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The newest chapter in 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 prolong the term in the patent, but did so only right before the patent expired. It was well past the usual deadline, therefore Inventhelp Innovation News had to seek an extension of your time to ensure that the application form for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products right after the patent expired but before the applying extending time where you can apply for an extension of term was considered. Because they launched at a time when Lundbeck had no patent rights, Sandoz argued that they should have been protected from patent infringement once rights were restored. However, the legal court held the extension of term should 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 and also the (-) enantiomer. Lundbeck held patents within 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 of the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). Inside an earlier chapter in this particular 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) has the ( ) enantiomer, and never on the registration of the ( ) enantiomer (LEXAPRO) on the ARTG .

Lundbeck produced a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. This time around the application for extension of term was based on the ARTG registration for Inventhelp Products. This is associated with an application for extension of energy (since the application should have been made within 6 months in the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which needed to be successful for that extension of term to get approved. A delegate of Commissioner held the extension of time was allowable because the original deadline for making the applying for extension of term was missed because of a genuine misunderstanding from the law on the area 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 just 3 days following the application for extension of term was made. The Commissioner of Patents approved an extension in the patent term on 25 June 2014 [3]. Lundbeck filed patent infringement proceedings inside the Federal Court of Australia on 26 June 2014.

Mind the Gap. In this instance the Federal Court held that a decision regarding the extension of the term of a patent could be delivered following expiry of the patent, and the effect of this delivery is retrospective. Even though application for extension of term was filed away from time, this could be rectified by making use of to extend the deadline because the failure to file over time was because of an “error or omission” on the area of the patentee. Although Sandoz launched their product at a time if it seemed Inventhelp Office had no patent rights, there is no gap in protection considering that the patent never ceased nor must be restored.

This might be contrasted using the situation when a patent is restored when, for example, a renewal fee is paid out of 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 never open the party to infringement proceedings.

The effect on generics. Generic manufacturers who attempt to launch soon after the expiry of any patent should pay attention to the possibility an application to have an extension of term can be produced with a late date the United States if some error or omission cause this not done inside the prescribed time. Such extensions of patent terms will have retrospective effect if granted following the expiry in the patent. It really is understood the decision is under appeal.

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