by
Kyle Deighan
Federal Circuit held that AstraZeneca failed to state a claim for patent infringement under 35 U.S.C. §271(e (2 against generic pharmaceutical manufacturers that filed abbreviated new drug applications ("ANDAs" seeking approval for uses of Crestor® (rosuvastatin calcium not covered by AstraZeneca's patents. The case is
AstraZeneca Pharms. LP v. Apotex Corp.
.
AstraZeneca alleged that ANDA filings by various generics infringed or would infringe several of its patents covering methods of using rosuvastatin calcium. These patents covered methods of using rosuvastatin compounds to treat heterozygous familial hypercholesterolemia ("HeFH" and elevated C-reactive protein ("CRP" . As per the Hatch-Waxman Act, AstraZeneca filed a New Drug Application ("NDA" and obtained approval from FDA to market the drug. FDA approved several indications for using rosuvastatin calcium, including those uses claimed in AstraZeneca's patents. Additionally, FDA approved the drug for treating homozygous familial hypercholesterolemia ("HoFH" and hypertriglyceridemia, uses not covered by AstraZeneca's patents-in-suit.
Defendants filed ANDAs seeking to market generic versions of the drug, but submitted so-called Section viii Statements under the Federal Food, Drug, and Cosmetic Act ("FD&C Act" indicating they sought approval for uses not covered by the patents. In other words, the ANDA filers requested approval to treat only HoFH and hypertriglyceridemia while "carving out" the indications covered by AstraZeneca's listed patents. The ANDA filers moved to dismiss AstraZeneca's complaint for several reasons, including that the complaints failed to state a claim for patent infringement under Section 271(e (2 because the ANDA filers were not seeking approval for uses of rosuvastatin calcium claimed in AstraZeneca's patents.
Accutest Research Laboratories (I Pvt. Ltd., the leading independent and internationally accredited Contract Research Organization (CRO in India, was founded back in 1998 by Dr. Satish Sawant and Dr. Santosh Joshi and is headquartered in
Navi Mumbai
. It primarily focused in conducting Bioavailability and Bioequivalence studies for the generic pharmaceutical industry. For over a decade Accutest’s success in Bioavailability/Bioequivalence services has earned it a strong reputation in the field both in domestic and international markets. With the passage of time, the company has widened its network by introducing more diversified services that includes Clinical Trial Management, Clinical Data Management and Formulation Development. The company sets itself apart by providing its global client base a process-oriented service coupled with high quality data on drug candidates at extremely competitive prices more quickly and efficiently than its competitors.
Post : Research Scientist at Mexico
No of Post : Two
Experience : 2 to 3 year
b. Should be well versed with regulatory requirements
c. Should have hands on experience of LC-MS/MS operations
d. Should be able to run the project independently
e. Should be willing to stay for 1-2 years on site in Mexico
Education : M.Pharma,
M.Sc
- Bio-Chemistry/Bio-Technology/
Life Science
Salary : As per the Qualification and Experience
Contact Details :
Executive Name : Ms. Swapna
Contact Company : Accutest Research Laborotories Pvt ltd
Address : A-31, T.T.C Industrial Area, MIDC, Khairane
Thane, Maharashtra,India 400709
Email Address :
hr@accutestindia.com
Reference Id : Research Scientist at Mexico
Deadline : 10.03.12
Researchers at the VTT Technical Research Center of Finland have been developing new wireless NFC-based (near field communication applications that make life easier for the visually impaired.
In a pilot study a group of people with poor eyesight tested a speech-based item identification system and new "talking" packaging for medicine and food, a VTT release said Thursday.
In the study, touching the info code on the packaging with a smartphone resulted in product and dosage information being wirelessly sent to the phone to be heard by the user.
A smartphone application developed in collaboration with VTT by Finnish company TopTunniste called Touch 'n' Tag enables visually impaired users to identify everyday items, including food, with the help of voice memos.
Another application developed during the project was a so-called speaking medicine packaging. When touched, it provides spoken dosage instructions and other important information from data sent to the NFC chip by pharmacy staff that can be listened to by the consumer at home.
While the project is ongoing, most current mobile phones do not support advanced NFC applications and the new solutions are designed for platforms not yet on the market, researchers said.
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