Home Archives 2007

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


Neil Henderson


Is ‘evergreening’ a cause for concern? A legal perspectivePDF
Scott Parker, Kevin Mooney
Exploiting the business opportunities in biotech connections: The power of social networksPDF
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 2007PDF
Graeme Ladds
Investing in new medical technologies: A decision frameworkPDF
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 perspectivePDF
Anuj Kumar Chandel, Ravinder Rudravaram, Linga Venkateswar Rao, Pogaku Ravindra, Mangamoori Lakshmi Narasu

Legal and Regulatory Updates

Legal and regulatory updatePDF
Gerry Kamstra, John Wilkinson

Book Reviews

Book Review: The Economics of Biotechnology: Volumes I and IIPDF
Iraj Daizadeh
Book Review: Global Governance of Food and Agriculture IndustriesPDF
Alan McHughen
Book Review: The International Politics of Genetically Modified Food: Diplomacy, Trade and LawPDF
Robert Paarlberg
Science Business: The Promise, the Reality and the Future of BiotechPDF
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

TradenameApplicantGeneric NamePatent NumberPatent Expiration
CLARINEXScheringdesloratadine4,659,716OCT 01,2007
CLARINEXSchering Ploughdesloratadine4,659,716OCT 01,2007
CLARINEX D 24 HOURScheringdesloratadine; pseudoephedrine sulfate4,659,716OCT 01,2007
CLARINEX-D 12 HOURScheringdesloratadine; pseudoephedrine sulfate4,659,716OCT 01,2007
COVERA-HSGd Searle Llcverapamil hydrochloride4,946,687OCT 02,2007
DYNACIRC CRReliant Pharmsisradipine4,816,263OCT 02,2007
DYNACIRC CRReliant Pharmsisradipine4,946,687OCT 02,2007
DYNACIRC CRReliant Pharmsisradipine4,950,486OCT 02,2007
ESTROSTEP 21Warner Chilcottethinyl estradiol; norethindrone acetate4,962,098OCT 09,2007
ESTROSTEP FEWarner Chilcottethinyl estradiol; norethindrone acetate4,962,098OCT 09,2007
LEXXELAstrazenecaenalapril maleate; felodipine4,803,081OCT 03,2007
NEXIUMAstrazenecaesomeprazole magnesium4,786,505OCT 20,2007
NEXIUMAstrazenecaesomeprazole magnesium4,853,230OCT 20,2007
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,266,331OCT 26,2007
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,549,912OCT 26,2007
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,656,295OCT 26,2007
PERMAXValeant Pharm Intlpergolide mesylate4,797,405OCT 26,2007
PLENDILAstrazenecafelodipine4,803,081OCT 03,2007
PRILOSECAstrazenecaomeprazole4,786,505OCT 20,2007
PRILOSECAstrazenecaomeprazole4,853,230OCT 20,2007
PRILOSEC OTCAstrazenecaomeprazole magnesium4,786,505OCT 20,2007
PRILOSEC OTCAstrazenecaomeprazole magnesium4,853,230OCT 20,2007
PROPULSIDJanssen Pharmacisapride monohydrate4,962,115OCT 09,2007
PROPULSID QUICKSOLVJanssen Pharmacisapride monohydrate4,962,115OCT 09,2007
VOLTARENNovartisdiclofenac sodium4,960,799OCT 03,2007
ZOVIRAXGlaxosmithklineacyclovir4,963,555OCT 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

TradenameApplicantGeneric NamePatent NumberPatent Expiration
BETAXONAlconlevobetaxolol hydrochloride4,911,920SEP 27,2007
BETOPTIC SAlconbetaxolol hydrochloride4,911,920SEP 27,2007
CARDIOLITEBristol Myers Squibbtechnetium tc-99m sestamibi kit4,885,100SEP 11,2007
COGNEXSciele Pharma Inctacrine hydrochloride4,816,456SEP 09,2007
COREGSmithkline Beechamcarvedilol4,503,067SEP 05,2007
COREG CRSb Pharmcocarvedilol phosphate4,503,067SEP 05,2007
MIRALUMABristol Myers Squibbtechnetium tc-99m sestamibi kit4,885,100SEP 11,2007
NEXIUMAstrazenecaesomeprazole magnesium4,738,974SEP 01,2007
PENLACSanofi Aventis Usciclopirox4,957,730SEP 18,2007
PULMICORTAstrazenecabudesonide4,907,583SEP 13,2007
TECZEMBiovaildiltiazem malate; enalapril maleate4,880,631SEP 24,2007
TIAMATEMerckdiltiazem malate4,880,631SEP 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.