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Yearly Archives: 2009

This is a guest post from Cliff Cramer, Director of the Healthcare and Pharmaceutical Management Program at Columbia Business School. Do you have a response to Cramer’s post? Post them in the comments section below.

  • Multi-national pharmaceutical and medical technology companies will increase their investments in emerging markets, notably China and India, to access cost effective human capital and a growing middle class of consumers better able to afford more advanced medical products.
  • Information technology will make greater strides in a healthcare industry which has been slow to adopt, driven by financial incentives (e.g., government subsidies) and employees and consumers demanding better and more accessible information (e.g., transportable e-records) as their share of healthcare spending increases.
  • Healthcare reform will continue across developed (U.S. and EU countries) and developing (China) markets, focused on increasing access to affordable and quality patient care. These initiatives are likely to be incremental due to political and economic (budget) considerations.
  • Consolidation will be a major theme in 2010 as insurers and hospitals seek additional leverage in contract negotiations, and pharmaceutical companies explore transformational mergers to broaden product lines, strengthen geographic breadth (emerging markets) and seek to manage earnings given major patent expirations in the near term.

About Cliff Cramer:

Cliff Cramer has spent more than 25 years in the healthcare / pharmaceutical and financial services sectors. He was managing director at Merrill Lynch in the Global Healthcare Investment Banking Group and managing director at JPMorgan in the Corporate Finance Group, where he served as head of M&A for the pharmaceutical sector. Earlier, Cramer was vice president, corporate planning & development, for Merck & Co., Inc., with worldwide responsibilities for strategic planning and business development. In addition, he was cofounder of American Health Capital / VHA Enterprises, Inc., a healthcare / financial services company serving the capital needs of multihospital systems.

This is a guest post from BiotechBlog reader Viren Konde. Do you have a response to Viren’s post? If so, you may respond in the comments section below.

The recent editorial on “Intellectual property and biotechnology innovation: To protect or not protect” by Dr Yali Friedman, Managing Editor of the Journal of Commercial Biotechnology was thought provoking and led to this write-up. The editorial emphasized on the intellectual property protection differences between the developing and developed countries, and their drug manufacturers on the issues of patents, price controls, and research & development investments in the biotechnology sector. The remarks indicate that, the developed countries, being the ‘technology producer’ have favored strong intellectual property protection to motive the innovation and apparently the trade; while the developing countries being the ‘technology consumers’ have exploited the benefits of it at much lower cost by building a weaker intellectual property protection system.

Although it is logical that all countries, whether, developing and developed, should offer the strongest intellectual property protection possible, it is believed that, there are no legal definitions of “developed” and “developing” countries. The WTO members have announced for themselves whether they are “developed” or “developing” countries, with an open option to challenge the decision of a member to make use of provisions available to the developing countries. It was also believed in the agreement that the developed countries need maximalist IP regimes, as they are highly innovative and strong IP regimes provide the requisite incentives in this regard. On the other hand, developing countries require minimalist IP regimes, as they are hardly innovative and are often net importers of technology. These norms have also formed the basis for the 1970’s Indian Patents Act for the ‘developing India’. The amendments to Indian Patent Act in a timely fashion [Indian Patent (Amendment) Acts of 1999, 2002, and 2005] have driven India to ‘innovative (Product Patents) regime’ in its intellectual property policy.

Today, although, India continues to remain a “developing” country; it is also considered a ‘technologically proficient’, and therefore as an innovative developing country. Therefore, in the present times, the older definitions of intellectual property based on the differences between developed versus developing countries can not relate to India. Some developing countries like India are more scientifically advanced than others as a result of decades of investments in education, medical infrastructure, and manufacturing capacity. India hosts more drug manufacturing facilities that have been approved by U.S Food and Drug Administration than any country other than the United States. India’s biotechnology industry is managing to position itself on the strength of contract research, clinical research and contract manufacturing services together with the sales of off-patent biologics in the local as well as lightly regulated markets in the Middle East, Africa and Asia.

Unfortunately, India’s patent regime does not appear to be satisfying to the developed world given that India, though “technologically competent” in certain technology sectors like software and pharmaceuticals have not yet witnessed any significant levels of “innovation” in the biomedical utility sectors like biotechnological products and processes. Recently, the US-based Biotechnology Industry Organization (BIO) criticized India’s patent law and the Office of the US Trade Representatives kept India (and some other countries) on the USTR’s “Priority Watch List” in order to bring India’s patent law more in line with Western IP protections. Clearly, there are some issues and concerns that need clarification and that will be discussed here, such as the patentability criteria under section 3(d), and the provision of compulsory licensing in the Indian Patent Act; the price control and the cost difference of the innovator verses generic biotechnology drugs; the TRIPS mandate on clinical data protection and exclusivity; and also the pre- and post-grant patent opposition provisions used by Indian biogeneric manufacturers.

