Last month, the European Court of Justice (ECJ) ruled that drug companies are eligible for extended patent protection on new medical uses for known products.
Neurim Pharmaceuticals Ltd. was entitled to a supplementary protection certificate (SPC), which provide additional patent protection for pharmaceutical products beyond the expiration date to compensate for the time spent getting regulatory approval.
In 1992, Neurim applied for a patent on using melatonin as an insomnia treatment. It was not until 2007 that the company was able to develop a drug based on the patent and obtained regulatory approval.
With less than five years remaining on the patent, Neurim applied for an SPC which the U.K. IPO rejected in 2009, citing a prior method of using melatonin to regulate sheep breeding.
Neurim appealed to the Court of Appeal for England & Wales, which asked the ECJ to determine whether a medicinal product that has received regulatory approval for one use should be prevented from obtaining an SPC based on the previous approval of a different use for the same active ingredient.
Contrary to the IPO, which defined the product as the active ingredient melatonin itself, the ECJ concluded that the product in question was the method of using melatonin to treat insomnia. Therefore, Neurim had the first approved use of the product and was eligible for an SPC.
The ECJ concluded that since “the fundamental objective of the SPC regulation is to ensure sufficient protection to encourage pharmaceutical research,” new uses of known active ingredients are entitled to SPC protection.
Commentators have remarked that the decision is one of the most significant in decades, and changes the European pharmaceutical landscape for the better.