Review of the Bayh-Dole Act: Testimony by Senator Dole

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s-leg_433_028_002_tr.txt

Transcription (Scripto)

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Extent (Dublin Core)

6 pages

File Name (Dublin Core)

s-leg_433_028_002

Title (Dublin Core)

Review of the Bayh-Dole Act: Testimony by Senator Dole

Description (Dublin Core)

Review of the Bayh-Dole Act Testimony by Senator Dole to the United States Senate Judiciary Subcommittee on Patents, Copyrights, and Trademarks. Dole discusses the successes of the Bayh-Dole Act, 14 years after it was signed.

Date (Dublin Core)

1994-04-19

Date Created (Dublin Core)

1994-04-19

Congress (Dublin Core)

103rd (1993-1995)

Topics (Dublin Core)

See all items with this valuePatent laws and legislation

See all items with this valueTechnology

See all items with this valueUniversities and colleges--Research

Policy Area (Curation)

Science, Technology, Communications

Creator (Dublin Core)

Dole, Robert J., 1923-2021

Record Type (Dublin Core)

testimonies

Names (Dublin Core)

See all items with this valueUnited States. Bayh-Dole Act

Location representation (Dublin Core)

See all items with this valueKansas

Rights (Dublin Core)

http://rightsstatements.org/vocab/CNE/1.0/

Language (Dublin Core)

eng

Collection Finding Aid (Dublin Core)

https://dolearchivecollections.ku.edu/index.php?p=collections/findingaid&id=23&q=

Physical Location (Dublin Core)

Collection 003, Box 433, Folder 28

Institution (Dublin Core)

Robert J. Dole Institute of Politics, University of Kansas, Lawrence, KS

Archival Collection (Dublin Core)

Robert J. Dole Senate Papers-Legislative Relations, 1969-1996

Full Text (Extract Text)

REVIEW OF THE BAYH-DOLE ACT

TESTIMONY BY SENATOR DOLE
THE U. S. SENATE JUDICIARY SUBCOMMITTE ON PATENTS, COPYRIGHTS, AND TRADEMARKS.

APRIL 19, 1994

MR. CHAIRMAN, I WANT TO THANK YOU AND THE SUBCOMMITTEE FOR THE OPPORTUNITY TO SPEAK ABOUT THE SUCCESS OF THE BAYH-DOLE ACT. AS ONE OF ITS PRINCIPAL AUTHORS, I WOULD ALSO LIKE TO EXPRESS MY CONCERNS ABOUT LEGISLATION THAT WILL UNDERMINE ITS VERY PREMISE.

TECHNOLOGY TRANSFER VIRTUALLY NON-EXISTENT BEFORE BAYH-DOLE

PRIOR TO THE BAYH-DOLE ACT, THE FEDERAL GOVERNMENT WAS SPENDING BILLIONS OF DOLLARS ON RESEARCH THAT NEVER SAW THE LIGHT OF DAY. FEWER THAN 4 PERCENT OF THE 28, 000 GOVERNMENT-OWNED INVENTIONS WERE COMMERCIALIZED PRIOR TO 1980. WHILE SOME MIGHT THINK OTHERWISE, MANY OF THESE PROJECTS HAD USEFUL APPLICATIONS. THE PROBLEM WAS THAT THE FEDERAL GOVERNMENT HELD ONTO TO THE PATENT RIGHTS. IT WAS VERY DIFFICULT, IF NOT IMPOSSIBLE, FOR PRIVATE INDUSTRY TO ACQUIRE THEM. WITHOUT THE SECURITY OF AN EXCLUSIVE LICENSE OR A PATENT, COMPANIES WERE RELUCTANT TO COMMIT THE NECESSARY TIME AND MONEY TO COMMERCIALIZE THESE PRODUCTS.

LET'S FACE IT, R&D IS EXPENSIVE, BUT IT HAS BEEN ESTIMATED THAT IT ONLY ACCOUNTS FOR 25 PERCENT OF THE COST TO BRING A NEW

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PRODUCT OR PROCESS TO MARKET. THE BOTTOM LINE IS THAT BUSINESS WOULD NOT INVEST IN NEW PRODUCTS IF IT DID NOT HAVE REASONABLE PROTECTION.

