Biotechnology: Commercialization of Academic Research

BIOTECHNOLOGY:

COMMERCIALIZATION OF ACADEMIC RESEARCH

ISSUE BRIEF NUMBER IB81160

AUTHOR:

J u d i t h A.

Johnson

Science Policy Research Division

T H E L I B R A R Y OF C O N G R E S S

CONGRESSIONAL RESEARCH SERVICE

MAJOR I S S U E S S Y S T E M

DATE ORIGINATED 10/26/81

DATE UPDATED 07/01/82

FOR ADDITIONAL INFORMATION CALL 287-5700

0702

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ISSUE DEFINITION

Technical discoveries of the past 10 years in the field of molecular

genetics have greatly expanded the horizons of industrial microbiology.

These new techniques provide the framework for the speciality commonly

referred to as genetic engineering. This expertise enables the researcher to

recombine DNA (the hereditary material of the cell) in a very precise manner.

The same techniques can be used to manufacture products which have never been

produced before by bacteria and to manufacture products a t a higher rate and

yield than previously possible. While the controversy concerning the ethical

issues associated with this new biochemical tool seems to have abated

somewhat, a new concern has arisen:

the role of the university i n the

commercialization of genetically engineered products which are developed on

campus. Congress has begun to address whether commercialization will have an

adverse impact on university biomedical research and, if so, whether there

are mechanisms available to protect the interests of the university.

BACKGROUND AND POLICY ANALYSIS

The issues associated with the commercialization of university research

recently received public attention due to the announcement by Harvard

University that it was considering the formation of a new biotechnology

company. On Oct. 9 , 1980, President Derek Bok released a "Discussion

Memorandum on Technology Transfer at Harvard University1' to the f a c u l t y . for

its consideration. The memorandum reviewed in general terms the formation of

a new company, in conjunction with a Harvard professor and outside venture

capital, that would make use of patents held by the University.

Harvard

would have been given a minority share (10%) in the company, and in return

the company would have received the rights to use the University's patents.

The many drawbacks to such a venture were also reviewed. The memorandum drew

extensive criticism, not only from the Harvard faculty but also from the

media and other universiti.es. On Nov. 17, 1980, President Bok announced that

Harvard had decided for a variety of reasons not to become a minority

shareholder in the new biotechnology company.

The more general issue of the relationship between commercialization and

university research, however, is not unprecedented.

Industry and the

academic community have long recognized that they have many mutual research

interests. During the first decades of this century, many liberal arts

colleges were expanded and rapidly transformed into research centers for the

emerging electrical and chemical industries. The financial ties between the

two gradually weakened, however, following World War I1 as government

spending for research on defense, nuclear energy, and medicine increased.

In

the mid 1950s the Federal Government provided about 55% of the support for

university research. Industrial firms supplied 8% of the funds while the

remaining 37% came from foundations and. State and local governments. By the

late 1960s, the Government's share had expanded to more than 70% while

industry's share fell to under 3%.

Lately, however, the trend appears to be changing:

industry support is

increasing relative t o that of the Federal Government. Private companies are

searching for technological innovations to help offset growing competition

from abroad, falling productivity, and rising energy costs.

The companies

also realize that as an adjunct to their own in-house research efforts the

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universities are a relatively

inexpensive source 'of new ideas.

duplication of facilities and staff available would be both wasteful

nonproductive.

On the other hand, the universities are in need of

funding sources to offset shrinking enrollments, fiscal austerity, and

overall decline in Government support of research.

The

and

new

the

The desire to lessen the regulations associated with the expenditure of

Federal dollars also influences the universities to increase their reliance

on industrial funding.

The amount of time spent by researchers in compliance

with Federal regulation has been increasing over the years.

I t has been

estimated that in 1975 the faculty of Harvard University spent 80,000 hours

filling out forms in compliance with Federal regulation.

The amount of time

i s certain to increase with the implementation of Circular A-21

(released

Feb. 26, 1979) from the Office of Management and Budget, Which requires that

each individual scientific investigator inform the Government how he spends

100% of his professional time, even if he is not entirely supported by

Federal grants.

