World Drug Regulatory Authorities Meet In Brazil; Biosimilars In Focus

Drug regulatory authorities are meeting this week in Rio de Janeiro, Brazil to discuss global regulatory issues such as vaccine regulation, falsified products, and pharmacovigilance. A “pre-conference” focused on biosimilars, with civil society warning on barriers to access to those products.

The Politicization Of The US Patent System

The Washington Post story, How patent reform’s fraught politics have left USPTO still without a boss (July 30), is a vivid account of how patent reform has divided the US economy, preempting a possible replacement for David Kappos who stepped down 18 months ago. The division is even bigger than portrayed. Universities have lined up en masse to oppose reform, while main street businesses that merely use technology argue for reform. Reminiscent of the partisan divide that has paralyzed US politics, this struggle crosses party lines and extends well beyond the usual inter-industry debates. Framed in terms of combating patent trolls through technical legal fixes, there lurks a broader economic concern – to what extent ordinary retailers, bank, restaurants, local banks, motels, realtors, and travel agents should bear the burden of defending against patents as a cost of doing business.

Global Medical Students Call For Shift To Health Over Trade, R&D

Universities Allied for Essential Medicines is calling for new incentive models for research and development so that new treatments can be found for neglected tropical diseases to fight antibiotic resistance, and is asking that health issues supersede trade interests.

Compulsory Licences Needed For Affordable Hepatitis C Innovative Drug Regimens

Compulsory licences should be issued to roll out generic versions of innovative HCV drugs. Only generic competition can push down the extortionate prices of these lifesaving medicines, while placing equitable access and public interest before monopolistic pharma companies’ business strategies, Daniele Dionisio argues.

New Medicines Patent Pool-Gilead Agreement For New HIV Drug In 112 Countries

The Medicines Patent Pool today announced a new licensing agreement with Gilead Sciences for a new treatment still undergoing clinical trials. This agreement is expected to allow Chinese and Indian generic manufacturers to provide low-cost versions of the drug in 112 low-and middle-income countries.

India IP Policy Misrepresented By US Trade Representative, Indian Pharma Says

An Indian pharmaceutical industry group has challenged the United States Trade Representative’s assessment of India’s intellectual property protection regime and suggested that India received more severe treatment than other countries solely on the basis of treatment of patented pharmaceuticals that it says is allowed under international rules.

Can The Dot Pharmacy New Generic Domain Be Impartial?

New generic top-level domain names seem set to be a constant source of discussions and dissension. The domain “.pharmacy” has been awarded to a United States pharmacy association with industry backing, stirring concerns among civil society and others. But the association insists it will work in an impartial manner to ensure safety of online pharmaceutical sales.

Medicines Patent Pool Signs 7 New Sub-Licences For Generic HIV Drugs

The Medicines Patent Pool has announced seven new sub-licensing agreements to produce generic HIV medicines in order to make more affordable versions available to developing countries.

Human Eggs That Can’t Develop Into Human Beings Should Be Patentable, EU High Court Advisor Says

Unfertilised human eggs that can’t develop into human beings are generally not “human embryos” within the meaning of the EU directive on the legal protection of biotechnological inventions, a 17 July European Court of Justice Advocate General opinion said. The opinion is good news for researchers into stem cell therapies, said a member of the industry group IP Federation, who added he hopes it will be upheld by the ECJ. But one biotech civil society member said the ruling, if it stands, could be abused.