David Branigan

David Branigan

  • Joined: 08/06/2018
  • Articles: 64

European Council Advances SPC Waiver For Generics; Negotiations Coming

The European Union Council of member states has approved a mandate for negotiations with the EU Parliament concerning a draft regulation aimed at boosting EU-based generic and biosimilar manufacturing for export by providing an exception to the extended intellectual property protection granted by special protection certificates (SPCs). The mandate brings the draft regulation a step closer to adoption, and it also suggests that Parliament’s recent amendments to the regulation are likely be key areas of debate in the negotiations, which are expected to begin in the coming weeks.

UNCTAD Finds Growth In Global Creative Economy Led By ‘New Breed’ Of Countries

In a new report on the creative economy, the United Nations Conference on Trade and Development (UNCTAD) found that despite a slowdown in global trade since the 2008 financial crisis, the creative economy has remained robust and has exhibited significant growth. Leading this growth is China, with four times the creative goods exports as the United States in 2015.

India Proposes Expediting Patents For Women, Small Entities, Waiving PCT Fees

The Indian Ministry of Commerce and Industry from the Department of Industrial Policy and Promotion recently published draft amendments to the Patent Rules of 2003 that would expand the eligibility for expedited examination of patent applications to include women and small entities, and would waive the fees for online filing of international patent applications through the Patent Cooperation Treaty (PCT), among other changes.

WHO Report Shows Global Progress On Influenza Preparedness Response

The World Health Organization has released a new report showing that significant progress has been made to build national and global preparedness for future influenza pandemics. This progress resulted from the collaborative multi-sectoral implementation of a WHO plan, funded by the benefit-sharing contributions of industry partners, to strengthen global health security against pandemic influenza.

EU Committees Amend SPC Manufacturing Waiver, Push Access To Generics, Biosimilars

The European Parliamentary Committees on Health and Trade have each voted in recent weeks to adopt amendments to the proposed Special Protection Certificate (SPC) manufacturing waiver, an intellectual property exception for the EU generic and biosimilar industry. The amendments include provisions that push the waiver toward increasing EU generic and biosimilar industry competitiveness in EU markets, and improving access for EU patients to affordable medicines. The waiver and amendments still have several hurdles to go, including a vote by the Legal Affairs Committee planned for January.

Experts Call For Global Accountability Mechanism For Access To Essential Medicines

Global health experts, including senior officials at the World Health Organization, are calling for a global accountability mechanism for access to essential medicines, noting that a the lack of data on medicines affordability and national pharmaceutical expenditures has hindered this process, according a recent article published in UK medical journal The Lancet.

OECD Report Presents Policies To Balance Innovation With Access To Medicines

The Organisation for Economic Cooperation and Development (OECD) has released a new report that presents policy options for countries to strike a better balance between promoting financial incentives for pharmaceutical innovation and ensuring affordable access to medicines. Finding this balance, the report explains, will be essential for ensuring the sustainability of health systems.

US IP Stakeholders Seek To Strengthen Public Support For IP, Ensure Future US Competitiveness

NEW YORK -- United States intellectual property stakeholders from academic, business and legal backgrounds gathered recently to discuss how to increase public support to strengthen the intellectual property rights system in the US, in light of China’s steady rise in numbers of patent and trademark filings. US IP stakeholders argued that developing public awareness and understanding of IP is key to building this support, with some holding diverging views on how to go about this.

Study Finds Arthritis Drug Enbrel Overpatented, Overpriced in US

Initiative for Medicines, Access & Knowledge (I-MAK) released a new study yesterday showing that the rheumatoid arthritis drug Enbrel has been overpatented by drugmaker Amgen, which has filed a total of 57 patents on the drug in the United States. Together, these patents were said to delay market competition by 39 years, rather than the standard 20 years for one patent. The study found that this market exclusivity for Enbrel resulted in US$ 8 billion dollars in sales in 2017 alone.