Eli Lilly and Company announced that the US Court of Appeals for the Federal Circuit court ruled that competitors attempting to market alternative salt forms of the vitamin regimen for Alimta (pemetrexed for injection) would be infringing on the company’s patent.
The patented vitamin regimen for Alimta includes a B12 injection a week prior to the first dose and then one every three cycles of treatment. Folic acid and corticosteroids are also part of the vitamin regimen used to mitigate the risk of harmful side effects associated with the treatment.
Alimta is a treatment for advanced nonsquamous non-small cell lung cancer (NSCLC) from Lilly. It generated global sales of $2.13bn (€1.90bn) in 2018.
The therapy can also be used in combination with cisplatin for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Almita is also prescribed to be used in addition to platinum chemotherapy and Merck’s blockbuster Keytruda (prembrolizumab).
Following appeals of US District Court decisions in the cases of Lilly versus Dr. Reddy’s Laboratories and Lilly versus Hospira, the US Court of Appeals once again ruled in favor of Lilly.
The ruling stated that competitors intending to market alternative salt forms of pemetrexed before the drug’s patent expired in May 2022, would be guilty of infringement.
Should the courts continue to rule in favor of Lilly in any additional challenges, no generic products to replace the vitamin regimen will be able to enter market before the expiration of Alimta’s patent.
Michael Harrington, senior vice president and general counsel at Eli Lilly said in a statement, “Lilly’s extensive research to discover this patent deserves intellectual property protection, which has been confirmed in every challenge in the US to date.”
Previous challenges to the drug that led to this recent appeal ruling saw the US District Court for the Southern District of Indiana rule in favor of Lilly against Dr Reddy’s in June 2018, and a separate decision from the US District Court rule in favor of Lilly against Hospira in the same month.
The US Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent for Alimta in March 2014 and ruled in Lilly’s favor regarding infringement of the patent in August 2015.
A unanimous decision in January 2017 confirmed the 2014 and 2015 rulings finding the patent valid and any generic challengers’ proposed products to be infringing on it.
