Harvard, Biogen Conclude New Genetics Agreement

Ethical Questions Raised Again

Harvard yesterday announced a business agreement with a firm carrying out genetic engineering, once again raising ethical questions about university-industry collaboration in biotechnology.

Officials said the University has obtained patents on a new process of producing proteins, like insulin, that is said to be more efficient and cheaper than previous methods.

Harvard has granted an exclusive license to use the process to Biogen N.V., an international biotechnology company chaired by former American Cancer Professor of Molecular Biology Walter Gilbert '53.

Gilbert and his research associates developed the genetic engineering techniques when the Nobel laureate was at Harvard in the 1970s.

Harvard will receive both a minimum yearly royalty, and royalties from the sale of goods produced using the Gilbert method.

Biogen and Harvard officials refused to detail the financial terms of the agreement, which was described as "standard" by Steven H. Atkinson '67, executive secretary of the University's Committee on Patents and Copyrights.

The granting of an exclusive license to Biogen follows a University trend in biotechnology, despite written and public statements by officials that the University prefers to grant non-exclusive licenses to any company that wants to develop a given invention.

Atkinson said that the Biogen license is one of about eight already granted by Harvard in biotechnology--all of which are exclusive.

But Atkinson stressed that the exclusivity was not unusual. Harvard, officials explained, will grant exclusive licenses if it believes it will speed development of a basic idea into tangible benefits for the public.

Officials explained that a company will often not develop a product if it believes that other companies will use advanced technology it has developed but is unable to protect.

"We were convinced that the development would take place faster this way than any other way," said Dean of the Division of Applied Sciences Paul C. Martin '51, who chairs a Harvard committee that reviews "technology transfer" agreements.

Martin and Atkinson stressed that, as in all cases where Harvard grants an exclusive license, the University retains a "march in provision Harvard has the right to regain the license after a certain period of time if the discovery is not developed satisfactorily.

While Harvard last year developed forms guidelines to regulate industry sponsorship of research officials stressed that this agreement effectively "predates" the procedures, though it is philosophically compatible with it.

When Harvard applied for the patent in 1978, it made the agreement to give exclusive licensing rights to Gilbert's company. Arkinson said.

Under the terms of the agreement Biogen said it would pay all the leagan tees lenthing from the effort to gain the patent, he added. Atkinson said that he was not sure of the exact amount, but estimated that this probably ranged into the hundreds of thousands of dollars.

The twisted nature of the patent process contributed to these costs. At about the same time Harvard applied for the patent, researchers at the University of California filed for a similar patent, launching lengthy litigation proceedings in the U.S. patent office.

The University of California, however, withdrew their claim about a year ago, clearing the way for Harvard's patent. The University also won a patent from the European Patent Convention.

New Development

Harvard's disclosure yesterday comes as the University is for the first time planning to grant non-exclusive licenses for a recombinant technique developed by a Harvard professor.

About 200 firms have been invited to apply for a license from a patent developed by Mark S. Ptashne, professor of Biochemistry and Molecular Biology, Atkinson said.

Last year, Harvard rejected granting an exclusive license for the method of two separate biotechnology firms. Ptashne is an active consultant to one of them.

Atkinson attributed the decision mostly to the fact that much of the technology involved in developing the process is already widely disseminated and would not require an unusual effort by one company.

Ptashne refused comment.

The different landing of the fiect a growing methratice of Harvard's policy on technology transfee maters. The Biogen agreements was concluded its Harvard was beginning to develop mechanism for dealing with the issue, and in a strict business sense it is believed that Harvard might have done better to grant a non-exclusive license on the Gilbert discovery.

Gilbert was unavailable for comment yesterday. But in a prepared statement he said that the methods described in the patent should be useful in the commercial production of proteins such as insulin, human search albumin, and other recombinant products.

The method is said to hold significant advantages over conventional protein production, where scientists must destroy the bacteria to recover protein. Under the new method, the cell secretes the protein and remains intact.

A Biogen spokesman said a commercial product from the technique is still several years away