INTENT OF BAYH-DOLE

WHEN WE DRAFTED THE BAYH-DOLE ACT MORE THAN A DECADE AGO WE WANTED TO BOLSTER COOPERATION BETWEEN THE FEDERAL GOVERNMENT, PRIVATE INDUSTRY AND UNIVERSITY RESEARCH FACILITIES. AT THE SAME TIME, WE WANTED TO ENCOURAGE GREATER TECHNOLOGY TRANSFER, TO STIMULATE INNOVATION, TO CREATE NEW JOBS, AND TO EXPAND MARKETS FOR NEW PRODUCTS. THERE IS NO QUESTION THAT ALL THESE GOALS HAVE THEN(?) MET.

BENEFITS OF BAYH-DOLE

ACCOMPLISHMENTS THAT CAN BE DIRECTLY ATTRIBUTED TO BAYH-DOLE ARE TOO NUMEROUS TO COUNT. NONETHELESS, I WOULD LIKE TO TAKE A MOMENT TO HIGHLIGHT A FEW.

ON THE TOP OF MY LIST WOULD BE THE BIOTECH INDUSTRY. THIS ONE OF THE FASTEST GROWING, MOST INNOVATIVE, AND MOST (word cut off) RATIVE INDUSTRIES TODAY. BAYH-DOLE IS UNIVERSALLY CREDITED HELPING SPUR ITS DEVELOPMENT, AND I AM PROUD TO SAY THAT I HAD(?) A HAND IN MAKING THE U.S. THE WORLD LEADER IN THIS NEW FIELD.

UNIVERSITY PATENT AND LICENSING ACTIVITIES HAVE ALSO (word cut off) ODED SINCE THE ACT WAS SIGNED INTO LAW. FORMER NATIONAL INSTITUTES OF HEALTH DIRECTOR, DR. BERNADINE HEALY, HAS NOTED

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THAT DURING THE 1980'S PATENT APPLICATIONS ON NIH SUPPORTED R&D WENT FROM 890 TO 2,600.

AND UNIVERSITY LICENSING ROYALTIES ARE UP. THIS REVENUE STREAM, WHICH IS PLOWED BACK INTO FURTHER RESEARCH, HAS NEARLY TRIPLED SINCE 1986. THE LATEST NUMBERS ARE IN, AND ROYALTIES NOW EXCEED $80 MILLION EACH YEAR.

IMPACT ON KANSAS

LET ME ALSO NOTE THAT IN MY HOMESTATE OF KANSAS, UNIVERSITIES HAVE TAKEN FULL ADVANTAGE OF TECHNOLOGY TRANSFER THAT BAYH-DOLE HAS MADE POSSIBLE. OVER THE LAST THREE YEARS, 30 PATENTS HAVE BEEN ISSUED TO KANSAS STATE UNIVERSITY, WHILE THE UNIVERSITY OF KANSAS WAS ISSUED 23 PATENTS.

FOR INSTANCE, THE UNIVERSITY OF KANSAS HAS DEVELOPED A NEW COMPOUND WHICH WILL ALLOW DOCTORS TO ADMINISTER MEDICINE WITHOUT WORRYING ABOUT TOXIC SIDE EFFECTS. THE UNIVERSITY HAS PATENTED THIS DISCOVERY AND ENTERED INTO A LICENSING AGREEMENT WITH PFIZER PHARMACEUTICAL CORPORATION TO BRING THIS NEW PRODUCT TO MARKET. KU IS ALSO CLOSE TO MAKING A SCIENTIFIC BREAKTHROUGH TO IMPROVE THE TREATMENT OF DIABETES.

THE DEVELOPMENTS IN KANSAS HAVE ALSO GONE BEYOND THE

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PRODUCTION OF NEW DRUGS. KANSAS STATE UNIVERSITY HAS DEVELOPED, IN CONJUNCTION WITH KICE INDUSTRIES, THE KSU FLOUR MILL THAT WILL MEET THE FOOD PROCESSING NEEDS OF DEVELOPING COUNTRIES. UNLIKE OLD MILLS THAT COST MILLIONS OF DOLLARS AND WERE DIFFICULT TO RUN, THE KSU MILL IS COMPACT, EASY TO OPERATE, AND RELATIVELY INEXPENSIVE.

CHALLENGES TO BAYH-DOLE

I AM VERY CONCERNED ABOUT NEW INITIATIVES OFFERED BY SOME MEMBERS OF CONGRESS AND SOME EXECUTIVE AGENCIES THAT, IN MY VIEW, FLY IN THE FACE OF THE BAYH-DOLE ACT.

