White House Picks Kappos to Lead USPTO

Yesterday the White House nominated David J. Kappos for Under Secretary of Commerce for IP and as the Director of the United States Patent and Trademark Office (USPTO). BIO released its commendation on the nomination today:

“We believe Mr. Kappos will bring a thoughtful perspective to the Department of Commerce and the USPTO. He has a long history of industry experience, providing a point of view and insights we have always thought to be highly valuable in this position. He also has a demonstrated track record of managing a large organization, and a true appreciation for industrial innovation.

“As a prominent and respected member of the patent community, Mr. Kappos brings much goodwill to this position. We look forward to working with him and his leadership team over the coming years.


BIO sent a letter to the Obama Administration outlining ideas for PTO reform in December 2008.


BIO to USA Today: Patents Promote Innovation

BIO President & CEO James Greenwood published an op-ed piece in yesterday’s USA Today on how “patents promote innovation”:

Public debate over access to, and use of, genetic technology is a good thing. It requires the consideration of many factors, including coverage and cost, concerns over genetic discrimination and myriad regulatory issues.

Even so, banning patents on gene-related breakthroughs would slow biomedical innovation to a halt — taking away the hope biotechnology offers to patients suffering from debilitating diseases such as cancer, Parkinson’s and HIV/AIDS — while doing nothing to address what is really a much more complicated set of issues.

You can post a comment (we assume you have one) at USA Today, and take PatentlyBIOtech’s poll below:

A Stimulated NIH Discovers the Devil in the Grant Details

In February, Congress awarded the National Institutes of Health with stimulus funds to the tune of $10.4 billion through the American Recovery and Reinvestment Act of 2009 (Recovery Act). The funding is directed towards helping the United States improve its “scientific infrastructure”: education initiatives, research, “investment in biomedical research and development, public health and health care delivery” (NIH Press Release), including $400 million for comparative effectiveness studies.

Acting National Institutes of Health Director, Raynard S. Kington, MD, has done an excellent job of diversifying the kinds of projects that funding will support, as well as looking for solutions to some of the more, well, I’ll call them opportunities for growth (read: beaurcratic red tape).

Science Magazine further describes these opportunities in the April 17 edition article “NIH Stimulus Plans Triggers Flood of Applications—and Anxiety.”

Grant applicants question whether the NIH has the capacity to manage the tsunami of applications.  Researchers in the Science article also ask if the NIH baseline funding “will grow at anywhere close to the rate needed to handle the blizzard of new ideas and expanded scientific work force” that the Recovery Act funding will produce once the stimulus funds expire. This would allow the projects to continue, if further research was recommended.

Additionally, an April 24 Burrill Report podcast (http://www.burrillreport.com/article-1311.html) interviews Reg Kelly, Director of the California Institute for Quantitative Biosciences (QB3), about whether the stimulus could slow down discoveries. University researchers, seeing state and alumni funding cuts, will spend all of their time preparing grant applications.  Researchers are forced to ignore current projects during the application process. Even if they do receive funding, they will face a technology transfer system that isn’t quite ready for a grand influx of fresh ideas just “waiting” to get picked up for further research & development. Kelly further asks if the technology transfer community is collectively incentivized (and collectively capable) of prioritizing funding for stated NIH priorities like personalized medicine, vaccines (read today: swine flu), cancer, and HIV/AIDS research.

While the stimulus created an “innovation backlog”, it can only be a good thing. For the next two years, NIH programs like “Grand Opportunities” and “Challenge Grants” will enable today’s bright minds to forge new paths into health and environmental sustainability – at least for the next 2 years, when the grant rivers run dry.  In 2012, the new challenge will be utilizing the innovation boomtown the stimulus will have inevitably created. 

If the stimulus succeeds in providing researchers enough funding to help form ideas to improve the world, it will take just as much effort for the biotechnology industry to turn that research into tangible products for a global audience.

Next question: Are the other United States federal agencies (FDA, USDA, and USPTO among them) ready to usher these innovations into the economy?

The Blunders of In Re Kubin

Biotechnology discoveries are made through a complex and lengthy process, often using well-established and validated research methods. But does the routine use of the tools of molecular biology mean that these discoveries aren’t inventions? On April 3, 2009, a U.S. Federal Circuit of Appeals decision (In Re Kubin, read here; read BIO’s amicus filing here) distorts the definition of what a patentable discovery is for the biotechnology industry, but may have a wider impact on all discoveries granted patents in the United States.

The decision logically conflicts with a long history of court decisions, and leaves one asking a simple question: Why?

