Translational Research Forum at BIO International Convention

BIO is hosting a Translation Research Forum at the BIO International Convention.  NIH 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.

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.

Supreme Court Affirms: High Level of Proof Needed to Invalidate A Patent

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now

The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance of the evidence” standard, under which patents could be invalidated by a mere “more likely than not” determination by a court or jury.  In a joint amicus brief with CropLife International and the Association of University Technology Managers (AUTM),  BIO argued that there are strong legal and policy justifications for a heightened standard in terms of investment in and reliance on patents to fuel R&D and innovation.

BIO also joined 260 other stakeholders representing U.S. innovation in all 50 states and the District of Columbia to express concerns about potentially negative consequences for domestic innovation, job growth and our nation’s technology leadership internationally in a letter to the Attorney General and Acting Solicitor General which likely helped persuade the U.S. Solicitor General to file a strongly supportive and influential brief.

The Court ruled 8-0 (with Chief Justice Roberts recusing himself) against Microsoft, holding that the standard for invalidating a patent in the courts remains “clear and convincing evidence,” regardless of whether the precise prior art cited to support invalidation was considered by the PTO or not.

This decision is a huge relief for the biotechnology industry, which relies heavily on the presumed validity of patents to generate investment and a reasonable return thereon.

Debunking the Myth: ‘Gene Patents’ are not necessary for healthcare innovation.

Myth: ‘Gene Patents’ are not necessary for health care innovation.

Facts:

1. Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built.  These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear alone the cost of development of these inventions into useful products. 
    
2. It is precisely these types of early-stage companies that hold roughly 2/3 of the future clinical pipeline for patients, and are developing novel DNA-based approaches to dealing with environmental contamination, climate change, renewable energy, and more sustainable agriculture.  Without these basic patents, these early-stage companies will not be able to attract the necessary funding for further R&D and to ultimately develop an approvable product based off of the original DNA-based invention.

3. In 2008, more than $30 billion in biotechnology-related research and development investment occurred in the United States alone.  (Ernst & Young, Beyond Borders: Global Biotechnology Report 34 (2009).) 

4. The average cost of bringing a single biotechnology-related therapeutic to market, including basic research, clinical trials, and post-approval testing, exceeds $1.2 billion.  (Grabowski, Follow-On Biologics, 7 Nature Reviews Drug Discovery 479, 482 (2008).)

5. Only 30% of biological therapeutics that make it as far as human trials succeed in gaining regulatory approval.  (See, e.g., id. at 481.)

6. Most biotechnology firms are emerging firms with 50 or fewer employees working on their first products, a process that can take 15 years or more.  (Guide to Biotechnology). 

7. The stage in a company’s lifecycle after the point of basic discovery but before proof of concept has often been described as the “valley of death,” during which tens or hundreds of millions of dollars are needed to take the invention to the next stage of development. 

8. Patents “are typically the only assets those firms possess that are sufficiently stable and valuable to attract the large amounts of capital they need to exploit promising research toward new drugs and diagnostics.”  (Barfield & Calfee, Biotechnology and the Patent System 27 (2007)).

9. A preview of what might happen if patent eligibility is limited by the courts occurred in March 2000, when investors mistakenly interpreted a statement by President Clinton and British Prime Minister Blair as announcing an intent to narrow patent protection for gene-based innovations.  Even though the statement was quickly clarified, leading American biotechnology companies lost $50 billion in aggregate shareholder value over the following two weeks.  (Davies, Cracking the Genome 205-207 (2001)).

10.  Government-funded research cannot reasonably be expected to replace research and development efforts conducted privately under the current patent-incentive system.  A recent GAO study found that only 4-6 of the top 100 drugs used by the Department of Defense were developed using government money. To the extent arguments are raised that government can step in to develop new therapeutics and diagnostics, the objective data is to the contrary: the system relies heavily on private research and development. (U.S. General Accounting Office, Technology Transfer Agencies’ Rights to Federally Sponsored Biomedical Innovations (GAO-03-536 2003).)

Joint Statement of BIO, AAU, ACE, APLU, AUTM and COGR

Contributed by dbking

 Earlier today, the United States Supreme Court issued its opinion in the appeal of Stanford University against Roche Diagnostics. This case is of significant interest to the Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and Council on Governmental Relations (COGR) because of its potential impact on university technology transfer, on development and commercialization of university-generated basic technology, and on scientific collaborations between university and private-sector scientists.

