BIO and USPTO Trace the Journey of Biotech Inventions

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S.patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.  The event will be held during the BIO International Convention on the morning of Thursday, June 30, at the Walter E.Washington Convention Center inWashington, D.C. 

See the BIOtech NOW article for more details.

BIO Hosts U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office and China’s State Intellectual Property Office

Press Release:

 
WASHINGTON, D.C. (Tuesday, April 05, 2011) – The Biotechnology Industry Organization (BIO) hosted a U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office (PTO) and China’s State Intellectual Property Office (SIPO) on March 28, 2011 in Beijing, China. The workshop which was organized by BIO for SIPO examiners, focused on biotechnology patenting and encouraged bilateral cooperation between SIPO and the USPTO.“BIO recognizes the commitment on behalf of the Chinese Government and SIPO to spur innovation in the biotech industry and, together with the PTO, we pledge to partner with Chinese leaders to move the industry forward to benefit patients and other consumers worldwide,” said Jim Greenwood, CEO and President of BIO.The workshop was the first of a series of meetings intended to open communication and establish a relationship between the two groups. BIO will work with the SIPO to strengthen China’s regulatory system to encourage innovation and protect intellectual property within the country. The commitment of SIPO will be critical for sending a message to companies that want to do business in China.

“Robust development of the biotech industry in China depends on an advanced intellectual property and patent system,” said Scott Sindelar, Minister Counselor of Agricultural Affairs. “Today’s workshop is timely in sharing experience and regulations of patenting and IP both in the U.S. and China, and establishing greater understanding of each other.”

“Since most Chinese attendees are examiners of intellectual property, [the workshop] provides an opportunity to share experiences and ideas with our American counterparts,” said Yang Xiaowei, deputy Director General of International Cooperation Department of SIPO.

In each of three panels, USPTO and SIPO speakers discussed how each issue is handled by the pertinent provisions in their current patent law and rules. They also addressed office practice and shared practical experiences with the different technical arts in biotech.  Industry and academic speakers provided user perspectives in their interaction with the patent law and practice in each country.

The workshop featured the following panels:

·         The first panel focused on taking a balanced approach to written description and enablement requirements, which are necessary for preventing impediments to patenting activity. Panelists also discussed the type of information that is required for an invention to satisfy the written description and enablement requirements.

·         The second panel focused on issues arising from claims with sequence homology. Panelists discussed the scope of claims using homology or percent of sequence identity language and issues that often arise during examination.

·         The third panel addressed meeting discussed China’s new requirements for patent disclosure for genetic resources, stakeholders’ experiences with China’s new genetic disclosure requirement, and alternative ways to ensure appropriate access and benefit sharing.

The three groups (BIO, PTO and SIPO) are looking forward to future opportunities to work together on issues of common interest.  

Upcoming BIO Events 

BIO Intellectual Property Counsels Committee Spring Conference and Committee Meeting
April 13-15, 2011
Seattle, WA

World Congress on Industrial Biotechnology & Bioprocessing
May 8-11, 2011
Toronto, Ontario, Canada

Partnering for Global Health Forum 2011
June 27, 2011
Washington, DC

BIO International Convention
June 27-30, 2011
Washington, DC

2011 BIO Human Resources Conference
June 26-28, 2011
Washington, DC

The Business Forum at the BIO International Convention
June 28-30, 2011
Washington, DC

BIO India International Partnering Conference
September 21-22, 2011
Hyderabad, India

BIO China International Conference
October 12-13, 2011
Shanghai, China

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtech Now, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtech Now.

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BIO’s Amicus Brief: Microsoft v. i4i

The Biotechnology Industry Organization, along with AUTM and CropLife International, filed an amicus brief in the Microsoft v. i4i Supreme Court case.

