(Reuters) – U.S. Supreme Court Chief Justice John Roberts on Friday denied a request by Teva Pharmaceutical Industries Ltd to stay a lower-court ruling in a patent case that favored the developers of generic versions of Teva’s top-selling multiple sclerosis drug.
The decision could help pave the way for generic competitors of Teva’s Copaxone drug to go on the market as soon as next month.
Teva had sought to prevent the lower-court ruling from going into effect while the Supreme Court considers its appeal in the patent fight.
Source: Business Standard
Top officials meet amid apprehension of sanctions under US law; decide to take Washington to the World Trade Organization if such action taken
Nayanima Basu | April 22, 2014
The government held a high-level meeting on Monday to discuss apprehensions that the US government might impose sanctions against Indian companies on the ground of a lax intellectual property rights (IPR) regime.
Delhi, it was decided, would not tolerate such a move from Washington. “It has been decided that India will not cooperate with the US on any sort of investigation on Indian IPR or trade laws,” an official said after Cabinet Secretary Ajit Seth took a meeting of top bureaucrats over the issue.
India, it was decided, might take the US to the World Trade Organization (WTO) if such unwarranted action was taken, while keeping open the door for discussion to allay perceptions on Delhi’s trade laws.
The Cabinet secretary reiterated that India was WTO-compliant on Trade Related Intellectual Property Rights, officials said. The government is also compiling cases where the US had breached IPR laws.
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
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 blog – Unsustainable 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
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.
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.
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.