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Archive for April, 2007

European Federation of Intellectual Property

Written by on Sunday, April 22nd, 2007

http://www.efipweb.org/

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Handling Intellectual Property in Business Transactions

Written by on Wednesday, April 18th, 2007

The Practicing Law Institute event Handling Intellectual Property in Business Transactions will be held in San Francisco on April 30-May 1, 2007.  The event will cover the following issues:

  • Strategies in creation of intellectual property assets;
  • Obtaining ownership of intellectual property assets;
  • Strategies for licensing of intellectual property assets;
  • Trademark licensing and branding issues;
  • Understanding and analyzing intellectual property assets;
  • Maximizing the value of intellectual property assets;
  • The impact of Sarbanes-Oxley and FAS 141/142 on IP issues;
  • Critical open source issues; and 
  • Protecting IP assets in the event of bankruptcy.

 

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Biotechnology Law Roundtable Teleconference

Written by on Wednesday, April 18th, 2007

The ABA Science and Technology Section’s Biotechnology Law Roundtable Teleconference on Regulatory & Policy Implications of Personalized Medicine & Pharmacogenomics will be held from 8:30 a.m. to 10:30 a.m. PST on April 30, 2007.  The speakers for this event are Janet Woodcock, Deputy Commissioner & Chief Medical Officer, U.S. Food and Drug Administration, Rockville, Maryland, and Ellen Flannery, Partner, Covington & Burling LLP, Washington, D.C.  The event will explore the regulatory and policy issues that will arise as researchers, industry, and government regulators move towards implementing a pharmacogenomic approach to medical care.

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Tech Transfer Office Culture Preventing Commercialization of Technology

Written by on Tuesday, April 17th, 2007

 A Kansas City Business Journal report, citing a report released by the Ewing Marion Kauffman Research Foundation, concludes that  a "’home run mentality’ in university technology transfer offices may be keeping many valuable research projects from reaching first base in the commercialization process."

The Kansas City Business Journal stated:

According to the report, universities tend to focus their limited technology-transfer resources only on the patenting and licensing of technologies that promise big, fast paybacks.

The report — written by Kauffman researchers Robert Litan, Lesa Mitchell and E.J. Reedy — argues that universities should shift from a sole focus on that patent/licensing model, which seeks to maximize income, to a volume model. A volume model emphasizes the number of innovations that university research generates and the speed at which those innovations are commercialized.

The Report outlined four volume models as follows:

    • Free agency model: Faculty members have the power to choose a third party (or themselves) to negotiate license agreements for entrepreneurial activities, provided they return some portion of their profits to the university.
    • Regional alliances model: Multiple universities form a consortium that develops mechanisms for commercialization. Economies of scale allow for lower costs of the commercialization function overall, and the universities are able to share costs among multiple participants. This model may prove particularly attractive for smaller research universities, which may not have the volume to support a seasoned and highly able licensing and commercialization staff independently. 
    •  Internet-based model: Closely related to the regional alliance model, Internet-based approaches use the Web to facilitate commercialization. The iBridge Network, a program funded by the Kauffman Foundation that works with a consortium of universities, is an example of such a model.
    • Faculty loyalty model: This calls for universities to consider giving up their intellectual property rights, anticipating instead that loyal faculty will donate a portion of their commercialization proceeds back to the university.  

The argument raised is an interesting one–there is a good argument that the focus of universities should be on commercializing good research for the societal good rather than making as much money as possible with "home runs".  From a commercial perspective, "home runs" make good business sense, but universities take pride in their higher purpose and there is certainly a good argument that tech transfer policies should reflect this higher purpose. 

 

 

 

 

 

 

 

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Senate Passes Stem Cell Funding Bill

Written by on Thursday, April 12th, 2007

As I reported earlier this week, the Senate was considering a stem cell funding bill, which was passed today by a vote of 63-34.  (See the Newsvine.com and The Associated Press Roll Call).

CNN reported that President Bush has indicated that he would veto the new bill, but that he would sign a Republican alternative that would encourage other forms of stem-cell research without changing his 2001 policy.  That bill passed by a 70-28 vote.

There is not much reaction to report on this vote or President Bush’s response.  The outcome of the vote as well as the President’s response have gone as anticipated. 

I will keep you posted as news unfolds on this issue.

 

 

 

 

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Bay Area Venture-Funded Life Science Companies Increase Valuations

Written by on Wednesday, April 11th, 2007

The Mercury News reported today that valuations for venture-funded life science companies in the Bay Area increased in 2006, according to a survey taken by Mountain View, CA law firm Fenwick & West.

As The Mercury News reported:

The percentage of local life-science companies that saw their per-share price increase from previous financing rounds rose to 79 percent last year, up from 65 percent the year before. . . "Down" rounds were reported by 15 percent of the companies surveyed, while no change was recorded by 6 percent.

For non-life-science ventures, 67 percent reported up rounds in 2006, while 22 percent recorded down rounds and 11 percent said there was no change.

The average price increase for life science companies receiving venture capital in 2006 compared with previous rounds was up 50 percent, with medical-device valuations increasing 55 percent on average compared with a 41 percent average increase in pharmaceutical valuations in 2006.

Non-life-science start-ups saw their average price increase by 55 percent.

This report confirm what those of us in the Bay Area already knew: the state of biotech in the Bay Area continues to be strong.

