Innovation Alliance Event “Patents, Innovation and Job Creation: A Virtuous Circle”

An event is coming up on patents, innovation and job creation at the Newseum on Friday January 21.  The keynote speakers are  PTO Director David Kappos and Retired Chief Judge of the Federal Circuit Paul Michel. 

Other industry experts and executives will participate in panel discussions.  Below is the news release.

As the U.S. economy struggles with high unemployment, the Innovation Alliance hosts a half-day discussion with inventors, entrepreneurs, business leaders, and industry experts on the economic value of patents and a vigorous USPTO. The conference features remarks from David Kappos, Director of the U.S. Patent and Trademark Office, and Paul Michel, U.S. Court of Appeals for the Federal Circuit, Retired Chief Judge. Gene Quinn, founder of IPWatchdog, Inc and Kim Hart, reporter at Politico will moderate morning panels on creating jobs and the impact of patents on the modern innovation economy. Email Innovation Alliance to RSVP

Here is the advertisement with further details.

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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

BIO Commends Supreme Court for Expansive View of Patentability in Bilski Decision

Decision Recognizes ‘Machine or Transformation” Test May Not Apply To Biotech and Other New Technologies

Washington, D.C. (June 28, 2010) – The Biotechnology Industry Organization (BIO) released the following statement in reaction to the Supreme Court’s decision to uphold the lower court’s ruling in Bilski v. Kappos.

“In our amicus brief, BIO urged the Supreme Court to overturn the lower court’s rigid new test for determining whether a method or process is eligible for patenting. We are pleased that the Justices crafted a narrow opinion that does just that. The Court was clearly conscious of the potential negative and unforeseeable consequences of a broad and sweeping decision,” stated BIO President and CEO Jim Greenwood.  “This ruling specifically states that the ‘machine-or-transformation test is not the sole test for patent eligibility’ and recognized that the lower court’s ruling could have created uncertainty in fields such as advanced diagnostic medicine techniques.”

“In the Diamond v. Chakrabarty decision 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 other consumers around the world,” continued Greenwood.  “We are pleased that the Court made it clear in today’s decision that the patent system was designed to be broad and inclusive in order to promote innovation.  Strong intellectual property protection is critical to our nation’s economy and global competitiveness.”

In an amicus brief filed last year, BIO urged the Supreme Court to overturn the decision of the U.S. Court of Appeals for the Federal Circuit which 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 “machine-or-transformation” test was, until today, the only way to determine the patent-eligibility of a patent application before it is examined for novelty, inventiveness, and usefulness.

BIO’s amicus brief is available at http://bio.org/ip/amicus/documents/08-964tsacBiotechnologyIndustryOrganizationetal.pdf.

About BIO

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

IP Professors: 12-Year Data Exclusivity a Win-Win for Patient Access & Biotech Innovation

David E. Adelman of the University of Texas School of Law and Christopher M. Holman of the University of Missouri – Kansas City School of Law recently published analysis on the “sideshow” of the data exclusivity debate in Washington.

Adelman and Holman use a cost-benefit analysis that incorporates the most important legal precedents and case law today in concluding that “policymakers should focus on mitigating the systematic barriers to entry that pose much greater and longer-term obstacles to lower-cost biotech drugs.”  Specifically, the draft paper provides solid analysis of the need for 12-year data exclusivity, which the authors describe as a right balance between providing access to important medicines to patients, and creating the incentives needed for investors and companies to prepare (and survive) the regulatory approval process for follow-on biologics.

Much like tort reform, the debate over pending legislation on biotech drugs—and particularly regulatory supplements to patent protection—has taken on a significance that dwarfs its impact on overall health care expenditures. Under the pending Health Care Reform legislation, Congress would enact two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics, which are the analogues of generics for conventional drugs. Second, establishment of a twelve-year “data exclusivity” period during which clinical testing data collected by brand-name producers could not be used by competitors to satisfy FDA testing requirements. While the abbreviated FDA approval process enjoys broad support, the data-exclusivity provision has been hotly contested, including strong opposition from the Federal Trade Commission.  (Paper Abstract)

The paper flies through data that’s been collected for over 20 years on intellectual property and biotechnology in a clear way as to make the longer data-exclusivity proposal an obvious non-issue for Congress in the health care debate. That is to say:

The economic studies used by critics of supplemental patent protection conclude that a twelve-year period of data exclusivity is essential to the profitability [and thus investment and research likelihood] of biotech drugs… data exclusivity could encourage development of clinically important biologics that would otherwise be abandoned because robust patents on the active ingredient are unavailable… the health care savings would be nominal, as drugs account for only about ten percent of total health care expenditures in the United States.

It’s important to understand the connection between health care and biotechnology, without “killing the goose” that lays the golden (innovation) egg. The authors note that “the successes of biomedical innovation are paradoxically  at the root of the health care crisis… limiting the term of data exclusivity could also be counterproductive for everyone…. safeguarding high short-term profits through a twelve-year data exclusivity term stands to mitigate the difficulties of balancing innovation and patient access.”

You can visit Chris Holman’s blog at http://holmansbiotechipblog.blogspot.com.

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.

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).

IP Counsels Committee Conference in Phoenix Discusses Patent Reform

At the latest IP Counsels Committee Conference this past March, Q. Todd Dickinson, Executive Director of the American Intellectual Property Law Association (AIPLA), and E. Anthony Figg of Rothwell, Figg, Ernst & Manbeck, P.C., spoke to BIO’s member companies, universities, and law firm members about patent reform legislation.

Patent Docs‘ Donald Zuhn wrote about Dickinson and Figg on Patent Reform yesterday:

In the three weeks since the panel session took place, Senate Judiciary Committee Chairman Patrick Leahy (D-VT) has managed to get his bill voted out of Committee and placed on the Senate Legislative Calendar. However, as the patent reform debate readies for a move to the House, it is worth reviewing some of issues that were discussed at the IPCC panel session.

Why is it worth reviewing another one of BIO’s substantive conversations on the intellectual property system? This author knows, but you should visit Patent Docs, or call your Congressional representatives, for the details.

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).