Yale University recently (Mar. 22, 1982) declined a $30,000

Federal grant when it decided not to comply with the regulation in circular

A-21.

An article in Science (1980; 210:

34-37) has estimated that Circular

A-21 would increase the number of forms filed with Washington from 3000 to

8 0 , 0 0 0 in the coming year. The less the dependence on Federal support, the

greater the freedom from Federal regulation.

There are many ways i n which the academic community may participate in the

commercialization process.

Perhaps the simplest and most well established i s

to obtain exclusive licenses of university patents.

In general, however,

molecular biologists have been less active than chemists and engineers in

obtaining patents, perhaps because their w o r k , until recently, has lent

itself less often to commercial applications.

In

addition,

medical

discoveries tended to remain unpatented since the tradition of dedicating

health-related research to the public was generally observed.

Another arrangement i s the research partnership in which one university

and one company work together on a

single

project.

The

Harvard

In

University/Monsanto arrangement i s an example of such a partnership.

1 9 7 4 , after a year and a half of negotiations, Harvard and Monsanto signed an

agreement that over a period of 1 2 years Monsanto will give the University

$23 million in research support, laboratory space construction, and endowment

money.

In return, Harvard gave Monsanto the patent

rights on TAF

(tumor

angiogenesis factor), a biological substance which may be involved in the

growth of cancerous tumors.

The agreement was touted a s an original,

imaginative, and precedent setting arrangement.

The research consortium, another collaborative effort, is

becoming

increasingly popular.

It joins a single university with a group of companies

that a r e interested i n a common area of research. The NSF (National Science

Foundation) introduced the idea several years ago and provided the initial

funding for a number of programs.

Among

the leading industry-funded

consortia are the MIT Polymer Processing Program and the Carnegie-Mellon

Robotics Institute.

A less formal version of the research consortium i s the industrial

associates (or affiliates) programs.

These a r e short term arrangements

in

which university scientists visit companies, listen to their pr.OblemS, and

explore approaches to solving them; these activities lay the groundwork

for

future cooperative efforts.

Stanford University's biochemistry department,

after rejecting a proposal similar to Harvard's, has decided upon an

industrial affliates program under which companies will give the University

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be

able

to

send

$12,000 annually.

In return the companies will

representatives to a seminar on the department's work, to receive one visit

per year from a faculty member for discussions on the company's research, and

to send a representative to Stanford to discuss this research with the

faculty. Stanford scientists feel that this arrangement allows them to avoid

direct commercial involvement while still seeing that research results reach

the public domain.

The University of Wisconsin runs more than 100 separate

projects of this sort ranging from forestry and fisheries to genetic

engineering.

'

On a smaller scale than the industrial affliates/associates programs a r e

the individual arrangements between a single faculty member and a particular

company. These can range from simple consulting contracts to partial

ownership/founder relationships. Herbert Boyer's (University of California,

S.F.) tie with Genentech is an example in the genetic engineering field of a

partial ownership/founder relationship.

A f e w new companies have emerged which attempt to bridge the gap between

the individual researcher or university and private venture capital.

The

much publicized D N A Science of E.F. Hutton i s one such company. DNA Science

recently (August 1981) underwent a transformation which would enable it to

capitalize on a new tax law, P.L. 97-34, and allow the creation of a series

of tax-advantaged partnerships.

The partnerships will allow the firm's

customers to invest in biotechnology and a t the same time receive substantial

tax benefits.

P.L. 97-34, the Economic Recovery Tax Act of 1981, allows

among other things a 25% tax credit for 65% of all of a n investor's payments

to universities for basic research.

The new law also permits a larger

deduction for charitable contributions of equipment used in scientific

research. A similar idea has been put forth by University Genetics

(or

Ugen), a private company owned by University Patents. The parent company i s

an established business which patents technologies or inventions developed by

university scientists and then licenses them to commercial concerns.

Ugen

emerged last October and has since raised over $30 million in capital.

It

provides a function which allows for private investment in university

research on genetic engineering and related topics.

