BIO submits comments on Australian Senate Patent Amendment

The Australian Senate has proposed the Patent Amendment (Human Genes and Biological Materials) Bill 2010 that aims to ban ‘gene patents’

From the BIO Submission to Australian Senate Legal Committee on Patent Amendment:

This amendment would exclude from patent protection “any” biological material, whether a human gene or otherwise, that is substantially identical to a naturally-occuring biological material.  Specifically, the amendment states that the following materials would be catergorically declared unpatentable:

            “biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature.”

“Biological materials” broadly “include,” but apparently not limited to, such fundamental biotechnology building blocks as “DNA, RNA, proteins, cells and fluids.”

As almost any biological material can be said to be “substantially identical” to some other natural biological material, this change would have the effect of banning large swaths of previously patentable innovative biological discoveries – thus, removing the protection needed to incentivize investment in biotechnology-related innovation in drugs and biological therapies, preventative treatments such as vaccines, animal healthcare products, renewable energy production and other “green” technologies, environmental mitigation and remediation, biodiversity, farming, food, nutrition, household cleaners, and industrial fermentation for food and fuel production.
BIO and its members believe that excluding biological inventions from patent protection is inconsistent with the demonstrated evidence of social benefit from isolating and purifying active compounds from previously ineffective mixtures occurring in nature. For example, the invention of isolated polymerase from certain thermophilic bacteria has provided valuable methods for amplifying DNA that enables forensic DNA analysis to establish guilt or innocence of crimes, the development of life-saving medical diagnostics, and molecular breeding for improved plants. If the amendment had been law, it would have prevented the patenting – and thus development – of significant advances in human health, like purified insulin, adrenaline, and antibiotics; vitamin D and B-12 compositions; human growth hormone; erythropoietin, and numerous vaccines and anti-cancer treatments on the market today.

Accordingly, BIO believes that this amendment, if adopted, would fail to affect its intended purpose of advancing medical and scientific research and the diagnosis and cure of human illness and disease. Indeed, it would slow such progress immeasurably. The public demands continuing the patent incentive for such biologic innovation.

 

 

 

 

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BIO’s Comments on proposed PTO Humanitarian Technologies and Licensing Through the Intellectual Property System

Here are the highlights from BIO’s recent submission on the proposed PTO “Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System.”  

Background:

1.  “BIO’s members also understand that problems with access to medicines and other biotechnology products in the developing world have very little to do with the patent system, and are generally caused by other factors outside the control of individual stakeholders, such as lack of adequate local manufacturing, delivery, public health and sanitation infrastructure, trade and tariff barriers, regulatory obstacles, lack of market incentives, inequitable local distribution and corruption, diversion of products to more lucrative markets, and a chronic underinvestment in public health, education and environmental conservation. In fact, access issues persist even in countries where there are no patents covering humanitarian products and technologies.”

 2.  “While the patent system cannot be a primary policy lever to address these complex questions above, BIO nonetheless believes that innovative businesses from all sectors of the U.S. economy, including the biotechnology industry, can help improve the lives of underprivileged populations in the developing world. Indeed, BIO member companies have long participated in specific access and licensing initiatives that have informed the policy choices of members of the industry.”  (See http://www.globalhealthprogress.org/, http://www.ifpma.org/healthpartnerships, http://www.bvgh.org/LinkClick.aspx?fileticket=867bPGw-kYo%3d&tabid=105, http://www.aatf-africa.org/, and http://www.cimmyt.org/.)

 “Most recently, in May of this year, BIO announced a policy statement containing its Options for Increasing Access to Medicines in the Developing World that it believes should be considered during the development and commercialization of biotechnology products.  Accordingly, BIO commends the USPTO for likewise exploring creative and market-oriented ways to incentivize the development and distribution of humanitarian technologies, a goal that BIO and its members have long shared and are working hard to achieve. In addition, BIO would support efforts to bring together all potential stakeholders to explore various approaches and initiatives.”

Key Points:

1.  Any program should be technology-neutral – “In BIO’s view, such a program should be applicable to innovators from all sectors who engage in the creation and dissemination of technology that has the potential to address the needs of impoverished populations in the developing world.”

 2.  Any proposal should ensure USPTO’s core mission is maintained and adequately resourced.

 3.  Value of any proposed vouchers should be maximized, but will remain limited – “BIO believes that the commercial value of the proposed voucher could be substantial under some situations, but difficult to express in monetary terms at this time.” 

4.  Clarity of standing for voucher use needed – “BIO members are seriously concerned that vouchers could potentially be used by third party requesters, or even unrelated third parties, to accelerate the ex parte reexamination of other party’s patents without the patentee’s consent.”

5.  Policy options for voucher award process require further discussion – “BIO members also raised the question whether the proposed vouchers should be awarded as an entitlement for meeting certain objective criteria, or as a more subjective prize for extraordinary humanitarian licensing efforts.”

Conclusion:

“BIO understands this Federal Register notice to be a first conceptual step in what will be a deliberative process with additional opportunities for public review and comment as more specific details and approaches are proposed. With this understanding, we look forward to engaging further on this effort in partnership with the USPTO and other industries and stakeholders.”

