Takeda loses again to Hikma in gout drug patent battle

Takeda's Shonan Research Center

Takeda suffered a defeat in its battle to keep a competitor to its version of an ancient gout drug off the market. A federal court backed Hikma's right to sell a med with the same active ingredient as Takeda’s Colcrys because it's approved for an off-patent indication.

U.S. District Judge Sue Robinson in Delaware said that Hikma did not cause doctors to infringe on Takeda’s patents by selling its drug Mitigare, because Mitigare is not indicated for uses covered by the patents in question, Reuters reports.

The ruling comes as bad news to Takeda, which has been trying to bring in brand-level sales for Colcrys after picking up the drug from URL Pharma in 2012. The drug, which is most commonly used to treat gout, has a slew of method patents URL had filed in hopes of protecting it from competition. Those patents are set to expire in 2028.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

But the FDA has not given much weight to the Takeda's IP. In September 2014, it approved Hikma’s version of colchicine to prevent gout flares. The agency’s move prompted Takeda to file a patent infringement suit against Hikma and the agency.

The Japanese drugmaker claimed that the FDA broke its own rules by approving Hikma’s drug because Mitigare doesn’t include the same information that the agency required on Colcrys’ label. The agency also did not require Hikma to mention Colcrys’ name, which prevented Takeda from taking advantage of a 30-month stay available under the Hatch-Waxman Act, the company said.

Takeda also tried to prevent Hikma from launching Mitigare, but ultimately did not succeed. In January 2015, Hikma launched its product after a federal circuit court of appeals denied the preliminary injunction.

- read the Reuters story

Related Articles:
Takeda wins temporary reprieve for controversial gout drug Colcrys
Study says no good has come from FDA's action on gout drug colchicine
U.S. lawmakers challenge URL on Colcrys price
Gout medicine Colcrys' pricing under scrutiny
FDA bans unapproved gout treatments

Suggested Articles

The second of AbbVie’s highly anticipated 2019 blockbuster candidates is here: Its crucial Humira follow-up, Rinvoq.

Bristol-Myers Squibb’s takeover of Celgene hasn’t always gone smoothly, but now a once-left-for-dead centerpiece of that deal is ready to launch.

Investors sued Novo Nordisk in Denmark, claiming it misled the public about trouble plaguing its insulin franchise—and demanding $1.75B in damages.