Teva to Appeal Court Ruling Invalidating Patents for Top-Selling MS Drug

Teva Pharmaceutical Industries says it plans to appeal a recent court ruling that invalidated four of its patents for Copaxone (glatiramer acetate injection), a multiple sclerosis (MS) drug. Copaxone, a leading product for Teva with 2015 sales of $4 billion, faces increasing competition, including from orally administered MS therapies and competing generic versions, and the recent ruling relates to patent-infringement litigation for the drug. 

reports that the US District Court for the District of Delaware has issued a ruling invalidating all asserted claims of four US patents (US Patent Numbers 8,232,250, 8,399,413, 9,155,776, and 8,969,302) for Copaxone 40 mg/mL, which cover a three-times a week dose administration of glatiramer acetate injection. The 40-mg/mL formulation for Copaxone is an important lifecycle product management strategy for Teva as the 20-mg/mL formulation faces generic competition. Patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched in the US in January 2014 and was approved in Europe in December 2015.

The 40-mg/mL formulation allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS. Teva’s business strategy for Copaxone relies heavily on the continued migration of a substantial percentage of Copaxone patients  using daily doses (the 20-mg/mL formulation) to  new 40- mg/mL, three-times-a-week version. Since the launch of Copaxone 40 mg/mL three times a week in the US, over 78% of the total US Copaxone prescriptions are  filled with the 40-mg/mL version, according to the company’s 2015 annual filing. 

The  four patents that are the subject of the recent ruling are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), which identifies drug products approved on the basis of safety and effectiveness by the US Food and Drug Administration, with expiry dates into 2030. The patent-infringement case involved five of six abbreviated new drug application (ANDA) filers.

Separately, a suit was filed against all six ANDA filers in December 2016 in the US District Court for the District of Delaware to assert a fifth Orange Book patent, US Patent Number 9,402,874, also covering a three-times a week dose administration of glatiramer acetate injection.

Additionally, Teva has brought suit against multiple ANDA filers in various jurisdictions to assert a non-Orange Book process patent, US Patent Number 9,155,775 in regards to a process for manufacturing glatiramer acetate product.

Teva had an earlier setback in August 2016 when a decision by the Patent Trial and Appeal Board of the US Patent and Trademark Office (PTO) from an inter partes review (IPR) invalidated all claims of two US Patents for Copaxone 40 mg/mL: the 8,232,250 and 8,399,413 patents, which cover a three-times a week dose administration of glatiramer acetate injection. The PTO ruled in favor of Mylan in its IPR proceeding and found all claims of these two Copaxone 40 mg/mL patents to be unpatentable.

Source: Teva Pharmaceutical Industries 

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