This case is widely viewed as one of the most fundamental and important patent cases to reach the Supreme Court in probably a decade. Most basically, this case is about the level of certainty a jury or judge must have before finding a patent invalid in litigation. Historically, the law has required a high level of proof, “clear and convincing evidence,” before a patent that has been examined and issued by the US Patent and Trademark Office can be declared invalid by a court. In the Microsoft v. i4i case, the Supreme Court is now being asked to adopt a lower burden of proof, under which patents can more easily be found invalid by a lower “preponderance of the evidence.”

In our joint brief, BIO, AUTM and CLI explain that the current high burden of proof has deep historic roots in Supreme Court law, and has been consistently applied by the lower courts for many decades. Under the current standard, issued patents benefit from a clear and meaningful presumption of validity that cannot be easily overcome. In this way, patents play their intended role as enduring legal instruments that confer real rights, and that developers and investors can rely on for investment and product development decisions. The importance of being able to rely on patent rights is illustrated very clearly in the biotech industry, which would not be able to make large investments over very long development times without assurances that the fruits of their investments are protected by robust patent rights. Lowering the standard for patent validity would frustrate decades of investment-backed reliance interests and would negatively impact biotechnology innovation going forward. Our brief explains that the existing high burden of proof to invalidate a patent is entirely consistent with other instances where the law imposes high burdens of proof to protect the public’s reliance on existing property rights.

In our brief, we also point out that Congress permits patents to be invalidated on a lower burden of proof only by the expert Patent Office, and then only on certain kinds of reliable evidence. Litigants who prefer to argue to a lay jury or generalist judge, or who want to use less reliable evidence, can do so only under a higher burden of proof. Any change to this carefully-crafted balance would have to be made by Congress, not the courts.

The United States’ brief in this case forcefully argues against changing the current standard of patent validity.

2011 BIO International Convention Super Sessions

2011 BIO International Convention Super Sessions Focus on State of the Industry

C-Level speakers lead broad conversations on global biotech, industry forecast, and key trends

WASHINGTON, D.C. (March 2, 2011) — The 2011 BIO International Convention will feature six high-level super sessions focused on the state of the industry, global biotech advancements and the outlook on the future of the industry. Hosted by the Biotechnology Industry Organization (BIO), the global event for biotechnology will take place June 27-30, 2011 at the Walter E. Washington Convention Center in Washington D.C.

“The last few years have presented significant economic challenges for emerging biotech companies trying to raise investment capital, which has had a global impact on the industry. Despite recent positive signs, it is still a tough market,” said BIO CEO and President Jim Greenwood. “These Super Sessions feature high-level speakers sharing their long-term outlook on the industry, and suggested strategies for successfully rebounding from the financial challenges and moving innovation forward to help heal, fuel and feed the world.”

Super Sessions include:

Ernst & Young’s 25th Annual Biotechnology Industry Report

Ernst & Young will present highlights from its 25th annual industry report. The session will discuss implications for biotech companies as they face a more uncertain future in the current business climate. As always, Ernst & Young will also summarize the sector’s performance using key metrics – financial performance, financing, deals and pipeline productivity.

Sponsored by: Ernst & Young 
Tuesday, June 28, Time: 10:00 am – 11:30 am
Confirmed Speakers: Glen Giovannetti, Partner and Global Biotech Leader, Ernst & Young LLP; Gautam Jaggi, Senior Manager and Editor, Beyond Borders and Progressions, Ernst & Young LLP

Burrill State-of-the-Industry Report
This presentation will look back over 25 years and describe some of the critical events that have shaped the industry into the global enterprise it is today and discuss what companies will need to do in order to remain competitive in a world being influenced by a tougher financial climate, rapidly evolving technology, globalization and new emerging markets.

Sponsored by: Burrill & Company
Tuesday, June 28, Time: 2:00 pm – 3:30 pm
Confirmed Speaker: G. Steven Burrill, Chief Executive Officer, Burrill & Company  

It Takes a Village– The Biotechnology Innovation Ecosystem

This session will detail the roles, relationships and interplay among government research labs, universities, and large and small biotechnology firms in the continuum from basic research to FDA-approved products and ultimately to the patient.

