SPC case of combination product (Co-diovan)

Just like 180 days exclusivity and its forfeiter in US, SPC is the matter in EU that always lead to a critical analysis and interpretation of such legislation. Recently Antwerp Court of Appeal has decided in a case of Novartis v Teva, case 2010/RK/456 on 9 february 2011. Court ordered to stop launching of generic version of Co-diovan due to existance of SPC of this combination. I got this details from SPC blog and they have provided translated case details that you can read from here.

Teva and Takeda settled patent dispute related to ACTOS

I am back to blog again after a long vacation.. Please enjoy the festival days and welcome the new year with lots of wishes, joy and success.....!!!

Teva, an Israel based generic pharmaceutical giant has ended the patent infringement litigation over Takeda's diabetes drug Actos by settlement way.

The deal was signed between Teva and Takeda and Takeda has given license to market an authorized generic version of Actos in the United States beginning on Aug. 17, 2012, or earlier under certain circumstances. Additionally Teva will also allowed to market an authorized generic version of Takeda's Actosplus met, which combines Actos with two other general diabetes medicines, in the US beginning Dec. 14, 2012.

Takeda has also settled the patent litigation of Actos and Actossplus met with Mylan Inc, Watson Pharmaceuticals Inc and India's Ranbaxy Laboratories Ltd before settlement with Teva in this year.

The game between Esai, Ranbaxy, Teva and FDA for Aricept

I have came across a nice compiled study of the Aricept case. Recently Ranbaxy got the approval and entitled 180 days exclusivity and Teva's generic launch was delayed until the expiry of 180 days exclusivity of Ranbaxy.
The whole story is very well explained here

One more P IV filer against INTUNIV(TM) of Shire

INTUNIV(TM) is product of Shire plc and contains 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets. This product has 3 patents listed in orange book; US5854290 ("the '290 patent") titled Use of Guanfacine in the Treatment of Behavioral Disorders; US6287599 ("the '599 patent") and US6811794 ("the '794 patent") both titled Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles. The three patents expire in 2015, 2020 and 2022, respectfully.

Previously Teva, Actavis and Anchen has already filed ANDA with paragraph IV certification and Shire has subsequently initiated litigation and all the cases are in discovery phase.

Recently Watson Labs. has also filed ANDA for generic version of INTUNIV(TM) with paragraph IV certification but only for 4 mg strentgh.

INTUNIV(TM) has NP (New Product) exclusivity till 02-September-2012, so no any ANDA will get approval till this date.

Advance notice to innovator for launch at risk is compulsory???

Recently, the U.S. District Court for the Southern District of New York ruled that a generic player may not be required to submit or provide advance notice to the innovator of their intent to launch at-risk a competing product in Teva et al. v. Sandoz, Inc., 08-7611 (S.D.N.Y. October 12, 2010).
This decision is noteworthy in that it contrasts with the practice in the District Court of New Jersey where at least one generic company has been ordered to provide advance notice to the brand companies of an impending at-risk launch.
For full details click here