- Viren Konde

Drug Patent Expirations for December 2009

TradenameApplicantGeneric NamePatent Number Patent Expiration
MIGRANALValeantdihydroergotamine mesylate5,169,849Dec 8, 2009
PHOTOFRINAxcan Scandipharmporfimer sodium5,145,863Dec 15, 2009
XENICALHoffmann La Rocheorlistat4,598,089*PEDDec 18, 2009
CEDAXSciele Pharma Incceftibuten dihydrate4,812,561Dec 20, 2009
OXILAN-300Guerbetioxilan4,954,348Dec 21, 2009
OXILAN-350Guerbetioxilan4,954,348Dec 21, 2009
DEFINITYLantheus Medclperflutren6,146,657Dec 22, 2009
ZANTAC 150Glaxosmithklineranitidine hydrochloride5,102,665*PEDDec 23, 2009
VALTREXGlaxosmithklinevalacyclovir hydrochloride4,957,924*PEDDec 23, 2009
ZIAGENGlaxosmithklineabacavir sulfate5,089,500*PEDDec 26, 2009
TRIZIVIRGlaxosmithklineabacavir sulfate; lamivudine; zidovudine5,089,500*PEDDec 26, 2009
EPZICOMSmithkline Beechamabacavir sulfate; lamivudine5,089,500*PEDDec 26, 2009
CORVERTPharmacia And Upjohnibutilide fumarate5,155,268Dec 28, 2009

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Courtesy of DrugPatentWatch.com

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin.

This is my initial response to the Kyoto Prize, which I was able to attend on a fellowship from Point Loma Nazarene University. For more details on the Kyoto Prize see my previous post.

kyotoprizeI had an opportunity to interact with each of the laureates, and focused on the question of how it was that they were able to accomplish their exemplary achievements. It is not enough to simply be brilliant or hard-working — all their peers likely share these characteristics. What are the differentiating factors that enabled their unique achievements?

I am still working on an expanded discussion for more formal publication, and I’ll link to the article when it is available. However, not to leave you in suspense, I’ll note that I was surprised by how well the enabling factors aligned with each laureate’s field — technology, basic sciences, and arts and philosophy.

At a recent event on the comparative advantages of small molecule vs. biologic drugs, several themes emerged which led me to re-examine the question of whether the practice of medicine is capable of keeping pace with medical innovation.

As mentioned in a previous post, the majority of patients receiving the personalized medicine drug Herceptin had not been previously administered Herceptin’s diagnostic test. This is extremely important, as the diagnostic test can identify those patients most likely to benefit from the drug and exclude those who are likely to see no benefits (and will likely only get sicker as they rotate through an ineffective drug). For all the talk of the promise of personalized medicine, it appears that the gatekeepers — physicians and payers — are unaware of how to effectively prescribe  personalized drugs.

This is not a new phenomenon. Antibiotic drugs have seen their effectiveness drop due to overprescription, which led to the emergence and rapid spread of antibiotic-resistant bacteria.

So, just as mis-prescription of antibiotics took the shine off many lucrative drugs, mis-prescription of personalized medicines stands to likewise diminish their value. What is particularly surprising is that this is not a new trend. For all the advances in drug development over the decades since over-prescription of antibiotics was recognized as a problem, physicians and payers are still hard pressed to prescribe drugs effectively.

When I asked the panel of potential solutions to the problem, I was given a list of emerging technologies such as bioinformatics, e-health, centralized databases, etc. that could solve the problem; adding technology to a problem isn’t necessarily going to solve it, it may just make it a more expensive problem! In reality the solution already exists. All healthcare payers need to do is require prior authorization before prescribing Herceptin, which would require physician consultation, and require a positive result in the diagnostic test prior to reimbursement for the drug.

As with most simple solutions, I’m sure that this one has already been conceived. So why is it not being used? Could it be that healthcare payers are afraid they might end up having to use a litany of diagnostic tests on all cancer patients, thereby offsetting any potential costs savings? I look forward to your thoughts in the comments section below.

Drug Patent Expirations for November 2009

TradenameApplicantGeneric NamePatent Number Patent Expiration
ACULAR LSAllerganketorolac tromethamine5,110,493*PEDNov 5, 2009
ACULARAllerganketorolac tromethamine5,110,493*PEDNov 5, 2009
PREVPACTakeda Pharms Naamoxicillin; clarithromycin; lansoprazole4,628,098*PEDNov 10, 2009
PREVACID IVTakeda Pharms Nalansoprazole4,628,098*PEDNov 10, 2009
ACEONSolvay Pharmsperindopril erbumine5,162,362Nov 10, 2009
PREVACIDTakeda Pharms Nalansoprazole4,628,098*PEDNov 10, 2009
PREVACID NAPRAPAC 500 (COPACKAGED)Takeda Pharms Nalansoprazole; naproxen4,628,098*PEDNov 10, 2009
CARDENEEkr Therapnicardipine hydrochloride5,164,405Nov 17, 2009
TROVAN PRESERVATIVE FREEPfizeralatrofloxacin mesylate5,164,402Nov 17, 2009
RESCULAR Tech Ueno Ltdunoprostone isopropyl5,166,178Nov 24, 2009
ATROVENT HFABoehringer Ingelheimipratropium bromide5,766,573Nov 28, 2009
PROAIR HFATeva Globalalbuterol sulfate6,352,684Nov 28, 2009
QVAR 40Teva Globalbeclomethasone dipropionate5,766,573Nov 28, 2009
XOPENEX HFASepracorlevalbuterol tartrate6,352,684Nov 28, 2009
QVAR 80Teva Globalbeclomethasone dipropionate6,352,684Nov 28, 2009
PROAIR HFATeva Globalalbuterol sulfate5,766,573Nov 28, 2009
PROVENTIL-HFA3malbuterol sulfate6,352,684Nov 28, 2009
QVAR 40Teva Globalbeclomethasone dipropionate6,352,684Nov 28, 2009
QVAR 80Teva Globalbeclomethasone dipropionate5,766,573Nov 28, 2009