Sponsored by: Eli Lilly and Company
Tuesday, June 28, Time: 3:45 pm – 5:15 pm
Confirmed Speaker: John Lechleiter, Ph.D., Chairman, President & Chief Executive Officer, Eli Lilly & Company

Emerging Markets: The Future of Growth for Biologics?

This panel will bring together leading business executives with senior government officials to talk about how Emerging Markets are shaping business thinking and what impact they will have on the future of the biotech sector.

Sponsored by: Merck
Wednesday June 29, Time: 10:00 – 11:30 am
Confirmed Speaker: Richard T. Clark, Chairman, Merck

Campbell Alliance 2011 Dealmakers’ Intentions

Campbell Alliance and BIO present updated findings from two unique forward-looking measures of deal-making in the industry – the Campbell Alliance Dealmakers’ Intentions Survey and the BIO One-on-One Partnering Forecast.  New analysis in 2011 will include year-over-year trends and the first assessment of the predictive value of these instruments.

Sponsored by: Campbell Alliance
Wednesday June 29, Time: 2:00 – 3:30 pm
Speakers to be announced. 

Worldview 2011: Scientific American’s Regional Bio-Innovation Scorecard

Worldview 2011 will feature the third annual Scientific American’s Regional Bio-Innovation Scorecard, a review of individual country programs and policies aimed at growing local innovative biotechnology sectors. 

Wednesday June 29, Time: 3:45 – 5:15 pm
Confirmed Speaker: Fareed Zakaria, CNN host, Editor-at-Large of TIME Magazine, Washington Post columnist, former Editor, Newsweek International

The 2011 BIO International Convention is expected to draw more than 15,000 industry leaders from 49 states and 65 countries.  This year, the Convention program will feature more than 125 sessions in 16 tracks.  In addition, this year’s BIO Exhibition will cover an estimated 180,000 net sq. ft. and host more than 1,700 exhibitors.

The BIO International Convention also includes the BIO Business Forum, which offers attendees an unparalleled opportunity for large and small biotech companies to gather in one place, at one time to engage in partnering discussions. The ability to schedule up to 80 one-on-one meetings within just a few short days with biotech leaders from around the world enables companies to maximize their ROI for the registration and travel investment for this event. In 2010, the BIO Business Forum hosted more than 17,000 partnering meetings with more than 2,000 companies participating.

The BIO International Convention helps to support the association’s programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.  For additional attendee and exhibitor information, please visit http://convention.bio.org.

For detailed descriptions and a full program, please visit http://convention.bio.org.

Advance media registration for the 2011 BIO International Convention is now open and will be available online through June 17, 2011. To register in advance, please visit http://convention.bio.org/media.

BIO Comments to USTR on 2011 Special 301 Review

BIO Comments to USTR on 2011 Special 301 Review (February 15, 2011)

In comments to the U.S. Trade Representative (USTR), BIO stresses the critical importance of protecting intellectual property abroad and made recommendations about which countries to include on the Priority Watch and Watch List, which to elevate as a Priority Foreigh Country, and which countries to monitor.

Read the Comments (link to http://bio.org/pdfs/BIO_2011_Special_301_Submission.pdf)

Read the Press Release (link to http://bio.org/news/pressreleases/newsitem.asp?id=2011_0221_01)

BIO’s Intellectual Property Counsels’ Committee Spring Conference and Meeting: Seattle

Over the past eight years, BIO’s semiannual IP Counsels Committee Conference has become a popular and growing event among our members’ IP and legal professionals. Our upcoming 2011 Spring IPCC Conference in Seattle, WA on April 13-15 will be an excellent opportunity for IP professionals to hear, listen, and learn about current and projected topics related to biotechnology IP.

We invite you to join us in an informal, fun and informative setting to meet fellow in-house legal and IP professionals, to make new acquaintances, to reconnect with old friends in the industry, and to take home a wealth of information – and maybe some new ideas.

