Category: Guest content

Leveraging affordable innovation to tackle India’s healthcare challenge

This article was originally published by Kiran Mazumdar Shaw in IIMB Management Review under a Creative Commons license. Abstract Affordable innovation, which presents ways to innovate, be flexible, and do more with…
The post Leveraging affordabl…


A Comparison of Generic Drug Prices in Seven European Countries: A Methodological Analysis

This paper was originally published by Olivier J. Wouters and Panos G. Kanavos in BMC Health Services Research  2017 17:242 https://doi.org/10.1186/s12913-017-2184-5 ©  The Author(s). 2017 Abstract Background Policymakers and researchers frequently com…


Calculating the Regulatory Review Period for Patent Term Extension

Identifying the testing phase can be tricky This is a guest post from Nicole Stakleff and Kyle Dolinsky in Pepper Hamilton’s Health Sciences Department. Nicole can be contacted at [email protected] Calculating…
The post Calculating the Regulator…


Patent Term Extension for Drugs not Limited to new Chemical Entities

Companies developing a new drug product, even if it is not an NCE, should explore ways to increase the likelihood of obtaining and maximizing PTE This is a guest post…
The post Patent Term Extension for Drugs not Limited to new Chemical Entities appear…


How to Obtain Multiple Patent Term Extensions for a Single Product

The value of obtaining multiple PTEs on different patents could incentivize innovators to revise their clinical development programs This is a guest post from Nicole Stakleff and Kyle Dolinsky in…
The post How to Obtain Multiple Patent Term Extensions …


Data Exclusivity: Is there a happy medium?

What is Data Exclusivity? In 1984, the USA was the first country to give legal sanctity to data exclusivity via the Hatch-Waxman Act. Under this new legislation five years of…
The post Data Exclusivity: Is there a happy medium? appeared first on DrugPa…


Patent linkage: Balancing patent protection and generic entry

Patent linkage refers to the relationship between the market approval of a generic drug and the patent status of its branded equivalent. It dictates that marketing approval for a generic…
The post Patent linkage: Balancing patent protection and generic…


Are Generic Drugs Less Safe than their Branded Equivalents?

What are generic drugs? A generic drug is an identical, or bioequivalent, version of a branded drug made by another party. For approval of a generic, the drug company must…
The post Are Generic Drugs Less Safe than their Branded Equivalents? appeared f…


A Brief Patent Primer

… the very first official thing I did, in my administration … was to start a patent office; for I knew that a country without a patent office and good…
The post A Brief Patent Primer appeared first on DrugPatentWatch – Make Better Decisions.


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