Twitter Twang – January 27, 2010

@eDougBanks: In biotech? Boston Irish Business Assn. has MassBio CEO Bob Coughlin talking about theindustry: http://bibabiotech.eventbrite.com/

@matthiasfromm Oh, ‘Technology’ als “most trusted industry sector”, dann ‘Biotech/life sciences’ und ‘Health care’ (S. 9) #edeltrust http://bit.ly/n3Iv8

@CampusRXBio Emerging biotech industry says R.I. lacks job skills Faced with a lack of qualified workers, leaders in Rhode Island..http://short.to/14pk0

@biotechnology Bacteria Transformed into Biofuel Refineries: The bacteria responsible for most cases of food poisoning in the U.S…http://bit.ly/awfk77

@BiosearchTech New Blog Article! The Grand Ballet: Wine and Biotechnology http://bit.ly/dfrKJe

@Boston_CP Boston: State grants to target life sciences firmshttp://bit.ly/9pl2AS

@ilsoy_news Several themes starting to emerge from our meetings, conversations. They include #bioenergy#transportation,#sustainability and #biotech.

@iskraIP #USPTO webpage re. the Green Technology Pilot Program (accelerated examination of green tech. patent applications).http://is.gd/7bdhk

@smithsonian: The #iPad debuts the same day Edison received the patent for the light bulb (in 1880)http://ow.ly/115Em (Via @LemelsonCenter)

Top News:

@joe_walston The Clown Union is outraged by the patent infringement of the #iPad http://tweetphoto.com/9737681

@Chris_Biele Patent pending: White eye patch that plays music…sell it as the iPatch.

@therealriley @ahugo68 I’m thinking “iPatent lots of IP”

Twitter Twang: January 26 2010

Here’s today’s Twitter Twang:

@Dialed_In Bio Ohio launches scholarship program… http://dialedin.org/?p=2236

@sanera09 A New Way to Look for Diseases’ Genetic Roots http://www.nytimes.com/2010/01/26/science/26gene.html

@MassHighTech: Women to Watch winners list, virtual world startup top our most-read stories of the past week:http://bit.ly/MHTRead

@SoCalBio Weekly Update (Jan 25, 2010) available now at http://bit.ly/d1ShRH

@jamie_love The German Association for the Protection of Intellectual Property (GRUR) was surprisingly cool at WIPO SCP this week. http://www.grur.de/

@CharlieRoseShow Tuesday 1/26 -Harrison Ford discusses his film “Extraordinary Measures” / Actor Colin Firth discusses “A Single Man”

@IPLawAlerts JDSupra: FTC Chair Calls for Ban to Pay-For-Delay Settlements http://bit.ly/aySku6

@CropLifeFdn Maine farmers looking for how #organic and conventional farmers can work together to benefit all http://bit.ly/9SuGtm That’s the spirit!

@Family_Health FHI working w/ @foodforthepoor to distribute medical supplies, clean water to Haiti’s Fermathe hospital…

@worldresources Reading – Joint Statement by BASIC Group (Brazil, South Africa, India and China) @ChinaFAQs -http://bit.ly/cbefaX

Today’s Twitter Twang – January 25, 2010

Tweets on Pompe Disease & Extraordinary Measures:

@biocrowd What Do “Extraordinary Measures,” Genzyme and Pompe Disease Have in Common? http://su.pr/4vyR4p

@DukeNews Extraordinary Measures: Movie depicts a fight against Pompe disease that began with Duke researchhttp://bit.ly/8JcGWp

@medicalprogress Extraordinary Measures? Read the story behind the film – and the starring role of #animalresearch of Pompedisease http://bit.ly/5OfxUx

@sciam Ask the Experts: What Is Pompe Disease?http://bit.ly/7PxEvE

@caruanascott Pompe disease, the topic of Harrison Ford’s new film, shouldn’t B confused w/ S. pombe, a valuable model organsimhttp://bit.ly/62sFR7

Otherwise, here’s today’s top Twitter news:

@COILifeScience Emory Will Partner with GlaxoSmithKline on Drug Research for Neglected Tropical Diseases http://bit.ly/4CuLkt

@CropLifeFdn How will we feed 9 bil in 2050?http://ow.ly/109pZ #ag

@travel_blogs Building Knowledge About Biotechnology in Africa: This is the first of a two-part series to Africa Harvest, …http://tinyurl.com/y8up88h

@science_ip Nice summary of USPTO Motion in ACLU Gene case by Patent Docs. http://bit.ly/6xqEBp

@ipatents A myriad of gene patents – Joe Mullin profiles the Myriad patent story. The company’s seven patents have been…http://tumblr.com/x9b5u13u5

