Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 20-F

 

(Mark One)

 

o

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

OR

 

 

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2008

 

 

OR

 

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

OR

 

 

o

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of event requiring this shell company report . . . . . . . . . . . . . . . . . .. .

 

For the transition period from                       to                        

 

Commission file number 0-51504

 

GENETIC TECHNOLOGIES LIMITED

(Exact name of Registrant as specified in its charter)

 

N/A

(Translation of Registrant’s name into English)

 

AUSTRALIA

(Jurisdiction of incorporation or organization)

 

60-66 Hanover Street, Fitzroy, Victoria, 3065, Australia

Telephone: 011 61 3 8412 7000; Facsimile: 011 61 3 8412 7040

(Address of principal executive offices)

 

Thomas G. Howitt

Telephone: 011 61 3 8412 7050; Facsimile: 011 61 3 8412 7040

Email: tom.howitt@gtg.com.au

60-66 Hanover Street, Fitzroy Victoria, 3065, Australia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

 

Securities registered or to be registered pursuant to Section 12(b) of the Act.  None

 

Title of each class

 

Name of each exchange on which registered

 

 

 

 

 

 

 

Securities registered or to be registered pursuant to Section 12(g) of the Act.

 

American Depositary Shares each representing 30 Ordinary Shares and evidenced by American Depositary Receipts

(Title of Class)

 

 

(Title of Class)

 



Table of Contents

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

 

None

(Title of Class)

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

 

362,389,899 Ordinary Shares

 

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

o Yes   x No

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

o Yes   x No

 

Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

x Yes   o No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer o

 

Accelerated filer o

 

Non-accelerated filer x

 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

U.S. GAAP o

 

International Financial Reporting Standards as issued
by the International Accounting Standards Board
x

 

Other o

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

o Item 17   o Item 18

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

o Yes   x No

 

(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.

 

o Yes   o No

 



Table of Contents

 

TABLE OF CONTENTS

 

INTRODUCTION

1

 

 

 

FORWARD-LOOKING STATEMENTS

1

 

 

 

ENFORCEMENT OF LIABILITIES AND SERVICE OF PROCESS

1

 

 

 

 

ITEM 1.

IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

2

 

 

 

 

ITEM 1.A

DIRECTORS AND SENIOR MANAGEMENT

2

 

 

 

 

 

ITEM 1.B

ADVISERS

3

 

 

 

 

 

ITEM 1.C

AUDITORS

3

 

 

 

 

 

ITEM 2.

OFFER STATISTICS AND EXPECTED TIMETABLE

3

 

 

 

 

 

ITEM 3.

KEY INFORMATION

3

 

 

 

 

 

ITEM 3.A

SELECTED FINANCIAL DATA

3

 

 

 

 

 

ITEM 3.B

CAPITALIZATION AND INDEBTEDNESS

5

 

 

 

 

 

ITEM 3.C

REASONS FOR THE OFFER AND USE OF PROCEEDS

5

 

 

 

 

 

ITEM 3.D

RISK FACTORS

6

 

 

 

 

 

ITEM 4.

INFORMATION ON THE COMPANY

13

 

 

 

 

 

ITEM 4.A

HISTORY AND DEVELOPMENT OF THE COMPANY

13

 

 

 

 

 

ITEM 4.B

BUSINESS OVERVIEW

15

 

 

 

 

 

ITEM 4.C

ORGANIZATIONAL STRUCTURE

38

 

 

 

 

 

ITEM 4.D

PROPERTY, PLANT AND EQUIPMENT

38

 

 

 

 

 

ITEM 5.

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

38

 

 

 

 

 

ITEM 5.A

OPERATING RESULTS

39

 

 

 

 

 

ITEM 5.B

LIQUIDITY AND CAPITAL RESOURCES

49

 

 

 

 

 

ITEM 5.C

RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.

51

 

 

 

 

 

ITEM 5.D

TREND INFORMATION

51

 

 

 

 

 

ITEM 5.E

OFF-BALANCE SHEET ARRANGEMENTS

52

 

 

 

 

 

ITEM 5.F

INFORMATION ABOUT CONTRACTUAL OBLIGATIONS

52

 

 

 

 

 

ITEM 6.

DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

52

 

 

 

 

 

ITEM 6.A

DIRECTORS AND SENIOR MANAGEMENT

52

 



Table of Contents

 

 

ITEM 6.B

COMPENSATION

55

 

 

 

 

 

ITEM 6.C

BOARD PRACTICES

59

 

 

 

 

 

ITEM 6.D

EMPLOYEES

61

 

 

 

 

 

ITEM 6.E

SHARE OWNERSHIP

62

 

 

 

 

 

ITEM 7.

MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

62

 

 

 

 

 

ITEM 7.A

MAJOR SHAREHOLDERS

62

 

 

 

 

 

ITEM 7.B

RELATED PARTY TRANSACTIONS

62

 

 

 

 

 

ITEM 7.C

INTERESTS OF EXPERTS AND COUNSEL

62

 

 

 

 

 

ITEM 8.

FINANCIAL INFORMATION

63

 

 

 

 

 

ITEM 8.A

CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION

63

 

 

 

 

 

ITEM 8.B

LITIGATION AND OTHER LEGAL PROCEEDINGS

63

 

 

 

 

 

ITEM 8.C

DIVIDENDS

63

 

 

 

 

 

ITEM 8.D

SIGNIFICANT CHANGES TO FINANCIAL INFORMATION

63

 

 

 

 

 

ITEM 8.E

SIGNIFICANT OTHER CHANGES

64

 

 

 

 

 

ITEM 9.

