Recent Federal Register Notices

 A collection of Federal Register Notices dating back to November 5th. 

Mainly for Small and Medium sized Enterprises: (SME) Government Programs to Assist Businesses Protect Their Intellectual Property Rights (IPR) in Foreign Markets; Notice of Extension of Comment Period

PTO Proposed Rule: Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals

PTO Notice: Expansion and Extension of the Green Technology Pilot Program

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 29th, 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

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

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.

IPWatchdog Blog: “In Search of Technology Transfer Best Practices”

Gene Quinn of IPWatchdog.com covered the BIO-AUTM Technology Transfer Symposium this past week, on May 4, 2010 at the 2010 BIO International Convention.

The Symposium attendees were high-level experts on technology transfer policy looking to get to the “brass tacks” of issues concerning innovation, federally funded research, and creative licensing schemes for product development in the United States.

Below is a quotation from IPWatchdog’s coverage:

Last week while at the 2010 BIO International Convention, I attended the Tech Transfer Symposium, which was held on Tuesday, May 4, 2010 at the Hyatt Regency Ballroom at McCormick Place. I had previously arranged an interview with Linda Katehi, Chancellor of the University of California (Davis), a transcript of that conversation appears below. At the outset of the Tech Transfer Symposium Katehi gave an introductory presentation on technology transfer that lead into a panel discussion.  As an Electrical Engineer, Professor and now Chancellor in the UC system, Katehi has a lot of experience with technology transfer, and for those Universities struggling to figure out how to license out technology in a successful manner they could learn an awful lot from Katehi. Her presentation and the time I spent thereafter with her continued to facilitate my understanding of why some Universities succeed and others fail.

Katehi also has some interesting suggestions regarding what the Patent Office could do to help Universities, both in speeding up the patent process and in keeping costs lower.  I learned a lot from speaking with Katehi, which supplemented my knowledge based on my experiences at Syracuse University.  What I am continually piecing together suggests that there is no great surprise why most Universities do not do a better job with respect to technology transfer.  There are things that are clearly considered best practices in the private sector that seem to elude Universities for the most part.  The University of California system seems to be out in front and trying to bring the best practices of the private sector into Universities.  It is no wonder they do a better job than most with technology transfer.

Full summary of the BIO-AUTM Technology Transfer Symposium:

Today’s Technology Transfer Symposium’s panel on The Role of Universities, Biotechnology Companies and Technology Transfer in the Innovation Economy included an active debate on issues ranging from increasing the odds for a successful partnership and the pros and cons of the Bayh-Dole Act.  Andrew Cittadine, Co-founder & CEO of American BioOptics, Linda P.B. Katehi, Chancellor of the University of California (Davis), Steve Mento, President and CEO of Conatus Pharmaceuticals, Inc., and Tom Skalak, Vice President for Research, University of Virginia, all participated in the conversation, moderated by Robin A. Chadwick of Schwegman, Lundberg & Woessner.

Skalak noted during the panel that one of the keys to a successful partnership is “diverse eyeballs on the project,” which can help in making good decisions.  As an example, he pointed to a deal his university is involved in with AstraZeneca.  Cittadine underscored the importance of finding a good fit between the university and the biotech firm.

In discussing Bayh-Dole, all the panelists agreed that the Act has brought a lot of benefit to the industry, although there is room for improvement.  The Act “provides incentives to institutions to bring research to the marketplace,” explained Katehi.  Under Bayh-Dole, “ideas can emerge,” she added.  While she acknowledged that changes are needed, Katehi explained that if the Act is eliminated “there will be millions of good ideas, but no process for bringing them forward.”

Mento agreed, stating, “Bayh-Dole made the biotech industry possible.”  He noted that the system worked in the beginning, but it has now “evolved into a system where the focus is on short term return.”  It’s “impossible” to make the economics work, Mento said.

Cittadine added, the framework in Bayh-Dole is what enables new ideas to get funding.  Skalak, meanwhile, noted that without Bayh-Dole, discovery-oriented research would not happen.

Did you attend the Symposium? Interested in materials, or in joining the BIO Technology Transfer Committee? Email me at mnoriega@bio.org.

