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Samsung Bioepis-AbbVie Humira patent trial in UK to start Monday

The UK High Court of Justice will commence Monday its trial on Samsung Bioepis and Biogen’s lawsuit against AbbVie and its patents for its top-selling rheumatoid arthritis drug Humira, according to official court documents obtained by The Korea Herald.

Japanese drugmaker Fujifilm Kyowa Kirin Biologics (FKB) will also be taking on AbbVie in the same trial, as a claimant siding with Samsung Bioepis and Biogen.

According to a ruling by Justice Henry Carr last month, which was made available on the British and Irish Legal Information Institute, the trial will take place Monday at the Patents Court, which handles intellectual property disputes under the High Court in London.

Samsung Bioepis and FKB have asked the court to invalidate AbbVie’s “overlapping” secondary patents for Humira so they can launch biosimilar versions of Humira (adalimumab) once the drug’s main patents expire in 2018.

Biosimilars are cheaper, near replicas of biologic drugs that have lost patent protection -- which firms such as Samsung Bioepis have been working to develop.

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 “indications” -- uses for treating particular diseases -- and other usage considerations to fend off biosimilars.

Samsung Bioepis and its partner and minority shareholder Biogen filed a lawsuit in the UK in March last year, challenging the validity of such new patents registered by AbbVie.

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.

AbbVie CEO and Chairman Richard Gonzalez has repeatedly pledged to aggressively challenge copies of its top-valued drug, saying that the company’s series of patents covering Humira will extend its exclusive status against biosimilars until at least 2022.

A win for the Samsung company would pave the way for the Korean drugmaker and others to commercialize its Humira biosimilar in the UK as well as other European markets -- as the UK ruling could impact future patent jurisdictions in neighboring countries.

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

Samsung Bioepis could not be reached for comment. AbbVie declined to comment on the case, saying it “does not comment on specific litigation” when previously contacted by The Korea Herald.

Lead up to trial

Months ahead of the upcoming trial, AbbVie had apparently attempted to settle the suit and end the UK-based proceedings, according to the court documents.

In November last year, the US drugmaker had asked the three biosimilar companies to drop the proceedings in the UK in return for AbbVie abandoning its rights to the patents they were challenging.

Samsung Bioepis and FKB did not accept this proposition, calling for a definitive judgment on this case.

According to court papers summarizing Justice Carr’s ruling on the need to continue this trial, the claimants argued that AbbVie’s actions reflect its “well-established strategy” of dragging out patent proceedings for as long as possible, abandoning its patent rights at the last minute and then filing new, similar patents.

Such conduct allows AbbVie to avoid courts from invalidating the US drugmaker’s overlapping patents and removing uncertainty for the future release of biosimilars in the UK and other European markets, the claimants said.

AbbVie had argued that a trial was unnecessary as it had already offered to give up its rights to the patents in dispute, clearing the way for the complainants to market their biosimilars in the future, according to the judge’s note.

However, the UK High Court dismissed AbbVie’s request to suspend the trial, as Justice Carr appears to have recognized the validity of the complainants’ arguments.

“The judge at trial may well conclude that AbbVie has consistently adopted a policy of publicly expressing its confidence in its Humira patent portfolio, and its intention to enforce it against competition from biosimilars, while at the same time shielding patents within the portfolio from scrutiny by the court,” Carr said.

“It may be considered that AbbVie is ‘willing to wound and yet afraid to strike’ and that the time has come to put its professed confidence in its ability to prevent biosimilar competition to the test,” he added.

AbbVie’s patent fight continues in US

In addition to the upcoming trial in the UK, AbbVie is engaged in other patent disputes over Humira in the US -- one with Coherus Biosciences and another with Amgen.

AbbVie’s composition patent on Humira expired in the US in December 2016, but the firm has filed multiple new additional patents to extend the drug’s patent life in the country.

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.

Though it has yet to take legal action in the US, Samsung Bioepis is preparing to debut its Humira biosimilar in the US market as well. It has already completed SB5’s phase III clinical trials in the US, according to the US National Institutes of Health’s ClinicalTrials.gov.

Samsung Bioepis is a subsidiary of Samsung BioLogics, a contract drug manufacturer which went public in November last year. Together, the two Samsung units are leading the group’s push into new, promising industries that could supplement its flagship electronics business.

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

Read the article: http://www.koreaherald.com/view.php?ud=20170115000120