German court rules against Lilly in Alimta patent case
pharmafile | March 10, 2015 | News story | Manufacturing and Production, Sales and Marketing | ACS, Actavis, Alimta, NICE, NSCLC, lilly, lung cancer, pemetrexed
A German court has ruled that Lilly’s patent for its lung cancer drug Alimta would not be infringed by generic competition when it expires later this year.
The court governed in favour of Actavis to develop a dipotassium salt form of Alimta (pemetrexed) – Lilly’s second-best selling drug last year, bringing in a total $2.7 billion in sales – to be marketed in Germany.
“We strongly disagree with the ruling by the German Court of Appeal regarding Alimta’s vitamin regimen patent,” comments Michael Harrington, who is the senior vice president and general counsel for Lilly.
Similarly in April 2014, the English High Court also ruled against Lilly citing once again that the vitamin regimen patent for the cancer drug would not be overstepped by a generic rival.
The appeal of this decision is pending, but if the final ruling does go against the US-based pharma firm, then copycat versions of Alimta will be available in the UK, Italy, France and Spain.
Harrington continues: “We continue to believe that Alimta’s vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June, 2021. We will seek permission to appeal this ruling to the German Supreme Court.”
Alimta can be used for NHS patients in combination with cisplatin – a chemotherapy drug – as a first-line treatment option for non-squamous non-small-cell lung cancer (NSCLC). But in 2014 NICE rejected the medicine to treat patients with locally advanced or metastatic – the spread of a cancer from one organ to another – NSCLC.
According to the American Cancer Society (ACS) about 85% to 90% of lung cancers are NSCLC, and both small cell and non-small cell are the second most common cancers in both men and women.
The ACS predicts that in 2015 around 221,200 people in the US will be affected by lung cancer, contributing to an estimated 158,040 deaths.
The compound patent for Alimta in Germany remains in force and is expected to provide exclusivity through December 2015.
Tom Robinson
Related Content
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
NICE recommends migraine treatment for NHS use
The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s …
FDA clears Oryzon’s phase 1/2 trial for lung cancer treatment
Oryzon Genomics has announced that the US Food and Drug Administration (FDA) has approved its …
