Novartis is claiming Regeneron has infringed Lucentis’s 5,688,688 (‘688) patent in the manufacture of aflibercept – marketed for wet macular degeneration under the brand name Eylea and as Zaltrap for metastatic colorectal cancer – in a lawsuit filed with the US District Court for the Southern District of New York.
The ‘688 patent is entitled ‘Vector for expression of a polypeptide in a mammalian cell,’ and the Swiss Big Biopharma firm claims Regeneron’s use of a pEE14 vector developed by Celltech (now part of Lonza) for the expression of aflibercept is an infringement.
“Regeneron’s method of manufacturing the recombinant fusion protein active ingredient used in both Eylea and Zaltrap meet every element of claim 1 of the ‘688 patent,” Novartis states, including the non-human mammalian host cell expression system, an upstream SV40 origin of replication, and a downstream SV40 polyadenylation region.
The monoclonal antibody Lucentis – approved in the US in June 2006 and Europe in January 2017 –raked in $1.9bn in sales for Novartis in 2017. Genentech holds the rights to commercialise Lucentis in the US, and last year saw sales of CHF 1.4bn ($1.5bn) in the region.
Eylea, also an anti-vascular endothelial growth factor (anti-VEGF), but a recombinant fusion protein, was approved in the US in 2011 and last year resulted in global sales of $5.9bn, split with Bayer which holds the marketing rights to Eylea outside the US.
In response to the lawsuit, Regeneron claimed the ‘688 patent expired in November 2014.
“The issued claims related to a vector for expression of a polypeptide in a mammalian cell. Vectors are used routinely in developing biologic drugs,” the firm said. “Regeneron is assessing the complaint and believes it has strong defenses that will preclude Novartis from enforcing the ‘688 patent against Regeneron.”
The company added in 2011, Novartis brought litigations alleging infringement of the ‘688 patent against Biogen, MedImmune and Alexion Pharmaceuticals, with each case being resolved by settlement.