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.