Barr Pharma announced that it has signed a settlement Agreement with innovator Boehringer Ingelheim to resolve the patent litigation w.r.t Mirapex Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.Following patents are listed in Orange Book for Pramipexole Dihydrochloride Tablets
US4886812 (Expiry: OCT 8, 2010)- Product patent (specific)
US6001861 (Expiry: JAN 16,2018)- method of use for restless leg syndrome
US6194445 (Expiry:JAN 16,2018)- method of use for restless leg syndrome
Earlier, the U.S. District Court for Delaware has invalidated the Orange Book listed product patent ‘812 of innovator. In a significant ruling, District Court Judge opined that the product claim in litigation is invalid because of double patenting.
Earlier, Barr received notification of the application's acceptance for filing in July 2005. Following receipt of the notice from the USFDA, Barr notified Boehringer Ingelheim, the New Drug Application (NDA) holder and patent owner. On September 26, 2005, Boehringer Ingelheim filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.Also, in Feb 2008, Barr got final approval on its ANDA but decided not to launch the product until decision from CAFC.
Importantly, Barr has got First to file exclusivity on this product and with favorable ruling from District court, Barr could have launched the product immediately, but Barr decided to settle with the innovator as Barr was reluctant to face the trial in Court of Appeal for Federal Circuit (CAFC). Under the agreement Barr will launch its product on January 1, 2010 (10 months earlier than the product patent expiry). The other generic companies can launch their product from July 1, 2010 (If any generic company invalidate innovator’s product patent in CAFC) otherwise from October 9, 2010.
Pramipexole was approved by USFDA on July 1, 1997. Barr has got final approval on February 19, 2008 and Mylan has got tentative approval on May 8, 2007.
Earlier, innovator has also sued Mylan for '812 parent and is in talk with Mylan for the settlement on this case.
Nowadays, generic companies prefer to have certainty of product launch without undue litigation expenses. This settlement is favorable for the Barr as it will have almost 10 months exclusivity (may be with Mylan) in the market and also for innovator as its product patent will remain in force and will act as barrier for other generic companies.
In addition, Barr Laboratories also entered into a Settlement to resolve the patent litigation regarding Boehringer Ingelheim's Aggrenox (Aspirin (25mg)+Dipyridamole 200 mg) extended release capsules, which will be launched as authorized generic version from July 1, 2015 onwards.
Earlier news of Ippharmadoc Here
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