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`clear that DOE will not withdraw the
`regulations entirely, as many of the crit-
`ics have urged. Restrictions are needed,
`he said, because of the widespread inci-
`dence of terrorist-related violence.
`This rationale drew a sharp response
`from Allan Adler,
`speaking for the
`
`American Civil Liberties Union. Arguing
`that DOE's regulations should be seen in
`the context of other Reagan Administra-
`tion attempts to restrict access to infor-
`mation, Adler argued that the Adminis-
`tration's "obsession with purported ac-
`tivities of foreign agents and lurking ter-
`
`rorist threats continues to push it toward
`increasingly dubious practices of infor-
`mation control."
`DOE is planning to hold a public hear-
`ing in Chicago in late September, and
`will then begin the process of drafting the
`final rules.-COLIN NORMAN
`
`Columbia Awarded Biotechnology Patent
`Columbia University has been assigned the ownership of
`a patent covering genetic engineering techniques that might
`become widely used in the biotechnology industry. The
`patent covers both the procedures for moving genes into
`cultured mammalian cells and the products that result from
`such procedures. It is based on the research of Richard
`Axel of Columbia College of Physicians and Surgeons and
`his collaborators Saul Silverstein and Michael Wigler, who
`is now at Cold Spring Harbor Laboratory.
`Although it is too soon to estimate the likely commercial
`success of the patent, the procedures developed by Axel
`and his colleagues are being used extensively in basic
`research. Mammalian cells may also
`have some advantages over microbes-
`now the favored host cells for gene-
`engineering-for
`useful
`synthesizing
`proteins on a commercial scale. Though
`microbes are generally easier and cheap-
`er to grow, they frequently do not se-
`crete protein products into the growth
`medium, thus necessitating sometimes
`expensive recovery procedures. Mam-
`malian cells also may be better suited
`than microbes to produce certain com-
`plex proteins. "Large companies with
`huge facilities for animal cell culture"
`already exist, Axel says. For them, the
`_
`inherent advantages in the mammalian- Richard Axel
`based genetic technology might out- Has several other
`weigh any alternatives.
`The patent, which contains 73 claims, is the first granted
`of several that Axel and his various collaborators have
`pending. This patent* describes a process called cotrans-
`formation whereby two or more unrelated genes are moved
`simultaneously and integrated stably into mammalian cells
`growing in vitro. One of those genes serves to improve the
`chances for accompanying genes, whatever they happen to
`code for, to move successfully into the recipient cells,
`according to Axel, who notes that this research appeared in
`the scientific literature 3 years ago.
`There are a number of strategies for synthesizing useful
`proteins in mammalian cells, each with its own advantages.
`The principal alternative to cotransformation is to use viral
`genes to bring other genes into cells. Its main disadvantage
`is the inevitable presence of those viral genes, which in
`some instances carry oncogenic (malignant) potential into
`cells. Axel's procedure avoids this risk. Moreover, he
`says, the use of cotransformation may broaden the choice
`of host cells and facilitate the playing of "genetic tricks" in
`
`/
`F I
`
`v00
`
`which a desired gene can be amplified a thousandfold or
`more. Some of those tricks as well as procedures for
`controlling cotransformed genes are described in applica-
`tions still pending before the Patent Office, he says.
`Because this research was performed at Columbia, Axel
`and his colleagues have assigned full ownership rights to
`the university. The office of science and technology at
`Columbia is planning to offer this know-how to industrial
`partners on a nonexclusive basis, according to William
`Ragan, who heads the office.
`The granting of such a broad patent to Axel and his
`collaborators could be a sign that the Patent Office will not
`become overly strict in judging applica-
`tions in the genetic engineering field.
`Observers have speculated that the delay
`of Stanford University's patent applica-
`tion-which covers products resulting
`from recombinant DNA-based proce-
`dures undertaken in microorganisms-
`is, in part, due to the broad nature of its
`claims. That patent application is based
`on methods developed by Stanley Cohen
`of Stanford and Herbert Boyer of the
`! University of California, San Francisco.
`viE <c Though a patent was granted for the
`^ X processes they described, an application
`Z covering products resulting from the
`technique has been pending for several
`years.
`The Columbia University patenting
`experience thus is different from Stanford's. "We captured
`both in one," exults Columbia's Ragan, referring to the
`process and product claims embodied in the Axel patent.
`Another difference is that Columbia has sought patent
`protection for these cotransformation procedures outside
`the United States. Stanford sacrificed such protection
`because Cohen and Boyer disclosed their techniques be-
`fore applying for patents in Europe and Japan. (The U.S.
`Patent Office permits a 1-year grace period after public
`disclosure before disqualifying an application.)
`At Columbia, inventors are assigned a portion of net
`royalty income that might result from licensing agree-
`ments, according to Ragan. The normal policy calls for net
`revenues to be apportioned to the inventors, to the inven-
`tors' labs (or some other inventor-designated fund within
`the university), and to the university's general revenues.
`The formula for this distribution varies, depending on the
`amount of the net income from royalties, but it is intended
`to provide both a direct incentive to the researchers and a
`means "to plow money back into the research area,"
`Ragan says.-JEFFREY L. Fox
`
`rents pending.
`pat
`
`*U.S. patent 4,399,216.
`
`2 SEPTEMBER 1983
`
`933
`
`Merck Ex. 1058, pg 1421