House Energy and Commerce Committee Vote Marks Another Step Forward on Pathway to Biosimilars

House Energy and Commerce Committee Vote Marks Another Step Forward on Pathway to Biosimilars

Strong bipartisan support for inclusion of pathway in health care reform legislation

Washington, D.C. (July 31, 2009) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the approval of an amendment to create a regulatory pathway for biosimilars by the House Energy and Commerce Committee in today’s mark-up of the America’s Affordable Health Choices Act (H.R. 3200):

“The strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a decisive win for the patients of today and tomorrow.  The approved amendment, introduced by Representatives Anna Eshoo (D, CA), Jay Inslee (D, WA) and Joe Barton (R, TX), strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical innovation.  For these reasons, it has the support of a variety of patient and academic organizations and other stakeholders including the ALS Association, Alliance for Aging Research, Association of American Universities and National Venture Capital Association.

“The amendment incorporates the principles of H.R. 1548, the Pathway for Biosimilars Act, which has more than 140 cosponsors, and the amendment offered by Senators Orrin Hatch (R, UT), Mike Enzi (R, WY) and Kay Hagan (D, NC) in the recent mark-up of health care reform legislation in the Health, Education, Labor and Pensions (HELP) Committee.  An overwhelming bipartisan majority of Senators, including Committee Chair Ted Kennedy (D, MA), voted for the amendment which will create a strong approval pathway and includes 12 years of data exclusivity to ensure continued biomedical innovation.  The amendment passed the Committee by a vote of 16 to 7 with majority support from both Democrats and Republicans.  The HELP Committee amendment also drew support from a diverse array of patient groups and other stakeholders including the AIDS Institute, National Minority AIDS Council, Children’s Tumor Foundation, National Kidney Foundation, and Vietnam Veterans of America.

“The amendment approved by the House Energy and Commerce Committee today embodies the bipartisan HELP Committee compromise while retaining the important provisions of H.R. 1548 aimed at avoiding patient and provider confusion over biosimilar products and ensuring patent disputes will be resolved prior to the expiry of the data exclusivity period.

“Today’s action also is an important vote for our nation’s economy and our global leadership in innovation.  Biotechnology helps drive more than 7.5 million high-wage, high value jobs across the nation, many of which have been created by small, highly innovative companies.  More than 90% of BIO’s research and development member companies have less than $25 million in annual revenue and the vast majority of our member companies have less than 50 employees.

“BIO thanks Representatives Eshoo, Inslee and Barton for their tireless leadership on this issue, and the many Members of the Energy and Commerce Committee from both parties who voted for the passage of the amendment.”

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Technology Transfer Symposium at BIO Investor Forum

  

Technology Transfer Symposium:

Promoting Public-Private Collaboration for Innovation

Wednesday October 28, 2009

7:30 am – 12 pm PT

The Palace Hotel

San Francisco, CA

The Technology Transfer Symposium, held in conjunction with the BIO Investor Forum, will explore the domestic and international policy challenges for professionals in university, industry, and legal areas regarding the administration of technology transfer.  This groundbreaking meeting will bring together stakeholder groups to discuss the challenges and opportunities of today’s pressing policy issues impacting technology transfer and innovation policy, university – industry relationships, university start-ups, and unique collaborative and translational mechanisms. BIO will unveil a first-of-its-kind licensing survey as well as a study of the evolving benefits of the Bayh-Dole Act in today’s economy.

Panel Speakers

Symposium panelists include representatives from important stakeholder groups, including the Universities Allied for Essential Medicines (UAEM), Association of University Technology Managers (AUTM), University-Industry Demonstration Partnership (UIDP), Georgia Institute of Technology, small, medium, and large biotechnology companies, and philanthropic venture capitalists attending the BIO Investor Forum.

Schedule

  • Breakfast Welcome
  • Today’s Technology Transfer Policy Landscape: An overview of and context to today’s most pressing policy issues
  • Economic Impact & Licensing Relationships between Universities & Industry: An analysis of recent research on the economic impact of technology transfer & licensing in the United States.
  • Unique & Creative Collaborative Mechanisms: A menu of mechanisms for facilitating transfer of innovative technology and partnerships

What Can Attendees Expect?

Attendees will meet today’s opinion leaders in intellectual property and technology transfer and biotechnology policy, examine and forecast domestic policy trends; study collaborations that successfully increased access to technology through unique partnerships both within the United States and internationally between governments, academia, philanthropic investors, companies and others; and exchange ideas on ways to foster sustainable, long-term biotechnology innovation.

Registration

The Symposium is free to attend. Space is very limited. For more information, email Margarita Noriega, Coordinator, Bioethics & IP, mnoriega@bio.org.  

