Patents for Humanity

Posted under Blog, Companies, David Kappos, development, Diagnostics, Funding, Global Development Agenda, humanitarian, Medical Devices, Medical Supply, Obama Global Development Agenda, patent, Patently BIOtech, Pharmaceuticals, PTO, Public Policy, Startups, Universities, USPTO, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

By David Kappos, Director of the United States Patent and Trademark Office (USPTO)

Originally Published on USPTO Director’s Forum

Sweeping revolutions in technology continue to fundamentally redefine the way we connect with one another and interact with the world. Today, an entrepreneur can do business with a remote village across an ocean just as quickly as a student in Boston can video-conference with a professor in Beijing. Political rallies can be organized by the click of a button, while gripping images of that rally can be shared across continents with a cell phone.

And while an ever-shrinking and increasingly interconnected world allows technologies and information to spread in unprecedented ways, it also reminds us of the unique challenges we face as a planet. That’s why the United States Patent and Trademark Office, during a global development event today at the White House, announced the Patents for Humanity pilot program. Because while 21st century challenges are global in scope, so too are their solutions.

By building smarter irrigation systems in towns plagued by drought, by delivering cost-effective medicinal vaccines to communities without hospitals, and by engineering weather-resistant crop strains to farms ravaged by natural disasters, patented inventions have the power to create lasting solutions for some of the most serious issues confronting the world’s poorest and underserved regions. By offering strong incentives for businesses of all sizes to engage in these humanitarian efforts, Patents for Humanity encourages up to 1,000 applicants to demonstrate how their patented, or patent-pending technologies, are advancing research and results in four categories: Medical Technology, Food and Nutrition, Clean Technology, and Information Technology.

Judges selected from academia for their expertise in these fields will review applications and recommend winners, and up to 50 awardees will receive certificates for accelerated patent processing at the USPTO—a powerful tool for helping businesses validate their technology and resolve investment decisions more quickly. Not only will the faster processing help technologists move solutions to the marketplace faster; it will also demonstrate that humanitarian endeavors and smart economic growth can work hand in hand.

By harnessing the power of science and technology with research and development, Patents for Humanity plays a key role in advancing President Obama’s global development agenda. By collaborating with parts of the world in ways unimaginable just a few years ago, and by unleashing broader prosperity in emerging economies, this important new USPTO initiative demonstrates that the power to innovate is the power to lead, by design and by solution.

For additional information including how to apply, please visit Patents for Humanity.

PTO Genetic Testing Study: What’s Patents Got to Do with It

Posted under Blog, Companies, coverage, Diagnostics, DNA, exclusive, Funding, gene, gene patent, genetic test, Genetic testing, insurance, license, Medical Devices, Medical Supply, nonexclusive, patent, Patent Office, Patently BIOtech, Pharmaceuticals, Public Policy, second opinion, Startups, Universities, USPTO, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The USPTO held a hearing on February 16 to collect testimony from interested parties to discuss factors affecting the availability of confirmatory, or second opinion, genetic testing.  However, the hearing quickly devolved into testimonies addressing so called ‘gene patents’ and genetic testing more broadly.

Dr. Hans Sauer testified on behalf of BIO and first raised the question whether there is in fact patient demand for an ‘independent second opinion genetic test.’  While doctors would likely agree that patients sometimes ask for a second opinion on a doctor’s treatment recommendations, how many patients desire a genetic test (or any other test) to be run again without any indication that there was something wrong with the initial test?  Insurance companies likely would not cover a confirmatory test, further limiting the desirability of seeking such confirmation as the patient would have to pay the full cost of a repeat genetic test out of pocket.  More generally, it must also be asked whether just offering a re-test really translates into a true patient benefit. A repeat test does not necessarily provide peace of mind. It can create doubts in the patient’s mind about the reliability of the doctor’s treatment recommendation. It can prolong uncertainty, give rise to unrealistic hopes, cause significant unnecessary out-of-pocket cost, and create indecision where treatment decisions are urgently needed. These potential negatives must be considered too.

