BIO Urges Supreme Court to Reject Rigid Bilski Rule

New patent test has fundamental implications far beyond business methods

Washington, D.C. (August 6, 2009) – In an amicus brief filed today, BIO urged the Supreme Court to overturn the decision of the U.S. Court of Appeals for the Federal Circuit in Bilski v. Doll.

In its decision, the Court of Appeals created a new test under which a method or process is only patent-eligible if it is tied to a specific machine or if it transforms a particular article or substance to a different state or thing. This test, which has become known as the “machine-or-transformation” test, is now the eligibility threshold that a patent application has to meet before it is examined for novelty, inventiveness, and usefulness.

“In 1980, the Supreme Court defined patent-eligible subject matter in a flexible and inclusive way that has fostered the tremendous growth of biotechnology for the benefit of millions of patients, farmers, and consumers around the world,” stated BIO General Counsel Tom DiLenge.  “If the Court of Appeals’ contrary approach in the Bilski case is permitted to stand, it would create uncertainty that would negatively impact investment in biotechnology, and thus stifle future growth of this remarkably beneficial industry.”

The biotechnology industry is among the many stakeholders that are concerned about this new rule because it applies to all technologies, even though it was crafted to deal with business methods and abstract, disembodied processes involving logical operations and human thinking. 

“The implications of this case for biological, diagnostic, and personalized medicine methods that depend on biomarkers or other correlations between a genetic or physiological predisposition and disease-susceptibility or likelihood of treatment success must be carefully considered by the Supreme Court,” stated DiLenge.  “This new rule could be applied in biotechnology patent litigation with very unclear and unsettling results.”

“Requiring that biotechnology process claims be tied to a machine or a transformation could jeopardize already-issued biotechnology claims and will create uncertainty surrounding future grants of biotechnology patents in these areas,” DiLenge concluded.

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BIO IP News Weekly for June 26, 2009

This week’s BIO IP News Weekly includes an analysis of Professor John Duffy in Business Week, an essay on technology transfer and university-industry collaboration in the Scientist Magazine, updates on USPTO funding and follow-on biologics, a blogger’s look at a U.S. Senator’s struggles to defend intellectual property rights, as well as a link to the recently published 2009 OECD Biotechnology Statistics report summary.

Also, note that Managing IP is having a free webinar on green tech innovation and intellectual property next Tuesday, June 30, 2009.

CAFC Judge Rader: “Strong IP System Allows Countries to Compete in World Marketplace”

I recently discovered an interview series on the intellectual property system on YouTube, produced by CropLife International.  Of particular interest is the interview with U.S. Federal Circuit of Appeals (CAFC)  Judge Randall R. Rader (Watch: http://www.youtube.com/watch?v=tB3OROLi9IM). I liked the way Judge Rader defined intellectual property: a way to protect the “know-how” of any economic entity (company, university, and individual) to do business in today’s global marketplace.

During the interview, Judge Rader focused on a part of the intellectual property system often left assumed by audiences professional, but ignored by audiences general: the importance intellectual property in building a solid economic foundation.  Like currency, without a mutual agreement on how much a dollar is worth — or how valuable a patent is — its hard to fund research or bring a new product to the marketplace.

I visited the United Nations Millenium Goals for further analysis: http://www.un.org/millenniumgoals/.  The goals have a target date of 2015, less than 6 years away. Among the goals were the end of poverty and hunger, maternal as well as children’s health, combatting HIV/AIDS, environmental sustainability, and global partnership. It’s exciting to see countries, one by one, supporting progress on behalf of their citizens.

Its hard to see how strong intellectual property rights can help humanity solve any of these problems — if you don’t know where to look. But if you talk to folks in the know about IP, they can tell you stories:

1. A university researcher whose child was diagnosed with a rare disease, and inspired that same researcher to dedicate his/her life to finding a cure. The researcher discovered an important part of the solution and now works for a biotechnology company, who uses the company’s intellectual property assets to get funding for further research, clinical trials, hoping to bring a product to market to the world and to their child;

2. A country that, after winning their national independence, seeks to build its economy using the traditional knowledge of its indigenous people;

3. A university working with a pharmaceutical company through technology transfer to begin funding research it would have otherwise been unable to afford;

4. A non-profit organization’s CEO, who while working with doctors in an inner-city clinic discovers a faster way to detect (called a diagnostic) early on-set of a disease. The non-profit then uses the knowledge, in an agreement with further funding from universities or companies or government entities, to patent the discovery. The patent eventually helps bring the diagnostic to market.

While no one knows how the struggles meeting our Millenium Goals will be described in 100 years, it is certain that a strong intellectual property system allows every country to provide a chance for its citizens to bring their good idea to the table.

A convergance occurs, then, between our goals for the world and our rights in a strong intellectual property system: a convergance producing solutions and a better world.

Below are two additional interviews on intellectual property within the series worth noting:

Carrie LaCrosse (http://www.youtube.com/watch?v=FCD54T-S1Xg)

Carrie LaCrosse (Office on Intellectual Property Enforcement, US Department of State) discusses the value of IP for agriculture, looking in particular at new plant varieties and how IP is part of the solution in addressing the issues of food security.

Howard Minigh (http://www.youtube.com/watch?v=EZZxke_-bkY)

Howard Minigh (CEO and President of CropLife International) discusses the importance of IP for agricultural production. With the world population increasing, more food will need to be produced on less land. IP rewards innovation, and encourages further investment in solutions that address food security issues in a sustainable manner.

CropLife International is a “global federation representing the plant science industry and a network of regional and national associations in 91 countries… committed to sustainable agriculture through innovative research and technology in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology” (website, here).

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).