Public Law 96-517 (the Patent and ' ~ r a d e m a r kAmendment Act of 1980) gave

organizations such a s Ugen a freer hand i n this type of research funding

arrangement.

The law took effect July 1 , 1 9 8 1 , and provides a single

Government-wide policy on the allocation of patent rights resulting from

federally supported research with preferential benefits for universities,

small business firms, and non-profit organizations.

P.L.

96-517 requires

that (with certain exceptions) small businesses, universities, and non-profit

institutions be given preferential title rights to inventions made under

Currently active grants are not affected under P.L.

federally funded R&D.

96-517, but new funding arrangements made after July 1 , 1981, are covered.

Its intent i s to encourage cooperation between universities and industry by

allowing the universities to offer future licenses in exchange for support

even if Federal money i s involved.

Even though commercialization of academic research i s not an entirely new

issue, there has been considerable discussion and controversy over the

entrance of biomedical research into this arena. Recent articles written on

the subject often mention that there are many differences between

the

commercialization of physics and chemistry and what is now happening in

biomedical research. The following are some of the differences which have

been cited, and perhaps account for this increased controversy.

.

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4

(1) Commercialization of biological techniques'seems to'have

occurred much faster than previous instances in chemistry

and physics.

(2) The commercialization experience in biology is thought

to involve a much broader spectrum of expertise in its

participants than was the case previously in chemistry

and physics.

The new technology involves many individuals

with interests in genetics, biochemistry, cell biology,

microbiology, immunology, development, etc., while

commercialization in the physical sciences frequently

involves only a small number of specialists.

(3) The range of application seems to be much greater than

in the commercialization of discoveries in the physical

sciences.

The areas of agriculture, medicine, waste

disposal, speciality chemicals, energy, and oil recovery

all have the potential for future innovation by recombinant

DNA techniques and have caught the interest of researchers

and the private capital of industry.

It may also be the case that since this is the first time biology has a

major technology which is saleable, the biologists are merely experiencing

the growing pains that physicists and chemists went through 50 years ago.

Whether or not biology is a case of commercialization distinct from

chemistry and physics, there have been a number of objections raised to its

commercialization.

Foremost is the issue of secrecy, which is frequently

widespread in high1.y competitive fields of even basic research.

Often a

scientist will not discuss the results of his work until he is sure that his

methodology and assumptions are correct. The possibility

t.hat a research

discovery may be patented is often cited as a source of secrecy.

While

patentability may contribute to secrecy over the short term, in the long run

it eliminates the need for secrecy.

After

the filing date of a patent

application, the information is at that point in the public domain and can

then be used for discussion and noncommercial use by others.

In the scientific community of the university, secrecy can be the source

of friction and conflict. For example, a t Harvard two researchers in the

same department are part owners in different genetic engineering companies:

Walter Gilbert of Biogen, a Swiss-based company, and Mark Ptashne of the

Genetics

Institute.

The Harvard proposal mentioned

earlier may

have

complicated matters even further if it had been approved, for the faculty

would have included those associated with "Harvard Companyn, those with other

industrial affiliations, and faculty members without commercial

ties.

Questions may have been raised as to whether the university administration

would have treated certain faculty members preferentially in terms of space

allocation, hiring, and promotion.

However, a s pointed out in a recent issue

of the New England Journal of Medicine (May 1 4 , 1981, p. 1232),

the problem

of preferential treatment

is

not

unique

to

situations

involving

commercialization.

Faculty salaries for an entire research department are

sometimes drawn from grants to individual faculty members.

Thus, the

influence on appointments in a department by individuals who are capable of

bringing with them external funding may be considerable.

As faculty members become increasingly involved with outside companies

(i.e., from consulting arrangements, to part ownership, to company officers),

critics question whether they will be able to remain equally dedicated

to

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campus activities such as teaching undergraduate students and guiding the

research efforts of graduate students.

The development of a new company i s

likely to require much more time than a consulting agreement.

They also

question whether it is wise for graduate students to work on projects related

to their thesis advisor's industrial interests, and whether commercialization

may cause a shift in the nation's research from basic t o applied biomedical

research.

