The most recent 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.
Your Decision. Lundbeck sought to prolong the phrase of the patent, but did so only just before the patent expired. This was well past the usual deadline, therefore Tech needed to seek an extension of time to ensure that the application for extension of term that need considering. Several generic manufacturers, including Sandoz, launched products right after the patent expired just before the application form extending enough time where you can submit an application for an extension of term was considered. Since they launched at the same time when Lundbeck had no patent rights, Sandoz argued they must have been shielded from patent infringement once rights were restored. However, the Court held the extension of term needs to 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 covering the racemic mixture and had 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 within this saga, it had been established the application form for extension of term must have been based on the earlier registration on the ARTG of citalopram, as citalopram (CIPRAMIL) has the ( ) enantiomer, and not on the registration of the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, the morning before patent no. 623144 expired. This time the applying for extension of term was based on the ARTG registration for Inventhelp Pittsburgh Corporate Headquarters. It was accompanied by a software for extension of your time (because the application must have been made within 6 months from the date of the ARTG registration of CIPRAMIL, making the deadline 26 July 1999) which must be successful for that extension of term to be approved. A delegate of Commissioner held that the extension of time was allowable considering that the original deadline to make the applying 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 for the market on 15 June 2009, just two days following the expiry of Lundbeck’s patent, and just 3 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 which a decision with regards to the extension in the term of a patent might be delivered following expiry from the patent, as well as the effect of that 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 because of an “error or omission” on the area of the patentee. Although Sandoz launched their product at the same time in the event it seemed Inventhelp Company News had no patent rights, there was no gap in protection because the patent never ceased nor should be restored.
This might be contrasted with all the situation in which a patent is restored when, for example, a renewal fee is paid out of time. Within these circumstances, because the patent did temporarily cease, steps taken by another party vagrgq exploit the patented invention inside the “gap” period will never open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to launch immediately after the expiry of any patent should pay attention to 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 result in this not being done within the prescribed time. Such extensions of patent terms may have retrospective effect if granted right after the expiry from the patent. It is understood that the decision is under appeal.