THE OFFER AND LISTING

65

 

 

 

 

 

ITEM 9.A

OFFER AND LISTING DETAILS

65

 

 

 

 

 

ITEM 9.B

PLAN OF DISTRIBUTION

66

 

 

 

 

 

ITEM 9.C

MARKETS

66

 

 

 

 

 

ITEM 9.D

SELLING SHAREHOLDERS

67

 

 

 

 

 

ITEM 9.E

DILUTION

67

 

 

 

 

 

ITEM 9.F

EXPENSES OF THE ISSUE

67

 

 

 

 

 

ITEM 10.

ADDITIONAL INFORMATION

67

 

 

 

 

 

ITEM 10.A

SHARE CAPITAL

67

 

 

 

 

 

ITEM 10.B

OUR CONSTITUTION

68

 

 

 

 

 

ITEM 10.C

MATERIAL CONTRACTS

69

 

 

 

 

 

ITEM 10.D

EXCHANGE CONTROLS AND OTHER LIMITATIONS AFFECTING SECURITY HOLDERS

69

 

 

 

 

 

ITEM 10.E

TAXATION

70

 

ii



Table of Contents

 

 

ITEM 10.F

DIVIDENDS AND PAYING AGENTS

76

 

 

 

 

 

ITEM 10.G

STATEMENT BY EXPERTS

76

 

 

 

 

 

ITEM 10.H

DOCUMENTS ON DISPLAY

76

 

 

 

 

 

ITEM 10.I

SUBSIDIARY INFORMATION

76

 

 

 

 

 

ITEM 11.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

77

 

 

 

 

 

ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

77

 

 

 

 

 

ITEM 12.A

DEBT SECURITIES

77

 

 

 

 

 

ITEM 12.B

WARRANTS AND RIGHTS

77

 

 

 

 

 

ITEM 12.C

OTHER SECURITIES

77

 

 

 

 

 

ITEM 12.D

AMERICAN DEPOSITARY SHARES

77

 

 

 

 

 

ITEM 13.

DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

78

 

 

 

 

 

ITEM 14.

MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

78

 

 

 

 

 

ITEM 15.

CONTROLS AND PROCEDURES

78

 

 

 

 

 

ITEM 15.A

DISCLOSURE CONTROLS AND PROCEDURES

78

 

 

 

 

 

ITEM 15.B

MANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

79

 

 

 

 

 

ITEM 15.C

ATTESTATION REPORT OF THE REGISTERED PUBLIC ACCOUNTING FIRM

79

 

 

 

 

 

ITEM 15.D

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING

80

 

 

 

 

 

ITEM 16.A

AUDIT COMMITTEE FINANCIAL EXPERT

80

 

 

 

 

 

ITEM 16.B

CODE OF ETHICS

80

 

 

 

 

 

ITEM 16.C

PRINCIPAL ACCOUNTANT FEES AND SERVICES

81

 

 

 

 

 

ITEM 16D.

EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

81

 

 

 

 

 

ITEM 16E.

PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

81

 

 

 

 

 

ITEM 17.

FINANCIAL STATEMENTS

81

 

 

 

 

 

ITEM 18.

FINANCIAL STATEMENTS

81

 

 

 

 

 

ITEM 19.

EXHIBITS

82

 

 

 

 

 

SIGNATURES

84

 

iii



Table of Contents

 

INTRODUCTION

 

In this Annual Report, the “Company,” “Genetic Technologies”, “we,” “us” and “our” refer to Genetic Technologies Limited and its consolidated subsidiaries.

 

Our consolidated financial statements are set out on pages F1 to F42 of this Annual Report (refer to Item 18 “Financial Statements”).

 

References to the “ADSs” are to our ADSs described in Item 12.D, “American Depositary Shares,” and references to the “Ordinary Shares” are to our Ordinary Shares described in Item 10.A, “Share Capital.”

 

Our fiscal year ends on June 30, and references in this Annual Report to any specific fiscal year are to the twelve month period ended on June 30 of such year.

 

FORWARD-LOOKING STATEMENTS

 

This Annual Report contains forward-looking statements that involve risks and uncertainties.  We use words such as “anticipates”, “believes”, “plans”, “expects”, “future”, “intends” and similar expressions to identify such forward-looking statements.  This Annual Report also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of Genetic Technologies and related service markets and spending.  You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Annual Report.  Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us described below under the caption “Risk Factors” and elsewhere in this Annual Report.

 

Although we believe that the expectations reflected in such forward-looking statements are reasonable at this time, we can give no assurance that such expectations will prove to be correct.  Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.  Important factors that could cause actual results to differ materially from our expectations are contained in cautionary statements in this Annual Report including, without limitation, in conjunction with the forward-looking statements included in this Annual Report and specifically under Item 3.D, “Risk Factors.”

 

All subsequent written and oral forward-looking statements attributable to us are expressly qualified in their entirety by reference to these cautionary statements.

 

ENFORCEMENT OF LIABILITIES AND SERVICE OF PROCESS

 

We are incorporated under the laws of Western Australia, in the Commonwealth of Australia.  All of our directors and executive officers, and any experts named in this Annual Report, reside outside the U.S.  Substantially all of our assets, our directors’ and executive officers’ assets and such experts’ assets are located outside the U.S.  As a result, it may not be possible for investors to affect service of process within the U.S. upon us or our directors, executive officers or such experts, or to enforce against them or us in U.S. courts, judgments obtained in U.S. courts based upon the civil liability provisions of the federal securities laws of the U.S.  In addition, we have been advised by our Australian solicitors that there is doubt that the courts of Australia will enforce against us, our directors, executive officers and experts named herein, judgments obtained in the U.S. based upon the civil liability provisions of the federal securities laws of the U.S. or will enter judgments in original actions brought in Australian courts based upon the federal securities laws of the U.S.

