PTAB grants IPR of Regeneron Eylea patents

The  US Patent Trial and Appeal Board will review the validity of two  Regeneron Pharmaceuticals patents related to its Eylea (aflibercept) medication.

The board granted an inter partes review of Regeneron’s US patents 9,254,338 and 9,669,069, which cover the company’s retinal disease treatment.

Mylan—which wants to sell and market a biosimilar of Eylea according to its recent  Q3 earnings call—claims that both the patents were anticipated and obvious over prior art

In  two separate decisions handed down on Wednesday, November 10, the board said that Mylan established a reasonable likelihood of prevailing in both of its petitions, granting both inter partes reviews with a decision expected within the year.

Mylan submitted the petition for a review of the ‘338 patents in May, arguing that claims 1, 3-11, 13-14, 16-24 and 26 should have never been issued. Mylan argued that the claims were anticipated by a known treatment “VEGF Trap-Eye”, which was known “long before” the patent alleged 2011 expiration date.

“At least two VEGF Trap-Eye clinical trials… and the dosing regimens used therein—were widely published in numerous, fully-enabled prior art references, by Regeneron and others, years before the alleged priority date,” Mylan argued in its petition.

Alongside this petition, it also challenged claims of Regeneron’s ‘069 patent, which is directed to the methods for treating angiogenic eye disorders.

Mylan argued that the patent was anticipated by a “mental step dosing regimen” or pro re nata dosing systems already known to persons of ordinary skill in the art.

The ‘069 petition states that Regeneron utilised the dosing regime in its own “widely published” clinical trials for age-related macular degeneration prior to the filing of the patent in 2011.

Mylan argues that Regeneron withheld these publications from the patent examiner in order to get the ‘069 patent issued.