Regeneron Pharms., Inc. v. Mylan Pharms. Inc

Authored by: Jeremy J. Gustrowsky

In a significant win for Regeneron Pharmaceuticals, the Federal Circuit affirmed a preliminary injunction that blocks Samsung Bioepis (SB) from launching its EYLEA® biosimilar in the United States. The dispute centered on U.S. Patent No. 11,084,865, which covers specific formulations of aflibercept, a drug used to treat eye diseases. SB, a South Korean company, had sought FDA approval to market its biosimilar nationwide, including through a partnership with Biogen for U.S. commercialization.

A major issue in the case was whether the West Virginia court had personal jurisdiction over SB, given that SB is a foreign company with no direct business presence in the state. The court found that by filing for FDA approval to sell the drug nationwide and setting up distribution channels that included West Virginia, SB had sufficient connections to be sued there. This ruling reinforces that companies seeking nationwide drug approvals can be brought into court in any state where their products are intended to be sold.

On the patent side, SB challenged the validity of Regeneron’s patent on two main grounds: obviousness-type double patenting and lack of adequate written description. The court rejected both arguments, finding that the patent’s requirements—such as at least 98% of the drug remaining in its native form after storage and the use of glycosylated aflibercept—were patentably distinct from earlier patents and were adequately described in the patent documents. The court also agreed that Regeneron would likely suffer irreparable harm if the biosimilar were launched before the patent expired in 2027.

This decision highlights the hurdles biosimilar makers face when challenging well-drafted patents and underscores the importance of detailed patent disclosures. It also serves as a reminder that U.S. courts can exercise jurisdiction over foreign companies seeking to sell products nationwide, especially in the pharmaceutical sector.