@IAmBiotech Your Own Biotech TV Station: http://ow.ly/10aH7

@NIMHgov Science Update: From Neurons to Thought: Coherent Electrical Patterns Observed Across the Brain. http://bit.ly/5ytAcO

@dcexaminer Pew Research Center: Health Care Ranks Eighth on List of Public Priorities http://goo.gl/fb/Q3ub

@ncbiotech Come to the CED 2010 Biotech Conference. — Connect with hundreds of leaders in the biotech community –…http://bit.ly/8YoZPL

@BiotechMD New STEM Labs To Be Added To Arundel Collegehttp://tinyurl.com/yb8gpqa #stem

Tomorrow Morning on NPR: BIO, ACLU Discuss Gene Patenting

Good afternoon IPers:  BIO’s Associate General Counsel for Intellectual Property, Hans Sauer, Ph.D., J.D.,  will participate in an hour-long segment on gene patenting on NPR tomorrow from 10-11am.

The host of On Point, Tom Ashbrook, will discuss gene patenting in the context of the ACLU/Myriad lawsuit with Hans and Chris Hansen, senior national staff counsel at the ACLU (http://www.aclu.org/national-security/chris-hansen-senior-national-staff-counsel).

You can listen from your desk at http://www.wbur.org/listen.  Callers will have the opportunity to ask questions after the first 20 minutes.

If you’re interested in the topic, you can find background material on gene patenting at http://bio.org/ip/genepat/ and our amicus brief in the ACLU lawsuit is posted at http://bio.org/ip/amicus/documents/BIOAmicusBriefACLU-Myriad12-09.pdf.

IP Professors: 12-Year Data Exclusivity a Win-Win for Patient Access & Biotech Innovation

David E. Adelman of the University of Texas School of Law and Christopher M. Holman of the University of Missouri – Kansas City School of Law recently published analysis on the “sideshow” of the data exclusivity debate in Washington.

Adelman and Holman use a cost-benefit analysis that incorporates the most important legal precedents and case law today in concluding that “policymakers should focus on mitigating the systematic barriers to entry that pose much greater and longer-term obstacles to lower-cost biotech drugs.”  Specifically, the draft paper provides solid analysis of the need for 12-year data exclusivity, which the authors describe as a right balance between providing access to important medicines to patients, and creating the incentives needed for investors and companies to prepare (and survive) the regulatory approval process for follow-on biologics.

Much like tort reform, the debate over pending legislation on biotech drugs—and particularly regulatory supplements to patent protection—has taken on a significance that dwarfs its impact on overall health care expenditures. Under the pending Health Care Reform legislation, Congress would enact two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics, which are the analogues of generics for conventional drugs. Second, establishment of a twelve-year “data exclusivity” period during which clinical testing data collected by brand-name producers could not be used by competitors to satisfy FDA testing requirements. While the abbreviated FDA approval process enjoys broad support, the data-exclusivity provision has been hotly contested, including strong opposition from the Federal Trade Commission.  (Paper Abstract)

The paper flies through data that’s been collected for over 20 years on intellectual property and biotechnology in a clear way as to make the longer data-exclusivity proposal an obvious non-issue for Congress in the health care debate. That is to say:

The economic studies used by critics of supplemental patent protection conclude that a twelve-year period of data exclusivity is essential to the profitability [and thus investment and research likelihood] of biotech drugs… data exclusivity could encourage development of clinically important biologics that would otherwise be abandoned because robust patents on the active ingredient are unavailable… the health care savings would be nominal, as drugs account for only about ten percent of total health care expenditures in the United States.

It’s important to understand the connection between health care and biotechnology, without “killing the goose” that lays the golden (innovation) egg. The authors note that “the successes of biomedical innovation are paradoxically  at the root of the health care crisis… limiting the term of data exclusivity could also be counterproductive for everyone…. safeguarding high short-term profits through a twelve-year data exclusivity term stands to mitigate the difficulties of balancing innovation and patient access.”

You can visit Chris Holman’s blog at http://holmansbiotechipblog.blogspot.com.

Technology Transfer Symposium Presentations Published

You can access all the presentations from the Technology Transfer Symposium, held in October 2009 at the BIO Investor Forum, by visiting http://bio.org/ip/techtransfer/. For more information, you can contact Margarita Noriega, Coordinator of Bioethics & IP Policy, at mnoriega@bio.org.

Director’s Forum: David Kappos’ Public Blog

The Director of the U.S. Patent & Trademark Office posted his first blog post today. You can visit the blog at http://www.uspto.gov/blog/.

