Blog Page 10

Stem cells are a rapidly developing technology area. The pace of scientific and clinical progress is accompanied by new patents, which can secure technology for innovators, and require careful observation by others to avoid infringement.

After discussions with Christian Walker, a colleague and entrepreneur in the stem cell space, I have launched StemCellPatentWatch to help track new IP developments in the stem cell space.

StemCellPatentWatch delivers on a simple premise: It scans new patent grants for those covering stem cell technologies. Complete details on inventorship, patent ownership, and claims are included. You can also use the search form to find patents of interest, and there is a weekly newsletter featuring the patent updates.

I look forward to your feedback on this new site, and for suggestions for further improvement.

Drug Patent Expirations for May 2014

Tradename Applicant Generic Name Patent Number Patent Expiration
RYZOLT Purdue Pharma tramadol hydrochloride 6,254,887 May 10, 2014
RYZOLT Purdue Pharma tramadol hydrochloride 5,591,452 May 10, 2014
TRITEC Glaxosmithkline ranitidine bismuth citrate 5,629,297 May 13, 2014
THALOMID Celgene thalidomide 5,629,327 May 13, 2014
IMAGENT Imcor Pharms Co dimyristoyl lecithin; perflexane 5,626,833 May 16, 2014
RESTASIS Allergan cyclosporine 5,474,979 May 17, 2014
CHILDREN'S ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,138,524 May 18, 2014
CHILDREN'S ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,138,524 May 18, 2014
RISPERDAL CONSTA Janssen Pharms risperidone 6,368,632*PED May 19, 2014
NATRECOR Scios Llc nesiritide recombinant 5,114,923 May 19, 2014
RISPERDAL CONSTA Janssen Pharms risperidone 6,110,921*PED May 19, 2014
RISPERDAL CONSTA Janssen Pharms risperidone 7,547,452*PED May 19, 2014
KALETRA Abbvie lopinavir; ritonavir 5,886,036*PED May 19, 2014
RISPERDAL CONSTA Janssen Pharms risperidone 5,965,168*PED May 19, 2014
LUPRON DEPOT Abbvie Endocrine Inc leuprolide acetate 5,631,020 May 20, 2014
LUPRON DEPOT Abbvie Endocrine Inc leuprolide acetate 5,631,021 May 20, 2014
ZINGO Powder Pharms lidocaine hydrochloride 5,630,796 May 20, 2014
LUPRON DEPOT-PED Abbvie Endocrine Inc leuprolide acetate 5,631,020 May 20, 2014
INOMAX Ino nitric oxide 5,558,083*PED May 22, 2014
TAXOTERE Sanofi Aventis Us docetaxel 5,438,072*PED May 22, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 6,342,476 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 5,981,589 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 6,054,430 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 8,367,605 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 6,620,847 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 6,362,161 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 7,199,098 May 24, 2014
COPAXONE Teva Pharms Usa glatiramer acetate 6,939,539 May 24, 2014
MALARONE Glaxosmithkline atovaquone; proguanil hydrochloride 6,166,046*PED May 25, 2014
MALARONE PEDIATRIC Glaxosmithkline atovaquone; proguanil hydrochloride 5,998,449*PED May 25, 2014
MALARONE PEDIATRIC Glaxosmithkline atovaquone; proguanil hydrochloride 6,291,488*PED May 25, 2014
MALARONE Glaxosmithkline atovaquone; proguanil hydrochloride 5,998,449*PED May 25, 2014
MALARONE Glaxosmithkline atovaquone; proguanil hydrochloride 6,291,488*PED May 25, 2014
MALARONE PEDIATRIC Glaxosmithkline atovaquone; proguanil hydrochloride 6,166,046*PED May 25, 2014
ALLEGRA Sanofi Aventis Us fexofenadine hydrochloride 5,578,610*PED May 26, 2014
CHILDREN'S ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 5,578,610*PED May 26, 2014
ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 5,578,610*PED May 26, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 5,578,610*PED May 26, 2014
NAROPIN Fresenius Kabi Usa ropivacaine hydrochloride 5,834,489 May 26, 2014
CHILDREN'S ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 5,578,610*PED May 26, 2014
ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 5,578,610*PED May 26, 2014
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 5,578,610*PED May 26, 2014
SPORANOX Janssen Pharms itraconazole 5,633,015 May 27, 2014
NEXIUM IV Astrazeneca esomeprazole sodium 6,143,771 May 27, 2014
NORDITROPIN Novo Nordisk Inc somatropin recombinant 5,633,352 May 27, 2014
RECTIV Aptalis Pharma nitroglycerin 7,189,761 May 27, 2014
CELEBREX Gd Searle celecoxib 5,563,165*PED May 30, 2014
CELEBREX Gd Searle celecoxib 5,466,823*PED May 30, 2014
ERTACZO Valeant Luxembourg sertaconazole nitrate 5,135,943 May 31, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Strategic alliances as a mechanism for wealth creation in the biopharmaceutical industry: An empirical analysis of the Spanish case

