Boston, Massachusetts 2020-10-17 07:00:41 –
FForty years ago this week, five events that shaped the future of the biotechnology industry and bioscience research took place in less than two months. Looking back on these significant events can remind us of the strange ways in which change occurs.
Event 1: Nobel Prize
Early on Tuesday, October 14, 1980, the phone rang at Paul Berg’s house in Stanford, California. Berg’s father was old and ill, so the phone ringing worried Berg and his wife, and they were afraid of the worst. Instead, Berg heard the voice of his colleague Arthur Kornberg at Stanford University and said Paul had won the Nobel Prize in Chemistry. The Royal Swedish Academy of Sciences couldn’t find Berg’s private phone number, but one of Kornberg’s sons heard the news on the radio early in the morning and called his father who called Berg.
Berg won half of the year’s awards for basic research on nucleic acids and “specific aspects of recombinant DNA.” The other half was shared by Frederick Sanger and Walter (Wally) Gilbert on their findings on how to sequence DNA.
Many scientists at Stanford and elsewhere have made important contributions to the development of recombinant DNA. Some wonder why Berg was the only recipient. Awarding prizes is always difficult, and there are no more than three winners for any prize (except for the Peace Prize), especially under the voluntary restrictions of the Nobel Committee.
When the Chemistry Commission decided to allow Sanger and Gilbert for sequencing (each made substantial progress in very different ways), there was only one slot for recombinant DNA. It was. There is no doubt that Berg and his lab contributed significantly to this area and were the driving force behind its progress. But Berg had another role to make him stand out from the crowd.He was definitely the leader Include Leader, organization of temporary moratorium on recombinant DNA research, and organization and operation of the famous Asilomar Conference on Recombinant DNA where the moratorium was discussed.
Event 2: Biotechnology IPO
Almost as soon as he learned that Berg had won the Nobel Prize, the common stock of a four-year-old biotechnology company named Genentech went public on the New York Stock Exchange. Genentech’s business is based on recombinant DNA, and its first product (at that time, still two years later) was a human protein made by a bacterium into which a human gene was inserted using recombinant DNA technology. .. When the market opened, the stock traded at $ 35 per share. By the end of the day, investors had blown up the price higher (up to $ 88 per share) before closing at $ 71.
The first biotechnology boom has begun, and many other emerging biotechnology startups will be available in the coming months. Was Genentech’s impressive IPO thanks to Berg’s Nobel Prize announcement for recombinant DNA that morning? We can never know.
Event 3: New Innovation Law
Just a week later, on October 21, President Jimmy Carter signed the Stevenson Widlar Innovation Act. It responded to concerns that government-sponsored technology was not commercialized sufficiently often. The law encouraged US national laboratories such as Fermilab, Brookhaven, Oak Ridge, Los Alamos, and the Stanford Linear Accelerator Center to disseminate information about government-owned technology by requiring them to establish a research and technology agency. .. An application for identifying and facilitating technologies with high commercial potential. The Carter administration supported the bill because it continued to control who would commercialize these new technologies in the hands of the federal government.
This is the least important of the five biotechnology events. The National Institute was engaged in a surprising amount of biological research for organizations derived from nuclear weapons research, but at the time it was not a hotbed of bioscience and biotechnology innovation.
Event 4: Patent No. 4,237,224
Tuesday, December 2nd was the fourth quietest of the series of biotechnology events, but the least important. The United States Patent and Trademark Office has told two inventors, Stanford University Stanley N. Cohen and the University of California, San Francisco Herbert W. Boyer, US Patent No. 4,237,224, “The Process of Generating Biologically Functional Molecular Chimera.” Was granted. The patent was assigned to Stanford Junior University and the University of California, Berkeley. As my colleague Jacob Sharkow and I wrote in 2015:
“The patent was the result of a 1974 study of the process of making recombinant DNA, the process of rebinding genes, and seemed to be a holy cup for geneticists. Cohen-Boyer Technology. Allowed geneticists to isolate, study, and create genes, rather than cumbersome mutation and mating studies. Recombinants as more research is done on the function and properties of limiting enzymes. DNA technology has opened the door for researchers to not only isolate and purify individual genes, but also to create their own analogs. “
When this patent was granted, I couldn’t find any significant publicity about it, but for the next 20 years, the Cohenboyer patent laid the foundation for both the biotechnology industry and many biological studies. did. It widely advocated the method of recombinant DNA and earned about $ 400 million for its assignees.
Stanford managed Cohenboyer’s patents and took 15% of its revenue due to the trouble. The rest was evenly divided by the Stanford and University of California systems and distributed in various ways. Stanford’s practice was (and still is) to donate one-third of the proceeds to the inventor, one-third to the inventor’s department, and one-third to the inventor’s school. This jackpot (about $ 70 million) from Cohen’s School of Medicine at Stanford University School of Medicine was the biochemistry department of Berg and Kornberg, who had done much of the research on recombinant DNA in Berg’s lab and elsewhere. Didn’t love it. The genetics department, on the other hand, was not very happy with those who won (and did not win) the Nobel Prize.
