Cliniminds, Delhi is organizing two days ICH - GCP WORKSHOP ON CONDUCT & MANAGEMENT OF CLINICAL TRIALS on 18th (Saturday) & 19th (Sunday) Dec 2010 at Delhi.
This workshop has been developed to provide overview of clinical research process with a comprehensive review of ICH GCP, Schedule Y and USFDA CFR 21 and the elements involved in coordinating a clinical trial.
Dates of Workshop : 18th-19th December 2010 (Saturday & Sunday) - Timings : 9 a.m. to 5 p.m.
Workshop Venue : Cliniminds Delhi
Last Date of Registration : 15th December 2010. Limited Seats.
Registration Fee :
Rs.6000/- per person. (Includes Certification, presentations; lunch, snacks and beverages).
10% Corporate Discount for 3 or more bookings.
For Registration & Information Please Contact
Cliniminds Delhi
Dr.Nidhi – +91-9311172560 ; Kamal Shahani-+91-9810068241
C-55 First Floor, Vikas Marg, Preet Vihar, Delhi-110092
Email : info@cliniminds.com; Website: www.cliniminds.com
Friday, December 10, 2010
Basics of patent learning series
Definition and interpretation of patentability criteria are different from country to country although the criteria by words remains almost same ie i) Novelty ii) Inventive step or Non obviousness and iii) Industrial application.
As per indian patent law definitions are defined as below
"invention" means a new product or process involving an inventive step and capable of industrial application.(Section 2(1))
"inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes theinvention not obvious to a person skilled in the art. .(Section 2(1)(ja))
"capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry. (Section 2(1)(ac))
Other than these few terms defined in the indian patent law are as under
"legal representative" means a person who in law represents the estate of a deceased person.Section 2(1)(k)
"assignee" includes an assignee of the assignee and the legal representative of a deceased assignee and references to the assignee of any person include references to the assignee of the legal representative or assignee of that person. (Section 2(1)(ab))
"patentee" means the person for the time being entered on the register as the grantee or proprietor of the patent. (section 2(1)(p))
"true and first inventor" does not include either the first importer of an invention into India, or a person to whom an invention is first communicated from outside India. (section 2(1)(y))
As per indian patent law definitions are defined as below
"invention" means a new product or process involving an inventive step and capable of industrial application.(Section 2(1))
"inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes theinvention not obvious to a person skilled in the art. .(Section 2(1)(ja))
"capable of industrial application", in relation to an invention, means that the invention is capable of being made or used in an industry. (Section 2(1)(ac))
Other than these few terms defined in the indian patent law are as under
"legal representative" means a person who in law represents the estate of a deceased person.Section 2(1)(k)
"assignee" includes an assignee of the assignee and the legal representative of a deceased assignee and references to the assignee of any person include references to the assignee of the legal representative or assignee of that person. (Section 2(1)(ab))
"patentee" means the person for the time being entered on the register as the grantee or proprietor of the patent. (section 2(1)(p))
"true and first inventor" does not include either the first importer of an invention into India, or a person to whom an invention is first communicated from outside India. (section 2(1)(y))
Intellipharmaceutics submits 4th ANDA in a year
Intellipharmaceutics has recently filed an ANDA with the USFDA for Focalin XR® 30 mg strength. They have already filed ANDA for the same product for , 10, 15 and 20 mg strengths. This filing of 30 mg strength is an amendment to the previous filing. This ANDA is the fourth such filing by Intellipharmaceutics in the last year.
For details click here
Wednesday, December 8, 2010
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
The whole story is very well explained here
Seminar on patent strategies for US, EU and India
AIPS, Mumbai is going to organize a one day seminar on "Patent Strategies for Protecting Inventions in U.S., Europe & India"
The Seminar will look at the challenges and pitfalls faced while prosecuting patents in the U.S., Europe and India, and suggest strategies that can be adopted to protect biotech and pharmaceutical inventions. IP challenges for biosimilars will also be studied, including freedom -to - operate issues, the regulatory pathway for approval of biosimilars, and the related IP strategies for innovator and generics companies. A combination of US and EP perspectives in a single event, supplemented by some specific aspects of national Indian law, will add value to the event.
Date:- January 18, 2011
Timing:- 9.30 am – 5.30 pm
Venue:- The Mirador, Andheri (E), Mumbai
Faculty
Gary J. Speier, U.S. patent attorney and shareholder with Schwegman, Lundberg & Woessner
Dr. Stefan Danner, German & European Patent Attorney, DHS Patentanwaltsgesellschaft mbH
Malathi Lakshmi Kumaran, PhD, FNASc, Lakshmi Kumaran & Sridharan
Contact Details:
Gita Chandrashekhar
6522 1097 / 2874 6123
The Seminar will look at the challenges and pitfalls faced while prosecuting patents in the U.S., Europe and India, and suggest strategies that can be adopted to protect biotech and pharmaceutical inventions. IP challenges for biosimilars will also be studied, including freedom -to - operate issues, the regulatory pathway for approval of biosimilars, and the related IP strategies for innovator and generics companies. A combination of US and EP perspectives in a single event, supplemented by some specific aspects of national Indian law, will add value to the event.
Date:- January 18, 2011
Timing:- 9.30 am – 5.30 pm
Venue:- The Mirador, Andheri (E), Mumbai
Faculty
Gary J. Speier, U.S. patent attorney and shareholder with Schwegman, Lundberg & Woessner
Dr. Stefan Danner, German & European Patent Attorney, DHS Patentanwaltsgesellschaft mbH
Malathi Lakshmi Kumaran, PhD, FNASc, Lakshmi Kumaran & Sridharan
Contact Details:
Gita Chandrashekhar
6522 1097 / 2874 6123
Tuesday, December 7, 2010
Reference indian patent manual by Brain League
Other than the official manual from indian patent office, Brain League a Bangalore based ip consultancy firm has introduced a reference manual for indian patent law and its practice. It is said to be more informative and filled with court case references related to the acts.
For full details click here
For full details click here
Subscribe to:
Posts (Atom)