Translational Research Forum at BIO International Convention

BIO is hosting a Translation Research Forum at the BIO International ConventionNIH Director Collins keynotes an event that will explore how private, public and academic sectors can leverage meaningful partnerships, highlight emerging best practices, explore risk-sharing at the clinical research stage, and explore ways to bridge the gap in funding and know-how necessary to take university research to the next level.

Read the Press Release for more information about panels and speakers.

For registration, conference agenda and exhibitor information, visit 2011 BIO International Convention.

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University-Industry Partnering at BIO Convention Webinar by AUTM June 16, 3-4PM

Get the inside information on what industry does and does NOT want from their academic counterparts: Join us June 16, 3-4 p.m. EDT for Insider’s Guide to Effective Partnering at BIO 2011, a FREE AUTM webinar to help you prepare for the BIO convention in Washington, DC, June 27-30.

BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act

by Stephanie D. Fischer

BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below:

“On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment to H.R. 1249, the America Invents Act. It is our strong desire to see this bill, as amended, passed by the House, and then we will work with you to ensure that any final product is perfected.

This legislation is similar to the bill adopted earlier this year by the U.S. Senate by a nearly unanimous vote, and we are pleased that the Manager’s Amendment to the bill has resolved many of the remaining concerns for the life sciences industry.

Your legislation will, once and for all, end the diversion of fees collected by the U.S. Patent and Trademark Office (PTO), increase the objectivity of our patent system, and increase patent quality. It is precisely these types of reforms that should receive bipartisan support, as they are good for inventors and investors, hence good for business and jobs in America.

We thank you for all of your hard work to move the patent reform process forward in the House, and we look forward to working with you and the Senate to ensure that patent reform legislation is ultimately enacted into law this year.”

Earlier this week, BIO joined a broad coalition of organizations, universities, companies and other stakeholders to express strong support for Section 22 of the bill which would prevent future fee diversion:

“Although each of our organizations has varying views on the reforms contained in H.R. 1249, we unanimously support Section 22 and believe that it is the cornerstone of any patent reform legislation. Absent a statutory mechanism to prevent future fee diversion, as we have seen all too often in previous years, the existing and new responsibilities vested in the USPTO will suffer, the ability of the USPTO to plan long-term and build the agency our innovation economy demands will be frustrated, and the job-stifling patent application backlog will continue.”  This letter is available on our website.

USPTO Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting

Biotechnology/Chemical/Pharmaceutical Customer Partnership  

Wednesday, June 8, 2011 Meeting 
Madison Auditorium  

Starting Time of 10:00 AM

 United States Patent and Trademark Office
Alexandria, Virginia 
600 Dulany Street, Alexandria, VA, 

Accessing the event:
Double click on the link below (or copy it into your internet browser)

https://uspto.connectsolutions.com/r80345544/
Click here   for detailed login instructions in MS Word.

  Driving & Metro Directions /Hotels (Word)   Campus Map (html)   Campus Map (Power Point)

 

Morning Session    
10:00 – 10:30 AM. Greetings, TC Update and Overview Jackie Stone, George Elliott and Remy Yucel, Directors, Technology Center 1600
10:30 – 11:15 AM Microsoft v. i4i Ltd.: How potential changes in
the evidentiary standard for an invalidity defense could affect patent prosecution and litigation
Garth M. Dahlen, Ph.D., Esq. Birch, Stewart, Kolasch & Birch, LLP 
11:15 – 11:30 AM Break  
11:30 – 12:15 PM COPA (Clearing the Oldest Patent Applications) – An Overview and Implementation Briefing   John Barlow   SPE, TC2800
12:15 – 1:00 PM Expedited Examinations (Track 1, PPH, Green Tech, AE, and to Make Special) Bennett Celsa   QAS, TC1600 
1:00 – 2:00 PM  Lunch   The Roundhouse Cafe Cafeteria is inside the Madison Building  lower level.
Menu for the Week in PDF will be here. 
Afternoon Session    
2:00 – 2:45 PM Current Sequence Listing Process for Nucleic Acids and Polypeptides  Joe Woitach   SPE, Art Unit 1633 
2:45 – 3:00 PM Break  
3:00 – 3:45 PM Common Issues Examiners Face Regarding PLTs and Plant Utility Patents Anne Marie Grunberg, SPE, Art Unit 1638/1661
3:45 – 4:00 PM Closing Remarks/Discussion Jackie Stone, George Elliott and Remy Yucel, Directors, Technology Center 1600

 

Photos of the speakers  will be here.

