Teva to appeal against invalidation of Copaxone patents
Teva will appeal against a decision which saw the invalidation of four patents covering its multiple sclerosis drug Copaxone (glatiramer acetate injection).
Yesterday, January 30, the US District Court for the District of Delaware invalidated all asserted claims of the patents.
Teva was looking to protect its multi-billion drug from rivals that are seeking to market generic versions of Copaxone.
The invalidated patents are US numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development and licensed to Teva.
One of the Abbreviated New Drug Application (ANDA) filers, Mylan, released a statement on the invalidation.
Mylan said that in December last year, the Patent Trial and Appeal Board reaffirmed a prior decision in an inter partes review (IPR) that three of these patents ('250, '413 and '302) were unpatentable.
The pharmaceutical company also challenged the '776 patent in an IPR proceeding and the board is expected to issue its institution ruling by May 16, 2017.
Earlier this month, Teva released a financial outlook, stating that Copaxone is not expected to face generic competition in the US during 2017.
However, it added that the entry of two generic competitors in the US in February this year could reduce its revenues to $1.2 billion. Without competition, Copaxone is expected to generate $3.8 to 3.9 billion in revenues.
“We intend to move forward with an immediate appeal,” said Erez Vigodman, Teva president and CEO. “We will continue to vigorously protect our Copaxone franchise against further challenges and through the duration of this process.”
Back in December last year, LSIPR reported that Teva had sued nine pharmaceutical companies including Dr Reddy's Laboratories, Sandoz and Mylan, asserting a fifth Orange Book patent, US number 9,402,874.
Teva has also brought suit against multiple ANDA filers to assert a non-Orange Book process patent, US number 9,155,775, in various jurisdictions.