To Register

Session Titles:

1.  Whose Rights are They, Anyway?  Implications from and a Discussion on Stanford v. Roche

2.  A Landmark Case: The Aftermath of Myriad

3.  Best Practices in Research Collaborations: Joint Inventorship Pitfalls and Ethical Issues in Joint Representation

4.  How to Stay in the Frying Pan and Out of the Fire: Hot Topics in Ethics for In-House IP Attorneys

5.  Emerging Markets

6.  Double Patenting

7.  Biosimilars

BIO’s IP Priorities for 2011

As we start a new year, the BIO Intellectual Property Department has determined their 2011 priorities.  Intellectual Property remains a foundational priority for BIO and our 1100 biotechnology company members.

BIO’s IP department has approved the following priorities for 2011:

1) PTO reforms to improve efficient, timely and quality examination

2) Congressional patent reform legislation

3) Improving IP protection in key foreign markets

4) IP legal developments in the courts

5) Protecting the breadth and flexibility of the patent and technology transfer system.

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

AUTM Bayh-Dole 30th Anniversary Event

Association of University Technology Managers Press Release

Deerfield, IL — December 12, 2010 will mark the 30th anniversary of the Bayh-Dole Act. This legislation changed fundamentally the way America develops technologies from federally funded university research and effectively secured the country’s leadership position in innovation.

As a result of Bayh-Dole, more than 6,000 new U.S. companies formed from university technologies, approximately 5,000 new products are on the market, 153 new drugs, vaccines or in vitro devices are protecting public health, and in just nine years 279,000 new jobs were created as part of a $187 billion dollar impact on U.S. gross domestic product.

AUTM, joined by the American Council on Education, Association of American Universities, Association of Public and Land-grant Universities, and BIO, is celebrating the occasion with an event in Washington, DC on the morning of Wednesday, December 1. The first half of the event will be moderated by former Rep. Jim Greenwood, CEO of BIO (Biotechnology Industry Organization), and will include remarks from original congressional sponsors of the Act, such as Sen. Birch Bayh. Sen. Bayh and Rep. John Conyers will comment on the importance of maintaining Bayh-Dole to secure America’s leadership position in innovation for the future.

The second half of the event will be a panel discussion among business, university and policy leaders who will discuss the current impact of the Bayh-Dole Act and how to build upon the success of the Act going forward.

Members of the news media and the public are invited, and coverage of the event is welcome.  For more information about the event, contact Jodi Talley, AUTM Communications Director, at +1-847-559-0846 or jtalley@autm.net.

WHAT: Event to celebrate the 30th Anniversary of the Bayh-Dole Act

DETAILS: Wednesday, Dec. 1, 10 a.m. to 12 p.m. at the Washington Convention Center, 801 Mt. Vernon Place, NW, Washington, DC, Room 140

FOR MORE INFORMATION: Visit http://www.B-D30.org 

                                                                      

 

About the Event Organizers

Founded in 1918, ACE (www.acenet.edu) is the major coordinating body for all the nation’s higher education institutions, representing more than 1,600 college and university presidents, and more than 200 related associations, nationwide.

The Association of American Universities (www.aau.edu) is an association of 61 U.S. and two Canadian research universities organized to develop and implement effective national and institutional policies supporting research and scholarship, graduate and professional education, undergraduate education, and public service in research universities.
Association of Public and Land-grant Universities (www.aplu.org) is an association of public research universities, land-grant institutions, and state university systems, founding in 1887. A۰P۰L۰U member campuses enroll more than 3.5 million undergraduate and 1.1 million graduate students, employ more than 645,000 faculty members, and conduct nearly two-thirds of all academic research, totaling more than $34 billion annually. As the nation’s oldest higher education association, A۰P۰L۰U is dedicated to excellence in learning, discovery and engagement.

The Association of University Technology Managers (www.autm.net) is a nonprofit organization with an international membership of more than 3,000 technology managers and business executives. AUTM members — managers of intellectual property, one of the most active growth sectors of the global economy —come from more than 300 universities, research institutions and teaching hospitals as well as numerous businesses and government organizations.

BIO (www.bio.org) represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.