Policy Leaders Discuss U.S. Innovation Economy at BIO-AUTM Technology Transfer Symposium

Today’s Technology Transfer Symposium’s panel on The Role of Universities, Biotechnology Companies and Technology Transfer in the Innovation Economy included an active debate on issues ranging from increasing the odds for a successful partnership and the pros and cons of the Bayh-Dole Act. 

Andrew Cittadine, Co-founder & CEO of American BioOptics, Linda P.B. Katehi, Chancellor of the University of California (Davis), Steve Mento, President and CEO of Conatus Pharmaceuticals, Inc., and Tom Skalak, Vice President for Research, University of Virginia, all participated in the conversation, moderated by Robin A. Chadwick of Schwegman, Lundberg & Woessner.

Skalak noted during the panel that one of the keys to a successful partnership is “diverse eyeballs on the project,” which can help in making good decisions.  As an example, he pointed to a deal his university is involved in with AstraZeneca.  Cittadine underscored the importance of finding a good fit between the university and the biotech firm.

In discussing Bayh-Dole, all the panelists agreed that the Act has brought a lot of benefit to the industry, although there is room for improvement.  The Act “provides incentives to institutions to bring research to the marketplace,” explained Katehi.  Under Bayh-Dole, “ideas can emerge,” she added.  While she acknowledged that changes are needed, Katehi explained that if the Act is eliminated “there will be millions of good ideas, but no process for bringing them forward.”

Mento agreed, stating, “Bayh-Dole made the biotech industry possible.”  He noted that the system worked in the beginning, but it has now “evolved into a system where the focus is on short term return.”  It’s “impossible” to make the economics work, Mento said.

Cittadine added, the framework in Bayh-Dole is what enables new ideas to get funding.  Skalak, meanwhile, noted that without Bayh-Dole, discovery-oriented research would not happen.

MIT: Stanford v. Roche “Could Have Adverse Impact on Tech Transfer”

Link to MIT News article (“MIT to file amicus brief in intellectual-property case“):

The brief argues that the case threatens to undermine the Bayh-Dole Act, a federal law that has played a central role in America’s system of innovation. Enacted in 1980 as an amendment to the Patent Act, Bayh-Dole expanded and accelerated the transformation of ideas in the lab into the products, jobs and revenues of commercial enterprise.

A Disin‘gene’uous Lawsuit: ACLU Challenges DNA Patents

From the mass production of life-saving medicines in cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules (often referred to as “gene patents”) are used in many ways to benefit society.

The term “gene patent” is something of a misnomer because genes as they exist in the body cannot be patented. A naturally occurring gene — even a newly discovered one — cannot be patented. Patents don’t provide ownership rights over genes newly discovered in our bodies, and nobody can infringe a patent by having a certain gene or by passing it on to their children.

Artificial preparations of isolated and purified DNA molecules, on the other hand, are patentable because they are chemicals with new qualities that fundamentally distinguish them from natural genes. Like other patentable chemicals that are derived from nature (such as antibiotics or organic dyes), purified preparations of DNA are patentable because they have been transformed through human intervention into something that is so different from the natural state that it qualifies as something new, useful, and man-made.

This transformation begins with the purification and isolation of the natural DNA, which strips it of everything that makes it capable of functioning like a natural gene. The resulting DNA preparation has new qualities, advantages, and technical applications that allow it to be used in important new ways that are not possible with the genes that exist in our bodies.

The inventor must also establish the detailed biological function of the gene from which the preparation was derived, and the claimed DNA must be new and distinct from all preexisting scientific knowledge. Finally, the inventor must disclose in a patent application a detailed scientific explanation that enables other scientists to replicate the invention. Identifying, deriving, characterizing and describing a DNA sequence in this way requires at least as much human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.

In May of 2009, the American Civil Liberties Union (ACLU) brought a lawsuit in the U.S. District Court of the Southern District of New York to challenge several patents owned by the University of Utah Research Foundation that relate to genetic testing for the BRCA1 and BRCA2 breast cancer genes. The licensee of these patents, Myriad Genetics Inc., the directors of the University of Utah Research Foundation, and the U. S. Patent and Trademark Office were all named in the lawsuit. The ACLU has indicated that this is intended as a test case to broadly invalidate human gene patents as unpatentable and unconstitutional.

