UK Appeals Court upholds Teva’s Copaxone patent

The Court of Appeal for England and Wales has upheld the Patent Court’s decision that Teva Pharmaceutical Industries’ UK patent 762,888, relating to the multiple sclerosis drug Copaxone, is valid.

Yeda Research and Development Co Ltd and Teva are, respectively, the registered proprietor and exclusive licensee of the patent.

Lord Justices Moses, Kitchin and Floyd decided on July 29 that Patent Court judge Justice Arnold was correct in ruling the patent is valid, dismissing Mylan Laboratories’ UK subsidiary Generic [UK] Limited’s claims that it is obvious because of a prior publication, and lacks technical contribution.

Although the publication, written by Dr Kenneth Johnson, was not published until after Teva’s patent priority date, the results that it relied on had been announced before the date.

Mylan brought the initial case against Teva while preparing to market a generic version of Copaxone. It sought to revoke Teva’s patent and requested declaratory judgment that its proposed product did not infringe.

While the panel dismissed Mylan’s request to invalidate the patent, the case did open up questions as to whether evidence submitted after the patent priority date may be used when challenging patent validity.

Brian Cordery, partner at Bristows LLP in London, said that when applying for a patent, the applicant must explain in plausible terms its technical contribution. The applicant may then supplement the application with further evidence.

However, referencing the European Patent Office Board of Appeal decision in Johns Hopkins University School of Medicine/Growth Differentiation Factor mentioned in the judgment, Floyd said this supplementary post-published evidence may not form the sole basis for establishing the patent solves the problem it purports to solve.

In this respect, Floyd concurred with Arnold, though disagreed where Arnold found that if the patent is found to be plausible, it may not be subsequently challenged using later evidence, Cordery explained.

“Usually the evidence when challenging obviousness will be from before the patent priority date but Floyd noted that in many instances you can bring evidence in from after the priority date to shed light on the issue, such as commercial success,” he said, noting the Schlumberger case in which the Court of Appeal had stressed that secondary evidence such as acclaim for the invention after the priority date can be important.

He described the ruling as a “robust and sensible decision” that is positive for patent holders.

“It’s a significant case that will be relied upon often in relation to this so-called lack of technical contribution obviousness,” he said.

Paul England, senior associate at Taylor Wessing LLP in London, said that the case takes a “step forward” after a series of lawsuits that have considered challenging patents on the grounds of obviousness for lack of technical contribution.

“The case says that you can invalidate a patent for lack of technical contribution using evidence that postdates the patent itself, to show that it never made a plausible technical contribution, or a step forward in knowledge, and that’s new,” he said.

He said the ruling means patent challengers may use information from clinical trials to show a patent doesn’t work. The case does not “open the floodgates”, he said, but gives patent challengers another tool to attack patents.

“It adds a new layer of complexity that’s slightly puzzling lawyers, and one that is no doubt puzzling clients too,” he added.

The Appeals Court also found that the Patent Court was correct to reject Mylan’s request for a declaration of non-infringement.

The UK decision contrasts with that of the US Court of Appeals for the Federal Circuit, which on July 26 that Teva’s US patent for Copaxone was invalid, reversing a district court's decision.