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ABSTRACT: The paper studies strategic alliances signed between traditional pharmaceutical companies (TPCs) and new biotechnology firms (NBFs) in Spain, on the initial basis that a firm's rate of new product development is a positive function of the number of strategic alliances that it has entered into. Nevertheless, we believe, as do others, that although strategic alliances may initially have positive effects on that rate, this relationship may exhibit diminishing returns...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Cell therapy: European legal and regulatory implications

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ABSTRACT: This paper reviews some of the legal and regulatory considerations that may arise in connection with the use in Europe of cell therapy approaches for the treatment of disease.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Bioterrorism and bioethics: Challenges for industry, government and society

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ABSTRACT: The emerging threat of bioterrorism raises important challenges for the biotechnology industry. Not only do new ethical issues arise for companies seeking to take advantage of opportunities for product development; so too must industry continue to grapple with longstanding issues that arise from advances in human genetics and medical research...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

This is a guest post by Gerry Langeler, Managing Director with OVP Venture Partners. Do you have a response to Gerry’s post? Respond in the comments section below.

gerry-langelerMany scientists conduct research they believe can have commercial value, and so they fancy themselves as budding entrepreneurs. But a remarkable number stumble over predictable hurdles when they try to make the switch from researcher to start-up founder.

Between academic research and commercial success lie a set of challenges that I discuss in my book “The Success Matrix – Winning in Business and in Life.” It turns out all business endeavors (and for that matter all personal endeavors) consist of three basic elements:

Vision – Process – Output

You have to know where you want to go.
You have to have the skills and resources to get there.
And then you have to execute.

It sounds so simple.
But history shows getting it right is very, very hard.

As a scientist and researcher, you have undoubtedly run this drill many times. The problem is the context changes when you go from academic activities to commercial ones. Regardless of your responsibilities, there are eight possible combinations of presence or absence of Vision, Process and Output, and we can name those combinations as “characters” with predictable strengths and weaknesses.

the-success-matrix

If you have Vision, but no Process or Output, you are a Dreamer.
If you have Vision and Process, but no Output, you’re an Academic.
If you have Vision, no Process, but Output, you’re a Brute.
If you have no Vision, have Process, but no Output, you’re a Bureaucrat.
If you have no Vision, have Process and have Output, you’re a Merchant.
If you have no Vision, no Process, but have Output, you’re a Grunt.
If you have none of the above, you’re a Loser.
And if you have them all, you’re a Success!

When you change from academia to business the definitions change, too

What makes this difficult for scientists is that the definitions of what makes good Vision, Process and Output are different when you change your objective from accepted peer-reviewed research papers to customer accepted commercial products.

Bulletproof experimental results may be required to pass muster with your peers before you can get published in Nature. But, in the world of commerce, you’ll need to blend scientific integrity with effective cost and time-to-market progress toward commercial stages that keep companies afloat.

Now, that doesn’t mean you can trot off to the FDA with just a smile and shoeshine. But it does mean that you’ll need a different Vision, a different Process, and be measuring yourself against different Output if you want to be considered a Success as an entrepreneur or a member of an entrepreneurial team. That presents for you a required change from what made you successful as a researcher. What got you here won’t get you there.

