This section is about issues of intellectual property in pharmaceutical industry.
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Intellectual Propriatery News
Written by Administrator
Wednesday, 30 April 2008
FDA Announces Measures to Improve Generic Drug Access
The Food and Drug Administration (FDA) im March 2004 announced that it
will provide more information to the public to help generic drug
applicants determine if they are eligible for 180-day marketing
exclusivity for their products. This period of marketing exclusivity
is generally provided to the first generic drug that challenges
a patent for the innovator product.
The continuing battle over Atorvastatin (Lipitor®)
In 2006, Pfizer’s product Lipitor (Atorvastatin) attained sales of US$ 11.7 billion. This was down by 3.6% from the figure for 2005, which disappointed Pfizer but still left it with enough turnover to make it a very attractive target for generic copies.
In October 2006, Senators Waxman, Schumer and Clinton introduced the “Access to Life-Saving Medicines Act” to the US Congress in an attempt to establish an abbreviated application process for biological products.
It was the same Senator Waxman who cooperated in 1984 with Senator Hatch to introduce what became known as the Hatch-Waxman Act to introduce a simplified method of registration for generics.
More than 63 million patent documents from 80 patent organisations worldwide can be searched via the International Patent Documentation Data Base, (INPADOCDB). It was created by merging and revising two existing databases of the European Patent Office (EPO).
The new access in semisolid dosage forms by adding or applying some new approaches to improve them from bioavailability, efficacy, drug dosing cost etc and also techniques which may be launched recently, but not widely used.
Vardenafil (Levitra®) - Opportunity for Proactive Generic Companies?
The recently released GenericsWeb Pipeline Developer patent report for Vardenafil (Levitra®) highlights the importance of high quality patent information when considering development of generic equivalents in the early stages of a product’s life cycle.
Closing the access gap for health innovations: an open licensing proposal for universities
This article centers around a proposal outlining how research universities could leverage their intellectual property to help close the access gap for health innovations in poor countries. A recent deal between Emory University, Gilead Sciences, and Royalty Pharma is used as an example to illustrate how 'equitable access licensing' could be put into practice.
More to Veterinary Anthelmintic ProHeart® than Green Book Indicates
Analysis of the GenericsWeb Pipeline Patent Intelligence for Wyeth’s top selling veterinary anthelmintic ProHeart® (Moxidectin) shows that generic manufacturers should be wary of relying upon the US FDA Green Book for their critical patent expiry information.
In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep
daily contacts and communication with National Agencies for Medicines
and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.
FarmavitaR+ Journal 
The continuing battle over Atorvastatin (Lipitor®)
