The newest chapter in 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.
The Choice. Lundbeck sought to extend the term in the patent, but did so only just before the patent expired. This was well beyond the usual deadline, and thus Inventhelp Success Stories were required to seek an extension of time to ensure that the applying for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products after the patent expired just before the application form extending the time where you can apply for an extension of term was considered. Since they launched at a time when Lundbeck had no patent rights, Sandoz argued they must 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 step arises in unusual circumstances. The anti-depressant drug citalopram is actually a racemic mixture of these two enantiomers, the ( ) enantiomer as well as 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 particular saga, it was established the application for extension of term needs to have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) provides the ( ) enantiomer, rather than on the registration in the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck produced a new application for extension of term on 12 June 2009, your day before patent no. 623144 expired. Now the application form for extension of term was based on the ARTG registration for Inventhelp Company News. This is associated with an application for extension of time (since the application must have been made within 6 months of the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for your extension of term to become 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 due to a genuine misunderstanding from the law on the part of the patentee.
Sandoz released their generic product for the market on 15 June 2009, just two days following the expiry of Lundbeck’s patent, and only 72 hours after the application for extension of term was created. 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 Gap. In this instance the government Court held that the decision concerning the extension in the term of the patent may be delivered following expiry from the patent, and also the effect of that delivery is retrospective. Even though application for extension of term was filed away 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 area of the patentee. Although Sandoz launched their product at any given time in the event it seemed How To Pitch An Idea To A Company had no patent rights, there was clearly no gap in protection since the patent never ceased nor should be restored.
This may be contrasted with the situation when a patent is restored when, for example, a renewal fee is paid out of time. During these circumstances, considering that 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 immediately after the expiry of a patent should pay attention to the possibility that an application for an extension of term can be produced at a late date America 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 after the expiry of the patent. It really is understood that this decision is under appeal.