As a board member of biotech companies, I’ve seen this struggle up close. By definition, we only want to invest in world-class researchers who we believe are on the cusp of scientific breakthroughs. But, then we have to get them accept that our money is not infinite, nor our patience, and so they need to “invent to a schedule.” Yet, as we all know, no one can actually schedule inventions, or breakthroughs.

So, what is needed is an appreciation by the scientists that “the perfect is the enemy of the good” and that “good” is often good enough to move forward, even if that feels uncomfortable to those for whom “perfect” (or nearly so) has been their standard.

It is still publish or perish, but with different rules

To be fair, in some ways the commercial world mirrors the academic when one considers the “publish or perish” doctrine. You can’t go on forever doing research without Output (what you publish) or your source of grant funding will dry up, or your tenure will never be approved. The difference is in the commercial world, the “time to publish” is more constrained. And in the commercial world, “publishing” means demonstrating enough progress, to whoever is your audience, so that checks continue to get written.

But those demonstrations of progress are not nearly as constrained as a peer reviewed research report. Those of us who invest in biotech for a living understand that sometimes your research results are preliminary, or even sketchy, but we need to make informed judgments on imperfect information. What we require from you is your best efforts within the time before we have to make another financial commitment.

And above all, we need the candor that comes from scientific inquiry. Many times your first experiment won’t yield the results you expect. That’s OK. Let’s try to find out why. Is your (and our) hypothesis wrong, or were the experimental conditions wrong, or did you learn something that opens a new avenue of investigation?

Unlike polished documents at the end of the research process, our Process is quite comfortable with the uncertainty that comes with the path to discovery.

So, that might mean for a while you look like a Brute to us. Great Vision and some interesting Output, albeit without a validated, repeatable Process yet. Essentially every start-up we’ve ever backed, not just in biotech but in all technology sectors, has been a Brute when they started out. They understood that to continue to get funding from venture capitalists, and ultimately get products to customers, brute-force was necessary.

Heroes are the stuff of legend, but not of longevity

Heroic efforts are often the difference between success and failure. But what we know is long-term heroes (and Brutes) don’t scale. Long-term, polished, repeatable processes need to be in place for the commercial enterprise to succeed.

Similar things can be said of the other “less than Success-ful” characters. For example, at times you just have to crank out stuff, even if it doesn’t seem to align with the grand Vision, or match up with a sophisticated Process. Welcome the “Grunt.”

Sometimes in a commercial enterprise, some Output is better than none. It keeps the wolf away from the door. Just as with the Brute, you don’t want to rely on Grunt behavior very long. But in the short-term, it can be all you need to fight another day.

What you need to avoid at all costs is to revert into “Academic” behavior, at least as defined in commercial company terms. All Vision and Process with no Output will not keep the lights on.

This is one of the reasons we like to pair up fantastic researchers with others who have already made the leap into commercial companies. Nothing can replace the breakthrough science. But those pragmatists who understand the differences between the two domains can be remarkably helpful in getting the scientists new to the corporate world to understand the different rules of the game.

And instead of failed scientist, the result can be a successful enterprise.

What do you think? Do you know people (or organizations) that fall into the character groups described in the Matrix? How do you deal with them? Sound off in comments below.

For over 20 years, Gerry Langeler has served as a Managing Director with OVP Venture Partners (OVP), the most experienced venture capital firm in the Pacific Northwest. OVP was formed in 1983, and raised seven venture capital funds, the most recent at $250 million. The firm focused on early stage companies in clean tech, digital biology, and information technology. OVP backed over 125 startups and saw over 50 major liquidity events, including 25 IPOs and more than 30 acquisitions by public companies.

google-glassI have been struggling to understand the utility of Google Glass in most of the presented use cases.