New Series: Biotechnology Companies at Forefront of Global Health Innovation – Post #1: GlaxoSmithKline & Alnylam Pharmaceuticals

On July 8 2009, GlaxoSmithKline (GSK) and Alnylam Pharmaceuticals, Inc. announced a patent pool to compile intellectual property (IP) to develop treatments for 16 tropical diseases as identified by the FDA including malaria, TB and Chagas, found in 49 Least Developed Countries as defined by the United Nations. (GSK press release)

The pool currently has two members (GSK and Alnylam) but is inviting others to participate. The donated IP will be non-exclusively licensed and royalty free for the purpose of addressing the above mentioned unmet needs. The current members of the patent pool will also provide for know-how, technical resources and training to be available to those who access the pool. The pool will also help in accessing financing where possible.
GSK has donated IP for some of its New Chemical Entities (NCEs) and Alnylam has donated its RNAi platform technology to the pool for limited field of use.   

For more information you can visit Alnylam and GSK websites. We will have updates as they become available.

Webinar: University Startups: Best Practices

Update: The presentation materials are available here: http://bit.ly/IBfmv (thanks to Jack Pincus, via Twitter)

The National Council of Entrepreneurial Tech Transfer (NCET2) is hosting a webinar on university spinouts and the MIT entrepreneurial ecosystem:

What Are Universities Doing to Create and Fund University Startups: Best Practices

The MIT Entrepreneurial Ecosystem

Wednesday, July 29, 1:00-2:30pm ET (10:00-11:30am PT)

With

Edward B. Roberts (David Sarnoff Professor of the Management of Technology MIT Sloan School of Management; Founder/Chair, MIT Entrepreneurship Center)

MIT alumni have founded 25,800 currently active companies that employ about 3.3 million people and generate annual world sales of $2 trillion. Professor Roberts will focus his presentation upon his recent major report “Entrepreneurial Impact: The Role of MIT”, which discusses MIT’s “production” of many thousands of alumni entrepreneurs. Beyond the widespread economic impact, he will portray the internal MIT entrepreneurial ecosystem (including courses, clubs, and more important the institutional values and policies) that has so strongly influenced this growing outflow of new enterprises. As the founder or co-founder of many of these contributing MIT organizations, Professor Roberts is ideally suited to communicate how the MIT case study can provide some transferable guidelines for other universities that desire to increase their entrepreneurial output. The webinar will help you understand the entrepreneurial impact that universities can have.

COST: Free, but registration required

HOW TO PARTICIPATE?: This webinar is online. You need a computer with web access for the visual and a regular phone line to hear the audio. Q&A is conducted by a chat box to the speakers.

WHO SHOULD PARTICIPATE IN THE WEBINAR?: This webinar is open to the public and anyone interested in the Innovation Economy and what universities are doing to create startups in their region is invited to attend.

To download the report “Entrepreneurial Impact: The Role of MIT” go to http://entrepreneurship.mit.edu/impact.php

_______________________

Edward B. Roberts

(David Sarnoff Professor of the Management of Technology, MIT Sloan School of Management, Founder/Chair, MIT Entrepreneurship Center)

Bio

A long-time expert on entrepreneurial endeavors, Edward Roberts has literally written the book on high-tech business creation and growth. His “Entrepreneurs in High-Technology: Lessons from MIT and Beyond” (Oxford University Press, 1991) won the Association of American Publishers Award for Outstanding Book in Business and Management. Roberts is Founder and Chair of the MIT Entrepreneurship Center and for over 30 years chaired MIT Sloan’s Management of Technological Innovation and Entrepreneurship Group. He co-founded and, for nearly 20 years, co-chaired the mid-career MIT Management of Technology (MOT) Program. Over the past 45 years, Professor Roberts has become internationally known for his research, teaching, and active involvement in many aspects of technology management, including technology strategy, corporate venturing, product innovation management, and technology-based entrepreneurship.

When not occupied with his MIT responsibilities, Roberts is actively involved as a co-founder, board member and angel investor in many high-tech start-ups. Roberts co-founded and was CEO of Pugh-Roberts Associates, an international management consulting firm specializing in system dynamics, strategic planning, and technology management, now a division of PA Consulting Group. He co-founded and is a director of Medical Information Technology, Inc., a leading producer of healthcare information systems. He also co-founded and serves as a director of Sohu.com, Inc., a leading Chinese Internet firm. In addition, Roberts co-founded and, for 20 years, served as a General Partner of the Zero Stage Capital and First Stage Capital Equity Funds, a group of venture capital funds investing in early-stage technology-based firms, and later co-founded CommonAngels, the largest angel group in Massachusetts. He has been a co-founder and/or director of numerous emerging technology companies including Advanced Magnetics, Pegasystems, PR Restaurants, Interactive SuperComputing, Visible Measures, DynoMedia (Beijing) and EdTech Networks. Roberts has authored 170 articles and eleven books, the most recent being “Innovation: Driving Product, Process and Market Change” (Jossey-Bass/Wiley, 2002). Roberts holds four degrees from MIT, including the PhD in Economics.

