More second medical use cases on horizon, say lawyers

After the English High Court yesterday heard the second day’s arguments in the dispute between Actavis and Warner-Lambert concerning second medical use patents, two lawyers have told LSIPR that similar cases may be on the horizon.

Paul England, a senior associate at law firm Taylor Wessing in London, said that as research yields more alternative uses of existing drugs for which the compound is off-patent, the issue of infringement of second medical use patents is likely to appear more often.

Stephanie Pilkington, a partner at patent and trademark attorney firm Potter Clarkson in Nottingham, said that there may be more cases of this nature to come, “unless the present case leaves the approach so clear-cut that parties know exactly what they have to do and are able and willing to do it”.

Warner-Lambert, now a part of Pfizer, developed Lyrica (pregabalin) for the treatment of epilepsy and general anxiety disorder (GAD).

After finding that the drug could be used to treat neuropathic pain, Pfizer received a  second medical use patent to cover that indication. The patent is due to expire in 2017.

As the original patent covering Lyrica expired in 2013, generic versions of pregabalin directed to epilepsy and GAD may enter the market. Actavis, now known as Allergan, makes a generic version of Lyrica called Lacaent.

After Pfizer discovered that Lacaent was being prescribed to treat neuropathic pain, it sought an interim injunction that required Actavis to take steps to prevent that from happening.

In February, Judge Richard Arnold, who heard the case on Monday, June 29, and yesterday, instead ordered the NHS to provide guidance on how to prescribe and dispense pregabalin so that Pfizer’s second medical use patent would not be infringed.

Earlier this month, Pfizer sent an open letter to UK-based healthcare providers apologising for any confusion caused, a move England described as “unprecedented”.

Pilkington added: “The present case raises a number of interesting questions on what generic manufacturers may need to do prior to product launch where there is a second medical use patent (or supplementary protection certificate) still in force, and on how any remedies or damages may be assessed.

“The present case shows that the courts are seeking to find a practical way of enforcing second medical use patents while allowing generic competition for non-patented indications—not an easy thing to do with the practicalities of drug supply in the UK and elsewhere.”