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-런던 위치한 영국 고등법원에서 1월 16일 재판 시작
-삼성 승소시 휴미라 바이오시밀러 유럽 출시 전망 밝아져
-애브비, 중복특허 ‘시간끌기’로 휴미라 경쟁제품 출시 막아
-영국 법원, ‘애브비 특허 보호전략 본격 테스트 올린다’
삼성바이오에피스와 바이오젠이 지난해 영국에서 다국적제약사 애브비를 대상으로 냈던 ‘휴미라’ 특허 무효소송의 첫 공식 재판이 16일(현지시간) 영국 고등법원에서 열린다.
일본 제약사 후지필름 교와 기린 바이오로직스도 삼성과 함께 원고 측으로서 법정에 서게 될 예정이다.
본 재판은 런던에 위치한 영국 고등법원 (UK High Court of Justice) 산하 특허법원 (Patents Court) 에서 열릴 예정이다. 해당 정보는 코리아헤럴드가 British and Irish Legal Information Institute를 통해 입수한 특허법원의 헨리 카르 (Justice Henry Carr) 판사의 공식 문건을 통해 확인되었다.
삼성바이오에피스는 파트너사인 바이오젠과 함께 작년 3월 영국 법원에 애브비가 새롭게 추가한 ‘휴미라’ 적응증과 투여 방법에 대한 특허를 무효화 시켜달라는 취지의 소송을 제기한 바 있다.
오리지널 의약품 업체가 특허가 만료된 제품에 대해 다른 형태의 특허를 지속적으로 신청하여 독과점 기간을 늘리면서 경쟁 의약품인 바이오시밀러 (바이오의약품 복제약)의 시장 진입을 막고 있다는 이유다.
당초 류마티스 관절염 치료제 휴미라의 물질 특허는 유럽에서 2018년 10월에 만료될 예정이었다. 그러나 애브비는 후발업체들의 시장 진입을 막기 위해 같은 물질에 대해 중복되는 적응증 특허를 추가해 특허 종료 시점을 약 2022년으로 연장했다.
휴미라는 전 세계 바이오의약품 판매순위 1위를 달성하고 있는 제품이다. 류마티스 관절염을 포함한 다수의 자가면역질환을 치료하는데 쓰인다. 2015년 기준 연간매출 140억 달러를 달성한 애브비의 ‘베스트셀러’ 제품이다.
지금까지 애브비의 리처드 곤잘레스 (Richard Gonzalez) 회장은 휴미라와 관련된 여러 기술의 특허를 통해 약 2022년까지는 경쟁제품의 출시를 차단할 것이라고 여러 번 공개적으로 밝혀왔다.
영국 소재 재판에서 삼성바이오에피스가 승소할 경우, 휴미라 바이오시밀러의 유럽 출시 전망이 더 밝아질 전망이다. 이르면 휴미라의 주요 특허가 만료되는 2018년에 삼성을 포함한 다수 바이오시밀러 개발사들이 영국과 다른 유럽 시장에 제품을 출시할 수 있을 것으로 보인다.
삼성바이오에피스는 이미 현지 파트너십을 맺고 있는 바이오젠을 통해 유럽에서 자가면역질환 치료제인 엔브렐, 레미케이드의 바이오시밀러를 판매하고 있다.
또한 자사의 휴미라 바이오시밀러 ‘SB5’에 대한 판매 허가를 유럽의약국 (EMA)에 신청해둔 상태이다.
삼성바이오에피스와 애브비 양사 모두 현재 진행소송 건에 대해선 공식 입장을 밝히지 않았다. 아직 진행중인 소송 건에 대해서는 의견을 밝힐 수 없다는 설명이다.
한편 입수된 법원 문건에 따르면 애브비는 본 소송이 열리기 약 두 달 전인 작년 11월에 현재 심리를 기다리는 휴미라 관련 특허들에 대한 권리를 포기하겠다며 원고 측에 재판을 포기해달라는 요청을 했다.
그러나 삼성바이오에피스를 포함한 세 회사는 애브비가 전형적인 ‘시간 끌기’ 전략을 펼치고 있다고 주장하며 에브비의 요청을 거절했다. 법원 역시 애브비의 재판 기각 요청을 거절했다.
애브비는 바이오시밀러 업체들 상대로 특허 소송을 진행하다 공식 심판 일정이 임박해질 무렵, 해당 특허에 대한 권리를 포기하고, 추후 또 비슷한 특허를 내는 행동을 취해왔다는 설명이다.
원고 측은 애브비가 이러한 전략을 통해, 재판부가 자사의 특허를 불인정하는 결정적인 판결을 내릴 가능성을 원천 봉쇄하고 있다고 설명했다.
영국 특허법원 헨리 카르 판사는 이러한 점들을 고려 및 인정하여 애브비의 심판 가결 요청을 받아들이지 않았고, 예정대로 1월 16일에 심판을 진행시키게 되었다. 애브비의 특허 보호전략 및 유효성에 대해 본격적인 법적 ‘테스트’를 펼친다는 입장이다.
현재 애브비는 유럽뿐만 아니라 미국에서도 ‘휴미라’ 관련 특허소송을 진행하고 있다. 미국 대형 제약사 암젠과 코헤러스 바이오사이언스를 상대로 법적 공방을 진행 중이다.
암젠의 경우 이미 자사가 개발한 휴미라 바이오시밀러 ‘암제비타(Amjevita)’가 미국 식품의약청(FDA)의 승인을 받았지만, 현재 애브비와 진행중인 소송으로 인해 판매시기가 불투명해졌다.
휴미라의 물질 특허는 미국에서 2016년 12월에 만료되었지만 유럽과 마찬가지로 애브비가 새로운 중복특허들을 통해 특허 종료기간을 연장시킨 상태이다.
코리아헤럴드 손지영기자 (jys@heraldcorp.com)
<관련 영문 기사>
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
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
