The UK High Court of Justice has judged that two patents held by AbbVie on its top-selling arthritis treatment Humira are invalid, ruling in favor of Samsung Bioepis, which had challenged the patents as it seeks to commercialize a biosimilar version of Humira in Europe in as early as 2018.

The London-based court, which handles intellectual property disputes, ruled last Friday in favor of Samsung Bioepis and its partner Biogen, invalidating AbbVie’s two secondary patents on Humira.

The ruling also marked a win for Japanese drugmaker Fujifilm Kyowa Kirin Biologics (FKB), which had taken on AbbVie in the same trial as a claimant siding with Samsung Bioepis and Biogen. 

Last year, Samsung Bioepis and FKB filed a lawsuit challenging the validity of AbbVie’s secondary patents over the dosage regimens for Humira (adalimumab) in treating rheumatoid arthritis, psoriatic arthritis and psoriasis.

Before the trial commenced, AbbVie had abandoned its two patents in question and proposed settling the dispute. However, the claimants did not accept the proposition, calling for a definitive judgment on the case.

The court, which proceeded with the trial, sided with the claimants’ view that Humira’s dosing regimens were “obvious” or “anticipated” at the time that the two patents were filed, and thereby not subject to patent protection.

AbbVie’s composition patent on Humira is set to expire in Europe in 2018. However, the US pharmaceutical giant has been filing new patents over the drug’s usage considerations to fend off biosimilars — cheaper, near-replicas of biologic drugs — until at least 2022.

Humira is the world’s best-selling drug for autoimmune diseases including rheumatoid arthritis, generating worldwide revenues of more than $14 billion for AbbVie in 2015.

“We welcome the court’s judgment. At Samsung Bioepis, we remain committed to driving positive change in the health care system through the development of affordable, high-quality biosimilars,” Samsung Bioepis said in a statement.

The UK ruling is expected to help speed up the release of Humira biosimilars — particularly ones developed by Samsung Bioepis and FKB — in the UK as well as across Europe.

“AbbVie has been filing overlapping patents on Humira to extend its patent life,” said Dongbu Securities analyst Koo Ja-yong, noting other biosimilar makers had lost their patents disputes over Humira in the US last year, dampening the sales outlook of Humira-referencing biosimilars.

“However, Samsung Bioepis has successfully obtained a ruling that invalidates AbbVie’s Humira indications. We expect this ruling to push forward the European launch of Humira biosimilars,” Koo said.


The UK court judge in charge of the case said that the ruling would serve a useful purpose in dispelling AbbVie’s “threats that it will enforce its patents against biosimilar competition anywhere in the world.”

“The declarations will serve a useful purpose of dispelling commercial uncertainty in the UK (and European) market, which those threats have created,” Justice Henry Carr wrote in his ruling.

“It is reasonably foreseeable that the grant of the declarations will promote a settlement on a European or even a worldwide basis,” he said, suggesting the ruling could impact future patent jurisdictions in neighboring countries.

Samsung Bioepis’ Humira-referencing biosimilar, SB5, was accepted for review by the European Medicines Agency, the region’s drug regulator, in July 2016.

Once it obtains marketing authorization, SB5 would become the Korean drugmaker’s third biosimilar to hit markets in Europe. The company already sells two biosimilars — one referencing Enbrel and another referencing Remicade — in Europe.

In addition to Samsung Bioepis, global pharmaceutical companies including Amgen, Novartis as well as Coherus Biosciences, FKB and others, are working to launch their own Humira-referencing biosimilars.

In Amgen’s case, it has already secured the US Food and Drug Administration’s approval of Amjevita, its Humira-referencing biosimilar. Yet the company most likely will not be able to commercialize Amjevita within this year, as AbbVie has filed a lawsuit claiming patent infringement.

By Sohn Ji-young (jys@heraldcorp.com)