Will graduate students receive a well rounded education if their

graduate school experience is in applied research?

Would they now choose

industry over teaching and basic research?

Would a shift from basic to

applied biomedical research be in the country's best interests?

New biotechnology companies emerge every month, and each seeks t o recruit

the best possible staff. These companies a r e prepared to pay

salaries much

higher than the academic community.

Thus commercialization is contributing

to the phenomenon known as "brain drain."

One writer has compared it to the

American Indians' being forced to consume their seed corn, and therefore

dooming the fate of the following year's crop (Science, July 1 0 , 1981).

If

the university faculties are being recruited for industry jobs, who will

remain to teach the next generation of scientists? The Harvard proposal and

companies such a s Ugen and DNA Science were designed to circumvent this

problem.

However, the Harvard proposal had problems which

made

it

unacceptable to the faculty, and DNA Science has had preliminary troubles in

starting up its new form of investment company.

It remains to be seen

whether companies such as Ugen and DNA Science will have an effect on the

"brain drain" phenomenon.

One of the qualities which university researchers take pride in i s their

objectivity:

the ability to be impartial When making statements on subjects

of public interest.

Recently, however, the credibility of university

scientists associated with industry has fallen into question.

During the

Supreme Court hearing on the patentability of a genetically

engineered

microorganism, reference was made t o Walter Gilbert's (Harvard/Biogen)

views

on the safety of recombinant DNA research.

The United States Solicitor

General argued that because of Dr. Gilbert's involvement with a biotechnology

company, "he i s thus hardly an impartial observer in the debate 'over the

biohazards associated with genetic engineeringw (Science, 1980, 208:688-692).

(Dr. Gilbert has recently announced that he will resign from Harvard a s of

July 1 , 1982, rather than relinquish his position in the company he helped

found. )

A final objection, which also was a major topic in a recent

(June 8 , 9 ,

1981) congressional hearing, is whether the American public i s indirectly

funding industry by allowing the commercialization process to continue.

Chairman Albert Gore of the

House

Subcommittee

on

Oversight

and

Investigations has asked if industry is "skimming off the cream produced by

A

case in point is the Massachusetts

decades of taxpayer funded work."

General Hospital (MGH) arrangement with Hoechst A.G., a West German chemical

and pharmaceutical company. Hoechst agreed to pay MGH $50 million over the

next 1 0 years and in return is receiving the first options rights for

licenses from any projects which the company has funded.

The licenses will

be negotiated on a case by case basis, reflecting the financial contribution

of the company to the specific patent being discussed.

Hoechst cannot

specify what type of work it would like MGH to perform, but i t may refuse to

support specific research projects.

In addition, Hoechst is allowed to send

individuals to MGH for training and consultation with the Hospital's faculty.

The individual scientists at MGH will be allowed to publish when they choose,

provided that hospital authorities are informed in advance. There will also

be no restrictions on collaboration with other scientists.

The MGH/Hoechst

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contract was the subject of a General Accounting Office

(GAO) investigation

a t the request of the House Science and Technology Investigations and

Oversight Subcommittee. The GAO report indicates that it should be possible

for MGH to separate research funded by Hoechst from federally funded

research.

According to the report, however, difficulties may arise when

there i s doubt over whether a patent exploited by Hoechst has been supported

exclusively by the German company.

In addition to the $50 million from

Hoechst A.G.,

MGH i s reportedly also receiving $15 million from two

philanthropists, Arthur 0. and Gullan M. Wellman, for the construction of

new laboratory facilities.

Massachusetts General Hospital is not the only biomedical research

facility with ties t o industry.

In addition to the funds Harvard is

receiving from Monsanto, Dupont recently announced (June 1981) a $6 million

grant for basic research in molecular genetics.

The research will be

directed by Philip Leder, formerly of NIH, who recently joined the Harvard

Medical School a s chairman of the newly formed Department of Genetics.

The

grant will be spread over a five year period with a $ 2 million payment in

July 1981 and annual payments of $1 million through 1985.