TWO SPECIFIC EXAMPLES STAND OUT. FIRST, THERE ARE THOSE WHO WOULD JEOPARDIZE BAYH-DOLE'S COOPERATIVE SPIRIT BY GIVING THE INDUSTRIAL PARTNER SOLE RIGHT TO DEVELOPED TECHNOLOGY AND LEAVE THE UNIVERSITIES IN THE COLD. SUCH ACTION WILL DRY UP AN IMPORTANT REVENUE STREAM FOR UNIVERSITIES AND WILL DECIMATE THEIR RESEARCH CAPABILITIES.

SECOND, A FEW MEMBERS WOULD LIKE TO INCREASE THE GOVERNMENT'S ROLE IN NEGOTIATIONS ON TECHNOLOGY DEVELOPED THROUGH FEDERAL FUNDING. I SHOULD REMIND MY COLLEAGUES THAT PRIOR TO BAYH-DOLE, THE GOVERNMENT HAD TOTAL CONTROL, AND TECHNOLOGY TRANSFER DID NOT HAPPEN. REINTRODUCING GOVERNMENT INTERVENTION IN PRICE SETTING, NEGOTIATIONS, AND LICENSING WILL DESTROY 13

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YEARS OF IMPROVING TECHNOLOGY TRANSFERS.

IF MY COLLEAGUES HAVE FORGOTTEN THAT CAPPING PRICES IS A BAD IDEA, LET'S LOOK BACK TO THE EARLY 70'S WHEN PRESIDENT NIXON TRIED IT ON PRESCRIPTION DRUG PRICES. RESEARCH STAGNATED, AND EVENTUALLY THE CAPS HAD TO COME OFF. IT DIDN'T WORK THEN, AND IT WON'T WORK NOW.

CONCLUSION

MR. CHAIRMAN, WHEN CONGRESS ORIGINALLY PASSED BAYH-DOLE IT TOOK INTO CONSIDERATION THAT UNFAIR ADVANTAGES OR ADDITIONAL GOVERNMENT COSTS MAY OCCUR. HOWEVER, THE BENEFIT TO SOCIETY WAS THE OVERRIDING CONCERN. IT WOULD BE A TRAVESTY IF WE WERE TO REVERSE OURSELVES NOW. I WOULD URGE THE SUBCOMMITTEE TO SERIOUSLY QUESTION PROPOSED CHANGES, AS THEY WILL ONLY DIMINISH AMERICA'S ABILITY TO BRING THE MOST ADVANCED PRODUCTS TO MARKET IN A TIMELY FASHION.

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April 19, 1994

TO: Senator Dole
FROM: David Wilson
SUBJECT: Bayh-Dole Act Talking Points

Below are your talking points for the Bayh-Dole Act. However, you will not be asked to answer questions at the hearing. The reading time for your speech is 4:45 minutes.

REASONS FOR HEARINGS:

TO WARD OFF CHALLENGES OF BAYH-DOLE

Executive Agencies and a few Members of Congress are seeking to take away some of the financial incentives that universities gain from Bayh-Dole. In particular, Rep. Wyden and Senator Pryor would like to place price restraints on the private applications which develop from university research (Senator Kennedy is also considering supporting this concept). Universities charge that such restraints will decimate their research capabilities.

TECHNOLOGY TRANSFER PRIOR TO BAYH-DOLE

Before the enactment of Bayh-Dole, fewer then 4 percent of the 28,000 government-owned inventions were commercialized prior to 1980.

BENEFITS OF BAYH-DOLE

Bayh-Dole has had numerous benefits, one of which is helping spur the growth of the Biotech industry. Due to our early entry, the United States is world leader in this new field.

• University patent and licensing application derived from federal research went up from 890 to 2600 in the 1980's.
• University licensing royalties now exceed $80 million each year, which nearly triples 1986 figures.

BENEFITS FOR THE STATE OF KANSAS

Both the University of Kansas and Kansas State University have seen tremendous benefits from Bayh-Dole.

KSU
In calendar 1993, KSU had 12 patents issued, which ranks them as 39th in national universities for that year. KSU is the second largest patent holder in the state of Kansas (second only to Coleman Systems, Inc.). More than 30 patents have been issued in the last three years.

KU
At KU, the number of disclosures of technology is also increasing. More than 23 patents have been issued to KU in the last three years, based on technology development at the main campus and at the Medical Center in Kansas City.