Teva win in Ireland evens playing field with Bristol-Myers Squibb

The Irish High Court has invalidated a Bristol-Myers Squibb patent, EP (IE) 14 27 415, covering the blood-thinning drug apixaban for insufficiency and obviousness. The decision is just one amid an ongoing battle with generic drug company, Teva.

EP 415 covers “compounds containing lactam and their derivatives as factor Xa inhibitors”. The patent covers a blockbuster drug and SPC containing the compound anticoagulent apixaban. Medical professionals use the drug to treat and prevent blood clots. EP 415 expired on 17 September 2022, while a marketing authorisation covering the active ingredient was issued in 2011.

Two-pronged attack

Following an expansive trial, taking 16 days over four weeks with 16 witnesses, the court found the patent invalid. In a two-pronged attack, Teva maintained that BMS Co. could not claim priority because the priority document instead assigned rights to BMS Pharma Co., which is not the company that applied for EP 415.

Teva also attacked the patent based on insufficiency and obviousness, which raised the issue of plausibility: namely, whether the patent application description, read in the light of the common general knowledge at the priority date about factor Xa inhibitors, renders apixaban plausible as a factor Xa inhibitor. Based on the guidelines as laid out in the EPO’s G2/21, the court found the patent lacked plausibility.

Following the UK decision

In April 2023, the UK Court of Appeal also confirmed the invalidation of EP 415. The decisions followed an appeal against High Court proceedings, which took place in 2022. Both Sandoz and Teva had brought proceedings against Bristol-Myers Squibb (case IDs: HP-2020-000042 and HP-2021-000003) to clear the way and launch a generic version of the lucrative anticoagulant. While the UK case did not focus on priority, the court also invalidated the patent and corresponding SPC for lack of plausibility based on insufficiency.

In July 2022, the UK High Court also invalidated four further Bristol-Myers Squibb formulation patents, EP 32 46 021, EP 30 17 811, EP 32 51 660 and EP 32 57 500 (case IDs: HP-2020-000048; HP-2021-000009), after finding them invalid for obviousness over the prior art. The party has appealed the decision to the Court of Appeal, but this is stayed pending the outcome of parallel EPO Technical Boards of Appeal proceedings.

Bristol-Myers Squibb successful on the continent

Thus, the Irish decision follows decisions in the UK and Spain, which found in favour of Teva. However, in the Netherlands, France, Norway and Sweden, the innovator drug company has been more successful.

For example, on 8 June 2023, the Judicial Court of Paris rejected Teva Santé’s request to invalidate EP 415 (case ID: 21/112727). Teva Santé is the French subsidiary of Israeli group Teva B.v. The company attempted to invalidate the patent and corresponding SPC, as well as claiming compensation and payment of legal fees. Ultimately, presiding judge Nathalie Sabotier rejected this on four grounds.

Dutch decision turns heads

Furthermore, Bristol-Myers Squibb succeeded for the first time in removing generic products sold by Sandoz, Stada and Teva from the market in the Netherlands. In mid-August, the Court of Appeal in The Hague ruled in an emergency decision that all three generic drug manufacturers’ products infringe Bristol-Myers Squibb’s apixaban SPC, which is based on EP 1 427 415 (case IDs: 200.327.532/01 and 200.327.173/01).

Bristol-Myers Squibb had already tried to force Sandoz out of the Dutch market, but failed to obtain a PI at the District Court of The Hague in May 2022. The appeal judges thus overturned the District Court of The Hague’s three PI judgments. However, parties are awaiting the results of the main action hearing on the merits. Sandoz’s took place in October 2023, while Teva’s took place on 12 January 2024.

Often Pinsent Masons

Teva has turned to its regular firm Pinsent Masons for representation in Ireland. Originally, partner Ann Henry led the team from the firm’s Dublin office, but in July 2023 she left to take up a position at Bird & Bird in the Irish capital. Now partner Karen Gallagher is leading the charge, alongside an array of in-house support from Teva’s London headquarters.

Teva also relied on Pinsent Masons in the Netherlands. Amsterdam-based partner Judith Krens is leading the Dutch case together with patent attorney firm NLO. In France, partner François Pochart of August Debouzy led for Teva. The relationship between Pochart and Teva is long-standing, with the patent lawyer acting for the generic drug company before he moved to the French IP boutique in 2011.

In Spain, IP specialist firm Vidal-Quadras & Ramon represents Teva, led by partner Oriol Ramon.

Karen Gallagher

Europe-wide firms

Irish law firm McCann FitzGerald represents Bristol-Myers Squibb, with partners Shane O’Brien and Fiona O’Beirne leading proceedings for the innovator drug company.

In the UK, WilmerHale is coordinating the European litigation for Bristol-Myers Squibb while also representing the company in US proceedings. The team, led by Matthew Shade, appeared as counsel alongside Hogan Lovells in the UK. Daniel Brook leads for the latter team.

Gide Loyrette Nouel and Regimbeau, under the Gide x Regimbeau – Patent Litigation brand, worked together for Bristol-Myers Squibb in Paris. Gide’s litigators handled court proceedings while Regimbeau’s patent attorneys lent expertise on the technical aspects. International firm Pérez-Llorca leads proceedings in Spain.

For Teva
Three New Square (London): Thomas Lunt
Pinsent Masons (Dublin): Karen Gallagher (partner, lead); associates: Sarah Power, Hannah McLoughlin
In-house (London): Laura Reynolds (associate general counsel), Alpha Indraccolo (VP and general counsel); counsel: Nessa Cahill, Bairbre O’Neill, Paul Gallagher (all senior counsel)
Clodagh Gartlan (barrister admitted in Ireland)

For Bristol-Myers Squibb
McCann FitzGerald (Dublin): Shane O’Brien, Fiona O’Beirne (both partners)

High Court of Ireland, Dublin
Max Barrett (presiding judge)