A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday 27 June 2008

Europe talks Turkey over SPCs

The fifth session of the European Union's Accession Conference with Turkey at ministerial level was held earlier this month in Luxembourg. The Conference, initiated in October 2005, opened negotiations on two further new chapters, one of which was Chapter 7 ("Intellectual property law").

The European Commission has closely examined Turkey's general state of preparedness in IP. Taking into account Turkey's present state of preparations, and in line with the Council conclusions on 11 December 2006, the EU emphasised that Turkey must complete its alignment with the Community acquis concerning Community-wide exhaustion of rights and the introduction of supplementary protection certificates, ensuring that these rights will be implemented by the date of accession [source: ABHaber.com]

Thursday 26 June 2008

The Angiomax bill -- does it stand a chance?

According to analyst Andrew Parmentier (Friedman, Billings Ramsey, left), the odds on the Angiomax patent term extension bill passing successfully through all its legislative stages are "still less than 50 per cent". The bill may have had a smooth passage through the House of Representatives but it still has to make it through the Senate and win the signature of the President. "We advise investors not to blindly interpret this event in the House as patent relief for Angiomax," said Parmentier in a note to investors: "we continue to see road-blocks in the Senate" [Source: CNNMonet.com].

Wednesday 25 June 2008

Ad hoc bill seeks to restore Angiomax term

Wall Street Politico today carries news of legislative moves in the United States to provide one-off patent term extension for the benefit of a US company -- The Medicines Co -- after the law firm that handled its patent work in 2001 accidentally filed its Bivalirudin (Angiomax) patent extension application one day after the deadline. The company reportedly lost half a billion dollars in sales after generic drug manufacturers entered the market some four years earlier than they might otherwise have done so.

House Judiciary Committee Chairman John Conyers Jr. has explained that
“this small but important change simply gives the [United States Patent and Trademark Office] discretion to accept a late application, within a limited time period, under specific conditions. This change is both good patent policy and good for public health.”
The language of the proposed legislation specifically restricts one subsection to “a drug intended for use in humans that is in the anticoagulant class of drugs”, the class of products to which Angiomax belongs.

The change has yet to be considered by the Senate, and Citizens Against Government Waste have denounced the bill.

Tuesday 24 June 2008

30 years on, EFPIA President sees SPC as a milestone

Medical News Today ("30 Years Contributing To The Health And Wealth Of EU Citizens") reports the speech given on the occasion of EFPIA's 30th anniversary Annual General Meeting by its President, Bayer HealthCare CEO Arthur J. Higgins. Calling a new spirit of cooperation and partnership between the pharmaceutical industry and the stakeholder community, Higgins cited the Innovative Medicines Initiative as a good example of partnership to accelerate the R&D of new medicines. Enumerating the EFPIA's achievements over the past three decades he specifically mentioned the Supplementary Protection Certificate, introduced in the early '90s to compensate for the long time required for marketing authorisation and providing up to five additional years of patent protection.

Thursday 19 June 2008

Welcome

This weblog is intended as a forum for investigating and becoming better acquainted with the phenomenon of the supplementary protection certificate ("SPC"), a legal device for the extension of patents beyond their normal expiry date. The SPC Blog hopes to provide a vehicle for the transmission of news, analysis and ideally the establishment of a little community of people who are interested in the many issues that the extension of patents raise. We hope to bring together the points of view of

* patent owners who feel they cannot obtain a reasonable benefit from the patent grant on account of the lengthy regulatory procedures that require compliance before pharma and agrichemical products can be marketed,

* investors who may be reluctant to fund research and development if the prospect of a good commercial return is lacking,

* manufacturers and distributors of generic products, who are excluded from the market by the extension of patent grants,

* public sector purchasers of products, whose budgets may be restricted and subject to conditions unrelated to market forces,

* consumers whose access to products may be reduced or less affordable for as long as patent protection remains,

* national and regional competition authorities, which bear responsibility for ensuring that patent monopolies are not the basis for abuse of a dominant position.

If you'd like to know more about us, or would like to contribute material to The SPC Blog, please email any of the contributors whose names (linked to their relevant coordinates) appear in the box which you will find in the box near the top of the side panel to your left.