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Oct 1, 2011 (Vol. 31, No. 17)

Highlighting the Course of Biotech Law

Patent Decisions Have Played a Pivotal Role in the Growth of the Industry

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    Gerry J. Elman, J.D.

    In August 1981 the National Law Journal proclaimed that “Genetic Engineering Creates a New Breed of Lawyer.”

    Fascinated by the headline, I devoured the article even though it didn’t say anything about artificial android attorneys. Rather, it reported that the previous year’s Chakrabarty decision by the U.S. Supreme Court had helped to unzip the wallets of venture capitalists, funding a field of start-up companies hoping to commercialize a cornucopia of wonders conceived in the labs of molecular biologists.

    The article identified a handful of lawyers spearheading these developments, and went on to quote a publisher who had recently planted an acorn in this fertile firmament.

    That publisher, of course, was Mary Ann Liebert, and the acorn was GEN, then too a start-up. Tracking her down by phone (not in the proverbial garage, but her Manhattan apartment) I introduced myself as aspiring to join the “new breed” of genetic engineering lawyers I’d just read about. Having taken a seminar in nucleic acid biochemistry while a graduate student at Stanford, then having become both a patent attorney and an antitrust lawyer with the U.S. Department of Justice, I figured I was as qualified as anybody.

    Coincidentally, the nativity of biotechnology patent law was just around the corner and Mary Ann was prescient enough to engage me to report on it.

    The first-ever training on the subject for patent practitioners was a seminar on “Genetically Engineered Microorganisms and Cells: The Law and Business” that Irving Kayton produced in New York City in 1981.

  • Predicting the Future


    Gerry J. Elman, J.D., discusses biotech’s biggest contribution to society over the past three decades and what will define the field over the next 30 years in skype interviews with John Sterling, GEN’s editor in chief.

    Kayton, a fiery law professor who founded a business to train patent lawyers called Patent Resources Group, foretold that advances in molecular biology would soon give rise to technologies that would spawn a whole new sector of human activity.

    Ever outspoken, Kayton prophesied medical developments that would lead to human immortality, while urging his off-Broadway audience of enthralled patent practitioners to brush up on, not your Shakespeare, but biochemistry and genetics. Because, as he accurately predicted, patent lawyers versed in that subject matter were destined to perform a pivotal role in the upcoming play.

    In the aftermath of my report in GEN of Kayton’s 1981 seminar, Liebert’s acorn was popping. She suggested that we generate a legal journal to chronicle developments in this field. As the term “genetic engineering” was becoming more focused on recombinant DNA, and it seemed that the broader term of “biotechnology” was entering the discourse, we chose to identify the subject matter as “biotechnology law,” probably the first time those two words were juxtaposed in print.

    At the time, we conceived a newsletter, something like the Antitrust & Trade Regulation Report I was regularly reading. We named the baby Biotechnology Law Report (BLR), which began publication at the beginning of 1982. Mary Ann instructed me to assemble an Editorial Board for BLR, and I promptly started asking colleagues to participate.

    Stephen M. Sammut, who’d attended Kayton’s seminar, signed on to manage the first issues with me. One of the first lawyers on the editorial board was Geoffrey M. Karny, who had contributed the legal section of the April 1981 study published by an arm of Congress, the Office of Technology Assessment, called “Impacts of Applied Genetics: Micro-Organisms, Plants & Animals.”

    Another who graced us on the editorial board with his presence from the outset was The Honorable Giles Sutherland Rich (1904–1999). Over the years, he joined us at gatherings in Washington, D.C., and stayed in touch until his passing at age 95, then the oldest living federal judge.

    As a member of the Court of Customs and Patent Appeals, Judge Rich had authored, in 1978, the initial appellate decision affirming the patent-eligibility of Dr. Chakrabarty’s organism. His written opinion paved the way to the favorable decision by the Supreme Court two years later, which quoted legislative history to say that Congress had intended patentable subject matter to “include anything under the sun that is made by man.”

    Before his appointment to the bench, Judge Rich had practiced patent law in New York City. As president of the New York Patent Law Association, he and chief patent examiner P.J. Federico famously drafted the major revision of U.S. patent law that was enacted by Congress in 1952. Among its innovations was a re-statement of the American test of what others have called “inventive height.”

    The 1952 patent act he is credited with co-authoring provides that a person be entitled to a patent for a novel and useful invention unless: “the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.”

    Schooled in the tension between antitrust principles favoring free and open competition and laws promoting protection of intellectual property, I was aware that a purpose for that provision was to overturn the unfortunate statement by the Supreme Court in 1941 in the Cuno Engineering case that a patentable invention arises from a “flash of creative genius.”

    The goal was to clarify that the patent system would protect inventions of a variety of “heights” even if enforcement of the patent would seem like a “monopoly” by preventing a second adopter of the invention from operating freely.

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