Mylan N.V. reports that the US Patent and Trademark Office (PTO) has instituted inter partes review (IPR) proceedings against two patents licensed to Teva Pharmaceutical Industries’ for Copaxone (glatiramer acetate) 40 mg/mL, US Patent Nos. 8,232,250 and 8,399,413, owned by Yeda Research & Development Co., Ltd. and licensed to Teva. The patents relate to methods for the treatment of multiple sclerosis (MS) through the administration of at least three 40 mg subcutaneous injections of glatiramer acetate over a period of seven days with at least one day between each injection. Mylan also has filed another petition for inter partes review of a related patent (U.S. Patent No. 8,969,302), which the PTO is expected to act upon shortly.

Copaxone is Teva’s top-selling drug with 2014 revenues of $4.3 billion. The US Orange Book patents covering Copaxone (20 mg) expired in May 2014. To combat generic-drug incursion for Copaxone, Teva developed a new formulation, Copaxone 40 mg/mL, which is administered three times a week. The new formulation, which was approved by the US Food and Drug Administration (FDA) in January 2014, allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS.

In August 2014, the FDA accepted Mylan’s abbreviated new drug application (ANDA) filing for a three times per week glatiramer acetate injection 40 mg/mL, the generic version of Copaxone 40 mg/mL. Mylan said it believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval. Copaxone 40 mg/mL had US sales of approximately $2.6 billion for the 12 months ending June 30, 2015, according to IMS Health. and as reported by Mylan.

Mylan CEO Heather Bresch commented in a company statement: “We believe that the patents at question are invalid and are pleased that, in instituting an inter partes review on all claims, the PTO has determined that there is a reasonable likelihood of prevailing on the invalidity assertion. We believe our generic version of Copaxone 40 mg/mL represents an exciting first-to-file opportunity for Mylan.”

In early August 2015, Pfizer and Synthon, a pharmaceutical company specializing in developing complex generic medicines, formed an agreement whereby Pfizer acquired the exclusive commercialization rights in the United States to glatiramer acetate for both dosage formulations of Synthon's glatiramer acetate. In November 2011, Synthon filed an ANDA with the FDA for a once-daily 20 mg/mL formulation of glatiramer acetate. In early 2014, Synthon filed an ANDA for a three times a week 40 mg/ml formulation of glatiramer acetate with the FDA. Under its agreement with Pfizer, Synthon is responsible for the clinical development, manufacture, and supply of glatiramer acetate. Pfizer is solely responsible for the commercialization of glatiramer acetate in the United States.

In April 2015, Sandoz, a Novartis company, received FDA approval for Glatopa, a generic version of Teva’s Copaxone (glatiramer acetate injection) 20 mg/mL.

Source: Mylan