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Courtesy of DrugPatentWatch.com

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin.

With the issue of data exclusivity for novel biologics re-emerging in the news, I’d like to present two arguments that will be published in the upcoming issue of the Journal of Commercial Biotechnology:

Why data exclusivity is the new patent protection
Peter J Pitts, Center for medicine in the public interest

Follow-on biologic drug competition – No need for new marketing exclusivities
Michael S Wroblewski(a) and Elizabeth A Jex(b)
a) Office of Policy Planning, Federal Trade Commission
b) FTC Office of Policy Planning

I am honored to have been selected for the 2009 Kyoto Prize Journalism Fellowship, offered by Point Loma Nazarene University.

This fellowship will allow me to attend the Kyoto Prize Ceremony, laureate lectures and workshops, and associated functions. The Kyoto Prize is one of the world’s most prestigious awards given to those who have made outstanding lifetime achievements in technology, science, or the arts. This year’s laureates are:

Dr. Isamu Akasaki, Blue LED pioneer

Drs. Peter and Rosemary Grant, Evolutionary Biologists

Pierre Boulez, World-renowned composer, conductor

I am honored to have the opportunity to attend this prestigious event and to learn more about innovation in diverse disciplines.

Courtesy of DrugPatentWatch.com:

Drug Patent Expirations in October 2009

TradenameApplicantGeneric NamePatent NumberPatent Expiration
BREATHTEK UBT FOR H-PYLORIOtsuka Americaurea, c-134,830,010Oct 27, 2009
CEDAXSciele Pharma Incceftibuten dihydrate4,634,697Oct 1, 2009
COLGATE TOTALColgate Palmolivesodium fluoride; triclosan5,156,835Oct 20, 2009
COVERA-HSGd Searle Llcverapamil hydrochloride5,785,994Oct 22, 2009
DOXILOrtho Biotechdoxorubicin hydrochloride5,013,556Oct 20, 2009
DOXILOrtho Biotechdoxorubicin hydrochloride5,213,804Oct 20, 2009
FLOMAXBoehringer Ingelheimtamsulosin hydrochloride4,703,063Oct 27, 2009
INVEGA SUSTENNAJohnson And Johnsonpaliperidone palmitate5,254,556Oct 27, 2009
MERETEK UBT KIT (W/ PRANACTIN)Otsuka Americaurea, c-134,830,010Oct 27, 2009
PERMAXValeant Pharm Intlpergolide mesylate5,114,948Oct 19, 2009

*Drugs may be covered by multiple patents

Courtesy of DrugPatentWatch.com

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin.

The October 2009 issue of the Journal of Commercial Biotechnology is now available. The links below will take you to the abstract for each paper:

Volume 15, Issue 4

Editorial

Intellectual property and biotechnology innovation: To protect or not protect?PDF
Yali Friedman

Commentary

The correlation between medical tourism and biotechnologyPDF
David G Vequist IV, Erika Valdez
The VC manifesto: Special pleading for a damaged cause: Commentary on Simon Witney interviewPDF
William Bains

Articles

Innovate America: The Technology Innovation Program at NISTPDF
Andrew S Klein, Mrunal S Chapekar
Valuation of complex license contractsPDF
Ralph Villiger, Boris Bogdan
How can pharmaceutical and biotechnology companies maintain a high profitability?PDF
Klaus J Nickisch, Joachim M Greuel, Kerstin M Bode-Greuel
Multiyear patterns regarding the relative availability of venture capital for the US biotechnology industryPDF
J Leslie Glick
Building biotechnology teams: Personality does matterPDF
Anne S York, Kim A McCarthy, Todd C Darnold
Beacon Sciences: Commercialisation from biothreat detection to beauty enhancementPDF
Rob Hanes, Damon Borich

Legal and Regulatory Updates

Legal and Regulatory UpdatePDF
Gerry Kamstra, John Wilkinson

Book Reviews

Book Review: Genomics & society: Legal, ethical and social dimensionsPDF
Dominic Clark
Book Review: Commercialization of innovative technologies: Bringing good ideas to the marketplacePDF
Arlen D Meyers
Book Review: Biotech funding trends: Insights from entrepreneurs and investorsPDF
J Leslie Glick