- A U.S. patent appeal board has handed Mylan a small win in the generic drugmaker's efforts to bring to market a copycat version of Sanofi's blockbuster insulin product Lantus, but ongoing litigation in federal court between the two companies remains a hurdle to any product launch.
- Ruling in favor of Mylan, the U.S. Patent Trial and Appeal Board found Sanofi's claims contained in two formulation patents on Lantus to be unpatentable, Mylan announced Thursday. The decision comes roughly 18 months after Mylan filed petitions for a so-called inter partes review of the two patents.
- While Mylan was quick to tout the ruling as a "key milestone" for the generic version of Lantus it's developing with Biocon, it remains unclear whether the PTAB's decision will accelerate a potential launch. Sanofi filed a patent infringement case against Mylan in October 2017, which remains pending in the U.S. District Court for the District of New Jersey. Due to the ongoing litigation, approval of Mylan and Biocon's copycat is subject to a 30-month stay which extends to early 2020.
Sanofi already faces direct competition to Lantus (insulin glargine) in the U.S., where Eli Lilly won approval of its follow-on biologic Basaglar in 2014 and launched the rival drug in December 2016.
Declining sales for Lantus offer some proof that the French drugmaker has begun to feel the effects, particularly after CVS and UnitedHealthcare removed Lantus from their formularies in favor of Basaglar. Payer pressure on insulin pricing has also played a role, forcing diabetes drugmakers like Sanofi to extend greater rebates on their products to protect market share.
That said, Lantus remains a multi-billion dollar franchise for Sanofi. In theory, such a large market should be attractive to generic and biosimilar developers.
But the reality is more complex, partly due to how insulin products are regulated. Although a biologic product, modern insulins — some of which are two decades old — are classified as drugs and approved under New Drug Applications. That regulatory nuance impedes development of biosimilar versions of insulin like Lantus, a state of affairs called out this week by Food and Drug Administration chief Scott Gottlieb.
Basaglar, for instance, is classified as a "follow-on biologic" and is not substitutable for Lantus.
Some developers, like Mylan and Biocon, remain committed to following the route of Eli Lilly, but others have opted against further development. In October, Merck & Co. and partner Samsung Bioepis decided to discontinue work on their Lantus copycat.
With the PTAB's ruling, Mylan and Biocon's challenge of the two Sanofi patents is substantiated, at least in one venue. But hurdles remain that make a near-term launch unlikely.
Most notable is the district court litigation with Sanofi. The patent infringement suit triggered a 30-month stay on an FDA approval decision for the generic companies' product. That halt will expire on March 18, 2020, or in the event that Mylan and Biocon win in court. A trial date has yet to be set.
"We believe that it is unlikely that the PTAB ruling on the formulation patents will have an impact on Mylan's timing for a launch of its glargine products," a spokesperson for Sanofi said in a statement to BioPharma Dive. "The PTAB decision alone does not affect the existing 30-month stay and Mylan does not have tentative FDA approval for its products at this time."
Sanofi also has a third patent on Lantus listed in the FDA's Orange Book database, while its SoloStar pen version has its own slate of legal defenses.
Shares in Sanofi, which trade as American Depositary Receipts on the New York Stock Exchange, fell by 1.5% in Thursday morning trading, while Mylan stock rose slightly before falling back.