At the time the patent is granted, I don’t know if anyone fully understands how important it is or how profitable it is. But in the end, Cohenboyer’s patents helped universities change the way they commercialize their research. The huge revenue has led to the first score, then hundreds of universities opening technology licensing offices. Today, there are about 200 such offices, but only about 12 make a profit in a particular year (these are about the same each year, including Stanford University and the University of California).
Event 5: Bayh-Dole becomes law
The fifth and final event took place on Friday, December 12, when then-President Jimmy Carter of Lame Duck signed the Patent and Trademark Law Amendment Act, commonly known as the Baydor Act. The law provided universities and other non-profit research institutes with a clear and easy way to own intellectual property that was created in whole or in part with federal research funding. It is often believed to have kickstarted the biotechnology industry. In addition to the success of the Cohen-Boyer patent, it certainly encouraged universities to consider some parts of biology as potential profit centers.
But that was rarely achieved.
An economy recognized as a “stagnation” in the 1970s when Indiana Democratic Senator Birch Bayh and Kansas Republican Senator Bob Dole first introduced the Small Business Nonprofit Organization Patent Procedure Act to the 95th Congress. It was a time of great concern about the American economy, plagued by challenges. From Japan.
That year, Congress did not act on the bill, but Bay and Dole reintroduced the bill in the 96th Congress. Democrats ruled both the Senate and the House of Representatives, but President Carter opposed the bill. He wanted a more government-led path, like the approach adopted by the Stevenson Widlar law. Russell Long (D-La.), A strong chairman of the Senate Finance Committee, opposed the bill from a more populist perspective. He wanted the government to benefit as much as possible from any patent. The bill did not pass either chamber of commerce before the November 1980 elections.
The election took Ronald Reagan to the White House and required the Democratic Party to have 12 Senate seats. This will give the Republicans the first Senate majority since 1954 in the 97th Congress, which begins in January 1981. The Senate was Birch Bay, defeated by future Vice President Dan Kiel.
The 96th Parliament, which still has a majority of the Democratic Senate, held the Lame Duck Conference, one of the 16 conferences in 39 Parliaments since 1940, after the November elections. That urgency came from the lack of budgetary authority of most governments. Not only that, but also about other important, difficult and controversial laws that were postponed until after the election.
Strong support for Beidor in their class prevented the upcoming majority of Senate Republicans from opposition to its passage. However, the Senate unanimous consent was required for the bill to be voted in that session. This meant a favor from Long. He tolerated, probably because of his respect and friendship with his leaving colleague, Birch Bye.
President Carter gave no suggestion as to whether he would sign the bill. The Constitution allows the President to reject the bill, sign it, or pass it without signing it for 10 days (except Sunday). On the last possible day, December 12, Carter signed it.
It’s ironic that the Cohen-Boyer patent was issued and assigned to Stanford University and UCSF before Bayh-Dole made it easier for universities to patent inventions that benefited from federal funding. Both institutions used funding from NIH and private foundations for related recombinant DNA research, but did not have to wait for Bayh-Dole to patent the invention. There is an existing patent agreement between the Federal Department of Health and Human Services (predecessor of the Department of Health and Human Services) and the Stanford University Technology License Authority, which allows Stanford University and UCSF to obtain technology patents before Baydor obtains them. was doing. effect.
So In less than two months, two days, early biotechnology industry and university biotechnology research was driven into the future by the Nobel Prize, a stunning biotechnology IPO, two research commercialization laws, and a basic patent. .. And at that time, no one seemed aware of their collective importance.Indeed, there was Other things are happening then. For the first three weeks, Republican Ronald Reagan, who at the time seemed to be at the conservative limit of American politics, challenged the moderately conservative Democrat Jimmy Carter for just one term on November 4. Defeated Carter. Throughout the period, 53 US diplomats and citizens of the US Embassy in Tehran, Iran, were detained and detained for the first year in early November. The economy was still upset by the second oil crisis and the resulting high inflation (and was about to plunge into a sharp recession).
In it, the components of a new era of biotechnology gathered, almost unnoticed.
And it’s often in history. Some important events are obvious. Others sneak up on us. And through all these significant historical periods, blatant or vague, we continue our daily work, love, and life, rarely looking back or noticing the times in which we lived.
Dr. Henry T. Greeley is a professor of law and genetics at Stanford University, directs the Stanford University Center for Law and Biological Sciences, and chairs the Steering Committee of the Stanford Center for Biomedical Ethics. .. He would like to thank Jacob Sharkow and Robert Cook Deagan for their helpful comments to his research assistants Brittany Kazakov and Cassidy Amber Pomeroy Carter.