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

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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

House Judiciary Committee’s Patent Reform Bill is in Need of Reform, Says BIO

PRESS RELEASE

WASHINGTON, D.C. (Friday, April 15, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the America Invents Act, H.R. 1249, which passed the House Committee on the Judiciary yesterday:
 
“BIO has consistently praised House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote.  Unfortunately, given the addition of the Goodlatte supplemental examination amendment, added to the bill during Committee consideration, we have no choice but to oppose floor consideration of the bill until this issue is repaired.

“The supplemental examination provision as passed by the Senate and originally included in the House bill would allow patent holders to seek a review of their issued patents at their own risk.  The Goodlatte amendment undercuts this provision by creating disincentives for patent owners to use the new procedure by having the U.S. Patent and Trademark Office (PTO) act as quasi-investigative body.

“We commend Chairman Smith for all the work he has done to craft a bill, the America Invents Act, which is a clear improvement over prior House versions of patent reform legislation.  BIO was very supportive of Chairman Smith’s Manager’s Amendment.  We are pleased that the legislation will end, once and for all, the diversion of fees collected by the PTO, allowing the agency to use all of its fees to hire more examiners, reduce the backlog of pending applications, and make other improvements to its operations.  We also commend the inclusion in the bill of many other reforms that will improve the patent system and enhance patent quality, including transition to a “first-to-file” system, the creation of an inter partes review system, and the elimination of other subjective elements of patent law.
 
“Nonetheless, given the importance of adopting a supplemental examination provision much like that which passed the Senate on a bipartisan, 95-5 vote, BIO notes our objection to this bill being considered on the House floor.  We commit to work with Chairman Smith and others to rectify this issue, so that a patent reform bill with broad support can be brought to the floor of the House.”

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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Coalition Urges Enactment of Patent Reform Legislation to Drive Job Growth and Innovation

Coalition Urges Enactment of Patent Reform Legislation to Drive Job Growth and Innovation (March 24, 2011)
BIO joined with 97 other manufacturers, scientists, researchers, academic institutions, and businesses to urge the U.S. House of Representatives to enact patent reform into law in order to strengthen our country’s patent system which will help get breakthrough products to market faster, maximizing our opportunities for job growth.
Read the letter (120 KB PDF)

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.

BIO’s Intellectual Property Counsels Committee Seattle Meeting Topics

Join us for BIO’s Intellectual Property Counsels Committee Meeting in Seattle April 13-15.  You can find the session topics below.

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

The pending Supreme Court review of Stanford v. Roche has brought out multiple perspectives on the disposition of ownership rights in federally funded inventions under Bayh-Dole. This session will explore the different interpretations of the Act’s provisions, and their practical implications for small business grantees or biotech companies who wish to collaborate with federal grantees.

A Landmark Case: The Aftermath of Myriad

This session will provide an update on the status of the case and the arguments that have been made by the various amicus groups, with particular emphasis on the US Government’s brief. We will also explore the impact of “gene patents” on up-and-coming technologies, especially whole genome/whole exome testing.

The Business Case for International Humanitarian Approaches to IP Management and Collaborations

Guest Speaker:

Erik Iverson, Associate General Counsel, Global Health, Gates Foundation

 

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

Don Ware of Foley Hoag will lead a discussion of pitfalls that may arise from prosecuting joint inventions conceived in the course of research collaborations among multiple institutions, including companies, universities and hospitals. Irene Pleasure, Associate General Counsel and Director of Patent Law at Genentech, will provide the in-house perspective on managing patent issues in research collaborations. David Hricik, Professor of Law at Mercer University School of Law and co-author of the treatises Patent Ethics – Prosecution (2009) and Patent Ethics – Litigation (2010), will address the professional responsibilities of patent attorneys involved in the prosecution of jointly-owned patent applications.

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

Professor David Hricik and Barbara Fiacco of Foley Hoag will present on developments in ethics law for in-house IP counsel, including law firm conflict issues, how to protect the attorney-client privilege, ethical dilemmas created by 21st century social media, in-house counsel ethical pitfalls, and recent developments in IP malpractice law. The game-show format of this panel will be thought-provoking and fun, and will encourage audience participation. CLE Ethics credit is being requested.

Learn How to Navigate IP Landscape in Emerging Markets

BIO members have indicated a strong desire to hear about challenges and key developments in emerging markets such as Korea, China, Brazil and India. Specific challenges, lay of the land, how to negotiate better in these markets.

Double Patenting

This panel will include new developments on the Boehringer Ingelheim Federal Circuit Case, collaboration of multiple parties/how to avoid double patenting rejections and possible coverage of the Sun v. Lilly case.

The Next Chapter: Biosimilars Beyond the Health Care Reform Act

Will Policy Issues Slow the Pace of Implementation? Will the FDA Look to Europe for Guidance on Antibody Biosimilars? Emerging Markets, Emerging Strategies? The panel will cover recent developments in biosimilar, including policy issues based on move to repeal healthcare reform, the recent FDA public hearing on biosimilars, further debate on the meaning of exclusivity, the necessity of clinical trials, the possibility of interchangeability, and developments in Europe with respect to antibody biosimilars.