Teva in pre-emptive strike to protect proposed Byetta generic

Teva has filed for a declaratory judgment that it did not infringe patents belonging to AstraZeneca and Amylin Pharmaceuticals that protect diabetes drug Byetta (exenatide).

In its complaint, filed at the US District Court for the District of Delaware on Monday (January 19), Teva alleged that it had not infringed and will not infringe “any valid or enforceable claim” of the patents, US numbers 7,297,761 and 7,741,269.

AstraZeneca had sued Teva for allegedly infringing five patents covering Byetta, but not the two in this lawsuit.

The ‘761 patent is entitled “pharmaceutical compositions containing exendins”, while the ‘269 patent is called “exendins and exendin agonists for weight reduction and obesity”.

These patents, along with six others, are listed in the US Food and Drug Administration’s (FDA) Orange Book. They are co-held by AstraZeneca and Amylin.

Byetta is prescribed for type 2 diabetes patients to manage blood sugar levels.

AstraZeneca acquired Amylin when the UK-based pharma company bought what was Bristol-Myers Squibb’s diabetes unit in late 2013.

Teva filed an Abbreviated New Drug Application (ANDA) with the FDA in autumn last year seeking approval to make and sell a generic version of Byetta in 300mcg/1.2ml and 600mcg/2.4ml strengths.

In its ANDA, Teva filed a paragraph IV certification covering seven of the eight Orange Book-listed patents protecting Byetta, including ‘761 and ‘269.

Teva’s notice had said the seven patents were not valid or enforceable, and would not be infringed by the proposed generic.

After receiving notice of Teva’s ANDA filing, AstraZeneca sued Teva for infringing all the patents detailed in the certification, apart from numbers ‘761 and ‘269.

As a result, Teva is now seeking to clarify that it won’t be sued over the two patents.

In addition to a declaratory judgment that Teva has not infringed the ‘761 and ‘269 patents, the Israel-based company has requested costs and expenses.