BIO Survey on Technology Transfer Shows Complexity of University-Industry Relationships

 I sat down with Cartier Esham, Director, Emerging Company Health and Regulatory Affairs at BIO, to discuss BIO’s new survey on licensing trends between universities and companies, part of a larger process of technology transfer. BIO will release the survey at this year’s BIO Investor Forum Technology Transfer Symposium, October 28, 2009. You can learn more about by visiting www.bio.org/ip/techtransfer.

 

Let’s start at the beginning – what makes the process of technology transfer interesting to those who care about innovation in America? What does technology transfer have to do with getting products out to people who want and need them?

Developing research into products and technologies for use by the public is a long and complex process. In the biotechnology sector once a company obtains a license for a discovery they will spend up to or more than a decade and hundreds of millions of dollars developing that discovery into a commercially available product that also meets all required regulatory standards.   Innovation, especially in the biotechnology sector, often requires that the public and the private sectors work together.  Since enactment of the Bayh-Dole Act in 1980 – which gave U.S. universities the right to retain rights to inventions made with government funding – more discoveries are being moved out of the laboratory into the public and providing enormous economic, health, an environmental benefits to our citizens.  Prior to this Act  only 5% of publicly-funded research were ever developed into publically available products.  It is imperative that we protect the laws and policies that have stimulated the transfer of technology and foster public and private sector interactions so that key discoveries in our laboratories are developed  into products/technologies available to the public.  We need to cultivate the dialogue among universities, the federal government and the private sector and work together to identify practices that will ensure the effective transfer of technology in the United States.

 

What’s so hard about making a deal about a technology?

There are always difficulties in public and private sector negotiations since while many of the goals are the shared some of the perspectives may differ.  And really, there is no one size fits all approach.  BIO recently conducted a  survey among its members on technology transfer and in-license agreement negotiations.  The survey showed that  monetary terms was the most difficult part of the in-license negotiation process.  We then asked several questions of our members on what types of payment structures they have for their license agreements and what metric they typically use to calculate value.  We will be unveiling this survey during BIO’s first annual Technology Transfer Symposium in California on October 28th.  It is our hope that by collecting this data we can facilitate discussions and collect information from the biotechnology industry and university and federal labs on best practices for in-license negotiations.

 

Licensing can be a pretty complicated process, from what it sounds like. You have lots of cooks in the innovation kitchen, so to speak… what wasn’t known about licensing that you hoped to understand with the survey?

I think one of the more startling findings of the survey is the lack of license agreements the biotechnology industry has with the federal government.  Given that the Unites States has some of the best research facilities and premier scientists working on break through research in the health, energy, food and environment fields, it seems critical that we work to ensure this research – where appropriate – should not sit in a lab but be developed in a way that will benefit the public.

 

Final question: if you were an inventor of a stellar, unfunded platform technology, how would you approach today’s market, given these licensing trends?

A fundamental part of successful transfer of technology is finding the right partner – this goes for universities who seek companies to license their technology and companies looking for a specific technology that fits into their research and development pipeline.  BIO would like work on how to improve communications between the public and private sectors on how to identify and find licensing opportunities.

BIO20100_banner_468x60

India Threatens European Union: ‘Don’t Stop Flow of Illegal Drugs’

India’s Commerce Ministry drew attention to the “plight” of producers of infringing copies of vaccines last week, highlighting a need to quell the dangers of swine flu, whose vaccine is in legal development and as we speak (WHO Link):

[Indian Company] Cipla has produced a generic version of the antiviral drug Tamiflu for sale to developing countries but no one, including India itself [emphasis added], has so far been willing to buy it, either because of financial constraints or concerns over violating intellectual property laws.

 The Financial Times does an excellent job of explaining the ”request” :

Myth One: The World is So Challenged by Swine Flu, It Should Allow the Unapproved, Illegal Flow of Drugs:

“When the world is being challenged in another area, by swine flu, India is one of the countries that has been mandated by the World Health Organisation as ­having the capacity to develop vaccine along with other major countries,” Mr Sharma told the Financial Times on a visit to Seoul.

Myth Two: India is Producing Illegal Drugs Out of Own Heart to Meet Global Health Needs:

Mr Sharma’s comments are an escalation of a dispute over protectionism between India and one of its main trading partners… India’s pharmaceutical industry is one of the sectors of India’s fast-growing economy worst hit by the global economic downturn.

Myth Three: India Is Trying to Solve the Problem:

India’s commerce ministry declined to say when it might file a complaint at the WTO against the EU over drugs seizures… “[A resolution with the EU] might be in the process through discussions. But as of now we have no reason to change our stand,” said Rajeev Kher, a joint secretary of commerce.

This story is courtesy of the Financial Times. In order to access the article, you must register (free).