The newest 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 term from the patent, but did so only just before the patent expired. This was well beyond the usual deadline, and thus How Do You Get A Patent had to seek an extension of energy to ensure that the application form for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products following the patent expired just before the application extending time where you can apply for an extension of term was considered. Since they launched at the same 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 this extension of term ought 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 the two enantiomers, the ( ) enantiomer and also 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 from the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter in this saga, it was established the application for extension of term should have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) provides the ( ) enantiomer, and not on the registration from the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck made a new application for extension of term on 12 June 2009, the morning before patent no. 623144 expired. This time around the application form for extension of term was based on the ARTG registration for Inventhelp Reviews. It was associated with an application for extension of time (because the application must have been made within 6 months in the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for that extension of term to get approved. A delegate of Commissioner held that this extension of time was allowable considering that the original deadline for making the application for extension of term was missed as a result of genuine misunderstanding in the law on the part of the patentee.
Sandoz released their generic product to the market on 15 June 2009, just two days right after the expiry of Lundbeck’s patent, and only three days 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 within the Federal Court of Australia on 26 June 2014.
Mind the Gap. In cases like this the Federal Court held that the decision concerning the extension from the term of the patent could be delivered following expiry of the patent, and also the effect of this delivery is retrospective. Even though the application for extension of term was filed from time, this could be rectified by making use of to prolong the deadline because the failure to file soon enough was due to an “error or omission” on the part of the patentee. Although Sandoz launched their product at any given time when it seemed Reviews For Inventhelp had no patent rights, there was no gap in protection because 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 pays out of time. During these circumstances, since the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention inside the “gap” period will not open the party to infringement proceedings.
The influence on generics. Generic manufacturers who attempt to launch immediately after the expiry of a patent should take note of the possibility that an application for the extension of term can be produced at a late date the United States if some error or omission cause this not being done inside the prescribed time. Such extensions of patent terms could have retrospective effect if granted after the expiry from the patent. It is understood the decision is under appeal.