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Humira patent extension hopes dashed
Posted 21 August 2017
Any hopes Abbvie had that it may have be able to extend three of its Humira (adalimumab) patents have been dashed, after the Federal Court threw out an earlier tribunal decision which had theoretically opened the way for the extensions.
Although Humira was originally ARTG listed on 10 December, 2003, Abbvie had argued for some years that additional patents covering later ARTG inclusions for ankylosing spondylitis, Crohn disease and ulcerative colitis could be extended.
The extension submission was founded on so-called 'Swiss claims'. Such claims are based on the premise that new treatment methods require inventiveness and can therefore justify patent life beyond that of the original drug patent, particularly in regard to recombinant DNA technology.
In an outcome that lawyers are already saying could affect similar extension claims, the court decided that Swiss style patents of the type Abbvie has been litigating are not eligible for extension.
When this question came before Deputy Commissioner of Patents Phil Spann in September, 2015 he rejected Abbvie's argument that extensions should be granted if the methods of treatment were associated with recombinant techniques.
The three patents in question - had Abbvie's claim been accepted by the Deputy Commissioner - could have theoretically extended out into late 2021 and early 2022.
Almost a year later the question came up again in an Abbvie appeal to the Administrative Appeals Tribunal (AATA), who saw it in a different light again.
The tribunal took the view in its decision that section 70(2)9b) of the Patents Act 1990 (Cth) did allow for the patent extensions though there were question marks that the date Abbvie had used was of first medical usage rather than first date of approval.
But that decision, which legal observers at the time said they expected would be overturned anyway, still had all parties agreeing that the maximum patent extension could be only to 10 December 2018.
In a clear case of 'back to the future', this latest decision from the Federal Court in the matter of the Commissioner of Patents vs Abbvie, allowed the Commissioner's appeal, upholding the original 2015 decision by Deputy Commissioner of Patents Spann that Abbvie had no case to extend the patents.
This is likely to be a particularly hard blow for the Australian operation with the blockbuster auto-inflammatory accounting for 79 per cent of Abbvie's PBS pre-rebate revenue in FY 2016/17. Internationally it accounts for 60 per cent of its revenue.
Meanwhile biosimilars are already lining up.
Amjevita, sponsored by Amgen, was the first biosimilar for Humira approved in the US in September 2016 and in the EU in March this year.
Boehringer Ingelgheim has a Humira biosimilar that has been successful in phase three trials and MSD, Samsung Bioepis, Shire, Allergan, Pfizer, Momenta and Novartis are all known to be working on their own versions as well.
David Rowley
david.rowley@lushmedia.com.au
Posted 21 August 2017
Any hopes Abbvie had that it may have be able to extend three of its Humira (adalimumab) patents have been dashed, after the Federal Court threw out an earlier tribunal decision which had theoretically opened the way for the extensions.
Although Humira was originally ARTG listed on 10 December, 2003, Abbvie had argued for some years that additional patents covering later ARTG inclusions for ankylosing spondylitis, Crohn disease and ulcerative colitis could be extended.
The extension submission was founded on so-called 'Swiss claims'. Such claims are based on the premise that new treatment methods require inventiveness and can therefore justify patent life beyond that of the original drug patent, particularly in regard to recombinant DNA technology.
In an outcome that lawyers are already saying could affect similar extension claims, the court decided that Swiss style patents of the type Abbvie has been litigating are not eligible for extension.
When this question came before Deputy Commissioner of Patents Phil Spann in September, 2015 he rejected Abbvie's argument that extensions should be granted if the methods of treatment were associated with recombinant techniques.
The three patents in question - had Abbvie's claim been accepted by the Deputy Commissioner - could have theoretically extended out into late 2021 and early 2022.
Almost a year later the question came up again in an Abbvie appeal to the Administrative Appeals Tribunal (AATA), who saw it in a different light again.
The tribunal took the view in its decision that section 70(2)9b) of the Patents Act 1990 (Cth) did allow for the patent extensions though there were question marks that the date Abbvie had used was of first medical usage rather than first date of approval.
But that decision, which legal observers at the time said they expected would be overturned anyway, still had all parties agreeing that the maximum patent extension could be only to 10 December 2018.
In a clear case of 'back to the future', this latest decision from the Federal Court in the matter of the Commissioner of Patents vs Abbvie, allowed the Commissioner's appeal, upholding the original 2015 decision by Deputy Commissioner of Patents Spann that Abbvie had no case to extend the patents.
This is likely to be a particularly hard blow for the Australian operation with the blockbuster auto-inflammatory accounting for 79 per cent of Abbvie's PBS pre-rebate revenue in FY 2016/17. Internationally it accounts for 60 per cent of its revenue.
Meanwhile biosimilars are already lining up.
Amjevita, sponsored by Amgen, was the first biosimilar for Humira approved in the US in September 2016 and in the EU in March this year.
Boehringer Ingelgheim has a Humira biosimilar that has been successful in phase three trials and MSD, Samsung Bioepis, Shire, Allergan, Pfizer, Momenta and Novartis are all known to be working on their own versions as well.
David Rowley
david.rowley@lushmedia.com.au
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