 

1



Table of Contents

 

PART I

 

Item 1.            Identity of Directors, Senior Management and Advisers

 

Item 1.A         Directors and Senior Management

 

The Directors of the Company as of the date of this Annual Report are as follows:

 

 

Name

 

Position/Function

 

Business Address

 

 

 

 

 

Fred Bart

 

Chairman

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

Sidney C. Hack

 

Non-Executive Director

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

Huw D. Jones

 

Non-Executive Director

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

The members of Senior Management of the Company as of the date of this Annual Report are as follows:

 

Name

 

Position/Function

 

Business Address

 

 

 

 

 

Thomas G. Howitt

 

Chief Financial Officer and Company Secretary

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

Ross Barrow (note)

 

Chief Operating Officer

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

W. Ian Smith

 

Business Development Manager - DNA Profiling

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

Jonathan S. Whitty (note)

 

Business Development Manager - Medical Diagnostics

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

M. Luisa Ashdown

 

General Manager - Licensing

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

 

 

 

 

Catherine M. Barclay

 

General Manager - Human Resources

 

60-66 Hanover Street Fitzroy Victoria 3065 Australia

 

Note:           Both Ross Barrow and Jonathan Whitty had tendered their resignations as of the date of this Annual Report.

 

2



Table of Contents

 

Item 1.B         Advisers

 

Our principal bankers, accountants and legal advisers are as follows:

 

Name of Adviser

 

Function

 

Business Address

 

 

 

 

 

 

 

Ernst & Young

 

Auditors

 

8 Exhibition Street Melbourne Victoria 3000 Australia

 

 

 

 

 

 

 

St. George Bank Limited

 

Bankers - Australia

 

530 Collins Street Melbourne Victoria 3000 Australia

 

 

 

 

 

 

 

KeyBank National Association

 

Bankers - USA

 

1130 Haxton Drive Fort Collins Colorado 80525 USA

 

 

 

 

 

 

 

Baker & McKenzie

 

General Counsel

 

525 Collins Street Melbourne Victoria 3000 Australia

 

 

 

 

 

 

 

Hamilton, DeSanctis & Cha

 

Licensing Attorneys

 

225 Union Boulevard, Suite 305 Lakewood Colorado 80228 USA

 

 

 

 

 

 

 

Sheridan Ross PC

 

Patent Attorneys

 

1560 Broadway, Suite 1200 Denver Colorado 80202-5141 USA

 

 

 

 

 

 

 

Greenberg Traurig, LLP

 

U.S. Securities Counsel

 

200 Park Avenue New York New York 10166 USA

 

 

Item 1.C         Auditors

 

The auditors of the Company’s financial statements for the years ended June 30, 2008, 2007, 2006, 2005 and 2004 were Ernst & Young, whose address is 8 Exhibition Street, Melbourne, Victoria, 3000, Australia.  Ernst & Young is the Company’s current independent registered public accounting firm, an appointment ratified at the Annual General Meeting held on November 28, 2003.

 

Item 2.            Offer Statistics And Expected Timetable

 

Not applicable.

 

Item 3.            Key Information

 

Item 3.A         Selected Financial Data

 

The following selected financial data for the four years ended June 30, 2008 is derived from the audited consolidated financial statements of Genetic Technologies Limited, prepared in accordance with International Financial Reporting Standards (“IFRS”), which became effective for our company as of our fiscal year ended June 30, 2006.  Under IFRS 1, “First-time Adoption of International Financial Reporting Standards,” or IFRS 1, a company adopting IFRS for the first time is required to adopt accounting policies that comply with IFRS and related interpretations that are in effect at the reporting date of its first annual financial statements prepared in accordance with IFRS, in our case June 30, 2006.  IFRS 1 also requires that those policies be applied as of the date of transition to IFRS, in our case July 1, 2004, and consistently throughout all periods presented in the first annual financial statements prepared in accordance with IFRS.  However, the Company was not required to recast its financial statements prior to July 1, 2004 in accordance with IFRS, and is therefore unable to provide the selected data for the year ended June 30, 2004 prepared in accordance with IFRS.  Accordingly, U.S. GAAP selected data for the 2004 financial year has been removed.  Our consolidated financial statements appearing in this report comply with both the IFRS as issued by International Accounting Standards Board and Australian equivalents to International Financial Reporting Standards, or A-IFRS.

 

3



Table of Contents

 

The balance sheet data as of June 30, 2008 and 2007 and the income statement data for fiscal years 2008, 2007 and 2006 are derived from our audited consolidated financial statements included in this annual report.  Balance sheet data as of June 30, 2006 and 2005 and income statement data for the 2005 and 2004 financial years are derived from our audited consolidated financial statements which are not included in this Annual Report.  The data should be read in conjunction with the consolidated financial statements, related notes and other financial information included herein.

 

All amounts are stated in Australian dollars as of June 30 as noted.

 

GENETIC TECHNOLOGIES LIMITED

 

CONSOLIDATED INCOME STATEMENTS
FOR 2008, 2007, 2006 AND 2005

 

 

 

 

Year ended
June 30, 2008

 

Year ended
June 30, 2007

 

Year ended
June 30, 2006

 

Year ended
June 30, 2005

 

 

 

AUD

 

AUD

 

AUD

 

AUD

 

 

 

 

 

 

 

 

 

 

 

Revenue from operations

 

15,702,336

 

14,978,819

 

10,048,703

 

9,607,237

 

Other income

 

276,606

 

340,486

 

708,411

 

782,714

 

Employee benefits expenses

 

(6,568,966

)

(5,556,644

)

(5,432,506

)

(4,853,853

)

Amortization and depreciation expenses

 

(4,755,155

)

(4,602,992

)

(4,817,277

)

(4,411,685

)

Impairment losses and other write-downs

 

(2,378,000

)

(1,306,960

)

(97,500

)

 

Genetic testing expenses

 

(1,599,644

)

(1,989,098

)

(2,008,546

)

(1,752,495

)

Contract research and trial expenses

 

(1,267,748

)

(1,247,775

)

(1,345,916

)

(873,501

)

Royalties, license fees and commissions paid

 

