Time is money, and that is what makes the lag between the filing of a patent application for a drug and the date it hits the market so painful for companies to endure. To make up for the wait, in 1992 the EU introduced 'supplementary patent certificates' (SPCs), which can grant up to five years of additional market exclusivity after the underlying patent of a medicine expires. Now, after two recent rulings in the EU, experts warn that drugmakers should plan more carefully when seeking SPCs for combination drugs, which can be complicated because these products often contain ingredients beyond those covered by a company's patents.

When it comes to combination drugs, SPC approval guidelines have varied from country to country in the EU—something that companies have not been too happy about. The law creating the SPC framework “was a very short piece of legislature that caused a huge number of problems,” says Robert Stephen, head of patent prosecution at the London law firm Olswang. But on 24 November, the Court Justice of the European Union (CJEU) handed down decisions on two cases, clarifying how countries across the EU should apply SPCs to combination products.

In one of the cases brought before the high court, Dutch drugmaker Medeva BV, now a subsidiary of the UK-based pharmaceutical company Celltech Pharma Europe, was seeking an SPC to cover the expanded use of its patented ingredients in the whooping cough vaccine to other types of vaccines that included additional unpatented components. But, ultimately, the gavel struck hard: the judges made it clear that an SPC can cover only those drugs listed in the basic patent and nothing more. “The idea that there is any way around this is, I think, wishful thinking,” says Jonathan Radcliffe, an intellectual property lawyer at Mayer Brown in London.

“What the court is looking for is that the combination—if it's going to be a truly different product—needs to represent a different innovation from the single active ingredients” covered in their patent, says Mike Snodin, a pharmaceutical lawyer at Potter Clarkson in the UK. “I imagine that there are a number of nervous companies out there.”

On the flipside, in the second decision on 24 November the EU high court said SPCs could be granted for drugs that involve only a subset of active ingredients listed in the underlying patent. That case involved several US universities—including Georgetown University in Washington, DC—seeking SPCs for a subset of elements of the human papilloma virus vaccine originally listed in their patents.

For patent lawyers, the immediate effects of the decisions—particularly the Medeva case—is clear: “Anyone who is filing patents in Europe on products that might be used in combination with other products will have to be very careful in the future in the way they write their patent claims,” says Duncan Curley, head of patents at Innovate Legal in London. Patent writers, he explains, will be forced to gaze into their crystal balls to predict every potential combination to ensure the patent will cover it later.