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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Pathogens and the Nagoya Protocol of the Convention on Biological Diversity

          Some nations have argued that the recent Nagoya Protocol of the Convention of Biological Diversity (CBD) includes pathogens. The inclusion of pathogens in the Nagoya Protocol could adversely affect the world’s ability to control outbreaks of infectious disease.  The following reasons demonstrate why pathogens are not and should not be included in the Nagoya Protocol.

Contrary to the Mission of the CBD:

• The three main objectives of the CBD are;

1. “The conservation of biological diversity,
2. The sustainable use of the components of biological diversity, and
3. The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.” 

 

• The objective for preventing pathogen-borne illness is to eliminate and not conserve the pathogen.  Therefore, conserving and sustaining pathogens seems like a tenuous application in light of the first two objectives of the CBD.  

 

• Some might argue that pathogens fall under the 3rd objective, addressed by the Nagoya Protocol.  However, analyzing the 3rd objective requires consideration of the other two objectives.  Benefit sharing is intrinsically linked to those genetic resources worthy of protection and sustainable use.  The following points clarify why the Nagoya Protocol does not cover pathogens.

 

 Nagoya Protocol Language

•  Pathogens are specifically mentioned in Preamble, clause 16

“Mindful of the International Health Regulations (2005) of the World Health Organization and the importance of ensuring access to human pathogens for public health preparedness and response purposes.”  

• The reference to the World Health Organization and the importance of access to pathogens indicates the intent that the WHO, not the CBD, is the place to address human pathogens.  

 

•  In fact, the clause reinforces the idea that access, not benefit, is paramount in an outbreak of infectious disease.  The CBD recognizes that WHO has the appropriate level of technical expertise and experience to handle pathogen access issues.   

 

• Some might argue Article 8(b) implies the inclusion of pathogens in the Protocol. 

Parties must “pay due regard to cases of present or imminent emergencies that threaten or damage human, animal, or plant health, as determined nationally or internationally.  Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries.” 

• If Article 8(b) were interpreted to include pathogens, the language “the need for expeditious access to genetic resources” in times of emergencies strongly argues for the circumvention or inapplicability of access and benefit sharing laws to pathogens.

 

Applying the Protocol to Pathogens is highly problematic

• Interpreting the Nagoya Protocol to include pathogens creates numerous practical and policy problems. 

 

• Prior drafts both included and excluded pathogens in the Protocol indicating no agreement on the inclusion of pathogens.  Including pathogens would be a disingenuous reading of the intent of the contracting parties.

 

• How do you identify the origin of a pathogen?  Pathogens are not bound by geography, quickly spreading globally by infected persons traveling on airplanes or infected birds flying across borders.  How can we identify who owns the next HIV clade, SARS virus, or the next variation of any pathogen?    

 

• Infectious disease outbreaks require instantaneous action.  Any delay caused by nations negotiating ‘fair’ prices for pathogens harms both the local and global population needing immediate protection. 

 

• Including pathogens in an access and benefit sharing system rewards bad luck.  The designers of the Nagoya Protocol sought to create a monetary incentive to conserve biodiversity and sustainability; not to create a system that allows nations to profit from misfortune. 

BIO’s take on the CBD Nagoya Protocol

After several years of negotiations, the 10th Conference of the Parties of the Convention on Biological Diversity (CBD) successfully adopted the Nagoya Protocol.  The Protocol provides benefits to the biotechnology industry by creating a legal framework to regulate access to genetic resources and provide fair and equitable sharing of benefits.  In addition, the Protocol does not apply retroactively or hinder regulation or a country’s intellectual property systems.  Assuming nations implement the Protocol appropriately, we can meet the joint goals of conservation and sustainable use of biodiversity. 

The biotechnology community recognizes several important aspects of the Protocol.

Mutually Agreed Terms

Article 4.1 creates the obligation to share benefits on mutually agreed terms between the provider and user of genetic resources.  Both parties will understand their rights and obligations regarding the transfer of genetic resources which will create a synergetic relationship.

Emergencies

The Protocol recognizes the need to access genetic resources to respond to imminent emergencies that threaten or damage human, animal or plant health.  Article 6(b) answers these needs by ensuring national access and benefit sharing (“ABS”) requirements do not impede a response to a public health crisis.

Transparency

Those Parties requiring prior informed consent must take legislative, administrative or other policy measures to provide legal clarity and transparency under the Protocol.  Article 5.2 requires a “clear and transparent written decision” in a reasonable time.  These requirements enable biotechnology companies to comply with national access and benefit sharing laws. 

Prospective

The Protocol appears to be prospective and applies only to genetic resources transferred after the entry into force of the Protocol.  This particular provision however, is a bit unclear and will require more study, particularly during the implementation phase.  Retroactive application would create widespread uncertainty and litigation and should be avoided.

Intellectual Property Laws/Marketing Approval

The Protocol does not create new rules or laws for intellectual property or for marketing approval for new products.  Article 13.1(a) provides for checkpoints which will help monitor the collection of information providing transparency and respect for mutually agreed terms. 

The Nagoya Protocol represents a series of compromises with many provisions in the text still unclear.  As a result, BIO will monitor the national implementation of the Protocol and the implementation of the “global multilateral benefit-sharing mechanism” used for genetic resources existing in transboundary situations or where no prior informed consent is obtainable. (Article 7 bis)  However, we believe that the successful implementation of the Protocol is likely to result in positive relationships between the biotechnology industry, governments, and other stakeholders.