On July 9, the House of Lords ruled in favour of Angiotech Pharmaceuticals in the closely watched case, Conor Medsystems Inc v Angiotech Pharmaceuticals Inc, upholding the validity of Angiotech’s European patent for a paclitaxel-eluting stent and reversing the decisions of the UK Court of First Instance and the Court of Appeal.
On May 24 last year, the House of Lords granted Angiotech Pharmaceuticals leave to appeal a Court of Appeal ruling that found the patent invalid on the grounds of obviousness.
The Court of Appeal ruling came just a day before a Dutch court ruled that the same European patent was valid, and highlighted the different approaches to obviousness taken by the UK and Dutch courts.
The UK courts had found the patent invalid as it contained insufficient experimental data or evidence to satisfy a reader that Taxol (a popular chemotherapy drug) was likely to be successful as a coating for a drug-eluting stent to prevent restenosis.
But in Wednesday’s judgment, Lord Hoffmann reversed the Court of Appeal and Court of First Instance decisions and deemed the patent valid.
Hoffmann did not agree with the previous courts’ test for obviousness, which asked whether or not the invention had a reasonable expectation of success. “This oxymoronic concept has, so far as I know, no precedent in the law of patents,” said Hoffmann.
Instead, he said that the proper question to ask was “whether it was obvious to use a taxolcoated stent to prevent restenosis”.
Lord Hoffmann said: “In my opinion, the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description.”
He added that “if a specification passes the threshold test of disclosing enough to make the invention plausible” then there should be no reason why “the question of obviousness should be subject to a different test according to the amount of evidence which the patentee presents to justify a conclusion that his patent will work”.
Lawyers said that the decision will probably result in more patents being upheld in the UK and characterized it as an encouraging sign for patentees.
Robert Anderson of Lovells said the decision was “refreshing”, since “the obviousness test had become complicated” in the UK.
“Hoffmann has helped patent law in getting back to basics. It was getting very complex and Hoffmann has simplified it. What is obvious means what is said, you don’t have to make it complicated,” he told Managing IP.
Michael Burdon, a partner at Olswang who is representing Boston Scientific, the licensee of the patent, said the House of Lords introduced concepts that will help provide clarity tin making obviousness determinations.
He said: “It will certainly affect the way UK courts approach obviousness. It is a positive judgment for the research community and particularly important to life sciences, where a lot of research is by trial and error.”
Conor Medsystems and Angiotech had already settled the dispute. But the House of Lords heard the case in order to examine the issue of obviousness and its interpretation in the UK.
Penny Gilbert of Powell Gilbert said that now courts will have a clearer way of assessing patent validity claims, and that this suggests a softening of stance by the English courts as well as the possibility that more patents may be upheld in future.
She said that Lord Hoffmann confirmed that “obviousness must be determined by reference to the claims and not some vague paraphrase based upon the extent of disclosure in the description”.
Mark Hodgson, a partner at Howrey, who represented Angiotech, said the House of Lords' ruling is a good decision for patentees and that the earlier decisions put a lot of emphasis on patent specifications and experimental data.
“It is gratifying to know you can now claim a patent if the idea is plausible. It is great not only for companies like GlaxoSmithKline, but also for the small younger companies. This is a sea change for all patentees in the UK and it brings the line far closer to EU jurisdictions and provides some consistency,” he said.
The issue of obviousness, and specifically the notion of whether an invention is “obvious to try”, has been the subject of much controversy in the US as well lately. Since the Supreme Court’s ruling in KSR v Teleflex last April, which mandated a more flexible approach to determining obviousness, the courts and the USPTO have been struggling with how to implement the decision.
The patent in this case, EP 0 706 376 B1, was filed at the EPO by Angiotech and the University of British Columbia in April 1996 and is licensed to Boston Scientific. It was opposed and amended at the EPO.
Due to the settlement between the parties, Conor was not represented in the House of Lords hearing.
