EPO Boards of Appeal Revokes BMS Opdivo Patent, Clearing Path for Nivolumab Biosimilars
核心洞察
The EPO Boards of Appeal revoked EP 3 288 980, a BMS patent covering anti-PD-1 (搜索) treatment of PD-L1 (搜索)-positive melanoma (搜索), in decision T 0715/24.
The Board ruled that combining a flat-dose regimen with nivolumab monotherapy extended beyond the content of the application as filed.
BMS also lost EP 3 322 731 after withdrawing its appeal, while the basic patent EP 2 161 336 remains protected by SPCs and data exclusivity until end of 2030.
The European Patent Office (搜索)'s Boards of Appeal has revoked EP 3 288 980, a Bristol-Myers Squibb patent covering treatment of PD-L1 (搜索)-positive melanoma (搜索) with an anti-PD-1 (搜索) antibody, in a decision published in the EPO register. The ruling removes another layer of protection around Opdivo (nivolumab) and brings biosimilar versions of the blockbuster immunotherapy a step closer to market entry in Europe.
According to the decision (case ID: T 0715/24), the Boards of Appeal found that the claimed subject-matter — in particular the combination of a flat-dose regimen with nivolumab monotherapy — extended beyond the content of the application as filed. The decision follows the Opposition Division's March 2024 revocation of the patent, which had found that claim 1 of what was then auxiliary request 20 related to subject-matter extending beyond the application as filed. BMS pursued that request as its main request on appeal, alongside 29 auxiliary requests.
Monotherapy Interpretation at the Center of the Dispute
Central to the case was the interpretation of the term "monotherapy" in claim 1. The claim contained a negative feature stating that "the patient is not administered a combination of nivolumab and an anti-CTLA-4 (搜索) antibody." BMS argued that this disclaimer redefined monotherapy to mean only that no anti-CTLA-4 antibody was administered, while other anti-cancer agents could still be given.
The respondents disagreed. The Boards of Appeal took the view that monotherapy has a well-recognised meaning in the technical field — the use of a single drug to treat a disorder. The Board further found that the application as filed did not directly and unambiguously disclose nivolumab as a monotherapy in the ordinary sense in combination with the specific fixed-dose regimen of 480 mg every four weeks.
Five opponents challenged EP 980, all of them straw men. The Munich-based firm df-mp represented three of the five, with partners Hans Ulrich Dörries, Elisabeth Greiner and Sandra Pohlman acting as straw men; partner Simon Geiger and associate Tom Schwarzer were also involved. Patent attorney Marco Fachini of Kraus & Lederer represented another anonymous opponent, while patent attorney and partner Andreas Obermeier of Bird & Bird acted for a further anonymous opponent through the firm's own entity for straw man oppositions, Pajaro, assisted by patent attorney Anne Halbach, with lawyers Boris Kreye and Elsa Tzschoppe advising on legal matters.
Second Patent Lost as Appeal Withdrawn
The EP 980 decision is the most recent in a series of setbacks for BMS. The Opposition Division revoked EP 3 322 731 in late 2023; BMS lodged an appeal but withdrew it early this year. The same set of firms was involved in the EP 731 opposition, with additional opponents including ISA Pharmaceuticals (represented by Kirkpatrick), Regeneron (represented by J.A. Kemp) and BioNTech (represented by ZSP). MSD and other straw men were represented by Patent Boutique, Maiwald and Appleyard Lees.
The latest rulings form part of a large-scale challenge — mostly by straw men — to several patents relating to Opdivo. Related patents include EP 3 464 373, EP 3 858 859 and EP 3 377 534, which are also subject to oppositions. EP 4 679 094 has just been filed and is currently subject to examination.
Basic Patent Protection Runs to 2030
Not all of BMS's exclusivity has been eroded. The active ingredient in Opdivo, the monoclonal antibody nivolumab, is covered by EP 2 161 336. The Opposition Division upheld the basic patent in amended form in 2017. Supplementary protection certificates exist in several countries, for example in France, and SPCs together with data exclusivity protect EP 336 until the end of 2030.
Nivolumab, marketed by BMS under the brand name Opdivo, is one of the leading immunotherapy antibodies used in oncology. Alongside MSD's pembrolizumab (Keytruda), it targets the PD-1 (搜索)/PD-L1 (搜索) pathway. The drug treats head and neck cancer (搜索) as well as melanoma (搜索).
Biosimilar Developers Advance
Several companies are known to be working on biosimilars for Opdivo. According to information on Amgen's website, trials for its own nivolumab product, ABP 206, are currently in phase 3. The Sandoz biosimilar pipeline states that its product is "in clinical development." Intas and its generics and biosimilars subsidiary, Accord (搜索), are also developing a biosimilar of Opdivo in collaboration with Xbrane (搜索).
Bristol-Myers Squibb relied on a Munich-based team from the UK patent attorney firm Mewburn Ellis before the Boards of Appeal, with Munich-based partner Thomas Wolter and Edward Couchman from the Cambridge office representing the company. Wolter has a long-standing client relationship with BMS stemming from his time at Munich-based IP firm Reitstötter Kinzebach; when he joined Mewburn Ellis in 2020, he took the client with him. The firm regularly undertakes filing and prosecution work for BMS at the EPO, as well as opposition proceedings.