Category Regional Policy

Agreement On SPC Manufacturing Waiver Reached, Benefitting EU Generic, Biosimilar Industry

The European Council reached a political agreement today on the SPC Manufacturing Waiver, which will allow the manufacture of generic and biosimilar medicines in the European Union for export and stockpiling during the period of extended patent protection provided for by the EU. This waiver will enable EU generic and biosimilar industries to benefit from sales outside the EU where patents have already expired, and to prepare to provide the EU market as soon as the extended period of patent protection ends.

EU Copyright Rules: Provisional Deal Struck On Changes

The European Council's Romanian presidency announced today it has struck a provisional agreement with the EU Parliament on a draft directive that makes changes to existing European Union copyright rules. The draft agreement, which will go before the full Council of member states and Parliament for approval, would make changes such as a controversial new "publishers' right," and strengthens copyright protections on online content sharing platforms. It also would introduce copyright exceptions for a range of purposes such as text and data mining, online teaching, and cultural heritage.

Malaysia Still Under Pressure To Make Hepatitis C Medicine More Expensive

The government of Malaysia continues to face pressure from the United States pharmaceutical industry and potentially the US government to undo an action taken to make a key hepatitis C medicine more affordable in the country. Now Médecins Sans Frontières (MSF, Doctors Without Borders) has weighed in to defend the government's right to use a patent flexibility in global trade law that allows them to take such actions on behalf of their citizens.

Women On The Rise In Patent Filings, But Still Underutilised Potential, USPTO Says

The United States Patent and Trademark Office (USPTO) released a report on 11 February showing an increase in US patents that include at least one woman inventor from 7 percent in the 1980s to 21 percent by 2016. This is still a “small minority” of patented inventors, the report finds, and suggests that it indicates an “underutilisation” of women’s innovative potential.

US Industry IP Index Released: US Advances, India Shows Leadership, EU, Singapore Near Top

The leading United States industry association yesterday released its annual International Intellectual Property Index, ranking countries on their progress in protecting US intellectual property rights. The ranks show the US advancing in the area of patent protection, while retaining the top overall score; India strengthening IP and charting a course for other developing countries; and EU countries dominating the higher scoring bracket with Singapore first on patent protection.

Pre-Grant Opposition Filed Against Janssen’s Bedaquiline Fumarate Application In India

Tuberculosis and its variant - Drug Resistant Tuberculosis (DR-TB) - are global public health emergencies. Current treatment regimens are expensive, tedious and prolonged: the overall treatment duration is 20 months or more, requiring daily administration of drugs that are more toxic and less effective than those used to treat drug-susceptible TB. Most of the drugs for treating TB are old and are known to have severe side-effects, writes Sandeep K. Rathod.