Some further reported arrangements are as follows:

(1) Phillips Petroleum invested $10 million in a joint venture with

Salk Institute to develop commercial applications of basic research from

Institute's laboratories.

the

the

(2) The new French biotechnology

company, Transgene, has distributed

equity to the Pasteur Institute in Paris and to the University of Strasbourg.

England's national biotechnology company, Celtech, will be sh sharing its

profits and research results with the Medical Research Council Molecular

Biology Laboratory at Cambridge.

(3) At the University of Wisconsin, two scientists with research interests

in agriculture have formed consulting/partnership

associations with two

biotechnology companies. Winston J. Brill is associated with Cetus, a firm

near San Francisco which is in the process of setting up a Madison,

Hall i s working with Agrigenetics.

Wisconsin, laboratory.

Timothy C.

(4) Several members of the molecular biology and microbiology

a t Tufts University medical

school have formed a research

partnership separate from the University.

department

consulting

(5) The University of California, Davis signed an agreement with Allied

Chemical for a $2.5 million grant over the next five years.

Raymond C.

Valentine, a plant geneticist a t Davis, played an instrumental role in the

contract negotiations which lasted for about two years.

While

the

negotiations were taking place, Valentine proceeded

to form a non-profit

institution called Cal Gene which was eventually transformed into Calgene, a

private corporation.

Shortly after the grant negotiations were finalized,

Allied announced that it had purchased a 20% equity interest in Calgene.

To

avoid possible charges of conflict of interest, Valentine agreed to cease his

A University committee

involvement with the University's $2.5 million grant.

i s in the process of preparing a detailed set of recommendations, to be

released in June, defining University-industry interactions.

(6) Washington University in St. Louis and Mallinckrodt Inc.,

a chemical

manufacturer, have signed a $3.88 million agreement for genetic research.

The research involves the production

of

monoclonal

antibodies

from

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artifically created cells called hybridomas.

Mallinckrodt will have the

option to license results from research it sponsors and will pay royalties to

the University. The scientists will be free to publish

their research

findings and to exchange new cell lines and antibodies with outside

scientists.

Washington University has also signed a $1.8 million agreement

with Monsanto Corp. to produce monoclonal antibodies.

(7) The Massachusetts Institute of Technology (MIT) accepted

(12/4/81)

a

gift of $7.5 million and $120 million for the establishment of the Whitehead

Institute for Biological Research.

Nobel laureate David Baltimore will

become the Institute's director while continuing as a professor of Biology at

MIT.

The money

for both gifts was donated by Edwin C. Whitehead

of

Connecticut who recently sold Technicon, a company he founded in 1939, to

Revlon for $400 million.

(8) Y a l e University and Celanese Corporation, a chemical manufacturer,

announced the signing of a three-year $1.1 million research contract on Feb.

1 7 , 1982. Celanese is interested in learning how to use naturally occurring

enzymes in the manufacture of chemicals and fabric.

Yale has also formed an

Office of Cooperative Research in an effort to tighten ties between the

University and corporations.

(9) The Alberta Research Council, an agency of Alberta

province, has

signed a 4-year, $ 8 million agreement with Biologicals, Inc. for the use of

enzymes in industrial applications. Work on the project will be conducted on

the campus of the University of Alberta in Edmonton.

(10) Dr. Herbert Boyer', director and vice president

genetic engineering company, still retains his faculty

University of California, San Francisco.

of Genentech, a

position a t the

(11) Cold Spring Harbor Laboratories, directed by Dr. James Watson, is , i n

the process of setting up a corporation which will help commercialize the

laboratories' scientific discoveries.

The

corporation

will

operate

separately from the Laboratory.

(12) The University of California at Berkeley, Stanford, and Engenics, a

biotechnology concern, have received financial backing from six major

corporations:

General Foods Corp.; Bendix Corp.; Elf Technologies unit of

Societe Nationale; Elf Aquitaine; Koppers Corp.;

Mead Corp.;

and Maclaren

Power and Paper Co., a subsidiary of Noranda, Mines Ltd.