GAO Report on Bayh-Dole: Leverage to Promote Commercialization of Federally-Funded Inventions

The General Accountability Office submitted its report to Congress today on the administration of the regulations found under the Bayh-Dole Act, the foundation of all federally-funded research in the United States and one of the key factors in the creation (and boom) of biotechnology as both a research field and industry in the 1980s.

A little background on Bayh-Dole:

Technological innovation is widely seen as responsible for much of the economic growth and increased standard of living in modern societies. Patent rights give inventors, or other patent owners, exclusive control over the use of their inventions for about 20 years, which promotes commercialization of new ideas and allows inventors to profit from their ideas. Patent rights ownership encourages the additional, and often substantial, investment of time and money needed to transform the technological innovations developed in the laboratory into goods, services, and processes available in the marketplace.

Since its enactment in 1980, the Bayh-Dole Act has provided recipients of federal research and development funding…the option to retain patents on the inventions they create, provided they adhere to certain requirements. A main goal of the act is to promote the utilization of inventions arising from federal supported research or development, and observers have judged the act a success in their regard. Prior to 1980, when the government routinely retained the patents on federally sponsored inventions, only 5 percent of these patents were ever used in the private sector. In contrast, some stakeholders, including federal and technology transfer officials, today believe that invention that arise from federally funded research are routinely commercialized, although comprehensive data are not available on how often this happens…

The report was prompted  by a single issue not many outside of legal circles understand: march-in rights, or in vernacular, the government’s ability to “march-in” and revoke ownership of federally-funded research under certain, rare circumstances:

In exchange for the right to retain ownership of federally sponsored inventions under the Bayh-Dole Act, contractors must agree to certain reporting requirements. More specifically, contractors agree to notify the funding agency within 2 months after the contractor learns that an invention has been created and to notify the funding agency within 2 years after this notification of the contractor’s decision to retain title to the invention. In addition, contractors agree to apply for a patent on the invention typically within 1 year of the election of title, attempt to commercialize the invention, and to provide additional reports. These additional reports, if requested by the agency, can provide such information as utilization of the invention and patent-related information such as the filing date, patent application number and title, and patent number and issue date for the invention in any country in which the contractor has applied for a patent. Failure by the contractor to disclose the invention, elect title to it, or file a patent application within the times specified, or failure to follow through with the patent application process, allows the relevant federal agency to obtain ownership of the invention.

The Bayh-Dole Act also reserved certain rights for the government to protect the public’s interests. Specifically, the government retains “a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world,” also known as a nonexclusive royalty-free license. In addition, the act provides the government march-in authority. Under this authority, the federal agency that funded the development of an invention has the right to require the contractor or exclusive licensee to grant a license in any field of use to a responsible applicant upon terms that are reasonable under the circumstances, if the agency determines that:

• the contractor has not made, and is not expected to make, efforts to commercialize the invention within an agreed upon time frame;

• public health or safety needs are not reasonably satisfied by the contractor or licensee;

• the use of the invention is required by the federal government and the contractor or licensee cannot meet the government’s requirements; or

• the owner of an exclusive license is not ensuring that the invention is “manufactured substantially” in the United States and has not obtained the necessary waivers to do so.

Indeed these situations are so rare they’re non-existant, as the report points out:

None of the four agencies we reviewed has chosen to exercise march-in authority under the Bayh-Dole Act. DOD, DOE, and NASA have neither discovered nor received information that would lead them to initiate a march-in proceeding or exercise their march-in authority during the last 20 years. In contrast, NIH has been petitioned formally to exercise its march-in authority three times, but in each case determined that the statutory requirements for march-in proceedings had not been met. Nevertheless, officials at three of the four agencies told us they value the authority because, together with other tools, it provides them leverage to promote commercialization of federally funded inventions. In contrast, DOE officials do not believe march-in authority has significant value as leverage, in part, because no agency has ever exercised the authority.

Specifically, the report details the history of repeated and failed attempts to use march-in rights to gain access to patented technologies after they have been commercialized, including a recent petition in 2004 regarding public health care and access to technology:

In 2004, NIH received two more petitions, in which the petitioner expressed concern that the price of two drugs—one to treat HIV/AIDS and the other to treat glaucoma—made them unaffordable for many people living with these diseases, posing a threat to their health and safety. However, NIH determined that the drugs were already on the market and widely prescribed, and therefore marching in would not alleviate health and safety needs that were not already being satisfied by the producer [italics added]. NIH also stated in its decisions that drug pricing is an issue more appropriately left to the Congress. Furthermore, as NIH noted in its decision on the 1997 petition, the agency is “wary of forced attempts to influence the marketplace for the benefit of a single company.”

