President Obama’s Plan to Win the Future by Catalyzing Invention, Innovation, and Economic Growth through Patent Reform

The White House Office of Public Engagement released the patent factsheet, “President Obama’s Plan to Win the Future by Catalyzing Invention, Innovation and Economic Growth through Patent Reform,” the night of Obama’s Jan. 25, 2011, State of the Union address.  Here are some highlights.

“ Improve the Operations of the Patent and Trademark Office (PTO): The President’s budget enables the PTO to address a backlog of over 700,000 patent applications.

 Promote U.S. Cooperation with International Patent Standards to Help U.S. Firms to Compete in the Global Economy: By moving towards greater coordination between patent systems, the United States can enable its innovators to receive lower-cost and higher-qualitypatents, enabling them to better compete and protect their inventions around the world.

 Address the Costs of Our Inefficient Patent Litigation System: To improve the patent system, President Obama has pledged to work with Congress to devise a post-grant review system to improve efficiency.”

 

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BIO Press Release: BIO and AUTM file Amicus Brief in Myriad Case

The Biotechnology Industry Organization (BIO) filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on Friday, October 29^th, in an appeal of a lawsuit brought by the American Civil Liberties Union on behalf of a number of plaintiffs against Myriad Genetics, the U.S. Patent and Trademark Office, and others.

The brief, filed jointly with the Association of University Technology Managers (AUTM), supports the patentability of isolated DNA molecules, noting that invalidating the patentability of these molecules would discourage future biotechnological innovation.  DNA-based patents are a critical tool that help enable the fundamental research and development of new biotech products, therapies and technologies to fight deadly diseases, expand agricultural production, clean the environment, and reduce our dependence on foreign sources of oil. 

Isolating a DNA molecule, in addition to creating a new chemical molecule that does not exist in nature, imparts new utilities and functions that are not available from native DNA.  The utility of isolated DNA molecules derives from their chemical structure, which is developed by human ingenuity using complex scientific expertise and equipment. As a result, isolated DNA molecules are patentable subject matter based on decades of U.S. case law.

 “Unless reversed, the district court’s ruling will seriously harm the U.S. biotechnology industry, which consists largely of small firms that are engaged in foundational research and dependent on private investment to fund their work,” stated BIO President & CEO Jim Greenwood.  “Patent protection is critical for the ability of biotechnology firms to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental and agricultural products. This innovation will lead to domestic job creation and help sustain our country’s global competitiveness.”

 If the Court of Appeals affirms the district court’s categorical rejection of the patentability of isolated DNA molecules, it would cast a cloud of uncertainty over thousands of similar patents and compromise the ability of biotechnology firms to pursue groundbreaking discoveries in human healthcare, renewable energy, and sustainable agriculture. 

 “Patentability of isolated DNA molecules is critical to the translation of university research discoveries for the public good. Without this, many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products which improve the public health,” stated AUTM President Ashley J. Stevens.

“From the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society,” concluded BIO President and CEO Jim Greenwood. 

The joint BIO-AUTM amicus brief is available at http://bio.org/ip/amicus/BIO_AUTM_Amicus_Brief_AMP_v_USPTO_2010-1406_FedCir.pdf.  Additional background materials are available at http://bio.org/ip/genepat

USPTO Requesting Comments on Humanitarian Technologies

In case you missed it, on September 20 the United States Patent Office issued a request for comments on incentivizing humanitarian technologies and licensing through the intellectual property system.

 The USPTO is trying to incentivize humanitarian technologies by creating a “fast-track ex parte reexamination voucher pilot program.”  The program will give priority to humanitarian technology patents shortening the review process to six months.  The USPTO also hopes the program will reduce costs for humanitarian technology patents.

 The proposed legal standard the PTO will use to define “humanitarian use” and “humanitarian research” are as follows;

 “‘‘Humanitarian use’’ would comprise four principles: subject matter, effectiveness, availability, and access. In general terms, subject matter evaluates whether the patented technology addresses a recognized humanitarian problem. Effectiveness judges whether the technology can be used or is being used to address that issue. Availability determines whether the technology is available to an affected impoverished population. Access evaluates whether the applicant has made significant efforts to increase access to the technology among such populations.”

 “‘‘Humanitarian research’’ would comprise two principles: significance and access. Significance requires that the patented technology make a significant contribution to research on a problem that predominantly affects an impoverished population, such as the tropical diseases identified by the FDA in its priority review voucher scheme. Access determines that the patented technology was made available to researchers on generous terms. “

 The PTO asks comments to focus on the twelve questions found in the Request for Comment.    

 To make a comment to the USPTO on this issue send an email to HumanitarianProgram@uspto.gov