US drug giant Eli Lilly and Co has won a lawsuit in the UK that prohibits British rival Actavis Plc to produce a generic form of its blockbuster cancer drug Alimta vitamin regimen before its UK patent expires in 2021.
The appeals court ruled that commercialisation of alternative salt forms in the products as proposed ''would constitute indirect infringement by supplying an essential means for putting the patented invention into effect.''
The court also said there was no difference between the law in the UK and that in France, Italy and Spain as it relates to indirect violation, and so reversed the high court's decision regarding Alimta vitamin regimen patents in those countries.
Lilly's senior vice president and general counsel Michael Harrington said, "We are pleased with the UK court of appeal's ruling that confirms the Alimta vitamin regimen patent would be infringed by the entry of these generic pemetrexed products in the United Kingdom prior to June 2021.''
''We are also pleased the ruling has cancelled the declarations of noninfringement with respect to France, Italy and Spain," he further stated.
Actavis may seek permission to make an appeal in the UK supreme court.
Alimta, a treatment for mesothelioma, a rare cancer related to asbestos exposure. The drug produced 11 per cent of the company's 2012 revenue. Lilly owns two patents for the drug; one for the compound's chemical composition and another for administering the drug to patients along with certain vitamins designed to reduce its side effects.
Actavis has also stated it may ask the high court to decide whether a different proposed product would infringe the patent.
The court of appeal has ruled that the high court will need to decide whether it will hear this new claim. If the high court decides to hear Actavis' case on the different proposed product, Lilly said it will defend the case vigorously.
Earlier this year, Lilly lost a similar case in a German court of appeal which ruled that the Alimta vitamin regimen patent would not be infringed by a generic competitor, after the patent expiration in December 2015. Lilly has sought permission to appeal against this verdict.
Further to the news, shares in Eli Lilly jumped over 3 per cent to $84.81 yesterday in New York.
Indianapolis-based Eli Lilly is a global pharmaceutical leader selling its products in the areas of endocrinology, oncology, neuroscience, cardiology and animal health among others in 120 countries. In 2014, the company reported revenue of $19.6 billion with a net profit of $2.4 billion.
Patent expirations of Lilly's blockbuster drugs Zyprexa, Cymbalta, and Evista have taken a toll on the company's financials over the last few years. After revenue and earnings peaked in 2011, the company has struggled to make up for the shortfall, and earnings have fallen by more than 50 per cent since.
Alimta accounted for 14 per cent of Lilly's 2014 revenue, and it will see its first leg of patent protection disappear in December in Europe and Japan. The company will pass through a rough year in 2017 as more drugs head for patent expiry during that year.