Amgen's patents protect Epogen. Again.

Amgen’s got a record of savvy patenting to protect their blockbusters, and they’ve just done it again.

A U.S. Federal District Court in Boston has ruled that Roche’s pegylated-erythropoietin infringes one of Amgen’s patents.

I’m eager to hear the backstory on this one. Amgen previously prevented Transkaryotic (now owned by Shire) from using a completely different production methodology to make a metabolite of Epogen. As described in my book, Building Biotechnology, Amgen’s strategy hinged upon filing continuation patents aimed specifically at Transkaryotic’s methods.

Litigation is expensive, but as Roche is demonstrating with their Vioxx defense strategy (that’s a whole other story), vigorously defending your case — and establishing a strong winning record — can eliminate the need to go to court!

Carnival of Biotechnology

Welcome to the second August 2007 edition of Carnival of Biotechnology.

International Biotechnology
The Times (UK) has a report on the UK biotech sector, calling for consolidation to overcome a lack of capital.

The Wall Street Journal has an article on Novartis’ lost patent case in India, where a patent on an improved version of Glivec (sold as Gleevec in the U.S.) was rejected for not being sufficiently improved to warrant protection. This sets a dangerous precedent for the use of evergreening strategies in India, and may potentially spread to other markets.

Pharmalot profiles a report from PriceWaterhouseCoopers projecting that Asia will become the new center of gravity in drug developing, with everything from R&D to manufacturing being relocated to Asian shores.

Generic Biologics
The Wall Street Journal has a case study of Genzyme’s problems getting approval to make Myozyme, a treatment for Pompe disease, in large batches. These regulatory problems underscore the challenges of manufacturing biologic drugs.

The In Vivo Blog has details on the challenges Sandoz is facing in producing biogenerics, and the outlook for market share given the higher costs of production relative to generic pharmaceuticals.

Health Records
Venture Beat has a great article on the race to lead in healthcare record management. You might recognize some of the competitors: Google and Microsoft.

That concludes this edition.
For more information, see the Carnival of Biotechnology Homepage, or submit a link for the next edition. Interested in hosting a future Carnival of Biotechnology? Let me know.

Call for chapters: Best practices in biotechnology business development

I’m in the final stages of preparing a book on best practices in biotechnology business development, and am looking for 1-2 more chapters. The chapters I’ve received so far are:

• Top Five Mistakes
• Communicating With Investors and The Media
• Securing Intellectual Property From The Inside Out
• Aggressive Intellectual Property Strategies
• Biotechnology Transfers And Models Facilitate Access To Biotechnological Inventions
• Valuation of technologies through services
• How Big is the World Market for Biopharmaceuticals? It Depends On How You Define Biopharmaceutical

Let me know if you have any developed ideas you can quickly update and turn around. I’d need a completed chapter in the next few weeks.