(889,520

)

(580,122

)

(177,283

)

(921,548

)

Legal and patent fees

 

(873,854

)

(748,605

)

(1,440,929

)

(4,555,642

)

Administration expenses

 

(839,226

)

(901,380

)

(910,776

)

(1,068,232

)

Rent and outgoings

 

(533,644

)

(535,045

)

(511,050

)

(495,749

)

Net foreign exchange losses

 

(254,954

)

(317,317

)

 

(186,222

)

Marketing and promotion expenses

 

(221,644

)

(437,087

)

(502,353

)

(504,974

)

Withholding tax

 

(94,524

)

(264,391

)

(90,500

)

(258,243

)

Finance costs

 

(66,763

)

(90,929

)

(112,082

)

(69,965

)

Other expenses

 

(1,086,938

)

(1,086,662

)

(1,218,519

)

(1,211,777

)

 

 

 

 

 

 

 

 

 

 

Loss before income tax

 

(5,451,638

)

(4,345,702

)

(7,908,123

)

(10,773,935

)

Income tax expense

 

 

 

 

 

Loss for the year

 

(5,451,638

)

(4,345,702

)

(7,908,123

)

(10,773,935

)

Net loss / (profit) attributable to minority interests

 

5,549

 

17,159

 

(10,650

)

(46,292

)

Net loss attributable to equity holders of Genetic Technologies Limited

 

(5,446,089

)

(4,328,543

)

(7,918,773

)

(10,820,227

)

 

 

 

 

 

 

 

 

 

 

Loss per share (cents per share)

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per ordinary share

 

(1.5

)

(1.2

)

(2.2

)

(3.4

)

 

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding

 

362,389,899

 

362,389,899

 

362,386,940

 

315,264,068

 

 

4



Table of Contents

 

GENETIC TECHNOLOGIES LIMITED

 

CONSOLIDATED BALANCE SHEET DATA
FOR 2008, 2007, 2006 AND 2005

 

 

 

 

Year ended
June 30, 2008

 

Year ended
June 30, 2007

 

Year ended
June 30, 2006

 

Year ended
June 30, 2005

 

 

 

AUD

 

AUD

 

AUD

 

AUD

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

Current assets

 

15,893,852

 

14,600,846

 

13,960,666

 

19,693,325

 

Non-current assets

 

8,200,726

 

14,848,181

 

19,756,241

 

23,805,732

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

24,094,578

 

29,449,027

 

33,716,907

 

43,499,057

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

Current liabilities

 

(3,047,002

)

(3,248,763

)

(2,946,212

)

(4,871,674

)

Non-current liabilities

 

(262,503

)

(97,455

)

(528,556

)

(944,144

)

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

(3,309,505

)

(3,346,218

)

(3,474,768

)

(5,815,818

)

 

 

 

 

 

 

 

 

 

 

Net assets

 

20,785,073

 

26,102,809

 

30,242,139

 

37,683,239

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

 

 

 

 

Contributed equity

 

70,243,996

 

70,243,996

 

70,243,996

 

70,235,396

 

Reserves

 

1,588,804

 

1,456,895

 

1,237,524

 

779,101

 

Accumulated losses

 

(51,189,189

)

(45,743,100

)

(41,414,557

)

(33,495,784

)

Minority interests

 

141,462

 

145,018

 

175,176

 

164,526

 

 

 

 

 

 

 

 

 

 

 

Total shareholders’ equity

 

20,785,073

 

26,102,809

 

30,242,139

 

37,683,239

 

 

Exchange rates

 

The following table sets forth, for the periods and dates indicated, certain information concerning the noon buying rate in New York City for Australian dollars expressed in U.S. dollars per $1.00 as certified for customs purposes by the Federal Reserve Bank of New York.

 

Period ended

 

At period end

 

Average rate

 

High

 

Low

 

 

 

 

 

 

 

 

 

 

 

Yearly data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 2004

 

0.6952

 

0.7132

 

0.8005

 

0.6345

 

June 2005

 

0.7618

 

0.7564

 

0.7792

 

0.7498

 

June 2006

 

0.7423

 

0.7475

 

0.7781

 

0.7056

 

June 2007

 

0.8491

 

0.7899

 

0.8491

 

0.7407

 

June 2008

 

0.9562

 

0.8965

 

0.9644

 

0.7672

 

 

 

 

 

 

 

 

 

 

 

Monthly data

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 2008

 

0.9562

 

0.9511

 

0.9610

 

0.9342

 

July 2008

 

0.9415

 

0.9620

 

0.9797

 

0.9415

 

August 2008

 

0.8563

 

0.8815

 

0.9317

 

0.8553

 

September 2008

 

0.8211

 

0.8168

 

0.8441

 

0.7831

 

October 2008

 

0.6574

 

0.6870

 

0.7937

 

0.6073

 

November 2008

 

0.6546

 

0.6591

 

0.7005

 

0.6191

 

December 2008 (note)

 

0.6985

 

0.6636

 

0.6985

 

0.6343

 

 

Note:                   Data for December 2008 covers the period up to December 18, 2008.

 

Item 3.B         Capitalization and Indebtedness

 

Not applicable.

 

Item 3.C         Reasons for the Offer and Use of Proceeds

 

Not applicable.

 

5



Table of Contents

 

Item 3.D                          Risk Factors

 

Before you purchase our ADSs, you should be aware that there are risks, including those described below.  You should consider carefully these risk factors together with all of the other information contained elsewhere in this Annual Report before you decide to purchase our ADSs.

 

Risks Related to Us

 

Our stock price is volatile and can fluctuate significantly based on events not in our control and general industry conditions.  As a result, the value of your investment may decline significantly.

