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Monthly Archives: August 2007

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!

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.

I’ve recently joined the Journal of Commercial Biotechnology as managing editor. Drop me a line if you would like to make a submission.

The most recent issue, edited by Neil Henderson, has just been published:

Volume 13, Issue 3

Articles

When should you fire the founder?PDF
William Bains
Constructing a processual model of communication in new product development from a multiple case study of biotechnology SMEsPDF
Jennifer Frahm, David C Ireland, Damian Hine
A maturing industry: Strategic patenting trends, US and academic dominance, and the global biotechnology landscapePDF
Gareth Williams
Measuring performance of field-medical programmes: Medical science liaison metrics consensusPDF
Jane Chin
The commercialisation of bioinformatics and the threat of open-source softwarePDF
Joseph F Greco
Intellectual property issues in nanotechnologyPDF
Lars Genieser, Michael Gollin
Fostering the process of adoption of personalised medicine: A matter of communication or a matter of cost?PDF
Pedro Reinares Lara, Emma Gutierrez de Mesa
Changing hopes and concerns about gene therapy in JapanPDF
Darryl Macer, Yoshihiro Okada, Makoto Nakagawa, MaryAnn Chen Ng, Masakazu Inaba

Legal and Regulatory Updates

Legal and regulatory updatePDF
John Wilkinson

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.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in August 2007
*Drugs may be covered by more than one patent

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ACCUPRILPfizer Pharmsquinapril hydrochloride4,743,450AUG 24,2007
ACCURETICPfizer Pharmshydrochlorothiazide; quinapril hydrochloride4,743,450AUG 24,2007
ANTARA (MICRONIZED)Oscientfenofibrate4,800,079AUG 10,2007
CEREBYXParke Davisfosphenytoin sodium4,925,860AUG 05,2007
COVERA-HSGd Searle Llcverapamil hydrochloride5,190,765AUG 14,2007
COVERA-HSGd Searle Llcverapamil hydrochloride6,146,662AUG 14,2007
DYNACIRC CRReliant Pharmsisradipine4,946,687AUG 07,2007
DYNACIRC CRReliant Pharmsisradipine4,950,486AUG 21,2007
EMSAMSomersetselegilineRE34579AUG 18,2007
ENLON-PLUSBaxter Hlthcare Corpatropine sulfate; edrophonium chloride4,952,586AUG 28,2007
FERIDEX I.V.Adv Magneticsferumoxides4,951,675AUG 28,2007
INSPRAGd Searle Llceplerenone4,559,332AUG 11,2007
PEPCID AC (GELTAB)Merckfamotidine4,820,524AUG 20,2007
PROSTEPAvevanicotine4,946,853AUG 07,2007
SUPRANEBaxter Hlthcare Corpdesflurane4,762,856AUG 02,2007

Courtesy of DrugPatentWatch.com

Welcome to the August 2007 edition of Carnival of Biotechnology.

Industry Trends
Singapore-based ES Cell International, the company that was poised to lead in stem cell therapeutics, has abandoned its plans for stem cell therapies. Sometimes its hard for a company to live up to the high expectations they engender in their quest for financing.

In other news, Signals Magazine reports that funding is on track for a record year.

Drug Pricing
Pharmalot has an update on the ongoing saga of international price controls. The New Zealand government’s drug buying agency has expressed their frustration at not reaching an agreement over pricing for cardiovascular drug Betaloc, accusing AstraZeneca of gambling with patients lives. Not exactly ‘building a golden bridge‘.

The Wall St. Journal has an interesting report on the efficacy of diabetes drugs: “Old, cheap diabetes drugs are as good as or better than newer, more expensive drugs at lowering blood sugar.

Innovation
The New York Times has an article on on how a lack of FDA guidance is impeding innovation in biotech foods.

According to the Wall St. Journal, Japan’s drug development industry is facing a crisis: “Domestic drug makers are having trouble competing overseas and the world’s drug makers are passing over Japan when introducing new products.”

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.