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

The Decision. Lundbeck sought to prolong the word of the patent, but did so only right before the patent expired. This is well past the usual deadline, and thus Inventhelp Products had to seek an extension of your time to ensure the applying for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products following the patent expired just before the application extending enough time in which to submit an application for an extension of term was considered. Since they launched at any given time when Lundbeck had no patent rights, Sandoz argued which they needs to have been protected against patent infringement once rights were restored. However, the legal court held that the extension of term should be retrospective., therefore 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 within the racemic mixture along with 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 absolutely 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, 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 day before patent no. 623144 expired. This time around the applying for extension of term was based on the ARTG registration for Inventhelp Caveman. It was accompanied by a software for extension of time (since the application must have been made within six months from the date from the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for the extension of term to become approved. A delegate of Commissioner held that this extension of energy was allowable since the original deadline for producing the application form for extension of term was missed due to a genuine misunderstanding in the law on the area of the patentee.

Sandoz released their generic product to the market on 15 June 2009, just two days following the expiry of Lundbeck’s patent, and just 3 days after the application for extension of term was made. The Commissioner of Patents approved an extension from the patent term on 25 June 2014 [3]. 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 regarding the extension from the term of a patent could be delivered following expiry of the patent, as well as the effect of the delivery is retrospective. Even though application for extension of term was filed from time, this could be rectified by applying to extend the deadline since 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 the same time if it seemed Patent Invention had no patent rights, there is no gap in protection because the patent never ceased nor needed to be restored.

This may be contrasted with all the situation in which a patent is restored when, for instance, a renewal fee is paid away from time. During these circumstances, since the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention inside the “gap” period is not going to open the party to infringement proceedings.

The influence on generics. Generic manufacturers who aim to launch right after the expiry of any patent should take notice of the possibility that an application for the extension of term can be created at a late date the USA if some error or omission lead to this not done inside the prescribed time. Such extensions of patent terms will have retrospective effect if granted right after the expiry of the patent. It is actually understood that this decision is under appeal.