 

The biotechnology sector can be particularly vulnerable to abrupt changes in investor sentiment.  Stock prices of companies in the biotechnology industry, including ours, can swing dramatically, with little relationship to operating performance.  Our stock price may be affected by a number of factors including, but not limited to:

 

·                  product development events;

 

·                  the outcome of litigation;

 

·                  decisions relating to intellectual property rights;

 

·                  the entrance of competitive products or technologies into our market;

 

·                  new medical discoveries;

 

·                  the establishment of strategic partnerships and alliances;

 

·                  changes in reimbursement policies or other practices related to the pharmaceutical industry; or

 

·                  other industry and market changes or trends.

 

Since our listing on the Australian Securities Exchange in August 2000, the price of our Ordinary Shares has ranged from a low of $0.038 to a high of $1.05 per share.  Further fluctuations are likely to occur due to events not within our control and general market conditions affecting the biotechnology sector or the stock market generally.  The most significant such event of which we have knowledge took place in August 2003 after a television report in Australia on our company was broadcast.  During that week, the price of our shares increased from $0.58 to $0.87 on a volume of 26,000,000 shares traded, which was exceptionally high for us.  The share price subsequently retreated.

 

In addition, low trading volume may increase the volatility of the price of our ADSs.  Trading volume in our Ordinary Shares on other markets has not been historically high, and the trading volume of our ADSs on the NASDAQ Global Market has typically also been low.  Further, because each of our ADSs represents 30 of our Ordinary Shares, trading volume in our ADSs is lower than that for our Ordinary Shares.  A thin trading market could cause the price of our ADSs to fluctuate significantly more than the stock market as a whole.  For example, trades involving a relatively small number of our ADSs may have a greater impact on the trading price for our ADSs than would be the case if the trading volume were higher.

 

The following chart graphically illustrates the fluctuation in the price of our shares (in Australian dollars) over the last five years:

 

 

6



Table of Contents

 

The fact that we do not expect to pay cash dividends may lead to decreased prices for our stock.

 

We have never paid a cash dividend on our Ordinary Shares and we do not anticipate paying a cash dividend in the foreseeable future.  We intend to retain future cash earnings, if any, for reinvestment in the development and expansion of our business.  Whether we pay cash dividends in the future will be at the discretion of our Board of directors and may be dependent on our financial condition, results of operations, capital requirements and any other factors our Board of directors decides is relevant.  As a result, an investor may only recognize an economic gain on an investment in our stock from an appreciation in the price of our stock.

 

You may have difficulty in effecting service of legal process and enforcing judgments against us and our Management.

 

We are a public company limited by shares, registered and operating under the Australian Corporations Act 2001.  All of our directors and officers named in this Annual Report reside outside the U.S.  Substantially all, or a substantial portion of, the assets of those persons are also located outside the U.S.  As a result, it may not be possible to affect service on such persons in the U.S. or to enforce, in foreign courts, judgments against such persons obtained in U.S. courts and predicated on the civil liability provisions of the federal securities laws of the U.S.  Furthermore, substantially all of our directly-owned assets are located outside the U.S., and, as such, any judgment obtained in the U.S. against us may not be collectible within the U.S.  There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia.

 

Because we are not necessarily required to provide you with the same information as an issuer of securities based in the United States, you may not be afforded the same protection or information you would have if you had invested in a public corporation based in the United States.

 

We are exempt from certain provisions of the Securities Exchange Act of 1934, as amended, commonly referred to as the Exchange Act, that are applicable to U.S. public companies, including (i) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q or current reports on Form 8-K; (ii) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and (iii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time.  The exempt provisions would be available to you if you had invested in a U.S. corporation.

 

However, in line with the Australian Securities Exchange regulations, we will disclose our semi-annual results, which, in accordance with Australian auditing standards, are required to have a limited review semi-annually and be fully audited annually.  The information, which may have an effect on the stock price on the Australian Securities Exchange, will also be disclosed immediately in the public media and to the Australian Securities Exchange.  Other relevant information pertaining to our Company will also be disclosed in line with the Australian Securities Exchange regulations and information dissemination requirements for listed companies.  We will provide our semi-annual results and other material information that we make public in Australia in the U.S. under the cover of an SEC Form 6-K.  Nevertheless, you may not be afforded the same protection or information, which would be made available to you, were you investing in a United States public corporation because the requirements of a Form 10-Q and Form 8-K are not applicable to us.

 

If a public market does not develop for our ADSs, your ability to resell your ADSs could be negatively affected because there would be limited buyers for your interests.

 

Historically, there was virtually no trading in our ADSs through the pink sheets after the establishment of our Level I ADR Program.  However, subsequent to the Level II listing of our ADSs on the NASDAQ Global Market on September 2, 2005, the trading volumes of our ADSs have increased.  An active trading market for the ADSs, however, may not be maintained in the future.  If an active trading market is not maintained, the liquidity and trading prices of the ADSs could be negatively affected.

 

In certain circumstances, holders of ADRs may have limited rights relative to holders of Ordinary Shares.

 

The rights of holders of ADSs with respect to the voting of Ordinary Shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York.  For example, although ADS holders are entitled under the deposit agreement, subject to any applicable provisions of Australian law and of our Constitution, to instruct the depositary as to the exercise of the voting rights pertaining to the Ordinary Shares represented by the American Depositary Shares, and the depositary has agreed that it will try, as far as practical, to vote the Ordinary Shares so represented in accordance with such instructions, ADS holders may not receive notices sent by the depositary in time to ensure that the depositary will vote the Ordinary Shares.  This means that the holders of ADRs may not be able to exercise their right to vote.  In addition, under the deposit agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions.  We have no obligation to take any action to permit distributions to holders of our American Depositary Receipts, or ADRs.  As a result, holders of ADRs may not receive distributions made by us.

 

7



Table of Contents

 

Our Company has a history of losses and we expect to continue to incur costs.

