It's about the tadalafil generic

Summary: "Just gimme the patent," says every greedy corporation looking to ban its competition (including generics) and facilitate monopoly pricing; the problem is, the EPO keeps granting invalid patents that take a lot of time and money to formally invalidate (in courts), as Actavis v ICOS has just shown

THE number of patents granted by the U.S. Patent and Trademark Office (USPTO) declined last year after certainty associated with these patents had declined and then number of patent lawsuits had totally collapsed. We now see something similar going on in Europe. Was it inevitable? Couldn't we learn from the mistakes of American lawmakers and USPTO officials?

We are pleased to see that IP Kat (Rose Hughes) has recently been covering some cases that relate to the European Patent Office (EPO). Hughes is doing an OK job without coming across as a patent extremist like the Bristows staff at IP Kat and yesterday she wrote this article about a (British) Supreme Court outcome. Yet another EPO-granted patent has been found to be nonsense:

This morning, the UK Supreme Court delivered its decision in Actavis v ICOS [2019] USKC 15, upholding the Court of Appeal's decision that ICOS's dosage regimen patent was obvious. In doing so, the Supreme Court (in a welcome change...) has followed the previous approach of the lower courts to the question of inventive step in both the UK courts and in the jurisprudence of the EPO.

The patent in question related to tadalafil (branded as CIALIS). Tadalafil is an orally administered drug for treating sexual dysfunction. Tadalafil works in a similar way to Pfizer’s famous blockbuster drug Viagra, but with fewer side effects. The original first medical use patent for tadalafil (EP 0740668, "Daugan") and its associated SPC have both expired. The latest decision related to ICOS's patent (EP 1173181) which claimed a particular dosage regime of tadalafil. Lilly is the exclusive licensee of the patent.

In an attempt to clear the market for their own tadalafil generic, Actavis brought revocation proceedings against the ICOS/Lilly patent. Actavis argued that the claims lacked novelty and inventive step in view of the original tadalafil patent ("Daugan"). The contentious claims related to a dose regime of up to 5mg tadalafil per day. The Court of Appeal, in overturning Mr Justice Birss' decision, found the patent invalid for lack of inventive step (Actavis v ICOS [2017] EWCA Civ 1671). Particularly, it was found that the claimed dose would have been obvious for the skilled person to try (IPKat post here).

Notice that first comment which asks: "Can every one of Lord Hodge's 9 factors be accommodated within Lord Hodge's exposition of the EPO's Problem and Solution Approach? If not all, which ones not?"

“Can every one of Lord Hodge's 9 factors be accommodated within Lord Hodge's exposition of the EPO's Problem and Solution Approach?”
      --AnonymousSomeone "from France" then added: "One important factor seems indeed to be missing, which is the "reasonable expectation of success", even though certain of the listed factors are usually considered for applying this factor. The reasoning that the clinical trial is somewhat a "one way street" (to use EPO standards) is not completely out of scope, but the specific dosage finding that has been identified for optimal effect could, in my view, not have been necessarily derived from this approach (the dosage plateau could not have been expected, considering it seems to necessarily imply some hindsight). I'm not sure I agree with the comment in the post that such a decision is welcome..., I can hardly consider a diverging view between the EPO and national courts to be welcome."

Another anonymous commenter quotes: "The original first medical use patent for tadalafil (EP 0740668, "Daugan") and its associated SPC have both expired."

Then comes the question (or questions): "Doesn't this mean it has already passed through clinical trials? By the courts' logic should a 5mg dose already be known? What have I missed?"

What about public interests as well? Either way, the court has trashed yet another European Patent. Will António Campinos get the message or just keep on lying about quality?

“I can hardly consider a diverging view between the EPO and national courts to be welcome.”
      --AnonymousFreshfields Bruckhaus Deringer LLP's Laura Whiting and Paul Abbott wrote about it this morning (publication time), calling it "its second patent decision in 6 months" (so rarely do we get to see, at least at this level, just how awful the quality of patents has become).

We'll probably hear a lot more about it in days if not weeks to come. ⬆