Policies & Legislation

India patent laws under close scrutiny

Home/Policies & Legislation | Posted 09/11/2012

The international pharmaceuticals community is watching closely as Pfizer appeals against a decision to revoke its patent on Sutent (sunitinib).

Generic drug user fees come into effect

Home/Policies & Legislation | Posted 19/10/2012

Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House Energy and Commerce Committee on 21 September 2012. FDA User Fee Corrections Act of 2012 amends the FDA Act to address certain issues raised by language included in the GDUFA.

MSF launches online ‘Patent Opposition Database’

Home/Policies & Legislation | Posted 26/10/2012

The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing countries challenge unwarranted drug patents.

India plans further cuts to drug prices

Home/Policies & Legislation | Posted 12/10/2012

The Indian government has announced plans to further extend price cuts on both generic and brand-name drugs in order to try to improve access to affordable medicines in the country.

Generics substitution: Ireland’s plan for reference pricing

Home/Policies & Legislation | Posted 21/09/2012

A bill that will be debated this autumn seeks to introduce generics substitution and reference pricing for medicines and medical and surgical appliances in Ireland.

India’s patent laws coming under repeated challenges

Home/Policies & Legislation | Posted 14/09/2012

India’s patent laws are being challenged by Big Pharma. Novartis is challenging India for denying the pharma giant a patent for Glivec (imatinib mesylate), its blockbuster cancer drug. While Bayer is challenging the Indian Government’s decision to grant a compulsory licence on its cancer drug Nexavar (sorafenib).

Malaysia objects to patent terms in free trade agreement

Home/Policies & Legislation | Posted 17/08/2012

Once again, the issue of patent protection and the periods of exclusivity given to originator pharmaceuticals (both small molecule and biological) has raised its ugly head in the negotiations for the Trans-Pacific Partnership (TPP) Free Trade Agreement. This time, the Malaysian Health Minister, Dr Datuk Seri Liow Tiong Lai, has spoken out against terms in the agreement which seek to extend the patent periods of medicines produced by foreign companies.

Is the end in sight for pay-for-delay?

Home/Policies & Legislation | Posted 17/08/2012

A Federal appeals court ruling may bring the US pharmaceutical industry before the Supreme Court. Will this put an end to a practice that is increasingly viewed as anticompetitive?

Rising tensions over drug pricing and patenting in India

Home/Policies & Legislation | Posted 10/08/2012

New developments in pricing and regulations of drugs in India mean that tensions are likely to mount over the coming months between international pharmaceutical interests and healthcare providers who are trying to improve access to affordable medicines.

Australia moves towards pricing policy for biosimilars

Home/Policies & Legislation | Posted 03/08/2012

The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry of biosimilars into the market place.