 

The business which is now known as Genetic Technologies Limited was founded in 1989.  We have incurred operating losses in every year of our existence.  We incurred net losses of $10,820,227 for the year ended June 30, 2005, net losses of $7,918,773 for the year ended June 30, 2006, net losses of $4,328,543 for year ended June 30, 2007 and net losses of $5,446,089 for year ended June 30, 2008.  As of  June 30, 2008, we have accumulated losses of $51,189,189.  The extent of future losses and the time required to achieve profitability remains uncertain.

 

Risks Related to our Industry

 

Our sales cycle is typically lengthy.

 

The sales cycle for our testing products and license generation is typically lengthy.  As a result, we may expend substantial funds and management effort with no assurance of successfully selling our products or services or granting new licenses.  Our ability to obtain customers for our genetic testing services depends significantly on the perception that our services can help accelerate efforts in genomics.  The sales cycle is typically lengthy.  Our sales effort requires the effective demonstration of the benefits of our services to, and significant training of, many different departments within a potential customer.  In addition, we sometimes are required to negotiate agreements containing terms unique to each customer.  With respect to license generation, it is common for negotiations with licensees to take many months before a license is eventually granted.  Our business could also be adversely affected if we expend money without any return.

 

If our competitors develop more effective products, the results from our operations and financial condition could be affected.

 

We are subject to limited competition from biotechnology and diagnostic companies, academic and research institutions and government or other publicly-funded agencies that are pursuing products and services that are substantially similar to our genetic testing services, or which otherwise address the needs of our customers and potential customers.  Our competitors in the testing market include private and public sector enterprises located in Australia and elsewhere.  Many of the organizations competing with us have greater experience in the areas of finance, research and development, manufacturing, marketing, sales, distribution, technical and regulatory matters than we do.  In addition, many current and potential competitors have greater name recognition and more extensive collaborative relationships.  However, because of our patents, we have virtually no competition in the licensing area.

 

Our competitive position in the testing area is based upon our ability to:

 

·                  create and maintain scientifically-advanced technology and offer proprietary products and services;

 

·                  attract and retain qualified personnel;

 

·                  obtain patent or other protection for our products and services;

 

·                  obtain required government approvals and other accreditations on a timely basis; and

 

·                  successfully market our services.

 

If we are not successful in meeting these goals, our business could be adversely affected.  Similarly, our competitors may succeed in developing technologies, products or services that are more effective than any that we are developing or that would render our technology and services obsolete, noncompetitive or uneconomical.

 

For a full discussion of competition see Item 4.B, “Competition”.

 

We rely heavily upon our patents and proprietary technology and any future claims that our patents are invalid could seriously affect our licensing business and adversely affect our revenues and our financial condition.

 

We rely upon our portfolio of patent rights, patent applications and exclusive licenses to patents and patent applications relating to genetic technologies.  We expect to aggressively patent and protect our proprietary technologies.  However, we cannot be certain that any additional patents will be issued to us as a result of our domestic or foreign patent applications or that any of our patents will withstand challenges by others.  Patents issued to, or licensed by, us may be infringed or third parties may independently develop either the same or similar technologies.  Similarly, our patents may not provide us with meaningful protection from competitors, including those who may pursue patents which may prevent, limit or interfere with our products or will require licensing and the payment of significant fees or royalties by us to such third parties in order to enable us to conduct our business.  We may sue or be sued by third parties regarding our patents and other intellectual property rights.  These suits are often costly and would divert valuable funds and technical resources from our operations and cause distraction to Management.

 

8



Table of Contents

 

We have important relationships with external parties over whom we have limited control.

 

We have relationships with a number of academic consultants who are not employed by us.  Accordingly, we have limited control over their activities and can expect only limited amounts of their time to be dedicated to our activities.  These persons may have consulting, employment or advisory arrangements with other entities that may conflict with or compete with their obligations to us.  Our consultants typically sign agreements that provide for confidentiality of our proprietary information and results of studies.  However, in connection with every relationship, we may not be able to maintain the confidentiality of our technology, the dissemination of which could hurt our competitive position and results of operations.  To the extent that our scientific consultants develop inventions or processes independently that may be applicable to our proposed products, disputes may arise as to the ownership of the proprietary rights to such information, and we may not win those disputes.

 

If we are unable to protect our proprietary assets, we may not be able to commercialize products or services.

 

Our commercial success will largely depend on our ability to obtain patent protection for many aspects of our business, including the products, methods and services we develop.  Patents issued to us may not provide us with substantial protection or be commercially beneficial to us.  The issuance of a patent is not conclusive as to its validity or its enforceability.  In addition, our patent applications or those we have licensed, may not result in issued patents.  If our patent applications do not result in issued patents, our competitors may obtain rights to commercialize our discoveries which could harm our competitive position.  We also may apply for patent protection on novel genetic variations in known genes and their uses, as well as novel uses for previously identified genetic variations discovered by third parties.  In the latter cases, we may need a license from the holder of the patent with respect to such genetic variations in order to make, use or sell any related products.  We may not be able to acquire such licenses on terms acceptable to us, if at all.

 

Certain parties are attempting to rapidly identify and characterize genes and genetic variations through the use of sequencing and other technologies.  To the extent that any patents are issued to other parties on such partial or full-length genes or genetic variations or uses for such genes or genetic variations, the risk increases that the sale of products or services developed by us or our collaborators may give rise to claims of patent infringement against us.  Others may have filed and, in the future, are likely to file patent applications covering many genetic variations and their uses.  Any such patent applications may have priority over our patent applications and could further require us to obtain rights to previously issued patents covering genetic variations.  Any license that we may require under any such patent may not be made available to us on commercially acceptable terms, if at all.

