On November 6, 2017, Sandoz, Inc. filed its eighth inter partes review (“IPR”) against AbbVie Biotechnology Ltd. (“AbbVie”), challenging yet another patent from the Humira® patent portfolio. Humira®, used for the treatment of autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, continues to be the number one selling drug in the world.[i] With over $16 billion in sales for 2016, pharmaceutical competitors have been targeting the drug, hoping to gain a piece of the market pie by developing biosimilar equivalents.[ii] However, with a shield of over 100 patents covering different aspects of the drug, from formulations and dosages to methods of production, challengers face a long road ahead in dethroning the Humira® giant.[iii]
Sandoz’s most recent IPR filing fits nicely into a pattern of Humira® patent challenges by the corporation, who, since July, has initiated post-grant review proceedings at the PTAB for one to two AbbVie patents each month. A list of the IPRs and the challenged patents is set forth in Table 1 below. Thus far, none of the Sandoz IPRs have progressed much beyond the filing of the petition, although that will change within the week. With the patent owner preliminary responses for both IPR2017-01823 and IPR201-01824 due on November 14, 2017, we will finally gain some insight into how AbbVie plans to defend Humira® against Sandoz and be able to better assess whether Sandoz stands to be a true threat to the drug’s market share.
Table 1. IPRs filed by Sandoz, Inc. against Humira® patents
Sandoz is currently developing and seeking approval for their Humira® biosimilar (adalimumab). Their application to the European Medicines Agency (“EMA”) for regulatory review of the biosimilar was accepted back in May, and is currently still pending.[iv] In September, following conclusion of the Phase III ADACCESS (NCT02016105) study, Sandoz confirmed that the biosimilar adalimumab matches the safety and efficacy profile of reference medicine Humira®.[v]
Other Major Players
Aside from Sandoz, several other pharmaceutical companies vying for a place in the adalimumab market have also challenged the Humira® patents at the PTAB, with varying degrees of success.
Coherus BioSciences, Inc. (“Coherus”) filed ten IPRs against AbbVie from November 2015 through March 2017.[vi] Of those, two were dismissed and five were denied institution. In the remaining three, the Board determined the patents to be unpatentable, although AbbVie has since appealed those decisions to the Federal Circuit. Coherus is also currently developing its own Humira® biosimilar, which has produced positive results in a recent bioequivalents study.[vii]
German pharmaceutical company Boehringer Ingelheim (“Boehringer”) was also successful in challenging the patentability of two of the Humira® patents through two IPRs filed at the end of 2015.[viii] In late July, AbbVie appealed both Board decisions to the Federal Circuit. Boehringer additionally faces a patent infringement suit brought by AbbVie, currently pending in the Eastern District of Delaware. However, Boehringer is ahead of other adalimumab competitors, receiving FDA approval of its Humira® biosimilar “Cyltezo” on August 25, 2017.
Amgen, Inc. (“Amgen”) also has FDA approval for its biosimilar “Amjevita,” granted on September 23, 2016. While Amgen filed two IPRs against the Humira® patent in 2015, the challenges were unsuccessful.[ix] Amgen also recently settled with AbbVie on September 28, 2017, in a patent infringement case initiated by AbbVie in the Eastern District of Delaware.
Samsung Bioepis (Bioepis), a joint venture between Samsung BioLogics and Biogen, is another key player in the market, having received approval for its Humira® biosimilar “Imraldi” in Europe on August 24, 2017. Although Bioepis has not yet challenged any of AbbVie’s U.S. patents, “Imraldi” will surely start to chip away at AbbVie’s record-high sales of Humira®, especially on a global scale, as soon as it is launched.
[i] https://www.humira.com/, last accessed on November 7, 2017.
[ii] https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2016-who-sold-the-blockbuster-drugs, last accessed on November 7 2017.
[iv] https://www.novartis.com/news/media-releases/sandoz-proposed-biosimilars-adalimumab-and-infliximab-accepted-regulatory-review, last accessed on November 7, 2017.
[v] https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilar-adalimumab-matches-reference-biologic-terms-efficacy, last accessed on November 7, 2017.
[vi] IPR2016-00172 (filed Nov. 9, 2015); IPR2016-00189 (filed Dec. 7, 2015); IPR2016-00188 (filed Dec. 7, 2015); IPR2016-01018 (filed May 9, 2016); IPR2017-00827 (filed Jan. 31, 2017); IPR2017-00826 (filed Jan. 31, 2017); IPR2017-00822(filed Jan. 31, 2017); IPR2017-00823 (filed Jan. 31, 2017); IPR2017-01008 (filed Mar. 2, 2017); IPR2017-01009 (filed Mar. 2, 2017).
[vii] https://www.coherus.com/our-products/, last accessed on November 7, 2017.
[viii] IPR2016-00408 (filed Dec. 29, 2015); IPR2016-00409 (filed Dec. 29, 2015).
[ix] IPR2015-01514 (filed June 26, 2015); IPR2015-01517 (filed June 26, 2015).