The biotechnology industry and the university community rely on effective collaborations to make the products of their research and development efforts available to the public.  The university’s mission of the discovery and dissemination of new knowledge is complementary to the biotechnology industry’s mission of translating basic science into products to benefit patients, farmers, and consumers. The discoveries arising from university research are most efficiently transformed into valuable new products with the participation of companies willing to invest in the long development process that is often necessary to bring new products to market.

By all accounts, the U.S. system of public-private technology transfer that was established under the 1980 Bayh-Dole Act has been extraordinarily successful in moving university discoveries from experimental laboratories to the marketplace through collaborations with private industry. This system has provided a rich return on public funding for basic research, in the form of countless innovative products that today benefit consumers, create jobs, and contribute to U.S. technological leadership internationally.  

Although BIO and the undersigned higher education associations held different views on the Stanford v. Roche case, the organizations are united in the desire to ensure that the U.S. technology transfer system continues to generate these public benefits through the robust provisions of the Bayh-Dole statute.  We are committed to working together in light of the Supreme Court’s decision to ensure the continued vibrancy of public-private partnerships and success of our shared objectives.

MEDIA CONTACTS

Biotechnology Industry Organization:

Stephanie Fischer, Director of Communications

(202) 312-9263

sfischer@bio.org

Association of American Universities:

Barry Toic, Vice President of Public Affairs

202-898-7847

barry_toiv@aau.edu

 

American Council on Education:

Erin Hennessy, Director of Public Affairs

202-939-9367

erin_hennessy@ace.nche.edu

Association of Public and Land-grant Universities:

Paul Hassen, Vice President of Public Affairs

202-478-6073

phassen@aplu.org

Association of University Technology Managers:

Jodi Talley, Marketing and Communications Manager

(847) 559-0846 x237

jtalley@autm.net

 

Council on Governmental Relations:

Robert Hardy, Director of Contracts and Intellectual Property

(202) 289-6655

rhardy@cogr.edu

Debunking the Myth: Your Genes are Patented

 

MYTH: YOUR GENES ARE PATENTED.

FACTS:  IT IS NOT POSSIBLE TO PATENT YOUR GENES

The term “gene patent” is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene – even a newly-discovered one – cannot be patented, patents don’t provide ownership rights over our genes, and nobody can infringe a patent by having a certain gene, or by passing it on to their children.

If genes aren’t patentable, what is?

Natural genes are not eligible for patenting, but artificial preparations of DNA molecules are, because they have new qualities that distinguish them from natural genes. Like other chemicals that are derived from nature (such as antibiotics or natural dyes), preparations of DNA molecules are patentable because they have been transformed through human intervention into something that is so different from the natural state as to qualify as new, useful, and man-made. This transformation begins with the purification and isolation of the natural DNA. But isolating and purifying is not enough. The resulting DNA preparation must have new qualities, advantages, and technical applications that allow it to be used in important new ways that are not possible with the natural gene, making it different not just in degree, but in kind. For these reasons, every nation in the developed world recognizes the patentability of such inventions.

How is a patented DNA preparation different from a natural gene?

Patented DNA preparations contain isolated DNA molecules that are stripped of everything that is necessary for the normal operation of a gene in its natural state. Such purified DNA molecules also are often reconfigured in ways that eliminate large parts of the genetic sequence of the natural gene, giving rise to DNA molecules that do not exist in nature. Such DNA molecules can be used in ways that are simply not possible with the natural gene – for example, to conduct gene transfer experiments, to make DNA vaccines, or to produce therapeutic proteins in large scale cell culture.

What else is required to make a DNA molecule patentable?

It is impermissible to patent a DNA molecule, even if isolated and purified, unless the scientist establishes the detailed biological function of the gene from which it was derived and identifies a credible, specific and substantial utility for it. Identifying a gene’s biological role and establishing a credible, specific and substantial use for the claimed DNA molecule are often harder than identifying the new gene itself, and certainly meets the standard thresholds for inventiveness. Furthermore, in every case, the inventor has to satisfy the “novelty” and “unobviousness” requirements under which the claimed DNA must be new and distinct from all preexisting scientific knowledge. Finally, the patent application must contain a detailed scientific disclosure that enables other scientists to replicate the invention.

Overall, identifying, deriving, characterizing and describing a DNA sequence in this way requires the same level of human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.

This post was authored by Hans Sauer, Ph.D., J.D. Deputy General Counsel for Intellectual Property at BIO and Adjunct Professor of Law, Georgetown Law.

Related Posts:

Patent Docs

IP Watch Dog

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.