Debunking the Myth: Your Genes are Patented

 

MYTH: YOUR GENES ARE PATENTED.

FACTS:  IT IS NOT POSSIBLE TO PATENT YOUR GENES

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

If genes aren’t patentable, what is?

Natural genes are not eligible for patenting, but artificial preparations of DNA molecules are, because they have new qualities that distinguish them from natural genes. Like other chemicals that are derived from nature (such as antibiotics or natural dyes), preparations of DNA molecules are patentable because they have been transformed through human intervention into something that is so different from the natural state as to qualify as new, useful, and man-made. This transformation begins with the purification and isolation of the natural DNA. But isolating and purifying is not enough. The resulting DNA preparation must have new qualities, advantages, and technical applications that allow it to be used in important new ways that are not possible with the natural gene, making it different not just in degree, but in kind. For these reasons, every nation in the developed world recognizes the patentability of such inventions.

How is a patented DNA preparation different from a natural gene?

Patented DNA preparations contain isolated DNA molecules that are stripped of everything that is necessary for the normal operation of a gene in its natural state. Such purified DNA molecules also are often reconfigured in ways that eliminate large parts of the genetic sequence of the natural gene, giving rise to DNA molecules that do not exist in nature. Such DNA molecules can be used in ways that are simply not possible with the natural gene – for example, to conduct gene transfer experiments, to make DNA vaccines, or to produce therapeutic proteins in large scale cell culture.

What else is required to make a DNA molecule patentable?

It is impermissible to patent a DNA molecule, even if isolated and purified, unless the scientist establishes the detailed biological function of the gene from which it was derived and identifies a credible, specific and substantial utility for it. Identifying a gene’s biological role and establishing a credible, specific and substantial use for the claimed DNA molecule are often harder than identifying the new gene itself, and certainly meets the standard thresholds for inventiveness. Furthermore, in every case, the inventor has to satisfy the “novelty” and “unobviousness” requirements under which the claimed DNA must be new and distinct from all preexisting scientific knowledge. Finally, the patent application must contain a detailed scientific disclosure that enables other scientists to replicate the invention.

Overall, identifying, deriving, characterizing and describing a DNA sequence in this way requires the same level of human ingenuity as synthesizing a new chemical, composing a new metal alloy, or other human creations that are commonly deemed patentable.

This post was authored by Hans Sauer, Ph.D., J.D. Deputy General Counsel for Intellectual Property at BIO and Adjunct Professor of Law, Georgetown Law.

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Media Coverage of BIO’s Intellectual Property Conference in Seattle

Stanford v. Roche: An Academic/Industry Collaboration Gone Wrong

A Landmark Case: The Aftermath of Myriad Genetics

Ethical Issues: Staying in the Frying Pan and out of the Fire

Myriad Oral Argument Review and Analysis by Patent Docs

Great comprehensive review of oral arguments at the federal circuit in the Myriad case by Kevin Noonan of Patent Docs.

BIO’s Intellectual Property Counsels Committee Seattle Meeting Topics

Join us for BIO’s Intellectual Property Counsels Committee Meeting in Seattle April 13-15.  You can find the session topics below.

Whose Rights Are They, Anyway? Implications from and a Discussion on Stanford v. Roche

The pending Supreme Court review of Stanford v. Roche has brought out multiple perspectives on the disposition of ownership rights in federally funded inventions under Bayh-Dole. This session will explore the different interpretations of the Act’s provisions, and their practical implications for small business grantees or biotech companies who wish to collaborate with federal grantees.

A Landmark Case: The Aftermath of Myriad

This session will provide an update on the status of the case and the arguments that have been made by the various amicus groups, with particular emphasis on the US Government’s brief. We will also explore the impact of “gene patents” on up-and-coming technologies, especially whole genome/whole exome testing.

The Business Case for International Humanitarian Approaches to IP Management and Collaborations

Guest Speaker:

Erik Iverson, Associate General Counsel, Global Health, Gates Foundation

 

Best Practices in Research Collaborations: Joint Inventorship Pitfalls and Ethical Issues in Joint Representation

Don Ware of Foley Hoag will lead a discussion of pitfalls that may arise from prosecuting joint inventions conceived in the course of research collaborations among multiple institutions, including companies, universities and hospitals. Irene Pleasure, Associate General Counsel and Director of Patent Law at Genentech, will provide the in-house perspective on managing patent issues in research collaborations. David Hricik, Professor of Law at Mercer University School of Law and co-author of the treatises Patent Ethics – Prosecution (2009) and Patent Ethics – Litigation (2010), will address the professional responsibilities of patent attorneys involved in the prosecution of jointly-owned patent applications.

How to Stay in the Frying Pan and Out of the Fire: Hot Topics in Ethics for In-House IP Attorneys

Professor David Hricik and Barbara Fiacco of Foley Hoag will present on developments in ethics law for in-house IP counsel, including law firm conflict issues, how to protect the attorney-client privilege, ethical dilemmas created by 21st century social media, in-house counsel ethical pitfalls, and recent developments in IP malpractice law. The game-show format of this panel will be thought-provoking and fun, and will encourage audience participation. CLE Ethics credit is being requested.