The universities'

shares of the research funding will be channeled through a new cooperative

nonprofit center for biotechnology research., The center will hold a 30%

equity share of Engenics and will channel any capital appreciation or stock

dividends from the new company back into basic research a t the two

universities.

The universities will cooperate in research with Engenics,

which received $7.5 million from the six corporations.

(13) Johns Hopkins University and Hybritech, a San Diego biotechnology

firm, signed an agreement Feb. 1 2 , 1982, to develop and evaluate radioactive

antibodies for cancer treatment.

Hybritech will provide the antibodies Which

Hopkins' oncology center will use in clinical trials.

(14) The Rockefeller University and Monsanto Co.

have announced

(March

1982) a five-year $4 million agreement under which Monsanto will support

basic research in plant molecular biology at the University.

(15) Dupont and the University of Maryland have an

agreement

to

produce

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interferon in Bacillus subtilis, a non-pathogenic soil bacterium.

(16) FMC Corporation has given (June 1981) Frederick M. Ausubel of Harvard

University $190,000 for each of the next 3 years for research on nitrogen

fixation in plants.

(17) A.M. Chakrabarty of the University of Illinois has agreed to a 2-year

Contract with Petrogen for the development of genetically engineered bacteria

for enhanced oil recovery.

(18) Monsanto Co. and Washington University announced on June 3 , 1982, a

$23.5 million 5-year biomedical research contract for study of the breakdown

of genetic functions and cell communication associated with several diseases.

Universities are beginning to set up their own conflict-of-interest-rules.

The University of California, Davis, mentioned above, is one example.

In

late September 1981, the faculty council of Harvard University agreed to

recommend to the full faculty a new set of procedures which would establish

the "Faculty Committee on Conflicts of Interest." If adopted, the new rules

would require that faculty members notify the Conflicts of Interest Committee

about any outside commitments. The rules would also limit such commitments

to 20% of the faculty member's time.

Stanford University already has a

formal set of guidelines due to its faculty's involvement with

the

microelectronics industry.

However, Stanford i s in the process of developing

new proposals to tighten up the existing guidelines.

In addition, on Mar.

27, 1982, the presidents of five leading U.S. universities (Stanford, Harvard

MIT, California Institute of Technology, and the University of California

system) attended a conference in Watsonville, California, with scientists and

business leaders on the commercial use of university scientific research.

The conference produced a 10-page statement containing recommendations for

universities that have recently

developed

relations

with

industry.

Meanwhile, the House Science and Technology Investigations and Oversight

Subcommittee has asked the National Academy

of Scien.ces and the American

Association of Universities to draft a code of ethics for financial

arrangements between universities and industry.

LEGISLATION

P.L.

97-34, H.R.

4242

The Economic Recovery Tax Act of 1981. Allows, among other things, a 25%

tax credit for 65% of all a firm's payments to universities to perform

basic

research. Also permits a larger deduction for charitable contributions of

equipment used in scientific research.

Introduced July 23, 1981.

Passed

House July 29, Senate July 31. Signed into law Aug. 1 3 , 1981.

H.R.

1937 (Kastenmeier)

Amends the patent law to extend the term of patents which encompass

specified products over a method for using a product any of which are subject

to certain nonpatent regulatory review periods.

Introduced Feb. 1 8 , 1981;

referred to Committee on Judiciary.

H.R.

4326 (LaFalce)

Amends the Small Business Act to require Federal agencies to

small business innovation research

(SBIR) programs.

Introduced

establish

July 29,

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UPDATE-07/01/82

1981; referred to Committee on Small Business.

Reported with amendment

(H.Rept. 97-349) N O V . 20, 1981. Referred sequentially t o several committees.

Passed House, amended, June 23, 1982. Measure laid on table in House; S. 8 8 1

passed in lieu June 2 3 , 1982.

H.R.

5919 (Waxman)

Amends the Public Health Service Act to revise and extend the authorities

under that Act relating to national research institutes.

Also, requests a

report from the Institute of Medicine on the effects of commercialization on

biomedical research.

Introduced Mar. 22, 1982; referred to Committee o n

Energy and Commerce.