 

We may be sued for infringing on the intellectual property rights of others.  We could also become involved in interference proceedings in the United States Patent and Trademark Office to determine the relative priority of our patents or patent applications and those of the other parties involved in the interference proceeding.  Intellectual property proceedings are costly, and could affect our results of operations.  These proceedings can also divert the attention of managerial and technical personnel.  If we do not prevail in any intellectual property proceeding, in addition to any damages we might have to pay, we could be required to stop the infringing activity, or obtain a license to or design around the intellectual property in question.  In interference proceedings, our patent rights could be invalidated and the scope of our patents could be limited.  If we are unable to obtain licenses to intellectual property rights that we need to conduct our business, or are unable to design around any third party patent, we may be unable to sell some of our products, which will result in reduced revenue.

 

We have in the past and may possibly in the future become a party to litigation involving patents and intellectual property rights.  We have previously commenced litigation against a number of parties to protect our rights pertaining to our intellectual property.  We may in the future receive claims of infringement of intellectual property rights from other parties.  If we do not prevail in any future legal proceedings, we may be required to pay significant monetary damages.  In addition, we could also be enjoined from use of certain processes or prevented from selling certain configurations of our products or services that were found to be within the scope of the patent claims.  In the event we did not prevail in any future proceeding, we would either have to obtain licenses from the other party, avoid certain product configurations or modify some of our products, services and processes to design around the patents.  Licenses could be costly or unavailable on commercially reasonable terms.  Designing around patents or focusing efforts on different configurations could be time consuming, and we may have to remove some of our products or services from the market while we were completing redesigns.  Accordingly, if we are unable to settle future intellectual property disputes through licensing or similar arrangements, or if any such future disputes are determined adversely to us, our ability to market and sell our products and services could be harmed.  This would in turn reduce demands for our services and harm our financial condition and results of operations.

 

In addition, in order to protect or enforce our patent rights or to protect our ability to operate our business, we may need to initiate other patent litigation against third parties.  These lawsuits could be expensive, take significant time, and could divert Management’s attention from other business concerns.  These lawsuits could result in the invalidation  or limitation in the scope of our patents or forfeiture of the rights associated with our patents.  We may not prevail in any such proceedings and a court may find damages or award other remedies in favor of our opposing party in any of these suits.  During the course of any future proceedings, there may be public announcements of the results of hearings, motions and other interim proceedings or developments in the litigation.  Securities analysts or investors may perceive these announcements to be negative, which could cause the market price of our stock to decline.

 

9



Table of Contents

 

We may be subject to professional liability suits and our insurance may not be sufficient to cover damages.  If this occurs, our business and financial condition may be adversely affected.

 

Our business exposes us to potential liability risks that are inherent in the testing, manufacturing, marketing and sale of genetic tests.  The use of our products and product candidates, whether for clinical trials or commercial sale, may expose us to professional liability claims and possible adverse publicity.  We may be subject to claims resulting from incorrect results of analysis of genetic variations or other screening tests performed using our services.  Litigation of such claims could be costly.  We could expend significant funds during any litigation proceeding brought against us.  Further, if a court were to require us to pay damages to a plaintiff, the amount of such damages could significantly harm our financial condition.  Although we have public and products liability insurance coverage under broadform liability and professional indemnity policies, for an aggregate amount of $60,000,000, the level or breadth of our coverage may not be adequate to fully cover potential liability claims.  To date we have not been subject to any claims, or ultimately liability, in excess of the amount of our coverage.  In addition, we may not be able to obtain additional professional liability coverage in the future at an acceptable cost.  A successful claim or series of claims brought against us in excess of our insurance coverage and the effect of professional liability litigation upon the reputation and marketability of our technology and products, together with the diversion of the attention of key personnel, could negatively affect our business.

 

We use potentially hazardous materials, chemicals and patient samples in our business and any disputes relating to improper handling, storage or disposal of these materials could be time consuming and costly.

 

Our research and development, production and service activities involve the controlled use of hazardous laboratory materials and chemicals, including small quantities of acid and alcohol, and patient tissue and blood samples.  We do not knowingly deal with infectious samples.  We, our collaborators and service providers are subject to stringent Australian federal, state and local laws and regulations governing occupational health and safety standards, including those governing the use, storage, handling and disposal of these materials and certain waste products.  However, we could be liable for accidental contamination or discharge or any resultant injury from hazardous materials, and conveyance, processing, and storage of and data on patient samples.  If we, our collaborators or service providers fail to comply with applicable laws or regulations, we could be required to pay penalties or be held liable for any damages that result and this liability could exceed our financial resources.  Further, future changes to environmental health and safety laws could cause us to incur additional expense or restrict our operations.  We have never had a reportable injury through the date of this Annual Report.

 

In addition, our collaborators and service providers may be working with these types of hazardous materials, including hazardous chemicals, in connection with our collaborations.  In the event of a lawsuit or investigation, we could be held responsible for any injury caused to persons or property by exposure to, or release of, these patient samples that may contain viruses and hazardous materials.  The cost of this liability could exceed our resources.  While we maintain broadform liability insurance coverage for these risks, in the amount of up to $40,000,000, the level or breadth of our coverage may not be adequate to fully cover potential liability claims.  To date, we have not been subject to claims, or ultimately liability, in excess of the amount of our coverage.  Our broadform insurance coverage also covers us against losses arising from an interruption of our business activities as a result of the mishandling of such materials.  We also maintain workers’ compensation insurance, which is mandatory in Australia, covering all of our workers in the event of injury.

 

We depend on the collaborative efforts of our academic and corporate partners for research, development and commercialization of some of our products.  A breach by our partners of their obligations, or the termination of the relationship, could deprive us of valuable resources and require additional investment of time and money.

 

Our strategy for research, development and commercialization of some of our products involves entering into various arrangements with academic and corporate partners and others.  As a result, our strategy depends, in part, upon the success of these outside parties in performing their responsibilities.  Our collaborators may also be our competitors.  We cannot control the amount and timing of resources that our collaborators devote to performing their contractual obligations and we have no certainty that these parties will perform their obligations as expected or that any revenue will be derived from these arrangements.

