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Policies & Legislation

EU blocks generics for Third World countries

Because of their behaviour against alleged patent infringements by Indian pharmaceutical manufacturers, according to the German Financial Times (FTD) the EU gets pressurised.

US FTC ‘hampered’ by Boehringer Ingelheim's delay tactics

The US Federal Trade Commission (FTC), which is investigating patent settlements between Boehringer Ingelheim and Barr (now part of Teva Pharmaceutical Industries) on Aggrenox (aspirin plus extended-release dipyridamole) and Mirapex (pramipexole), has asked for a court order requiring Boehringer to fully comply with a subpoena issued nine months ago for documents and data.

COSTEFF: Parallel trade, generics, biosimilars and home care can reduce European healthcare costs

We are all familiar with the pressures piling up on healthcare systems around the world. People are living longer and diseases of ageing, such as dementia, are becoming more prevalent. Some illnesses linked to lifestyle, such as diabetes, are also on the rise.

US Senate panel votes to outlaw ‘pay-for-delay’ deals

The US Senate Judiciary Committee has voted 12-7 in favour of legislation to outlaw deals agreed between branded drugmakers and generics firms to delay the entry of generic competitors to the market.

Indian firms race to sell generic oseltamivir

With the Indian government permitting ‘restricted’ sales of oseltamivir, a generic version of Roche's Tamiflu for influenza A H1N1, the domestic market is seeing a flurry of activity as Indian firms move to stock their products at retail pharmacies.

US court upholds Lilly’s Evista (raloxifene) patents through 2014, blocking Teva’s generic

A US federal judge has upheld Lilly's method-of-use patents for its osteoporosis drug Evista (raloxifene) through to March 2014, blocking an attempt by Teva Pharmaceutical Industries to sell a generic version. The product has annual US sales of around US$650 million (Euros 442 million). Teva said it plans to appeal the decision.

Generic drugmakers criticise US health plan rebates

The US government could save more money by increasing the use of cheaper generic drugs rather than hiking rebates paid by manufacturers, an industry executive said on 17 September 2009.

Roche and Amgen agree on temporary Mircera import ban

Roche has agreed not to oppose Amgen's request for a limited exclusion order that would block the import of Roche's anaemia drug Mircera into the US Amgen filed a motion recently with the US International Trade Commission (ITC) asking for a summary determination that Roche had violated a section of the Smoot-Hawley Tariff Act by importing the pegylated erythropoietin product Mircera (methoxy polyethylene glycol-epoetin beta), which Amgen claims infringes its patents.

EU assures India to take steps to resolve drug seizure cases

The EU has assured India that it will take steps to resolve the issue related to the recent cases of life-saving generic or off-patent medicines exported from India to other countries being seized at European ports, but would prefer not to do so through a legal battle at the World Trade Organization (WTO).

Biosimilars advancing along European approval path

With an EU regulatory framework in place to address the safety of biosimilars – also known as follow-on biologics (FOBs) – the opportunity represented by these products has been proven, and it is growing, as reported by Cynthia Challener in ICIS Chemical Business.