PTAB institutes IPRs on Sanofi patents
The US Patent Trial and Appeal Board (PTAB) has instituted inter partes reviews (IPRs) of two patents owned by Sanofi covering Lantus (insulin glargine injection).
Lantus is used to help control the blood sugar level of those with diabetes.
Mylan, the party which challenged the patents, made the announcement on Thursday, December 14.
The two patents are US numbers 7,476,652 and 7,713,930, both called “Acidic insulin preparations having improved stability”.
In October, Sanofi sued Mylan over the injection, after Mylan notified the company that it had filed a New Drug Application with the US Food and Drug Administration for insulin glargine pre-filled pen and vial drug products. The lawsuit, which was filed at the US District Court for the District of New Jersey, alleged infringement of 18 patents centring on Lantus.
Mylan filed its IPR petitions against the two patents back in June this year, alleging that all of the patent claims were obvious in light of prior art.
Heather Bresch, CEO of Mylan, said: “The PTAB’s decision to institute IPR proceedings against the two Orange Book-listed patents for Lantus is another step forward in our ongoing efforts to bring an interchangeable insulin glargine injection to diabetes patients as soon as possible.”
She claimed that there are more than 29 million people in the US living with diabetes and that they should have access to more affordable treatment options.
“As a leading producer of oral diabetes medicines, we are deeply committed to this patient community and believe bringing lower-cost alternatives to Lantus and Lantus SoloSTAR will fulfil a critical medical need,” concluded Bresch.
In September 2016, Sanofi sued Merck, accusing the company of infringing ten of its patents for Lantus.
Two years before that, Eli Lilly was hit with a lawsuit which claimed that the company had infringed seven Lantus patents.
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