The newest chapter in the extensive and longstanding litigation around Australian patent no. 623144, properties of Danish pharmaceutical company H. Lundbeck A/S , highlights a practical difficulty for generic manufacturers.
The Choice. Lundbeck sought to increase the term of the patent, but did so only just before the patent expired. This was well past the usual deadline, and thus Lundbeck were required to seek an extension of energy in order for that application for extension of term to be considered. Several generic manufacturers, including Sandoz, launched products after the patent expired but before the applying extending enough time in order to apply for an extension of term was considered. Given that they launched at any given time when Lundbeck had no patent rights, Sandoz argued that they must have been protected against patent infringement once rights were restored. However, a legal court held the extension of term needs to be retrospective., and so 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 the (-) enantiomer. Lundbeck held Patent A Product covering 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 in the ( ) enantiomer, as LEXAPRO, on the Australian Register of Therapeutic Goods (ARTG). In an earlier chapter in this particular saga, it absolutely was 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 never on the registration of the ( ) enantiomer (LEXAPRO) on the ARTG .
Lundbeck created a new application for extension of term on 12 June 2009, the day before patent no. 623144 expired. Now the application form for extension of term was based on the ARTG registration for CIPRAMIL. It was combined with an application for extension of time (since the application should have been made within six months from the date of 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 the extension of your time was allowable considering that the original deadline for producing the application form for extension of term was missed as a result of 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 after the expiry of Inventhelp New Products, and just three days right after the application for extension of term was developed. The Commissioner of Patents approved an extension in the patent term on 25 June 2014 . Lundbeck filed patent infringement proceedings in the Federal Court of Australia on 26 June 2014.
Mind the Gap. Within this case the government Court held which a decision regarding the extension in the term of a patent could be delivered following expiry of the patent, and also the effect of this delivery is retrospective. Although the application for extension of term was filed from time, this was able to be rectified by using to extend the deadline since the failure to file over time was as a result of an “error or omission” on the part of the patentee. Although Sandoz launched their product at any given time when it seemed Lundbeck had no patent rights, there is no gap in protection because the patent never ceased nor must be restored.
This may be contrasted with the situation where I Have An Invention Where Do I Start is restored when, as an example, a renewal fee is paid from time. During these circumstances, because the patent did temporarily cease, steps taken by another party to exploit the patented invention in the “gap” period will not open the party to infringement proceedings.
The effect on generics. Generic manufacturers who seek to produce immediately after the expiry of the patent should take note of the possibility that an application to have an extension of term can be produced at a late date within australia if some error or omission frfuaj to this particular not being done inside the prescribed time. Such extensions of patent terms may have retrospective effect if granted following the expiry of the patent. It really is understood that this decision is under appeal.