(Bloomberg) -- Bayer AG and Johnson & Johnson won a judge’s ruling that upheld the validity of a patent on the blood-thinning drug Xarelto and will keep Mylan NV from selling a generic, low-cost version until August 2024, when the patent expires.
Mylan NV and Sigmapharm Laboratories LLC failed to prove the patent shouldn’t have been issued, U.S. District Court Judge Lawrence Stengel in Wilmington, Delaware, said. The companies can’t sell their generic versions of the drug until the patent expires, the judge said in a separate order.
The patent covers the chemical compound of the drug, rivaroxaban, which is used to prevent clots like deep-vein thrombosis. The generic-drug makers unsuccessfully argued that it would have been obvious to select a certain lead compound to then modify to get the active ingredient in Xarelto. That base compound, Stengel said, was being tested for use as an antibiotic, not an anticoagulant.
Officials at J&J and Mylan didn’t immediately respond to requests for comment.
Xarelto had sales of $2.5 billion in 2017, 3.3 percent of J&J’s revenue, according to data compiled by Bloomberg. Analysts surveyed by Bloomberg estimate that will rise to $3.98 billion by 2021.
Hundreds of scientists were looking for ways to find a replacement that had fewer side effects than warfarin or other established blood-thinners, the judge said.
“Xarelto revolutionized the treatment of thrombotic disorders” and its blockbuster success was as much because it is “effective, safe and easy to administer” as to the marketing of the medicine, the judge said.
Bayer and J&J’s Janssen unit are seeking to prevent the generic versions of Xarelto even longer, until a different patent expires in 2034. Mylan is challenging that patent, for the dosing regimen, at the U.S. Patent and Trademark Office.
The case is Bayer Intellectual Property GmbH v. Aurobindo Pharma Ltd., 15-cv-902, U.S. District Court, Delaware (Wilmington).
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