The latest chapter within 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.
Your Decision. Lundbeck sought to prolong the phrase in the patent, but did so only right before the patent expired. This was well beyond the usual deadline, and thus How To Pitch An Invention To A Company were required to seek an extension of time in order for the applying for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products following the patent expired but before the application form extending the time in order to make an application for an extension of term was considered. Because they launched at a time when Lundbeck had no patent rights, Sandoz argued they should have been protected from patent infringement once rights were restored. However, the Court held the extension of term needs to be retrospective., and so Sandoz infringed the patent.
Background. This step arises in unusual circumstances. The anti-depressant drug citalopram is really a racemic mixture of the 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 greater-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 within this saga, it was established the application for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) contains the ( ) enantiomer, rather than on the registration from the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, your day before patent no. 623144 expired. This time the application for extension of term was based on the ARTG registration for Product Patent. It was combined with a software for extension of energy (considering that the application needs to have been made within half a year of the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for the extension of term to become approved. A delegate of Commissioner held that the extension of your time was allowable considering that the original deadline for making the applying for extension of term was missed due to a genuine misunderstanding of the law on the portion of the patentee.
Sandoz released their generic product for the market on 15 June 2009, just two days after the expiry of Lundbeck’s patent, and merely 3 days following 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 space. In this case the Federal Court held that the decision with regards to the extension of the term of a patent may be delivered following expiry in the patent, and also the effect of this delivery is retrospective. Even though the application for extension of term was filed away from time, this was able to be rectified by using to increase the deadline since the failure to submit in time was due to an “error or omission” on the part of the patentee. Although Sandoz launched their product at a time when it seemed How To Patent An Idea had no patent rights, there is no gap in protection because the patent never ceased nor needed to be restored.
This might be contrasted with all the situation in which a patent is restored when, for instance, a renewal fee is paid from time. During these circumstances, because the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention inside the “gap” period is not going to open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to launch immediately after the expiry of the patent should take note of the possibility that an application for an extension of term can be created at a late date within australia if some error or omission cause this not done in the prescribed time. Such extensions of patent terms could have retrospective effect if granted after the expiry in the patent. It is understood the decision is under appeal.