhelp had no patent rights, there was clearly no gap in protection considering that the patent never ceased nor should be restored.
This might be contrasted using the situation where a patent is restored when, as an example, a renewal fee pays away from time. Within these circumstances, since 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 impact on generics. Generic manufacturers who aim to launch soon after the expiry of a patent should take notice of the possibility an application to have an extension of term can be produced at a late date America if some error or omission lead to this not done within the prescribed time. Such extensions of patent terms will have retrospective effect if granted after the expiry from the patent. It is actually understood that this decision is under appeal.