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Patent litigation settlements at Sanofi, BMS and J&J

Apotex settlement over Plavix generic ends decade long saga, while J&J resolves its case with Watson Pharmaceuticals over generic Ortho Tri-Cyclen Lo

Sanofi, Bristol-Myers Squibb (BMS) and Johnson & Johnson (J&J) have all settled patent litigation regarding generic versions of their products.

The settlement involving Sanofi and BMS relates to patent infringement of their blood thinner Plavix (clopidogrel bisulfate) by Canada-based generics firm Apotex, which released a generic version in 2006.

Apotex will pay the companies $442m to satisfy damages over sales of its generic product, with Sanofi and BMS also awarded $1.26bn in post-judgement interest and $900,000 in legal costs.

The settlement ends nearly a decade of proceedings between the companies, with patent challenging litigation first issued in March, 2002, over a proposed generic version of Plavix.

Despite this Apotex still went ahead with the 2006 launch of its generic product, although a later injunction brought by Sanofi and BMS halted sales of the drug.

The legal saga also led to a criminal antitrust investigation by the US Justice Department, with BMS suspected of attempting to block generic competition of Plavix in a case that saw a guilty plea from former senior vice president of strategy at BMS Andrew Bodnar regarding dishonest dealings.

Plavix is due to lose patent in three months time, with Sanofi expecting to lose €1.4bn in sales due to generic competition for it and its hypertension treatment Avapro.

Watson settles Ortho Tri-Cyclen Lo litigation with J&J

Meanwhile, Watson Pharmaceuticals has agreed to settle outstanding litigation with J&J's Janssen Pharmaceuticals subsidiary regarding a generic version of version of the birth-control pill Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol).

The agreement will see Janssen manufacture and supply Watson with an authorised generic version of the drug, with Watson obtaining the right to market and distribute the authorised generic from December 31, 2015.

Other details of the settlement, including financial terms, were not disclosed.

9th February 2012

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