Google Search the BCP Web Site

[Caveat – Google’s spiders have not searched through all the links to all of the Power Point slides. These results are only  partial. For example, type in Morning Session  and as of 2/20/11 you only see the Agendas for 17 meetings. Note for some of the earlier links to meetings in 2001 and 2002 they are at the PTO site as listed below and thus no agendas or slides are here for Google to find.]

Supplemental Materials:
    Carlyle Site Drawings
   
Perspective 3D drawing of the building on campus click here 
    Floor plan for a building (pdf 178K) click here
    Close-up plan view of campus map click here 
    Go to http://www.ptoinalexandria.com/index.php for more views and info

 See the BCP’s PTO web page http://www.uspto.gov/web/patents/biochempharm/  for the official announcement for the next meeting close to the final date.

For questions about obtaining these materials
contact Cecilia Tsang at Cecilia.Tsang@USPTO.GOV

To be placed on the BCP’s e-mail announcement list 
contact Cecilia Tsang at Cecilia.Tsang@USPTO.GOV

BIO’s “What Every State Should Know About Bayh-Dole” Webinar

BIO’s “What Every State Should Know About Bayh-Dole” Webinar

The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.”

The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands of the university and enabled universities to out-license technologies for commercialization.  As a result of the Act, more than 7200 companies were created (including nearly 600 last year despite the national recession) and 8818 new products were made available to patients and other consumers.   Since the Bayh-Dole Act, university start-ups have contributed at least $187 billion to the U.S. Gross National Product, and created a minimum of 279,000 jobs within a nine year period.

The webinar provides an overview of the Bayh-Dole Act and how the Act has allowed states to leverage university funded research to spur economic growth.  It also explores recent economic data and provides several examples of successful licensing agreements.  Finally, the webinar provides an overview of the challenges to the Bayh-Dole Act and how these challenges could negatively impact job creation and economic growth at the state level. 

Lila Feisee, Vice President for Global Intellectual Property Policy at BIO, acted as moderator with Dr. Ashley J. Stevens, Special Assistant to the Vice President of Research at Boston University, and Joe Allen, former staffer to Senator Birch Bayh, as panelists.

Please follow the following links to view the webinar.

Streaming recording link:

https://biotechnology.webex.com/biotechnology/ldr.php?AT=pb&SP=MC&rID=60992482&rKey=cb4322ff92c9c107

Download recording link:

https://biotechnology.webex.com/biotechnology/lsr.php?AT=dw&SP=MC&rID=60992482&rKey=12a4f24204098489

Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right

     A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be limited somehow (not 50 years) to ensure generics can entire the market and lower costs.    Finally, the author states that lowering the data exclusivity period from 12 years will only increase the costs of biologics in that period, that sharing drug data will result in an immitative and not innovative medical system, and that longer periods result in safer biosimilars because they are held to the same high standard as the innovator.

BIOtech NOW: The Role of Intellectual Property in Global Health

The Role of Intellectual Property in Global Health

BIO is committed to increase access to biologic medicines for patients throughout the world.  As BIO President and CEO Jim Greenwood said last year when announcing our policy statement on Options for Increasing Access to Medicines in the Developing World, “We believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are mutually supportive.”

While there are frequent misguided calls to circumvent intellectual property (IP) rights in order to provide therapies to undeveloped countries, BIO and many policy experts understand that IP rights are necessary to bring innovative new therapies to market and into the hands of patients.  Medicines cannot be utilized if they are not developed, and IP rights are often the only asset emerging biotech companies can leverage in order to attract the investment necessary to fund the lengthy and expensive research and development and clinical review processes.

Bill Gates has been an ally in our efforts to increase access to medicines in developing countries.  In 2004, BIO launched BIO Ventures for Global Health (BVGH) with a start-up grant from the Bill & Melinda Gates Foundation to speed the development of medicines for unmet diseases of developing countries. 

In a recent interview with Intellectual Property Watch, Bill Gates discussed the important role of IP in his Foundation’s work on global health:

“We fund research and we actually ourselves or our partners create intellectual property so that anything that is invented with our foundation money that goes to richer countries, we’re actually getting a return on that money.”

“By doing that we have more money to devote for research into neglected diseases and the diseases of the poor,” he said. “Now when our medicines go into the poor countries, they are always going in without any intellectual property fee, at very lowest cost pricing.”

 “But,” he said, “the intellectual property system has worked very well to protect our investments so that when they are used in rich countries we get a payback and then we have the control to make sure that it is not creating any financial burden on the countries that are the poorest.”

You can read the full article on Intellectual Property Watch’s website (subscription required).