S. 255 (Mathias et al.)

Amends the patent law to extend the terms of patents which encompass

specified products or a method of using a product, any of which are subject

to certain nonpatent regulatory review periods.

Introduced Jan.

27, 1981;

referred to Committee on the Judiciary. Reported (S.Rept. 97-138) June 1 6 ,

1981; passed Senate amended July 9 , 1981; referred to House Committee on the

Judiciary July 1 3 , 1981.

S. 881 (Rudman et al.)

Amends the Small Business Act to require Federal agencies to establish

Introduced Apr. 7, 1981;

small business innovation research (SBIR) programs.

referred to Committee on Small Business. Reported with amendment

(S.Rept.

97-194) Sept. 25, 1981; passed Senate Dec. 8, 1981. Passed House, amended,

in lieu of H.R. 4326 June 23, 1982.

HEARINGS

U.S.

Congress.

House. Committee on Energy and Commerce.

Subcommittee on Health and the Environment.

Small Business

Innovation Development Act, H.R. 4326.

Hearings, 97th Congress, 2nd session.

Feb. 2 , 1982.

(not yet printed)

U.S.

Congress.

House.

Committee on the Judiciary.

Subcommittee

on Courts, Civil Liberties and the Administration of Justice.

Patent Term Restoration Act, S. 255 and H.R. 1937.

Hearings, 97th Congress, 1st session. July 22; Sept. 30;

Oct. 1 , 7; Nov. 5 , 1 2 , 1 8 , 1981.

(not yet printed)

U.S.

Congress.

House.

Committee on Science and Technology.

Small Business Innovation Development Act, H.R. 4326.

Hearings, 97th Congress, 2nd session. Jan. 26-28, 1982.

(not yet printed)

U.S.

Congress.

House.

Committee on Science and Technology.

Investigations and Oversight.

Subcommittee on Science, Research

and Technology. University/industry cooperation in biotechnology.

Hearings, 97.th Congress, 2d session.

June 1 6 and 1 7 , 1982.

(not yet printed)

U.S.

Congress. House. Committee on Science and Technology.

Subcommittee o n Investigations and Oversight.

Subcommittee

on Science, Research and Technology.

Commercialization of

academic biomedical research.

Hearings, 97th Congress, 1st session. June 8 and 9 , 1981.

Washington, U.S. Govt. Print. Off., 1981. 166 p.

U.S.

Congress.

Senate. Committee on Small Business.

Subcommittee

on Innovation and Technology.

Small Business Innovation

Research Act, S.881.

Hearings, 97th Congress, 1st session.

July 15-16, 1981.

(not yet printed)

U.S.

Congress.

House.

Committee on Veterans' Affairs.

Subcommittee on Hospitals and Health Care.

Small

Business Innovation Development Act, H.R. 4326.

Hearings, 97th Congress, 2nd session. Jan. 27, 1982.

(not yet printed)

CHRONOLOGY OF EVENTS

03/27/82

-- The presidents of five leading U.S.

01/06/82

-- The American Association for the Advancement of Science

universities

(Stanford, Harvard, MIT, California Institute of

Technology, and the University of California system)

attended a conference in Watsonville, California,

with scientists and business leaders on the commercial

use of university scientific research.

(AAAS) held a session entitled wCommercial Genetic

Engineering:

Impacts on Universities and Nonprofit

Institutions."

12/04/81

-- Massachusetts Institute of Technology (MIT) accepted

gifts of $7.5 million and $120 million from E.C.

Whitehead for the establishment of the Whitehead

Institute for Biological Research.

10/16/81

-- The General Accounting Office published a legal

analysis of the research contract between

Massachusetts General Hospital and Hoechst A.G.,

a West German chemical company.

08/13/81

-- H.R.

07/10/81

-- The editorial "The fate of the seed c o r n m appeared i n

4242, the Economic Recovery Tax Act, was signed

into law (P.L. 97-34).

Allows tax credits for basic

research.

Science.

Highlighted the impact of losing experienced

university professors to the biotechnology industry.

06/29/81

-- Dupont announced a $6 million grant to Harvard Medical

School in support of basic research in molecular

genetics.