BIO’s Full Comment

Recent Federal Register Notices

 A collection of Federal Register Notices dating back to November 5th. 

Mainly for Small and Medium sized Enterprises: (SME) Government Programs to Assist Businesses Protect Their Intellectual Property Rights (IPR) in Foreign Markets; Notice of Extension of Comment Period

PTO Proposed Rule: Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals

PTO Notice: Expansion and Extension of the Green Technology Pilot Program

Sharing & Promoting Innovative Technology in Public-Private Global Development Partnerships

Sharing and Promoting Innovative Technology in Public-Private Global Development Partnerships

World Trade Organization (WTO) Public Forum, Geneva

September 29, 2009

The World Trade Organization Public Forum has become one of the most important platforms for dialogue among stakeholders of the multilateral trading system. Each year representatives from key international agricultural and development agencies attended the Public Forum as panellists and participants. The Public Forum draws significant attention from governments, non-government organizations, academics, businesses and the mass media.

This year, CropLife International is assembling a diverse panel with substantial experience to offer their views on innovative solutions to critical global agricultural problems on Tuesday, September 29 (16:30-18:30) in Geneva.

Panelists will discuss:

  1. The increasing importance of public-private partnerships for development;
  2. How such partnerships stimulate, protect, and share innovation, and
  3. The case of agricultural innovation as an example of the role of public-private global development partnerships in stimulating, protecting, and sharing innovation

Technological advances can play a particularly central role in addressing agricultural challenges such as drought and destructive pests. Meeting these challenges sustainably will require new ideas, tools and technologies. The WTO Public Forum is an excellent opportunity to have a productive discussion on these important topics; we look forward to your participation.

Invited Panelists:

  • Mr. Grant D. Aldonas – Senior Associate, Center for Strategic and International Studies (Invited)
  • Dr. Gerard F. Barry – Head, IPMU and Program 4 Leader, Golden Rice Network Coordinator, International Rice Research Institute (Invited)
  • Professor Sir Gordon Conway – Chair in International Development, Imperial College London, Imperial College (Confirmed)
  • Mr. Gavin Power – Deputy Director and Head of Financial Markets, UN Global Compact (Invited)

For more information, visit Croplife’s website.

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 IP News Weekly for June 26, 2009

This week’s BIO IP News Weekly includes an analysis of Professor John Duffy in Business Week, an essay on technology transfer and university-industry collaboration in the Scientist Magazine, updates on USPTO funding and follow-on biologics, a blogger’s look at a U.S. Senator’s struggles to defend intellectual property rights, as well as a link to the recently published 2009 OECD Biotechnology Statistics report summary.

Also, note that Managing IP is having a free webinar on green tech innovation and intellectual property next Tuesday, June 30, 2009.

A Stimulated NIH Discovers the Devil in the Grant Details

In February, Congress awarded the National Institutes of Health with stimulus funds to the tune of $10.4 billion through the American Recovery and Reinvestment Act of 2009 (Recovery Act). The funding is directed towards helping the United States improve its “scientific infrastructure”: education initiatives, research, “investment in biomedical research and development, public health and health care delivery” (NIH Press Release), including $400 million for comparative effectiveness studies.

Acting National Institutes of Health Director, Raynard S. Kington, MD, has done an excellent job of diversifying the kinds of projects that funding will support, as well as looking for solutions to some of the more, well, I’ll call them opportunities for growth (read: beaurcratic red tape).

Science Magazine further describes these opportunities in the April 17 edition article “NIH Stimulus Plans Triggers Flood of Applications—and Anxiety.”

Grant applicants question whether the NIH has the capacity to manage the tsunami of applications.  Researchers in the Science article also ask if the NIH baseline funding “will grow at anywhere close to the rate needed to handle the blizzard of new ideas and expanded scientific work force” that the Recovery Act funding will produce once the stimulus funds expire. This would allow the projects to continue, if further research was recommended.

Additionally, an April 24 Burrill Report podcast (http://www.burrillreport.com/article-1311.html) interviews Reg Kelly, Director of the California Institute for Quantitative Biosciences (QB3), about whether the stimulus could slow down discoveries. University researchers, seeing state and alumni funding cuts, will spend all of their time preparing grant applications.  Researchers are forced to ignore current projects during the application process. Even if they do receive funding, they will face a technology transfer system that isn’t quite ready for a grand influx of fresh ideas just “waiting” to get picked up for further research & development. Kelly further asks if the technology transfer community is collectively incentivized (and collectively capable) of prioritizing funding for stated NIH priorities like personalized medicine, vaccines (read today: swine flu), cancer, and HIV/AIDS research.

While the stimulus created an “innovation backlog”, it can only be a good thing. For the next two years, NIH programs like “Grand Opportunities” and “Challenge Grants” will enable today’s bright minds to forge new paths into health and environmental sustainability – at least for the next 2 years, when the grant rivers run dry.  In 2012, the new challenge will be utilizing the innovation boomtown the stimulus will have inevitably created. 

If the stimulus succeeds in providing researchers enough funding to help form ideas to improve the world, it will take just as much effort for the biotechnology industry to turn that research into tangible products for a global audience.

Next question: Are the other United States federal agencies (FDA, USDA, and USPTO among them) ready to usher these innovations into the economy?