Novartis sues Regeneron over manufacturing methods
- Novartis AG has filed a lawsuit claiming rival drugmaker Regeneron Pharmaceuticals Inc. infringed on a patent through its manufacturing of eye drug Eylea and cancer treatment Zaltrap.
- The intellectual property in question, known as patent '688, covers a vector for expression of a polypeptide in a mammalian cell, and was ultimately used in the development of Novartis' Lucentis. The Swiss pharma contends that to produce Eylea and Zaltrap, Regeneron tapped a commercial gene expression system developed by Lonza Group AG that employs the same technology covered in the '688 patent.
- "Vectors are used routinely in developing biologic drugs," Regeneron said in a statement, adding that the company "is assessing the complaint and believes it has strong defenses that will preclude Novartis from enforcing the ‘688 patent against Regeneron."
Lucentis (ranibizumab) secured its first Food and Drug Administration approval in 2006 for the treatment of wet aged-related macular degeneration (AMD). And for years, it sat essentially unopposed on the market.
Then came Regeneron's Eylea (aflibercept).
"Prior to the approval of Eylea in 2011, Lucentis was the only approved protein-based therapy indicated for the treatment of AMD and the other vitreoretinal disorders for which Lucentis is indicated. As such, a demand for Lucentis existed in the market," Novartis said in its lawsuit, filed on March 19 in the U.S. District Court for the Southern District of New York White Plains Division.
In fact, it didn't take long before Regeneron's drug took a commanding lead over Lucentis. By the end of 2017, Eylea was raking in net sales of $3.7 billion in the U.S. and nearly $6 billion worldwide.
Despite a heavyweight competitor on the tracks, Novartis worked to keep the Lucentis train going. Pairing the drug with Ophthotech Corp.'s Fovista (pegpleranib) was one attempt, though it resulted in a string of clinical failures.
Where Novartis has seen success is in defending the '688 patent — and not just as it relates to eye drugs. Zaltrap (ziv-aflibercept), for instance, carries an indication for colorectal cancer. But, as Novartis points out, "the recombinant fusion protein active ingredient used in Zaltrap is identical to [the one] used in Eylea."
The big pharma also sued Biogen Inc., Alexion Pharmaceuticals Inc. and AstraZeneca plc's subsidiary MedImmune Inc. in 2011 for infringing on the patent through the manufacturing of their respective drugs Tysabri (natalizumab), Soliris (eculizumab) and Synagis (palivizumab). According to Regeneron, all that litigation was resolved via settlement.
Now, Novartis is seeking damages from Regeneron for infringing on the '688 patent. The biotech said it "intends to vigorously defend against this litigation."
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