Yearly Archives: 2007

A new issue of the Journal of Commercial Biotechnology has just been posted. Drop me a line if you would like to make a submission.

Volume 13, Issue 4

Editorial

Editorial PDF
Neil Henderson

Articles

Is ‘evergreening’ a cause for concern? A legal perspective PDF
Scott Parker, Kevin Mooney
Exploiting the business opportunities in biotech connections: The power of social networks PDF
Ian P McCarthy, Leyland Pitt, Colin Campbell, Rian van der Merwe, Esmail Salehi-Sangeri
The roles and responsibilities of the EU qualified person for pharmacovigilance under Volume IXa March 2007 PDF
Graeme Ladds
Investing in new medical technologies: A decision framework PDF
Emma Cosh, Alan Girling, Richard Lilford, Helen McAteer, Terry Young
Innovative capabilities and strategic alliances: Who is gaining what in the pharmaceutical industry? PDF
Marisa Ohba, Paulo N Figueiredo
Industrial enzymes in bioindustrial sector development: An Indian perspective PDF
Anuj Kumar Chandel, Ravinder Rudravaram, Linga Venkateswar Rao, Pogaku Ravindra, Mangamoori Lakshmi Narasu

Legal and Regulatory Updates

Legal and regulatory update PDF
Gerry Kamstra, John Wilkinson

Book Reviews

Book Review: The Economics of Biotechnology: Volumes I and II PDF
Iraj Daizadeh
Book Review: Global Governance of Food and Agriculture Industries PDF
Alan McHughen
Book Review: The International Politics of Genetically Modified Food: Diplomacy, Trade and Law PDF
Robert Paarlberg
Science Business: The Promise, the Reality and the Future of Biotech PDF
Weijun Li

Wired has an article on the potential for the pharmaceutical industry to support the international space station, using the microgravity environment to grow better quality crystals than can be grown on earth, in less time.

Protein crystals can be used to improve drug discovery, but the distance from crystal to drug is very long. Much time and money need to be invested to develop or modify drugs based on crystallographic findings, which makes me wonder what the value of improved crystals might be — enough to justify growing them in orbit?

Courtesy of DrugPatentWatch.com:

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

Tradename Applicant Generic Name Patent Number Patent Expiration
CLARINEX Schering desloratadine 4,659,716 OCT 01,2007
CLARINEX Schering Plough desloratadine 4,659,716 OCT 01,2007
CLARINEX D 24 HOUR Schering desloratadine; pseudoephedrine sulfate 4,659,716 OCT 01,2007
CLARINEX-D 12 HOUR Schering desloratadine; pseudoephedrine sulfate 4,659,716 OCT 01,2007
COVERA-HS Gd Searle Llc verapamil hydrochloride 4,946,687 OCT 02,2007
DYNACIRC CR Reliant Pharms isradipine 4,816,263 OCT 02,2007
DYNACIRC CR Reliant Pharms isradipine 4,946,687 OCT 02,2007
DYNACIRC CR Reliant Pharms isradipine 4,950,486 OCT 02,2007
ESTROSTEP 21 Warner Chilcott ethinyl estradiol; norethindrone acetate 4,962,098 OCT 09,2007
ESTROSTEP FE Warner Chilcott ethinyl estradiol; norethindrone acetate 4,962,098 OCT 09,2007
LEXXEL Astrazeneca enalapril maleate; felodipine 4,803,081 OCT 03,2007
NEXIUM Astrazeneca esomeprazole magnesium 4,786,505 OCT 20,2007
NEXIUM Astrazeneca esomeprazole magnesium 4,853,230 OCT 20,2007
OXYCONTIN Purdue Pharma Lp oxycodone hydrochloride 5,266,331 OCT 26,2007
OXYCONTIN Purdue Pharma Lp oxycodone hydrochloride 5,549,912 OCT 26,2007
OXYCONTIN Purdue Pharma Lp oxycodone hydrochloride 5,656,295 OCT 26,2007
PERMAX Valeant Pharm Intl pergolide mesylate 4,797,405 OCT 26,2007
PLENDIL Astrazeneca felodipine 4,803,081 OCT 03,2007
PRILOSEC Astrazeneca omeprazole 4,786,505 OCT 20,2007
PRILOSEC Astrazeneca omeprazole 4,853,230 OCT 20,2007
PRILOSEC OTC Astrazeneca omeprazole magnesium 4,786,505 OCT 20,2007
PRILOSEC OTC Astrazeneca omeprazole magnesium 4,853,230 OCT 20,2007
PROPULSID Janssen Pharma cisapride monohydrate 4,962,115 OCT 09,2007
PROPULSID QUICKSOLV Janssen Pharma cisapride monohydrate 4,962,115 OCT 09,2007
VOLTAREN Novartis diclofenac sodium 4,960,799 OCT 03,2007
ZOVIRAX Glaxosmithkline acyclovir 4,963,555 OCT 16,2007

Courtesy of DrugPatentWatch.com

On the same day that AstraZeneca has announced that it intents to completely outsource all of its drug manufacturing, citing the prevalence of external parties who can do it better and cheaper, Sanofi has announced plans toIf you understand the rules and strategies of <a href=”http;//www.now-blackjack.com” mce_href=”http;//www.now-blackjack.com”>free blackajck online</a> it won’t be difficult for you. increase it’s biotechnology presence, particularly in manufacturing.

With the start of a new school year, a new cohort of students are entering biotechnology programs. In order to facilitate those who are using my book, Building Biotechnology, I have set up a networking and information group on facebook.

I’m always interested in tracking the outcomes of students in biotechnology programs. If you’re a student using my book, are already in the industry, or are just interested in biotechnology, go ahead and join. I also invite you to join my network on LinkedIn.

Courtesy of DrugPatentWatch.com:

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

Tradename Applicant Generic Name Patent Number Patent Expiration
BETAXON Alcon levobetaxolol hydrochloride 4,911,920 SEP 27,2007
BETOPTIC S Alcon betaxolol hydrochloride 4,911,920 SEP 27,2007
CARDIOLITE Bristol Myers Squibb technetium tc-99m sestamibi kit 4,885,100 SEP 11,2007
COGNEX Sciele Pharma Inc tacrine hydrochloride 4,816,456 SEP 09,2007
COREG Smithkline Beecham carvedilol 4,503,067 SEP 05,2007
COREG CR Sb Pharmco carvedilol phosphate 4,503,067 SEP 05,2007
MIRALUMA Bristol Myers Squibb technetium tc-99m sestamibi kit 4,885,100 SEP 11,2007
NEXIUM Astrazeneca esomeprazole magnesium 4,738,974 SEP 01,2007
PENLAC Sanofi Aventis Us ciclopirox 4,957,730 SEP 18,2007
PULMICORT Astrazeneca budesonide 4,907,583 SEP 13,2007
TECZEM Biovail diltiazem malate; enalapril maleate 4,880,631 SEP 24,2007
TIAMATE Merck diltiazem malate 4,880,631 SEP 24,2007

Courtesy of DrugPatentWatch.com

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.