Apollo Global Management’s wholly-owned unit, Covis Pharma, alleged that Indian pharmaceutical company Eugia and its parent Aurobindo infringed upon two of its patents (US10471075B1 and US9844558B1). Both patents concern its Makena product, an injectable treatment that is used to reduce the risk of premature birth.
Covis Pharma and its subsidiary AMAG Pharmaceuticals, stated that the two patents are valid until May 2036 in a complaint filed in the federal court of Delaware last January 4.
AMAG, the current assignee of the patents, markets and distributes Makena in the US and was acquired by Covis in November 2020 as part of its strategy to expand its portfolio of products in “new therapeutic areas”.
The complaint stated that Eugia has submitted its allegedly infringing product ANDA No. 215275 (ANDA) to the US Food and Drug Administration (FDA) for approval to manufacture, use, or sell an allegedly generic version of Makena prior to the expiration of AMAG’s patents. The FDA has yet to approve ANDA at the time the complaint was filed.
Covis and AMAG are seeking an order that any FDA approval of ANDA would not occur until the expiration date of its patents. The companies are also seeking a permanent injunction to block the sale or import of ANDA in the US until its patents remain valid, as well as damages in the form of compensation if infringing copies of Makena are made before the end of its patents’ validity, according to the complaint.
Makena is also the subject of scrutiny by the FDA’s Center for Drug Evaluation and Research (CDER). CDER proposed to withdraw the drug from the market after a required postmarket study failed to verify Makena’s clinical benefit and available evidence failed to show its effectiveness for the approved use. AMAG has requested a hearing and submitted supporting documentation, highlighting that Makena remains approved and available pending the FDA’s review.
Covis Pharma is headquartered in Luxembourg and markets therapeutic solutions for patients with chronic illnesses and life-threatening conditions. In May 2020, it announced that it has initiated Phase 3 clinical trials to test the efficacy of its asthma drug Alvesco (Ciclesonide) in the treatment of COVID-19.