This lawsuit aims to broaden access for clinical test providers and patients to patented genetic tests, but the legal arguments in the case reach far beyond breast cancer genetic testing, human gene patents, or even gene patents generally. If the ACLU’s legal arguments were adopted, whole classes of patents that today protect biologic drugs, biotechnology manufacturing processes, and other molecular biology inventions could be invalidated or drawn into question. Denying patent protection for such basic molecular biology inventions would not only impact genetic testing, but also remove incentives for the development of biologic therapeutics and personalized medicine products for many unmet medical needs.

In our amicus brief on the case, BIO argues that decades of case law support the patentability of DNA-based inventions and, further, that patents claiming isolated DNA molecules are an important part of the intellectual property portfolios of many biotech companies. If DNA-based inventions were not patentable, these companies could be deterred from funding further gene discovery efforts and would find it much harder to attract the investment necessary for the lengthy and expensive process of producing life-saving therapies and diagnostics.

Late in March, a federal district judge ruled some of the patents at issue in the ACLU case were products of nature that were not patentable under the Patent Act. While BIO believes this decision is in error, it is important to note that the judge explicitly excluded from his consideration of the issues the ACLU’s allegations that patents supposedly stifle research or impede patient access to genetic tests — allegations that BIO argued were contrary to the repeated findings of well-regarded research on this question. Further, the judge’s invalidation of the diagnostic method claims in the ACLU case was done under a Federal Circuit opinion (In re Bilski) that will soon be clarified further by the Supreme Court.

BIO also notes that the District Court’s determination is only a preliminary step in the legal process, does not affect how the U.S. Patent and Trademark Office (PTO) evaluates patent applications relating to DNA-based inventions, and is not binding on any other courts. Myriad Genetics has indicated that it will file an appeal to the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., and some legal analysts predict that the Supreme Court eventually could hear the case.

Additional background materials on gene patenting can be found here.

This article is by BIO’s Associate General Counsel for Intellectual Property, Hans Sauer.

Burrill Report Podcast: Implications of Gene Patent Ruling

April 5, 2010 – The Burrill Report interviews a university professor on the impact of the recent decision invalidating patents on genetic materials:

On March 29, a federal judge invalidated seven Myriad Genetics and University of Utah Research Foundation patents relating to two genes linked to breast and ovarian cancer in a decision that surprised patent attorneys. If upheld on appeal, it could alter the landscape for thousands of other gene patents held by biotechnology and diagnostics companies. We spoke to Ken Chahine, a visiting professor of law at the University of Utah about the decision, what it means to the industry, and whether companies that rely on such patents will need to rethink their business models.

Listen to the podcast here.

Tomorrow: BIO is “To the Point” on Gene Patenting

BIO is participating in an NPR segment at approximately 2:08pm ET tomorrow, Friday, April 2, 2010, on the nationally-syndicated national radio program “To the Point” which originates in NYC.  It should air on WAMU in DC, too, for those of you in the Nation’s capital.

BIO’s Deputy General Counsel for Intellectual Property, Hans Sauer, will be joined by:

  • ANDREW POLLACK: Correspondent for The New York Times. He has covered the business and science of biotechnology since 2000.
  • DR. MARY CLAIRE KING: American Cancer Society Professor of Medical and Genome Science, University of Washington
  • ARTHUR CAPLAN: Director of the Center for Bioethics, University of Pennsylvania
  • HANS SAUER, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization

Ways to tune in: Listen on the radio:

• See a list of NPR stations that carry On Point.

Listen online:

• You can listen live on the web by choosing a live stream from WBUR.

Subscribe to the podcast:

• You can get the On Point podcast by following the instructions on WBUR’s podcast page.

More about the show:

Hosted by Warren Olney, To the Point is a fast-paced, news based one-hour daily national program that focuses on the hot-button issues of the day, co-produced by KCRW and Public Radio International. Featuring three discrete segments – Newsmaker, Defining the Story, Reporter’s Notebook – To the Point presents informative and thought-provoking back-and-forth discussion. A mix of guests cover a range of concerns – politics, international affairs, technology, the environment – the front-page stories that attract a savvy news audience.

(Source: http://www.onpointradio.org/ways-to-listen)