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The Ethics of Paying to Continue a Clinical Trial

Written by on Wednesday, April 11th, 2007

The Wall Street Journal ran a disturbing story today about a clinical trial that ran low on funding and has depended on payments by patients to continue. 

The clinical trial in question is an amyotrophic lateral sclerosis ("ALS") study run by James P. Bennett Jr., director of the Center for the Study of Neurodegenerative Diseases at the University of Virginia. 

Is this ethical?  According to The Wall Street Journal:

[S]eeking funds directly from patients. . . raises a number of ethical and economic questions — questions that any research effort considering such a solution would have to face. It means soliciting patients at a very vulnerable time, when they may be desperate for hope. With ALS, for instance, there is no cure; the disease attacks the nerves that control movement and usually leads to death within five years. Already struggling to pay for aspects of their own care, patients could quickly find themselves tapped out.

There is also less accountability for how money is spent when it is donated directly to a study rather than through a grant-giving nonprofit. And while Dr. Bennett has no financial interest in his ALS drug, investigators in other trials may financially benefit from their research role, causing potential conflicts of interest.
Clearly, this story is not the norm.  But I can’t help but wonder how often this scenario is arising today.  How often are patients funding their own trials?  And is that really any different than starting your own foundation and funding it to do the same thing?  Certainly, there may be more oversight in the case of a foundation, but in both scenarios, a patient is taking his health in his own hands and taking a risk in the hope of finding a cure or even a treatment for his illness. 
 
On the other hand, when the patient is acting directly to fund a trial, there is an increased risk that such patient will be taken advantage of or even coerced into paying for a treatment that has not yet been proven to work.
 
Of course, how often do patients go bankrupt paying for treatments that have only a small chance of working?  You hear stories in the news each day like this, and I even know a few people who have personally experienced such a fate.  Luckily they are still around to share their experiences.  This story is troubling on a number of levels and raises some difficult ethical issues that we should definitely be discussing, but I think that we also have to put it into its proper context before condemning what has taken place here.  What is ethical when it comes to a clinical trial, particularly in the case of a terminal disease such as ALS?   And what would you be willing to do yourself if you were the one with the unfortunate diagnosis? 

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Stem Cell Bills Set to Be Debated in Senate

Written by on Monday, April 9th, 2007

Reuters is reporting that two stem cell bills are set to be debated in the Senate when it returns tomorrow.

According to Reuters, the first bill is virtually identical to one that was vetoed by President Bush last year expanded and encouraged federal funding of human embryonic stem cell research.

The second is  a compromise measure worked out by Republicans Sen. Johnny Isakson of Georgia and Norm Coleman of Minnesota.

Reuters reports as follows:

[The bill] would encourage stem cell research on embryos that have naturally lost the ability to develop into fetuses, such as those that have died "naturally" during fertility treatments. 

The compromise bill also would support the creation of a bank of stem cells taken from amniotic fluid and placentas — two recently discovered potential sources.

This bill replaces last year’s alternative sponsored by Kansas Republican Sam Brownback, which would ban human embryonic stem cell research and encourage research using other types of stem cells.

Will the outcome of these bills be any different year than last , given the Democratic-controlled Senate?  I must say that I have my reservations.  My suspicion is that even if the bills are voted into law, President Bush will veto them.   Surely, the Senate recognizes that this will be the likely outcome.  Is this really a good use of their time and resources?

Having said this, the compromise bill is likely to receive more support  from the American public, given its focus on embryos that have naturally lost the ability to develop into fetuses.  Time will tell if this makes any difference.

 

 

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April Breakfast Meeting: HRx for Success – Strategies every Life Science Leader Should Know to Increase Company Performance

Written by on Sunday, April 8th, 2007

The event HRx for Success–Strategies every Life Science Leader Should Know to Increase Company Performance will be held on Thursday, April 26, 2007 from 7 a.m. to 9 a.m. at the

Hilton Garden Inn, 6450 Carlsbad Blvd., Carlsbad, CA  92011.  The speakers will include the following:

  • Julie A. DeMeules, Senior Vice President, Human Resources, Santarus;
  • Phyllis Huckabee, Vice President, Human Resources, Quidel Corporation;
  • Gaylene Xanthopoulos, President, The Leadership Edge, Inc.; and
  • Mary Yaroshevsky-Glanville, Vice President, Human Capital, Anadys Pharmaceuticals.
 
 

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NanoBioNexus’ Patenting & Licensing Nanotechnology – “Where Much Can Go Wrong If You Don’t Get It Right”

Written by on Sunday, April 8th, 2007

The event NanoBioNexus’ Patenting & Licensing Nanotechnology–"Where Much Can Go Wrong if You Don’t Get it Right" will be held at the Radisson La Jolla, 3299 Holiday Court, La Jolla, CA  92037 on April 26, 2007 from 5:30 to 8:30 p.m.  The speakers will include:

  • Vicki G. Norton, Ph.D., J.D., Partner, Intellectual Property, IP Litigation, IP Counseling & Patents, Life Sciences, Wilson Sonsini Goodrich & Rosati Law Firm;
  • Esther Kepplinger, Director, Patent Operations, IP Counseling & Patents, Wilson Sonsini, Goodrich & Rosati Law Firm; and 
  • Jane Moores, Ph.D.
    Interim Director, UCSD Technology Transfer.

 


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