Since August 2007, however, a change of administration creates cause for concern:

As a result of changes mandated by the America COMPETES Act, the Technology Administration has been disbanded and Commerce has shifted responsibility for the Bayh-Dole Act to the National Institute of Standards and Technology (NIST). Officials from two technology transfer organizations told us that, as a result of this change, the department currently has little expertise on the march-in process. Specifically, technology transfer officials told us they were concerned that NIST did not have the knowledge and experience of the Technology Administration with regard to oversight of march-in procedures and officials at one organization believed that this might cause some ambiguity in facilitating agencies’ implementation of the act.

NIST officials acknowledged that no one currently in their office has any experience with the march-in authority and said the process appears to be very time-consuming and complex. However, these officials told us that when the Technology Administration was disbanded, the same lawyers who worked on Bayh-Dole issues continued to provide their services, which allowed continuity in the overall legal aspects of oversight for the act. They also noted that most of the questions they have addressed for agencies concern aspects of the act other than the march-in authority. They also believe that because agencies are not required to contact NIST with questions related to the Bayh-Dole Act, that NIST’s role in any future march-in proceedings will likely be very limited.

For further background, you can read BIO’s response to the 2004 petition here; also; read BIO’s statement to the House Science & Technology Committee in 2007 titled, “The Bayh-Dole Act: The Next 25 Years” here .

Department of State: Foster Climate Change Solutions, Biodiversity, & Economic Development with IPR Protections

CropLife recently posted their newest video interview last week with Carrie LaCrosse, of the Office of Intellectual Property Enforcement at the U.S. Department of State.

LaCrosse discusses the value of IP for agriculture, looking in particular at new plant varieties and how IP is part of the solution in addressing the food security. LaCrosse states that intellectual property rights protections (IPR) encourages the development of plant varieties, including protected varities, at reduced or free prices — thus allowing countries to protect their biodiversity while also meeting increased demand for crops due to climate change and economic crisis.  My favorite quotation comes near the end, where LaCrosse aptly states that innovation is historically sparked by challenging times.

Don’t forget to add the Indian insect-resistant eggplant to the list of innovative plant varieties changing the world.

BIO CEO: Patient Groups Join Call for Data Protection

“Biomedical innovation is not only key to our industry’s future, but more importantly, continued medical breakthroughs are vital to patients living with debilitating diseases and their families. Without ongoing progress in our industry, patients of today and tomorrow have limited hope for future cures and therapies.

“Many patient groups have entered the debate on Capitol Hill over establishing a pathway for approval of biosimilars because they know how critical continued innovation is to finding new therapies and cures for diseases. A number of these groups are asking Congress to ensure biotechnology companies are able to continue to innovate, with many joining BIO in asking for a minimum of 12 years of data exclusivity, the amount of time during which the Food and Drug Administration (FDA) may not rely on an innovator’s proprietary safety and efficacy data to approve a competitor’s product.

“As the AIDS Institute, Community Access National Network, CAEAR Foundation and National Minority AIDS Council noted in a July 13th letter to Senator Ted Kennedy (D-MA), “innovations have turned what was once a terminal illness into a potentially chronic, manageable condition.” They added, “We believe health care reform should improve quality and reduce costs, but it must be crafted in such a way as to strongly support continued medical innovation. That is why we strongly urge you to include a period of data exclusivity relative to biologics of 12 years.”

“In a July 16th letter to Rep. Anna Eshoo (D-CA), the ALS Association noted that there is no effective treatment for people with ALS, which is a terrible neurodegenerative disease that erodes a person’s ability to control muscle movement. According to the group, “legislation that reduces costs without promoting new technologies will be of little help to people with ALS whose lives depend on the development of new treatments.” Likewise, the Alliance for Aging Research noted in a letter to Rep. Eshoo that, “The creation of a well-defined process for approving biosimilars will help sustain investment in this vital area of therapy development and allow for these treatments to one day be made widely available to patients who otherwise could not have access to them.”

“Thanks to billions of dollars in research and development, we are getting closer to discovering cures to diseases we once thought uncurable. HIV/AIDS was once seen as a death sentence. Today, people with HIV/AIDS are living longer, healthier lives – something we didn’t think was possible when the disease was first beginning to spread just a few short decades ago. According to the American Cancer Society, between 1991 and 2006, the cancer death rate decreased by 16 percent.

“The progress shouldn’t stop here. Biotech companies across the nation have more than 600 new products in the pipeline, and the future is wide open. Let’s hope Congress keeps it that way.

(reposted from BIOtech Now blog)