Learn How to Navigate IP Landscape in Emerging Markets

BIO members have indicated a strong desire to hear about challenges and key developments in emerging markets such as Korea, China, Brazil and India. Specific challenges, lay of the land, how to negotiate better in these markets.

Double Patenting

This panel will include new developments on the Boehringer Ingelheim Federal Circuit Case, collaboration of multiple parties/how to avoid double patenting rejections and possible coverage of the Sun v. Lilly case.

The Next Chapter: Biosimilars Beyond the Health Care Reform Act

Will Policy Issues Slow the Pace of Implementation? Will the FDA Look to Europe for Guidance on Antibody Biosimilars? Emerging Markets, Emerging Strategies? The panel will cover recent developments in biosimilar, including policy issues based on move to repeal healthcare reform, the recent FDA public hearing on biosimilars, further debate on the meaning of exclusivity, the necessity of clinical trials, the possibility of interchangeability, and developments in Europe with respect to antibody biosimilars.

BIO’s Intellectual Property Counsels’ Committee Spring Conference and Meeting: Seattle

Over the past eight years, BIO’s semiannual IP Counsels Committee Conference has become a popular and growing event among our members’ IP and legal professionals. Our upcoming 2011 Spring IPCC Conference in Seattle, WA on April 13-15 will be an excellent opportunity for IP professionals to hear, listen, and learn about current and projected topics related to biotechnology IP.

We invite you to join us in an informal, fun and informative setting to meet fellow in-house legal and IP professionals, to make new acquaintances, to reconnect with old friends in the industry, and to take home a wealth of information – and maybe some new ideas.

To Register

Session Titles:

1.  Whose Rights are They, Anyway?  Implications from and a Discussion on Stanford v. Roche

2.  A Landmark Case: The Aftermath of Myriad

3.  Best Practices in Research Collaborations: Joint Inventorship Pitfalls and Ethical Issues in Joint Representation

4.  How to Stay in the Frying Pan and Out of the Fire: Hot Topics in Ethics for In-House IP Attorneys

5.  Emerging Markets

6.  Double Patenting

7.  Biosimilars

Is the Myriad Case Decision and/or the DOJ Brief TRIPS Compliant?

Judge Sweet seemed to dismiss Myriad’s constitutional taking and TRIPS claims by indicating:

“Finally, Myriad’s suggestion that invalidating the patents-in-suit would constitute an unconstitutional taking in violation of the Fifth Amendment of the Constitution or a violation of the United States’ obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is unpersuasive. Myriad’s novel taking argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent. Similarly,Articles 8.1 and 27.3 of TRIPS permit governments to incorporate public health concerns into their intellectual property law and to exclude from patentability diagnostic, therapeutic, or surgical methods as well as particular inventions on the grounds of public interest. As a result, invalidation of the patents-in-suit would constitution neither a constitutional violation nor a conflict with the Untied States’ treaty obligations.” Pages 106-107. Emphasis added.

Alnylam’s Appellate Brief to the Circuit Court in the Myriad case argues that “excluding certain “compositions of matter” from patent-eligibility would violate the United States’ treaty obligations under the TRIPS Agreement.” pg. 17  The Brief goes on to discuss this legal issue as well as international policy implications.  pg. 18-19

Questions for thought:

1.  Would ‘isolated DNA’ even constitute an “invention” under TRIPS Article 27.1?  How do other nations view patentability of ‘isolated DNA’ and how does that affect a TRIPS analysis? See European Union Biotechnology Directive and WIPO’s “Information provided by WIPO Member States Concerning Practices Related to the Protection of Biotechnology Inventions.”

According to practice, a Dispute Panel would use the ordinary meaning of the word (probably from the Oxford English Dictionary) and look at common practice around the world.  Isolated DNA seems to meet the definition of ‘invention’ and the resources mentioned above seem to back up the assertion. 

2.  What about Alnylam’s “discriminatory… as to the field of technology” argument?  Does Judge Sweet’s opinion discriminate against DNA based patents and/or the Biotechnology Industry?  How does the DOJ’s Brief fare? 

Based on a WTO Dispute Panel analysis on discrimiation in a similar context (see CANADA – PATENT PROTECTION OF PHARMACEUTICAL. PRODUCTS), it seems that both Judge Sweet and the DOJ Brief are discriminating against DNA based patents and the biotechnology industry.  Judge Sweet creates a patentability exemption for ‘isolated DNA’ and DNA based inventions (to an unknown point).  The DOJ seem to create a new ‘isolation’ test which implicates much more than ‘isolated DNA’.  Both approaches specifically target the biotechnology ‘field of technology’ and have devastating effects on the industry.

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