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The latest chapter within the extensive and longstanding litigation around Australian patent no. 623144, owned by Danish pharmaceutical company H. Lundbeck A/S [1], highlights a practical difficulty for generic manufacturers.

The Choice. Lundbeck sought to extend the term of the patent, but did so only right before the patent expired. This was well beyond the usual deadline, and so Patent Your Idea were required 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 but before the application form extending enough time where you can submit an application for an extension of term was considered. Because 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., therefore 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 greater-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). Inside an earlier chapter in this saga, it had been established the application form for extension of term needs to have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, rather than on the registration of 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. Now the application form for extension of term was based on the ARTG registration for Inventhelp George Foreman Commercials. This was combined with a software for extension of time (because the application should have been made within six 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 get approved. A delegate of Commissioner held that the extension of energy was allowable because the original deadline to make the application for extension of term was missed due to a genuine misunderstanding in the law on the portion of the patentee.

Sandoz released their generic product to the market on 15 June 2009, just two days after the expiry of Lundbeck’s patent, and merely three days right after the application for extension of term was made. The Commissioner of Patents approved an extension of the patent term on 25 June 2014 [3]. Lundbeck filed patent infringement proceedings in the Federal Court of Australia on 26 June 2014.

Mind the Gap. In this case the government Court held that a decision concerning the extension from the term of the patent could be delivered following expiry from the patent, and the effect of the delivery is retrospective. Even though the application for extension of term was filed away from time, this was able to be rectified by applying to extend the deadline as the failure to submit soon enough was due to an “error or omission” on the portion of the patentee. Although Sandoz launched their product at any given time when it seemed How To Pitch An Invention Idea To A Company had no patent rights, there was no gap in protection because the patent never ceased nor should be restored.

This might be contrasted using the situation where a patent is restored when, for instance, a renewal fee is paid out of time. Within these circumstances, since the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention within the “gap” period is not going to open the party to infringement proceedings.

The effect on generics. Generic manufacturers who seek to launch right after the expiry of a patent should take note of the possibility that an application to have an extension of term can be made at a late date the USA 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 in the patent. It is understood the decision is under appeal.