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.
The Choice. Lundbeck sought to prolong the phrase of the patent, but did so only prior to the patent expired. It was well past the usual deadline, and so New Invention Ideas were required to seek an extension of time in order for the application form for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products right after the patent expired before the application extending time in which to make an application for an extension of term was considered. Because they launched at any given time when Lundbeck had no patent rights, Sandoz argued they needs to have been shielded from patent infringement once rights were restored. However, a legal court held that the extension of term needs to be retrospective., and thus Sandoz infringed the patent.
Background. This action arises in unusual circumstances. The anti-depressant drug citalopram is a racemic mixture of these two enantiomers, the ( ) enantiomer and also the (-) enantiomer. Lundbeck held patents within 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 in the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter in this particular saga, it absolutely was 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 of the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, the morning before patent no. 623144 expired. This time around the applying for extension of term was based on the ARTG registration for Inventhelp Phone Number. This was associated with an application for extension of your 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 that extension of term to get approved. A delegate of Commissioner held that the extension of your time was allowable because the original deadline for producing the applying 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 towards the market on 15 June 2009, just two days following the expiry of Lundbeck’s patent, and only 3 days after the application for extension of term was made. 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 which a decision regarding the extension from the term of the patent might be delivered following expiry in the patent, and also the effect of this delivery is retrospective. Although the application for extension of term was filed away from time, this managed to be rectified by using to extend the deadline because 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 New Invention Ideas had no patent rights, there was clearly no gap in protection since the patent never ceased nor must be restored.
This may be contrasted with the situation when a patent 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 vagrgq exploit the patented invention within the “gap” period will not open the party to infringement proceedings.
The impact on generics. Generic manufacturers who aim to launch right after the expiry of a patent should pay attention to the possibility that the application to have an extension of term can be created with a late date America if some error or omission lead to this not being done in the prescribed time. Such extensions of patent terms will have retrospective effect if granted right after the expiry in the patent. It is actually understood the decision is under appeal.