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Law and Genomics

The Information Society Project is taking the lead in addressing the complex legal, social, ethical, and policy impacts of the genomic revolution, including outlining the benefits and harms created by intellectual property and patent claims on biological entities.

In the past few decades, patent filings in biotechnology have become an almost mandatory part of the progression of science itself. Defensive intellectual property policies and aggressive patent protections sought by universities, companies, and individuals for new biotechnologies made 2006 the year with the most patents ever filed at the United States Patent and Trademark Office (USPTO) for DNA-related inventions. However, the varied impact of exclusive ownership and rights over parts of the human genome, and other organisms' genomes, has prompted calls for reform and restructuring from academics, lawmakers, non-governmental organizations (NGOs), and even from companies within the biotechnology industry. In order to address the myriad issues raised by intellectual property (IP) in the medical and life sciences, a broad perspective is needed that not only includes the expertise of scientists, politicians, social scientists, economists, and lawyers, but also the input from the those patients and institutions affected by this relatively nascent form of property rights.

The Yale Law School is just such a place where many varying opinions are weighed and considered, and serves as a fertile framework for engaging in difficult IP issues. The Genomics, Ethics, and Law (GEL) Project at Yale Law School works with members of the Information Society Project (ISP) and other fellows to tackle these issues. We work faculty and researchers at the Medical School to put immediate traction to the abstract concepts and plans created at the Law School. From this base of amalgamated ideas, we pursue four goals:

  1. To examine the standards and guidelines in place for patents relating to biological entities (BEs, from the molecule to the entire
    organism).
  2. To research and document both the benefits and harms created by intellectual property and ownership of BEs (medically, economically,
    scientifically, sociologically).
  3. To write, promote, and comment upon legislation that reforms current patent law, both nationally and internationally.
  4. To educate and inform academics, governments, businesses, and laypeople of our findings through printed and online publications, symposiums, and open classes.
To achieve these goals, we work with members from The Public Patent Foundation, the National Academy of Sciences, and Universities Allied for Essential Medicine.