BIOtech NOW: The Role of Intellectual Property in Global Health

The Role of Intellectual Property in Global Health

BIO is committed to increase access to biologic medicines for patients throughout the world.  As BIO President and CEO Jim Greenwood said last year when announcing our policy statement on Options for Increasing Access to Medicines in the Developing World, “We believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are mutually supportive.”

While there are frequent misguided calls to circumvent intellectual property (IP) rights in order to provide therapies to undeveloped countries, BIO and many policy experts understand that IP rights are necessary to bring innovative new therapies to market and into the hands of patients.  Medicines cannot be utilized if they are not developed, and IP rights are often the only asset emerging biotech companies can leverage in order to attract the investment necessary to fund the lengthy and expensive research and development and clinical review processes.

Bill Gates has been an ally in our efforts to increase access to medicines in developing countries.  In 2004, BIO launched BIO Ventures for Global Health (BVGH) with a start-up grant from the Bill & Melinda Gates Foundation to speed the development of medicines for unmet diseases of developing countries. 

In a recent interview with Intellectual Property Watch, Bill Gates discussed the important role of IP in his Foundation’s work on global health:

“We fund research and we actually ourselves or our partners create intellectual property so that anything that is invented with our foundation money that goes to richer countries, we’re actually getting a return on that money.”

“By doing that we have more money to devote for research into neglected diseases and the diseases of the poor,” he said. “Now when our medicines go into the poor countries, they are always going in without any intellectual property fee, at very lowest cost pricing.”

 “But,” he said, “the intellectual property system has worked very well to protect our investments so that when they are used in rich countries we get a payback and then we have the control to make sure that it is not creating any financial burden on the countries that are the poorest.”

You can read the full article on Intellectual Property Watch’s website (subscription required).

Biotech, Gates Foundation, and Global Health

Great interview by Gene Quinn with Erik Iverson, Associate General Counsel with the Bill & Melinda Gates Foundation.  A summary article is on BIOtech Now and the full interview can be found on IPWatchdog.com.

 Highlights:

Iverson told me in no uncertain terms, “[A] fundamental premise at the foundation is that we absolutely respect intellectual property rights.  We recognize their importance and we certainly recognize the importance of companies and their involvement in developing products and having them commercialized both in developed and developing countries.”  But how can the Gates Foundation balance the intellectual property rights of those who create live saving technologies and treatments while at the same time ensuring the humanitarian mission? 

According to Iverson, this requires a different approach to each situation taking into consideration the unique factual circumstances involved, such as the disease at issue, the marketability that may exist in developed countries and the need to incentivize the desired outcome.  Iverson explained, “[T]he life science community is all about helping people and saving lives… [we are] trying to figure out how to balance them to push the development of products that well, very few people historically have put much effort into…”

IPWatchdog.com interview of Bayh-Dole insider

A great article from IPWatchdog.com giving Joe Allen’s (a Birch Bayh staffer) insider perspective on the passage of the Bayh-Dole Act. 

The Article’s Introduction:

William Shakespeare once wrote:

There is a tide in the affairs of men
Which taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.

See Julius Caesar.

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

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