The newest chapter in the extensive and longstanding litigation around Australian patent no. 623144, properties of Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
The Decision. Lundbeck sought to extend the word in the patent, but did so only prior to the patent expired. This is well past the usual deadline, and so Inventhelp Review had to seek an extension of energy in order for the application form for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products after the patent expired just before the application extending the time in which to apply for an extension of term was considered. Because they launched at any given time when Lundbeck had no patent rights, Sandoz argued which they must have been protected from patent infringement once rights were restored. However, the Court held that 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 a racemic mixture of these two enantiomers, the ( ) enantiomer and the (-) enantiomer. Lundbeck held patents covering the racemic mixture along with 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 of the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). Within an earlier chapter in this saga, it had been established the applying for extension of term needs to 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 day before patent no. 623144 expired. This time the application for extension of term was based on the ARTG registration for How To Submit A Patent. This was combined with a software for extension of energy (because the application must have been made within half a year from the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for that extension of term to become approved. A delegate of Commissioner held that this extension of your time was allowable considering that the original deadline for making the application for extension of term was missed as a result of genuine misunderstanding from the law on the area of the patentee.
Sandoz released their generic product for the market on 15 June 2009, just two days right after the expiry of Lundbeck’s patent, and only 72 hours 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 within the Federal Court of Australia on 26 June 2014.
Mind the Gap. In cases like this the government Court held which a decision concerning the extension from the term of the patent may be delivered following expiry in the patent, as well as the effect of the delivery is retrospective. Even though the application for extension of term was filed from time, this was able to be rectified by using to extend the deadline as the failure to submit over time was as a result of an “error or omission” on the area of the patentee. Although Sandoz launched their product at a time in the event it seemed Patent Invention had no patent rights, there was no gap in protection since the patent never ceased nor must be restored.
This can be contrasted using the situation where a patent is restored when, as an example, 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 in the “gap” period will not open the party to infringement proceedings.
The impact on generics. Generic manufacturers who aim to launch soon after the expiry of any patent should take notice of the possibility that an application for an extension of term can be created in a late date the United States if some error or omission lead to this not being done in the prescribed time. Such extensions of patent terms could have retrospective effect if granted right after the expiry of the patent. It is actually understood that the decision is under appeal.