Gilead to brief US Congress on its pricing strategy for new oral Hep-C drug

US Congress demands briefing from Gilead on its pricing strategy for Sofosbuvir (Sovaldi)- new oral drug for Hep-C treatment for which it recently received marketing approval in US.

The Committee of Energy and Commerce, House of Congress asked for providing reasons for pricing the drug at cost of 84,000$ which will be un-affordable for majority of patients in the country. The letter sent to Gilead raised concern on the high cost despite of role played by the Federal Government in speeding up the approval for this drug and the savings arising from this process.

The Committee in specific asked Gilead to share its methodology used to establish price of Sovaldi and the discounts planned for low income patients, key government and private sector purchasers.

Read the full article here

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Recent developments on Hep-C treatment and access

Recently, there have been two key developments in the area of Hep-C treatment– firstly the release of the first ever WHO guidelines for screening, care and treatment of persons infected with HCV and secondly the specific discussion on generic production and use of TRIPS flexibilities to address access barriers. A parallel to the situation with treatment for HIV/AIDS in 2000 is being drawn when HIV drug prices in the absence of competition were dramatically high.

The full text of the guidelines is available here

Read the articles on new oral regimens and pricing below -

WSJ says U.S. Spending on Hepatitis C Medications to Skyrocket 1,800 Percent by 2016, read full article here

WSJ blogUnsustainable for Our Country: Express Scripts Calls Out Pricey Meds

Reuters: Global response to hepatitis C hangs on access to new oral drugs, MSF warns of countries’ inability to scale up treatment in wake of first-ever WHO guidelines, unless medicines are more affordable. Access the full article here

WHO Guidelines May Help With Price Reductions For Hepatitis C Drugs, Published on 9 April 2014, Intellectual Property Watch
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32 Members of US House of Representatives ask USTR to sanction Canada for not granting patents on drugs

Source: KEI

Submitted by James Love,, 11. April 2014

A letter dated April 10, 2014 signed by a bipartisan group of 32 members of the House of Representatives, have asked USTR to elevate Canada to the Special 301 “priority watch list,” for “violation of their international obligations” for not granting enough patents on “innovative medicines.” According to the members of Congress signing the letter, Canada is in violation of its WTO TRIPS obligations. USTR is asked to use “all tools available to address the issue,” including placing Canada on the USTR Priority Watch List. But the members of Congress did not ask USTR to file an actual case against Canada in the WTO, which in theory could bring real sanctions against Canada. Why not? Presumably because the members of Congress think the US would lose and Canada would win.

The letter can be accessed here.

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Eli Lilly vs. Canada: The Patent War Moves to Washington

Angered by Canadian court decisions that invalidated patents on two drugs, Eli Lilly is striking back by urging Washington to pressure Canada to change its stance toward intellectual property. Its efforts underscore growing frustration the pharmaceutical industry has toward some foreign governments over patent rights, although much of the vitriol has often been directed toward India.

The drug maker wants the U.S. Trade Representative to place Canada on its Priority Watch list for countries that provide insufficient patent protection or enforcement, and is lobbying Capitol Hill for support. Last week, a bipartisan group of 32 lawmakers obliged the drug maker by writing to the U.S. Trade Representative to reinforce Lilly’s request. Seven of the lawmakers are from Indiana, where Lilly is based.

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UK court overturns patents on Roche’s Herceptin

Source: Pharma Times

15 March 2014

The likelihood of a biosimilar version of Herceptin reaching the UK market
in the next few months has increased dramatically after the High Court
overturned two key patents on Roche’s breast cancer blockbuster.

The ruling, which stated that the patents (relating to dosage and
composition) were invalid, is a major boost for Hospira, the US firm which
brought the case against Roche’s Genentech unit. The patents on Herceptin
(trastuzumab) for HER2 positive breast cancer expire in Europe at the end
of July and Hospira will be ready to launch in the UK.

Hospira has been working with Celltrion to develop a number of biosimilars
and the latter has already launched their version of Herceptin, called
Herzuma, in its home market of South Korea. The firms are already marketing
a biosimilar of Johnson & Johnson’s and Merck & Co’s anti-inflammatory
Remicade (infliximab) in Europe, as Inflectra.


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International Liver Conference: activists demand affordable hepatitis C treatment

Source: Hep Coalition

15 April 2014

International Liver Conference: activists demand affordable hepatitis C treatment

Pills cost pennies, greed costs lives.

As the 49th International Liver Conference is officially starting, activist held a demonstration in the main hall to raise the issue of access to hepatitis C treatment in low and middle-income countries. Their protest targeted Gilead whose recently-approved direct-acting antiviral, Sovaldi, sells for USD $84,000.

Activists chanted, “pills cost pennies, greed costs lives”, “sovaldi, so expensive” and “let doctors cure people”.

Symbolically, activists lay dead under golden blankets while others distributed golden pills representing Solvaldi, which Gilead sells for USD $1,000 per pill.

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Natco seeks to block Gilead’s hepatitis C drug patent in India: source

Source: Reuters

11 April 2014

(Reuters) – India’s Natco Pharma Ltd has formally asked the Indian patent office to deny U.S. drugmaker Gilead Sciences Inc’s new hepatitis C drug Sovaldi a patent in India, a source with direct knowledge of the matter said.

If successful, the move could clear the way for the Indian company to launch a cheap generic version of the drug.

Gilead, whose medicine has been hailed by doctors as a breakthrough in treating the liver-destroying disease, has come under fire over its product’s $1,000 per pill price tag in the United States.

India’s patent laws allow a third party to dispute the validity of a pending patent application. Natco has filed a so-called “pre-grant opposition” with the Controller General of Patents, Designs & Trademarks, said the source, who declined to be named because the information was not public yet.

It was not clear when Natco filed the opposition and Reuters could not immediately obtain a copy of the filing.

Natco Chief Executive Rajeev Nannapaneni declined to comment. Officials at Gilead and at the patent department in Mumbai were not immediately available for comment.

Natco has opposed the patent on the same grounds as New York-based Initiative for Medicines, Access & Knowledge (I-MAK), arguing that Sovaldi is not “inventive” enough, the source told Reuters.

I-MAK, a group of lawyers and scientists, filed an opposition in November 2013 to the grant of a patent in India on Sovaldi, chemically called sofosbuvir, saying the drug uses “old science”.

Natco’s opposition comes amid a growing clamor by healthcare campaigners and doctors to ensure that Sovaldi and other new hepatitis C pills are made affordable in developing countries. Continue reading

Posted in Generic drug, Hepatitis - C, patent, Patent Opposition | Tagged , , | Leave a comment