Letters, Testimony & Comments

Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are...
July 8 2013
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations...
June 19 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting...
June 7 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products....
March 21 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of...
February 22 2013
BIO commends the INPI for their efforts to devise guidelines for examining biotechnology related inventions. Given the technological...
February 1 2013
  The House Judiciary Committee conducted a hearing on World IP Day on "International Patent Issues: Promoting...
April 26 2012
Selected Excerpts: The vast majority of BIO’s members are small and medium sized enterprises that currently do not have products...
March 7 2012
BIO has identified the following countries of interest and recommends the following for our 2011 Special 301 submission. Priority...
February 14 2012
By Electronic Submission Ip.policy@uspto.gov Office of Policy and External Affairs United States Patent and Trademark Office...
November 10 2011
Re: Request for Comments on the Strategy for American Innovation Subject: Innovation Strategy RFI Email: competitiveness@doc.gov Dear...
April 1 2011
I'm writing on  behalf of the Biotechnology Industry Organization (BIO) in response to your invitation for public comments on...
June 22 2007
Perhaps no other industry is as dependent upon patents as is the biotech industry.  In 2004 alone, more than 10% of the PTO's...
October 6 2006
Dear House Leadership: On behalf of the Biotechnology Industry Organization (BIO), I urge you to seek prompt passage of H.R. 1561, the...
October 24 2003
Under Secretary of Commerce for Intellectual Property and Director of the USPTO on Patent Harmonization
May 6 2002
Acting Undersecretary of Commerce and Acting Director of the United States Patent and Trademark Office Regarding Patent Law Harmonization
May 4 2001
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
July 8 2013
As the Mexican government looks to establish a pathway to market for biosimilar biological products, BIO offers the following important considerations to ensure patient safety, as well as continued innovation in the life sciences industry.
June 19 2013
We understand the challenges that India faces with respect to healthcare and the innovative biotechnology industry stands ready to work with India to help address them.  
June 7 2013
BIO applauds the government of Brazil for taking steps towards developing regulatory requirements to ensure patients suffering from rare diseases have access to treatment.   
March 21 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products. Peru is a growing market for biotechnology products and with the implementation of the US-Peru TPA, it promises to become an even bigger market.
June 13 2013
The SCOTUS decision represents a departure from judicial and PTO precedent supporting patentability of DNA molecules. The decision could create business uncertainty for a range of inventions.
April 5 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.
March 15 2010
David Kappos, Director of the U.S. Patent and Trademark Office and Under Secretary of Commerce for Intellectual Property, will be a featured speaker at the Intellectual Property Super Session taking place during the 2010 BIO International Convention.