The UK’s highest court decided in March that a patent licensed from former biotech company Icos to Eli Lilly for the erectile dysfunction (ED) drug Cialis (tadalafil) was invalid.
Sources say that while the decision does not represent a major shift in patent law, it does confirm that dosage regimens are patentable and that businesses will need to demonstrate an unexpected or surprising benefit to a suggested dosage for it to attain patent protection.
“The decision, I would say, confirms the view that the dosage regimen should be patentable because it has not been disclosed before and because it is efficacious is not enough,” an industry source tells Patent Strategy. “You need to be able to show some unexpected advantage to the dosage regimen.”
Originally tadalafil was administered in an on-demand single dosage of 10mg or 20mg, depending on the strength needed by the patient. An IP director at an innovator company in the UK adds that Eli Lilly argued a daily 5mg dosage change was an unexpected benefit because patients experienced the same benefit of taking a daily pill at a lower dosage as they would a higher dosage on demand.
He adds the biotech industry worried the courts would make the UK unattractive to the bioscience industry by striking down the patent. But these fears have largely passed now that the court has given greater insight into what is and is not obvious.
The industry source says that the danger of a reduction in R&D as a result of this case was always more of a hypothetical risk in any case. He adds that is not aware of any products that companies said they would not launch because of questionable decisions by the UK Supreme Court.
“Ultimately, the UK is still a big market for pharmaceuticals,” he says. Other in-house sources add that the ruling did not take dosage regimen patents off the table but simply laid out what would be considered non-obvious to a skilled person.
The dosage commandments
An industry source points out that biotech worries have been alleviated partly because the court issued guidelines that set out 10 factors shedding light on what can be considered obvious to a skilled person in dosage regimens and what could be considered a routine discovery during pre-clinical trials.
In explaining the added clarity of these 10 factors, a director of a UK life sciences company says: “These factors are the sort of thing you would explain to a client if they asked you what I should look at to establish if something is patentable. I wouldn't have written it down exactly like the Supreme Court did, but nothing in there was revolutionary.”
An industry source adds that the 10-step process brings together elements of other cases in an effort by the court to answer what is obvious to a skilled person.
“This guidance is something people will start using a lot more,” he says.
He adds, however, that the guidance does not set out which of the 10 factors are more important than others, which may lead to some controversy and confusion in the future.
“In some cases one factor might be more important than others. It sets a framework.” In-house lawyers say that the ruling will make companies question whether or not to pursue patents for drug dosage modifications. ED drugs, which are large revenue generators for companies, are predicted by DrugBank to become a $3.2 billion industry by 2022. With so much money at stake, pharma innovators might want to test the waters to see what drug modifications they can patent. In-house sources say that at some point a drug becomes so valuable that it is worth taking a risk to see if they can get a different ruling.
Case comments
The panel of five judges decided that the daily dosage of 5mg for tadalafil lacked the inventive step needed for a patent.
The High Court had earlier backed Eli Lilly and Icos by saying that a 5mg daily dose of tadalafil was not an obvious treatment for ED.
The case pitted Eli Lilly and Icos against several companies and associations led by Actavis. These respondents had sought to have the patent – EP (UK) 1,173,181 – revoked, with Eli Lilly counterclaiming for infringement at the High Court.
“It is a huge win for the generics industry,” says an industry source, adding that the court has opened the door for generic companies to profit from the lucrative drug.
An in-house source adds: “There is an underlying tone that the patent is a sort of bargain between the state and the company. If you have an amazing invention, it justifies you having a monopoly, but if you have a small step invention it probably won’t.”
In this case, he says, 5mg was too small for ED.
Teva, the parent company of Activis, tells Patent Strategy: “We are pleased at the outcome of the UK Supreme Court case. The court rejected Eli Lilly’s attempt to maintain a patent that covers the results of ‘familiar and routine testing of a drug’. Teva will continue to serve the needs of the patients, including by challenging invalid IP.”
