Radius Health accused Orbicular Pharmaceutical of infringing several patents related to compounds and methods of treating osteoporosis and stimulating bone growth. Radius asserted that the patents covered its TYMLOS® osteoporosis drug, and that Orbicular’s ANDA application to make and sell a generic version of the drug constituted infringement of the patents. In March 2024, the parties stipulated that the commercial manufacture and sale of the product would infringe certain of the patents and Judge Stearns subsequently found on summary judgment that other of the patents would be infringed, leaving the issue of validity for the jury to determine. After a ten-day bench trial in the Spring, Judge Stearns determined that the asserted claims were not proven by clear and convincing evidence to be invalid, while finding two claims of one of the patents to be invalid. He accordingly found the ANDA submission to be infringing and held (pursuant to 35 U.S.C. § 271(e)(4)(A)) that no approval of Orbicular’s ANDA application should issue earlier than the expiration of the last of the patents-in-suit, which (absent some action to the contrary) would be April 30, 2038.
Orbicular has noticed its intent to appeal this decision.
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