English High Court affirms the validity of Eli Lilly’s ADHD patent

The English High Court has affirmed the validity of Eli Lilly’s European patent covering the use of the drug Strattera (atomoxetine), used to treat attention-deficit hyperactivity disorder (ADHD).

In a judgment handed down yesterday, November 17, Mr Justice Henry Carr rejected Allergan’s challenge to the validity of the patent European patent number 0,721,777.

The patent is called “Use of tomoxetine  for the manufacturer of a medicament for treating ADHD”. Eli Lilly has also obtained a supplementary protection certification for the patent which is due to expire May 2019.

Tomoxetine is also commonly referred to as atomoxetine.

Eli Lilly has sold the atomoxetine drug used under the name Strattera since 2004.

Allergan had sought the revocation of the patent in order for it to begin marketing a generic version of the drug. Eli Lilly counterclaimed that Allergan had infringed the patent.

Allergan argued that the patent was obvious and made “no more than a bald assertion that atomoxetine is effective and safe for the treatment for ADHD”.

Carr, however, was not convinced.

“I have concluded that the disclosure of the patent that atomoxetine is effective in the treatment of ADHD is plausible. It is a technical contribution that has proved valuable in the treatment of this serious condition.

“The prior art lacks this technical contribution. Neither citation makes it obvious to try atomoxetine for the treatment of ADHD,” he added.

Carr also concluded that Allergan’s generic application had infringed the patent.

A spokesperson for Eli Lilly told LSIPR that it is pleased with the court's ruling.

"The protection of intellectual property rights is extremely important to the pharmaceutical industry and the patients we serve. These rights provide assurances of market exclusivity that help support investment into the research and development that will ultimately bring the next generation of innovative medicines to patients.”