06/08-09/81

-- House Science and Technology Subcommittee on

Investigations and Oversight and Subcommittee on

Science, Research and Technology held hearings on the

"Commercialization of Academic Biomedical Research."

06/08/81

-- The advisory committee to the director of NIH held a

meeting which discussed whether the quality of basic

research is compromised by industrial support.

05/20/81

-- The West German Chemical f i r m , Hoechst A.G.,

12/12/80

-- H.R.

11/17/80

-- Harvard President Derek Bok announced that Harvard

announced

a $50 million grant to Massachusetts General Hospital

to support basic research in molecular genetics.

6933, the Patent and Trademark Amendment

Act was enacted (P.L. 96-517), providing a new policy for the

allocation of patent rights resulting from

federally-supported research.

University would not become involved in a new

genetic engineering company.

02/00/75

-- Monsanto announced a $25 million grant to Harvard

University in support of investigations in molecular

biology.

ADDITIONAL REFERENCE SOURCES

Bodde, Tineke.

Pursuit of knowledge and of profit clash over DNA

marketing.

BioScience, July/August 1981:

486-490.

Bok, Derek C. Business and the academy.

May/June 1981:

23-35.

Bromley, D. Allan.

1981.

Harvard Magazine,

The fate of the seed corn.

Science, July 1 0 ,

the $23-million

Culliton, Barbara J. Harvard and Monsanto:

alliance.

Science, Feb. 25, 1977:

759-763.

----- Biomedical research enters the marketplace.

England journal of medicine.

May 1 4 , 1981:

The New

1195-1201.

Davis, Bernard D.

Profit sharing between professors and the

university.

The New England journal of medicine.

May 1 4 ,

1981: 1232-1235.

Dickson, David.

Conflict of interest on California campus:

Davis

scientist Steps away from grant.

Nature, Oct. 8, 1981:

417.

Fox, Jeffrey L.

Can academia adapt to biotechnologyls lure?

Chemical and engineering news.

Oct. 1 2 , 1981:

39-44.

Glaucon.

Biology loses her virginity.

25, 1980:

826.

New scientist.

Dec. 1 8 ,

Greenberg, Dan.

Academic science for sale.

July 1 6 , 1981:

174.

New scientists.

Harvard backs off recombinant DNA.

423-424.

Dec. 4, 1980:

Nature.

House panel examines

Hoechst makes deal with Mass General.

June 1 8 , 1981:

525-526.

overseas ties.

Nature.

Joyce, Christopher.

N&w company could turn academics into

tycoons.

New scientists. May 2 8 , 1981:

542.

Kiefer, David M.

Forging new and stronger links between

university and industrial scientists. Chemical and

engineering news.

Dec. 8 , 1980:

38-51.

Murray, Thomas J.

Industry's new college connection.

review.

May 1981:

52-59.

Duns

Business goes back to

Nobel, David F. and Nancy E. Pfund.

college. The Nation.

Sept. 20, 1980:

233, 246-252.

ROark, Anne C. Academic ties face challenge.

Dec. 23, 1981: p. 1 , 22.

Los Angeles T i m e s ,

Tenner, Edward. The laboratory a s profit center.

magazine.

January/February, 1981:

15-19.

Harvard

U.S.

General Accounting Office. Report to Hon. Albert Gore, Jr.,

Chairman, Subcommittee on Investigations and Oversight.

Committee on Science and Technology. U.S. House of

Representatives.

Legal analysis of a contract signed in

May 1981 between Massachusetts General Hospital and Hoechst

Chemical Company of West Germany.

Oct. 1 6 , 1981. 9 p.

Document no. B-204687

U.S.

Library of Congress.

Congressional Research Service.

Recombinant DNA molecule research [by] Vikki A . Zegel and

James M. McCullough.

Archived Issue Brief 77024.

Yanchinski, Stephanie. Deafening silence from genetic engineers

4.

about commercial threats.

New scientist. Oct. 1 , 1981:

----- Universities take to the market place.

Dec. 3, 1981:

675-677.

New scientist.