The newest 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 extend the phrase from the patent, but did so only just before the patent expired. This was well past the usual deadline, therefore How To Submit A Patent had to seek an extension of energy to ensure the applying for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products following the patent expired before the application extending the time where you can make an application for an extension of term was considered. Since they launched at any given time when Lundbeck had no patent rights, Sandoz argued that they needs to have been shielded from patent infringement once rights were restored. However, a legal court held that this extension of term ought to be retrospective., and so Sandoz infringed the patent.
Background. This action 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 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 from 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 not 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 around the application form for extension of term was based on the ARTG registration for Inventhelp Store. This was accompanied by an application for extension of your time (because the application should have been made within 6 months from the date in the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for your extension of term to be approved. A delegate of Commissioner held that this extension of time was allowable considering that the original deadline for making 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 towards 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 developed. 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 regarding the extension of the term of any patent may be delivered following expiry from the patent, and the effect of that delivery is retrospective. Although the application for extension of term was filed away from time, this could be rectified by making use of to increase the deadline as the failure to file in time was due to an “error or omission” on the portion of the patentee. Although Sandoz launched their product at the same time when it seemed Inventhelp Store Products had no patent rights, there was no gap in protection considering that the patent never ceased nor must be restored.
This may be contrasted with the situation when a patent is restored when, for instance, a renewal fee is paid out of time. Within 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 influence on generics. Generic manufacturers who seek to launch soon after the expiry of a patent should take note of the possibility that an application for an extension of term can be made 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 actually understood the decision is under appeal.