13 Biotechnology Law Report 120 (Number 2, March- April 1994)

An important element in the court's ruling that the scientists were not involved in theconception of the invention, McGough points out, was the fact that Burroughs had decided tofile a patent application for AZT as an anti-AIDS drug on the basis of the drug's effectivenessagainst mouse retroviruses before samples were sent to the NIH for testing against HIV, thehuman retrovirus linked to AIDS. Moreover, the company had begun drafting a patentapplication before confirmation was obtained that the drug was effective in slowing HIV.

In considering the implications of the decision, McGough stresses that "the conceptionof a biotechnology invention should be memorialized as quickly [as] and in [the] broadfest]terms possible." One way to do this, he notes, is the method chosen by BW: a draft patentapplication based on the inventor's best understanding of precisely how an invention can bereduced to practice.

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{BLR 1632} Amylin-

Diabetes-

Renovascular Hypertension.

AMYLIN PHARMACEUTICALS FILES INDAPPLICATION FOR AMYLIN BLOCKER—Hopes to Control High Blood Pressure Associated with Obesity

SAN FRANCISCO, CAL. 1/11/94-

Amylin Pharmaceuticals, Inc. has filed an

Investigational New Drug (IND) application with the U.S. Food and Drug Administration forits amylin blocker, AC625.

Amylin is a recently discovered pancreatic hormone. It is present in excess in patientswith syndrome X+, who are resistant to the normal blood sugar-controlling actions of anotherpancreatic hormone, insulin. Such patients suffer elevated plasma concentrations of the kidneyhormone renin, which leads to high blood pressure (renovascular hypertension). Thecondition is linked to obesity. Preclinical data have suggested that excessive amylin can induceinsulin resistance and a rise in the blood renin concentration.

The company hopes that blood pressure can be controlled by blocking amylin actionwith AC625 in people with insulin-resistance syndrome.

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{BLR 1633} T Cell Diagnostics-

HIV-

AIDS.

T CELL SCIENCES TO CONDUCT ANOTHER STUDYOF TRAxTM CD4 CELL COUNTING SYSTEM-- Will Study Accuracy of Measurements in Samples from HIV-PositivePatients with Syphilis or Tuberculosis

CAMBRIDGE, MASS. 2/28/94 - T Cell Sciences has been asked by the U.S. Foodand Drug Administration (FDA) to carry out a clinical trial of its TRAx™ CD4 assay system,which is now being considered for 501k clearance by the agency. TRAx CD4 is being testedas an alternative to flow cytometry for the counting of the numbers of CD4 lymphocytes, a wayof monitoring persons with immunologie deficits, particularly infection with HIV. The FDA

13 Biotechnology Law Report 121 (Number 2, March-April 1994)

asked the company to conduct a study specifically on blood samples from patients infected withsyphilis or tuberculosis as well as HIV.

Syphilis and tuberculosis are increasingly common problems in patients infected withthe AIDS virus.

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{BLR 1634} Environmental Release-

SV40.

BRITISH LABORATORY SHUT DOWN BECAUSE OFINADEQUATE PRECAUTIONS AGAINSTENVIRONMENTAL RELEASE— Adenovirus with SV40 OncogeneWas Disabled

BIRMINGHAM, UK 12/93 - The Health and Safety Executive (HSE) of the Britishgovernment has temporarily shut down a research laboratory at the University of Birmingham,where scientists were working with a human adenovirus containing an oncogene from simianvirus 40 (SV40). Although the virus had been disabled to prevent it from replicating in humancells, the HSE was concerned that too many people were coming and going from the areawhere the virus was located and that the genetically engineered virus might be carried into theenvironment as a result. The agency therefore instructed laboratory director Phillip Gallimoreto make some changes.

The action was the first taken by the British government to enforce the GeneticallyModified Organisms (Contained Use) Regulations of 1992.

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{BLR 1635} Laboratory Animals-

National Academy of Sciences.

NATIONAL ACADEMY OF SCIENCES PREPARINGSEVENTH EDITION OF GUIDE ON LAB ANIMAL CARE-- Book is Standard Reference on Subject

WASHINGTON, D.C.-

The Institute of Laboratory Animal Resources of theNational Research Council

-

National Academy of Sciences is at work on the seventh edition ofthe Guide for the Care and Use ofLaboratory Animals. The committee producing the book,chaired by J. Derrell Clark, D.V.M., D.Sc, held a public hearing on the subject in November.

No publication date was provided.# # #