Teva gets under Leo’s skin, knocks out two patents

Drug business Teva invalidated two patents held by Leo Pharma today (October 6) and will seek to launch a generic version of one of the company’s skin condition treatments.

The English High Court ruled that the patents, directed to treating psoriasis with an ointment, were obvious.

Psoriasis is a skin condition that causes red, flaky patches of skin covered with silvery scales. It is thought to affect around 2% of people in the UK.

Leo sells a product called Dovobet Ointment, whose sales are substantial, according to the court.

The ointment comprises a combination of a corticosteroid such as betamethasone and a vitamin D analogue such as calcipotriol.

The company said the two patents in question would be infringed if Teva launched its proposed generic product.

However, Teva claimed that both patents are invalid on three grounds: obviousness, insufficiency, and added matter.

Leo applied to amend the patents’ claims in response, arguing that they would be valid in their amended form.

But in a 105-paragraph ruling, Mr Justice Birss invalidated all the claims in both patents for having a lack of inventive step (being obvious).

“There is no reason to doubt that the skilled formulator would succeed in producing an ointment formulation consisting of betamethasone, calcipotriol and the compound,” he said.

“The skilled team would expect a stable, bioavailable formulation to provide a compliance benefit and to be an effective treatment for psoriasis, better than monotherapy. They would be motivated to carry out a clinical study to confirm that expectation. The study would show that formulation was an effective treatment.

“Accordingly all the claims of both patents are obvious,” he added.

Teva is one of several companies to have opposed both patents in this case before the European Patent Office, while there are also parallel proceedings in the US and in Canada.

According to Leo’s website, its portfolio of products has helped “generations of people achieve healthier skin”, alleviating the physical and social discomfort associated with dermatological conditions.

Leo told LSIPR that it is unable to comment on a legal case. Teva did not respond to a request for comment.