Patent oppositions filed on three essential drugs

HIV Treat Bull - Vol. 7, No. 7/8, September 2006

In the continuing struggle to ensure that patents are not granted at the cost of human lives, health groups in India recently filed three more pre-grant patent oppositions against essential medicines.

Copies of these oppositions can be obtained at the Lawyers Collective

In the Patent Office in Chennai, the Indian Network for People Living with HIV/AIDS (INP+) and the Karnataka Network of People Living with HIV/AIDS filed an opposition against Novartis’s patent application for atazanavir (subsequently licensed to Bristol Meyers Squibb), a critical second-line protease inhibitor.

The opposition is based on four grounds: (1) that a prior patent discloses the compound that is claimed in the atazanavir application, and thus is not “new” under Indian law; (2) that the application is not “inventive” and is not patentable under Indian law; (3) that the application describes a “new form of a known substance” and is thus not an “invention” under Indian law; and (4) that the applicant has failed to provide the Patent Office with certain information that it was required to submit. If successful, this opposition will pave the way for generic companies to produce affordable versions of this critical second-line drug.

INP+ and the Uttar Pradesh Network for People Living with HIV/AIDS filed an opposition against GSK’s patent application for amprenavir in the Delhi Patent Office. Amprenavir is the base molecule for the important protease inhibitor fosamprenavir, and thus the grant of patent for amprenavir could allow GSK to prevent other manufacturer from producing generic versions of fosamprenavir. This opposition is also based on the ground that the application is not “new,” that it is not “inventive,” and that it is just a “new form of a known substance.” Additionally, the opposition is based on the grounds that the application is merely a “new use of a known substance,” and thus not patentable under Indian law, and that it is, at most, a “mere admixture” and is thus unpatentable.

Finally, INP+ and the Tamil Nadu Network People Living with HIV/AIDS filed an opposition against valganciclovir, a critical treatment for CMV retinitis, a common AIDS-related opportunistic infection that can cause blindness. This opposition is based on the procedural grounds that the application concerns an invention from before 1995 and is thus unpatentable in India. India incurred its obligations under TRIPS as of 1 January 1995, and thus any inventions that pre-date 1995 are considered “public domain” in India and thus are not patentable.

We are hopeful that the PLHA groups will prevail in their struggle for access to the medicines that sustain their health. We are also hopeful that other health-related groups will take this information and broaden the fight against patents on essential drugs by opposing patents on their own.

Source: Press release from Lawyers

Collective HIV/AIDS Unit

2006-09-10
IB060709-04

©2008. I-BASE HIV Treatment Bulletin. Permission to reproduce courtesy of HIV i-Base, Third Floor East, Thrale House, 44-46 Southwark Street, London SE1 1UN - T: +44 (0) 20 7407 8488 F: +44 (0) 20 7407 8489

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2008. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2008. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.