Researchers pursue discoveries using existing research tools in a process called the scientific method. Researchers hope that by forming a hypothesis, and by testing that hypothesis with tools that have helped previous researchers in their field, their work will eventually lead to a discovery. In all areas of scientific inquiry, the scientific method and research tools are time-tested, reliable, and are not the discoveries themselves. To the U.S. Patent & Trademark Office, the tools and methods are used to make, find, or produce discoveries which are called “patentable inventions.” For example, if you’re a mechanical inventor, and you put together a new machine using known components like screws and bolts in the “prior art” (think of prior art as a master patent database), you can still invent a new, patentable machine. No one would argue that the machine was not new (or “obvious”) because the screws and bolts were already in the prior art. No one would say the new machine (let’s say it combs your hair and reads you romance novels simultaneously) was obvious because other inventors knew how to turn a wrench like you at the time you invented the machine. In other words, no one could correctly claim other inventors would have known to build the same machine just because of the tools or method you used.

In the course of the U.S. Patent & Trademark Office’s existence, the determination of an invention’s improvement over the prior art (called “novelty” and “nonobviousness”) has been made by comparing inventions to previous inventions in its field. Novelty or nonobviousness is not determined by comparing the tools/method used to create the invention to the tools/methods used in the field. At least, not until In Re Kubin. In Re Kubin tells biotechnology inventors that if they work in similar lab setups and use the same starting point, and test their hypotheses the same way with the same lab tools, what they discover is the same thing.

Second, In Re Kubin creates a burden on inventors to show that their invention wasn’t even possible at the time: something was unexpected, something really didn’t go according to plan. But sometimes we discover new things without anything going “wrong”. Biotechnology inventions are often created as a result of using reliable tools/methods in new areas of research to find new discoveries. If taken to its logical conclusion, In Re Kubin would make many biotech inventions that we now think are legitimate inventions obvious because of the used tools or methods in the process of their discovery, and would make it much harder to get a patent for what today are legitimate discoveries and patentable inventions.

Third, we don’t know where Kubin’s reasoning stops. In Kubin, a protein blot on a gel made the later-discovered gene unpatentable because it would have been obvious to any scientist to try routine cloning methods to get to the same result. Sure: “obviously,” many scientists would have wanted to discover that gene, and the tools for doing so apparently existed. But Kubin discovered it first.

Would the Patent Office rather that Kubin hadn’t even tried? What about further discoveries that build upon Kubin’s gene? Are those also unpatentable if they are made with routine research tools and methods? What about a medicine that might one day be developed based on Kubin’s discovery? Is that also just the result of routine experimentation, undeserving of a patent?

Fourth, In Re Kubin may have a damaging impact on information sharing within the scientific community. Inventors will have to protect their tools and methods used in the discovery process. It’s going to stifle information sharing in the scientific community, and will delay solutions yet to be found for today’s health, environmental, and industrial problems.

In Re Kubin is a legal “hindsight” blunder: If an inventor could have guessed (with or without any background knowledge) in a million years that his/her discovery could be made, then it must have been obvious in the prior art at that time.

Hindsight is 20/20… and harmful in determining the patentability of any invention at the time of its discovery.

This post was co-written by Hans Sauer, Associate General Counsel, and Margarita Noriega, Coordinator of IP & Bioethics, at the Biotechnology Industry Organization (BIO).

US Court of Appeals for the Federal Circuit Issues Decision in Tafas v Dudas

Read the Decision here: http://tinyurl.com/ce6o7r

Read BIO’s Comments to the US Patent and Trademark Office on Proposed Rule Changes Concerning Claims Containing Alternative Language: http://www.bio.org/ip/domestic/20071009.pdf

Help the United States Patent and Trademark Office (USPTO)

Recently our President & CEO, Jim Greenwood sent a letter to President Obama, congratulating him on his historic election, and providing him with a few suggestions as to how to improve things at the USPTO.

For those of you who aren’t super-familiar with the USPTO, let me just say that they have been charged with the processing of patent applications and granting patents.
Patents, as our sixteenth president, Abraham Lincoln very eloquently said, “add the fuel of interest to the fire of genius, in the discovery and production of new and useful things”. Consequently, the USPTO has made important contributions to our nation’s technological and economic progress by granting patents that serve as an incentive for innovation.

Unfortunately however, today the USPTO is an agency in crisis. There are more than 1.2 million patent applications pending before approximately 6,000 examiners. Despite a dramatic increase in staffing, the USPTO has been unable to keep up with the increasing number of new applications. This in turn has created concern by some about the quality and timliness of the patents being granted. As a result, there are many proposals for reforming the patent system, not all of which would actually get to the crux of the problem.. which is that the USPTO has limited resources to tackle an extraordinary amount of work. We think we have a solution that will help the USPTO meet its workload challenge and also improve the quality of the patents it grants.

This is just the beginning. To help the USPTO we submitted our letter.

Let us know what you think. How can we help the USPTO?