The Google Glass homepage features largely recreational consumer-driven uses, such as taping a ballet concert, performing Google searches, and navigation. A regular cellphone or GoPro can readily serve these needs, which leads me to question where the killer app for Google Glass may lie. Just as the Segway was supposed to change the world, its uses now are primarily saving security guards and tourists from too much walking.

Why is Google pushing a bunch of soft ‘wants’ instead of painful ‘needs’?

The life sciences, along with many other technical disciplines, face a substantial challenge both in visualization, and in real-time information delivery. Consider the cases of surgeons using Google Glass here and here, or the US military’s use of augmented reality to speed vehicle repair. Surgeons can use Google Glass to beam images and obtain remote guidance in real-time, and students can gain a first-hand view and ask questions in real-time. Augmented reality can permit fewer mechanics to repair vehicles faster and more effectively, reducing the number of personnel and equipment needed to be stationed in warzones or other dangerous areas.  These applications represent currently pressing, painful, unmet needs.

Google Glass needs to take a lesson from the Segway debacle. Instead of pushing trivial or contrived applications on consumers (which may kill the technology), they would be better served by focusing on strong unmet needs, and letting consumers and hackers develop their own derivatives.

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

ATMP in practice: Towards a new industry landscape in tissue engineering

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ABSTRACT: Regulatory divergences and market fragmentation across member states have hampered the development of the tissue engineering industry in the EU. Addressing this situation by providing a harmonised and more predictable regulatory regime, the regulation on advanced therapy medicinal products (ATMPs) is based on a regulatory strategy that aims to consolidate the increased activity in the domain of regenerative medicine while maintaining the pace of technical development and innovation in this area...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Drug Patent Expirations for April 2014

Tradename Applicant Generic Name Patent Number Patent Expiration
MAXALT-MLT Merck rizatriptan benzoate 5,457,895*PED Apr 1, 2014
FROVA Endo Pharms frovatriptan succinate 5,616,603 Apr 1, 2014
ABELCET Sigma Tau amphotericin b 5,616,334 Apr 1, 2014
BROVANA Sunovion arformoterol tartrate 6,589,508 Apr 3, 2014
INCRELEX Ipsen Inc mecasermin recombinant 6,207,640 Apr 7, 2014
VIRACEPT Agouron nelfinavir mesylate 5,952,343*PED Apr 7, 2014
NIZORAL A-D Mcneil Cons ketoconazole 5,456,851 Apr 7, 2014
VIRACEPT Agouron nelfinavir mesylate 5,484,926*PED Apr 7, 2014
VIRACEPT Agouron nelfinavir mesylate 6,162,812*PED Apr 7, 2014
INVEGA SUSTENNA Janssen Pharms paliperidone palmitate 5,254,556*PED Apr 15, 2014
ATELVIA Warner Chilcott Llc risedronate sodium 5,622,721 Apr 21, 2014
ALREX Bausch And Lomb loteprednol etabonate 5,540,930*PED Apr 25, 2014
LOTEMAX Bausch And Lomb loteprednol etabonate 5,540,930*PED Apr 25, 2014
ZYLET Bausch And Lomb loteprednol etabonate; tobramycin 5,540,930*PED Apr 25, 2014
ALREX Bausch And Lomb loteprednol etabonate 5,747,061*PED Apr 25, 2014
LOTEMAX Bausch And Lomb loteprednol etabonate 5,747,061*PED Apr 25, 2014
ZYLET Bausch And Lomb loteprednol etabonate; tobramycin 5,747,061*PED Apr 25, 2014
ABREVA Glaxosmithkline docosanol 4,874,794 Apr 28, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.

journal-of-commercial-biotechnology_160The April 1 2014 issue of the Journal of Commercial Biotechnology has just been published, and features the following papers:

Building biotechnology in India – Drugs are not the answer
Yali Friedman
I have had the pleasure of participating in national forums on biotechnology development in diverse countries. A common theme I see is that emerging economies wish to develop ‘a biotechnology industry like the United States.’ I generally temper these ambitions by explaining that the United States does not have a biotechnology industry per se, but rather a handful of states have very strong biotechnology concentrations and many other states are still trying to build their domestic biotechnology industries…
Full details at the Journal of Commercial Biotechnology

