For AbbVie’s third quarter, sales totalled $5.9bn (€5.1bn), up 18% year-on-year. The majority - $3.6bn – was due to sales of the firm’s TNF inhibiting anti-inflammatory mAb Humira (adalimumab), US sales of which rose 30% on the same period last year.
But with biosimilars already infringing on sales of reference biologics in some markets and with the launch of the first copycat in the US in September , the firm told investors it is not worried about dwindling sales due to its complex IP protection which will ward off US Humira competition for at least seven years.
“Any company seeking to market a biosimilar version of Humira will have to contend with [our] extensive patent estate, which AbbVie intends to enforce vigorously,” CEO Richard Gonzalez said last week. “We believe the litigation process and our intellectual property estate will protect Humira from biosimilar entry until 2022.”
Biosimilar developers beware!
The drug’s composition patent loses its exclusivity in the US in December 2016, but Gonzalez said Humira has over 70 additional patents expiring between 2022 and 2034.
“The vast majority of these patents, which reflect significant innovation and investment, were granted by the US patent and trademark office within the past two years,” he said. “The size of AbbVie's patent estate is a direct consequence of the ground-breaking work of AbbVie scientists in a new field of biologics.”
Copycat versions of Humira are in development by a number of firms - including Amgen, Pfizer, Sandoz and Boehringer Ingelheim - and with increasing players entering the biosimilar space AbbVie could well be entering into a lot of lawsuits.
However, “given the unique properties of Humira and the lack of any prior experience with fully human monoclonal antibodies these patents are strong,” Gonzalez said. “Courts considering request for preliminary injunctions have considered these factors important and have granted injunctions where they are present.”
Formulation, manufacturing and methods of use patents
Formulation patents – of which Gonzalez said a further 14 have been issued - cover related formulations that biosimilar companies might employ, while he added manufacturing patents expire no earlier than 2027.
“The living cells that produce biologic drugs such as Humira can be sensitive to small changes in the manufacturing process... 24 patents have been issued covering methods of manufacturing Humira and Humira compositions resulting from those methods.”
Gonzalez was also confident over 22 method of treatment patents would be another factor biosimilar developers will have to contend with.
“These patents reflect the development work of more than 100 clinical trials, spanning 18 years,” he said. “These patent in uses have been key to the success of Humira.
“Our method of treatment patents cover the approved dosing regimens for each indication and are not mere refinements of previous dosing regimens, which is often the case with method of treatment patents in the small molecule arena.”