In a unanimous decision, the five Lords (the UK’s highest court) ruled on February 25 that Lundbeck’s patent for escitalopram – branded as Lexapro, Cipralex or Cipramil as well as other names – is valid. The drug is the world’s biggest selling antidepressant by volume.
The validity of the European patent, which has a priority date of June 14 1988, had been challenged by three generic manufacturers – Generics (UK), Arrow Generics and Teva.
At first instance, Mr Justice Kitchin rejected their attacks of lack of novelty and obviousness. But he agreed with their insufficiency claim.
The patent claimed escitalopram as a product, though the invention itself was essentially just one means of making it.
Citing the House of Lords 1997 decision in Biogen v Medeva, Kitchin said the technical contribution of the patent was not to find a new product, but rather just one way of making a product. A patent that effectively covered all ways of making the product would be disproportionate, he said: “The first person to find a way of achieving an obviously desirable goal is not permitted to monopolise every other way of doing so.”
However, the Court of Appeal disagreed, and upheld the patent. But given that there were questions about the consistency of its ruling with Biogen, the House of Lords agreed to hear an appeal from the generic companies.
In his opinion, with which the other judges broadly agreed, Lord Neuberger described the Biogen opinion (written by Lord Hoffmann) as a “tour de force” but added that it “is of no assistance to the appellants in this case”.
In the Biogen case, said Neuberger, the claim was “very unusual”: “The claim was to a product identified in part by how it was made and in part by what it did – almost a process-by-product-by-process claim.”
But he said it is wrong to regard that reasoning as being “of much wider application”, even though some judges and commentators appear to have taken that view.
Neuberger added that there is a distinction between “inventive step” and “technical contribution to the art”: “In the case of a product claim at any rate, one is primarily concerned with what has been allegedly invented, not how it has been done. On the other hand where the claim is for a process or (as in Biogen ... ) includes a process, the issue of how the alleged invention has been achieved seems to be more in point.”
Patent practitioners welcomed the decision, saying it brought clarity.
“The wider application of Biogen has been disapproved,” said Tim Powell, of Powell Gilbert. “This decision provides much greater certainty. To that extent, everyone will welcome it. Under Biogen, it was difficult to know where the limits of your freedom-to-operate were.”
Brian Cordery of Bristows said the ruling confirms that finding an inventive way of making a product means you can obtain a patent covering the product, all ways of producing it and all uses of it. “My pharmaceutical clients are delighted with the decision,” he said.
He added that the UK judges had “got themselves into a pickle” over obviousness and insufficiency, but that the decision draws a line between the two concepts. “The fusion of obviousness and sufficiency since Biogen made it very hard to advise clients. Now we have returned to an old-fashioned approach to insufficiency: can you tell the public how to make what you’ve claimed?”
The Lundbeck decision is the latest in a series that have been welcomed by patent owners in the UK, including Lilly v Reddy, Actavis v Merck and Conor v Angitoech. “There has been quite a pro-patent trend in the past year,” said Ewan Nettleton of Bristows.
“This latest ruling is another indication that the UK courts are moving away from their reputation for being very hard on patents,” added Powell.
The ruling also fits a pattern in which UK judges have explicitly sought to align protection with settled law in the EPO Boards of Appeal. Neuberger considered EPO precedents in detail in his ruling.
Lundbeck’s global sales of Cipralex/Lexapro in 2007 amounted to Dkr6.69 billion ($1.15 billion).
Anders Schroll, head of corporate communication at Lundbeck, told Managing IP: “We are very pleased that the House of Lords has reaffirmed the validity of the escitalopram patent in the UK. Lundbeck is a company focusing on innovation and developing new treatments, we need IP rights and will actively defend our intellectual property.”
He added that the company also has patent cases pending in Australia, Belgium, Canada, France, the Netherlands, Germany, the US and Austria.
