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AbbVie wins Humira patent appeal
Posted 14 September 2016
An Administrative Appeals Tribunal (AATA) decision has potentially opened the way for sponsors to push for patent term extensions in biologics which use recombinant DNA technology.
The decision overturned last year's ruling by the Deputy Commissioner of Patents Phil Spann against AbbVie, which was using "Swiss-style" claims to extend patents on the blockbuster auto-inflammatory drug Humira (adaliumumab) to 2021 and 2022.
Originally approved and listed on the ARTG of 10 December 2003 for rheumatoid arthritis, Humira also has additional patents covering later ARTG inclusions for ankylosing spondylitis, Crohns disease and ulcerative colitis. These later inclusions are the basis of the patent extension claims.
A so-called 'Swiss' claim uses the premise that although an active ingredient remains the same, the particular method of treatment is new. This convention permits patent extensions based on new indications attached to the same active ingredint. The theory is that there is novelty or inventiveness involved in making the drug capable of use for additional conditions.
Deputy Commissioner Spann rejected that claim last year on the basis that, although different indications led to distinct ARTG listings, they didn't mean the make-up of the drug was necessarily different.
But last week's AATA decision found that when recombinant DNA technology was involved the "substance falls within the scope of the claims of the patents within the meaning of section 70(2)(b) of the Patents Act 1990 (Cth) where such patent is granted in respect of a particular therapeutic use".
But despite finding the patents may qualify for extension, the AATA said they would not be extended in this case because the date AbbVie had used was the first medical use date and not the first date of approval.
It said AbbVie could apply to correct the error but the parties agreed the maximum patent extension would be to 10 December 2018.
Although observers believe the latest AATA finding will itself be challenged and likely over-turned, an opinion piece in Lexology by Patrick McManamny and Prue Cowin from the Melbourne office of patent lawyers FB Rice said it might be worthwhile considering filing for additional patent term extensions.
"The AATA's decision has paved the way for manufacturers of biotherapeutics to obtain additional patent term extensions for patents directed to a second or subsequent medical use of a known pharmaceutical substance produced using recombinant DNA technology," they wrote.
David Rowley
david.rowley@lushmedia.com.au
Posted 14 September 2016
An Administrative Appeals Tribunal (AATA) decision has potentially opened the way for sponsors to push for patent term extensions in biologics which use recombinant DNA technology.
The decision overturned last year's ruling by the Deputy Commissioner of Patents Phil Spann against AbbVie, which was using "Swiss-style" claims to extend patents on the blockbuster auto-inflammatory drug Humira (adaliumumab) to 2021 and 2022.
Originally approved and listed on the ARTG of 10 December 2003 for rheumatoid arthritis, Humira also has additional patents covering later ARTG inclusions for ankylosing spondylitis, Crohns disease and ulcerative colitis. These later inclusions are the basis of the patent extension claims.
A so-called 'Swiss' claim uses the premise that although an active ingredient remains the same, the particular method of treatment is new. This convention permits patent extensions based on new indications attached to the same active ingredint. The theory is that there is novelty or inventiveness involved in making the drug capable of use for additional conditions.
Deputy Commissioner Spann rejected that claim last year on the basis that, although different indications led to distinct ARTG listings, they didn't mean the make-up of the drug was necessarily different.
But last week's AATA decision found that when recombinant DNA technology was involved the "substance falls within the scope of the claims of the patents within the meaning of section 70(2)(b) of the Patents Act 1990 (Cth) where such patent is granted in respect of a particular therapeutic use".
But despite finding the patents may qualify for extension, the AATA said they would not be extended in this case because the date AbbVie had used was the first medical use date and not the first date of approval.
It said AbbVie could apply to correct the error but the parties agreed the maximum patent extension would be to 10 December 2018.
Although observers believe the latest AATA finding will itself be challenged and likely over-turned, an opinion piece in Lexology by Patrick McManamny and Prue Cowin from the Melbourne office of patent lawyers FB Rice said it might be worthwhile considering filing for additional patent term extensions.
"The AATA's decision has paved the way for manufacturers of biotherapeutics to obtain additional patent term extensions for patents directed to a second or subsequent medical use of a known pharmaceutical substance produced using recombinant DNA technology," they wrote.
David Rowley
david.rowley@lushmedia.com.au
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