The law suit said that Par voluntarily dropped its abbreviated new drug application with the U.S. Food and Drug Administration, but notified Takeda pharmaceuticals later when it was renewing efforts to bring a generic colchicine pill to market.

“If Par’s generic colchicine product is approved by the FDA, Par will infringe and/or induce others to infringe one or more claims in the patents.” Takeda’s lawsuit said, Par’s actions “indicate a refusal to change the course of its actions despite knowledge of Takeda’s unexpired patents,”.
GOUT is characterized by recurrent attacks of inflammatory arthritis, symptoms are a red, tender, hot, and swollen joint. At high levels, the uric acid crystallizes and the crystals deposit in joints, tendons and surrounding tissues, and the attack of gout occurs. Accumulation of crystals in joint fluid or tophus confirms gout by diagnosis. Blood uric acid levels may be normal during an attack.

Days back, colchicine was prescribed for patients to take orally without knowing drug interactions warnings from the FDA and dosage recommendations since it was unapproved drug for several years.

Since 2006, the FDA has been trying to persuade pharmaceutical companies to perform rigorous safety-and-efficacy testing for drugs that had entered the market before such testing was required. As an inducement, the first company to win a formal approval for one of these “grandfathered” drugs under current standards received 3 years of marketing exclusivity — 7 years if the drug is for an orphan disease. (Familial Mediterranean fever is an orphan indication.)

Firms taking advantage of the incentive have argued that it — and the prices they charge while enjoying what amounts to a monopoly — are needed to allow them to recover their investment in conducting the necessary clinical studies. (Colcrys’s sponsor had tested the drug in a 1-week trial involving 185 patients, as well as lab studies to document product purity and consistency.)

Mutual was able to discover new information about colchicine, including issues concerning safety and efficacy, tolerability, dangerous side effects and interactions with other medicines.

The court documents said Colcrys was developed in 2009 by Mutual, which marked the first time the FDA has approved an oral single-active-ingredient colchicine product. The drug is used to treat the rare disease known as familial Mediterranean fever, as well as gout.

Through its outstanding research, Mutual discovered important new information about colchicine, including previously unknown information concerning safety and efficacy, tolerability, dangerous side effects and interactions with other substances,”

When Takeda bought Mutual, it acquired the rights to the Colcrys patents, including U.S. Patent Nos. 7,906,519; 7,935,731; 8,093,298; 7,964,648; and 8,093,297, along with the exclusive right to produce the medication until July 2016, the complaint said.

Colcrys was central to Takeda’s interest in purchasing Mutual parent company URL Pharma Inc. URL Pharma has been growing its business over the past decade. The 60-year-old company commercialized its first internally developed and self-branded product in 2006, and quickly followed it up with two more treatments, including its signature product Colcrys, a prescription medicine used to treat and prevent gout flares.

The complaint echoes one Par faced from Mutual Pharmaceutical Co. in April 2012, about the time Takeda acquired mutual parent URL Pharma for 800M dollars. And Takeda Pharmaceuticals USA Inc. hit Par pharmaceuticals Inc. with a second patent suit in federal court, claiming that Par’s revived effort to produce a generic gout medication infringes five of Takeda’s patents.

Keywords: Takeda pharmaceuticals, Par pharmaceuticals, GOUT, colchicine, Colcrys.