Fostering technology transfer in industrial biotechnology by academic spin-offs
Gunter Festel, Philipp Rittershaus
Industrial biotechnology is the commercial application of biotechnology using cells or components of cells, like enzymes, for industrial production processes including consumer goods, bioenergy and biomaterials…
Full details at the Journal of Commercial Biotechnology

Pharmaceutical R&D Productivity: The Role of Alliance
Sarah Kruse, Mark Slomiany, Rema Bitar, Sarah Jeffers, Mahmud Hassan
In recent years, the major research-intensive biopharmaceutical companies (big pharma) have come face to face with a perfect storm of eroding profit margins from blockbuster expiration and generic competition coupled with growing R&D expenses and declining advances in truly novel therapeutics…
Full details at the Journal of Commercial Biotechnology

Deciding between biobetter versus biosimilar development options based on net present value calculations
Kerstin Marie Bode-Greuel, Klaus Nickisch
AbstractThe growing share of biopharmaceuticals is paralleled by an increasing interest in biogenerics, as blockbuster biologics are approaching their patent expiries. Companies need to make decisions whether to invest in biosimilars or in biobetters with enhanced properties, the latter enabling favorable differentiation vis-à-vis the original product on the one hand and biosimilars on the other hand…
Full details at the Journal of Commercial Biotechnology

Market Orientation, Alliance Orientation, and Business Performance in the Biotechnology Industry
Grant Alexander Wilson, Jason Perepelkin, David Di Zhang, Marc-Antoine Vachon
The purpose of this study was to test the unexplored relationship between market orientation (MO), alliance orientation (AO), and business performance (PERF) in the medical/healthcare subsector of the Canadian biotechnology industry.  The study surveyed Canadian biotechnology executives via mail and web-based questionnaires…
Full details at the Journal of Commercial Biotechnology

Bioentrepreneurship Education and Training Trends
Arlen Meyers
Biomedical and health entrepreneurship continues to expand around the world. Driven by global pressures to optimize the allocation of scarce resources, life science bioentrepreneurs are creating innovative products, platforms, service and systems that deliver more value…
Full details at the Journal of Commercial Biotechnology

Where is the eBay for Intellectual Property?
Matthew B Klusas, Raymond H. Cypess, Seth Rosenfield, Adam Gerstein
This paper is an examination of the economics, organizational dynamics and structural factors inhibiting an electronic market for intellectual property.  Several intermediaries exist to facilitate the transition of intellectual property (IP) from sellers to buyers.  Over the past 20 years, a number of companies attempted to create an online “eBay for IP…
Full details at the Journal of Commercial Biotechnology

Biotech IPOs Steam Ahead in 2014
G. Steven Burrill
If you walk into most private biotech company boardrooms today, it is likely that you will hear a discussion about whether to go public. Companies at every stage of development are either getting ready to file for an initial public offering or thinking about it. Although the slowdown in new issues at the end of 2013 gave observers pause that the robust biotech IPO market of 2013 might slow down in 2014, the reality has been just the opposite…
Full details at the Journal of Commercial Biotechnology

Considerations for Start-Up Biotech Company Valuation
Walter Bratic, Justin R Blok, Megan M Gostola
The prospect of government regulation, product liability lawsuits, and customer reliance on third-party payers contribute to the complexity of valuing biotech start-ups. In addition, the inherent complexity of biologic drug manufacturing and storage creates secondary risks that must be considered in a valuation…
Full details at the Journal of Commercial Biotechnology

Canadian Venture Capital – Unlocking the Funding Challenge
Christopher H. Jones
Canada plays a significant role in the global advancement of scientific discoveries and their translation into commercial opportunities, but is viewed as not fully realizing its commercial potential. A significant problem has been a lack of sufficient venture capital to take early-stage companies to the next level…
Full details at the Journal of Commercial Biotechnology

New Books
Yali Friedman
New books from the publisher of the Journal of CommercialBiotechnology
Full details at the Journal of Commercial Biotechnology