On the broader question of access to genetic tests in the first instance, Dr. Sauer highlighted that available data indicates that a patent premium for genetic tests does not seem to exist.  One study compares similar genetic tests with one test based on exclusively licensed ‘gene patents’ and the other nonexclusively licensed finding no “obvious price premium attributable to exclusive patent rights.”

Finally, Dr. Sauer showed a map of Medicaid coverage by State of a particular type of genetic test for breast cancer, highlighting the differences in coverage.  As Dr. Sauer points out,

“If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California a similar patient has access to the same test, there’s obviously something wrong with that, but how can that be a patent problem? How can it be a patent problem in Nevada and not a patent problem in California? That’s not how we understand patents to operate – inescapably, there’s something else at work here. “

Patent Awards for Humanitarian Ventures

Posted under Blog, Companies, development, Diagnostics, Funding, humanitarian, Medical Devices, Medical Supply, patent, patent application, Patently BIOtech, Pharmaceuticals, Public Policy, reexamination, Startups, Universities, USPTO, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The USPTO recently announced the Patents for Humanity Challenge which awards patent owners and licensees for innovations that address humanitarian needs.  Judges will chose winners from four categories:

1. Medical technology – includes medicines, vaccines, diagnostic equipment, or assistive devices.
2. Food and nutrition – includes agricultural technology like drought-resistant crops, more nutritious crop strains, farming equipment, and technologies that improve food storage, preservation, or preparation.
3. Clean technology – includes technologies that improve public health by removing or reducing harmful contaminants in the environment, such as water filters, sterilization devices, and cleaner sources of energy for light, heat, cooking, or other basic needs.
4. Information Technology – encompasses both physical devices and software which markedly improve the lives of the poor, such as portable computers, cell phones, or internet access devices being used to foster literacy, education, or other knowledge which improves living standards.

The reward is of particular interest.  Award winners have the option to accelerate either:

1. Ex parte reexamination proceeding including one appeal to the BPAI from that proceeding
2. A patent application including one appeal to the BPAI from that application or
3. An appeal to the BPAI of a claim twice rejected in a patent application or reissue application or finally rejected in an ex parte reexamination.

For more specifics see the Federal Register Notice.

Exclusive Licenses Do Not Discourage Follow On Research

Posted under Blog, Companies, Diagnostics, Funding, licensing, Medical Devices, Medical Supply, patent, Patent and Trademark Office, Patently BIOtech, Pharmaceuticals, Public Policy, Startups, U.S. Patent and Trademark Office, United States Patent and Trademark Office, Universities, USPTO, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

A recent study presented at the Patent Statistics for Decision Makers Conference organized at the United States Patent Office questions the logic behind a nonexclusive license preference often found in U.S. government technology transfer policy.

In “The Role of Exclusive Licensing in Follow-on Research of Academic Patented Inventions” presentation the authors demonstrate that, contrary to the belief by some, exclusive licensing does not impede future research.

The authors ask two questions.  First, does exclusive licensing affect licensee follow-on research?  Second, does exclusive licensing affect non-licensee follow-on research?  The first question addresses the concern that a company will take a license of a university invention and not develop it.  The second question addresses the concern that follow-on research will not occur without the license thereby limiting the amount of knowledge available.  And the results…

With respect to the first question, the researchers find that exclusive licensee patent citations increase significantly after exclusive licensing.  In other words, the company or entity that receives the exclusive license continues to research and invent as evidenced by the numerous patents that follow based on the licensed technology.

With respect to the second question, the authors find that non-licensee citations increase significantly after exclusive licensing.  In other words, even the people/companies that have no license to the technology continue to research and invent as evidenced by their numerous patents that follow based on the licensed technology.

Maybe it is time to rethink the rationale behind a government lab preference for non-exclusive licenses.