 

If our collaborators breach or terminate their agreement with us or otherwise fail to conduct their collaborative activities in a timely manner, the development or commercialization of the product candidate or research program under such collaborative arrangement may be delayed.  If that is the case, we may be required to undertake unforeseen additional responsibilities or to devote unforeseen additional funds or other resources to such development or commercialization, or such development or commercialization could be terminated.  The termination or cancellation of collaborative arrangements could adversely affect our financial condition, intellectual property position and general operations.  In addition, disagreements between collaborators and us could lead to delays in the collaborative research, development, or commercialization of certain products or could require or result in formal legal process or arbitration for resolution.  These consequences could be time-consuming and expensive and could have material adverse effects on us.

 

Other than our contractual rights under our license agreements, we may be limited in our ability to convince our licensees to fulfill their obligations.  If our licensees fail to act promptly and effectively, or if a dispute arises, it could have a material adverse effect on our results of operations and the price of our Ordinary Shares and ADSs.

 

10



Table of Contents

 

We rely upon scientific, technical and clinical data supplied by academic and corporate collaborators, licensors, licensees, independent contractors and others in the evaluation and development of potential therapeutic methods.  There may be errors or omissions in this data that would materially adversely affect the development of these methods.

 

We may seek additional collaborative arrangements to develop and commercialize our products in the future.  We may not  be able to negotiate acceptable collaborative arrangements in the future and, if negotiated, we have no certainty that they will be on favorable terms or will be successful.  In addition, our collaborative partners may pursue alternative technologies independently or in collaboration with others as a means of developing treatments for the diseases targeted by their collaborative programs with us.  If any of these events occurs, the progress of the Company could be adversely affected and our results of operations and financial condition could suffer.

 

Problems associated with international business operations could affect our ability to license our technology and our results of operations.

 

We seek to license our intellectual property on a global scale, including eventually in countries that are considered to provide significantly less protection to intellectual property than the United States and Australia.  In addition, a number of other risks are inherent in international transactions and commerce, including political and economic instability, foreign currency exchange fluctuations and changes in tax laws.

 

Government regulation of genetic research or testing may adversely affect the demand for our services and impair our business and operations.

 

Apart from accreditation requirements, we are generally not subject to regulation.  Federal, state and local governments, however, may adopt regulations relating to the conduct of genetic research and genetic testing.  These regulations could limit or restrict genetic research activities as well as genetic testing for research or clinical purposes.  In addition, if state and local regulations are adopted, these regulations may be inconsistent with, or in conflict with, regulations adopted by other state or local governments.  Regulations relating to genetic research activities could adversely affect our ability to conduct our research and development activities.  Regulations restricting genetic testing could adversely affect our ability to market and sell our services.  Accordingly, any regulations of this nature could increase the costs of our operations or restrict our ability to conduct our testing business and might adversely affect our operations and financial condition.

 

In Australia, there is no law that prohibits the performing of a paternity test by using just a sample obtained from a father and child.  In May 2003, the Australian Law Reform Commission (ALRC) released its report into Human Genetic Testing in Australia.  In relation to paternity testing, it made various recommendations, the most significant of which was that the testing of a child without the knowledge or consent of both parents should be made illegal.  In December 2005, the Australian Government formally responded to the ALRC report.  Although it accepted most of the report’s recommendations, it did not accept its recommendation that it should be illegal to test a child without the knowledge or consent of both parents.  Instead, it recommended that the body that formally accredits laboratories, National Association of Testing Authorities (NATA) should review its accreditation requirements for DNA parentage testing to ensure that laboratories meet the highest technical and ethical standards, particularly in relation to consent to testing, protecting the integrity of genetic samples, and providing information about counselling.  As of December 2008, it is not clear what NATA has done in relation to the Government’s recommendation.

 

In November 2008, the Federal Government released a discussion paper on non-consensual genetic testing which it proposes to make illegal.  The purpose of this paper is to obtain feedback from the public and industry on this issue prior to formulating legislation in this area.  In the area of paternity testing, the paper discusses the issue of consent but makes no recommendation as to what the required consent for taking a sample from a child would be.  For example, does this require the consent of both parents or just one?  If the testing of a sample eventually requires the consent of both parents, then this will have a negative impact on our revenue as father/child testing is a substantial and growing market.

 

Responses to the discussion paper must be submitted by the end of January 2009. It is not known how long the Government will take to consider these submissions nor its timeframe to draft and then pass any proposed legislation.  If passed, this legislation will immediately become law in the Australian Capital Territory and the Northern Territory.  All other States would then be required to pass mirror legislation but are under no obligation to do so.  It is not clear how long it would take the States to pass this legislation.

 

We rely on the services of individuals who possess special skills and experience.

 

Much of the future success of the Company depends on the continued service and availability of skilled personnel, including members of its senior executive team, and those in technical, marketing and staff positions.  While we are actively recruiting new employees with such skills and experience to reduce our reliance on these individuals, skilled personnel, with specific experience in the biotechnology industry, are in high demand and competition for their talents is intense.

 

11



Table of Contents

 

Ethical and other concerns surrounding the use of genetic information may reduce the demand for our services.

 

Public opinion regarding ethical issues related to the confidentiality and appropriate use of genetic testing results may influence governmental authorities to call for limits on, or regulation of the use of, genetic testing.  In addition, such authorities could prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure.  Furthermore, adverse publicity or public opinion relating to genetic research and testing, even in the absence of any governmental regulation, could reduce the potential markets for our services, which could materially and adversely affect our revenues.

 

Although we are a leader in the field of genetics in Australia, we do not undertake any activities in the contentious areas of cloning, stem cell research or other gene-altering areas.  As such, many of the ethical issues that may be relevant to other participants in the genetics industry are not applicable to us.

 

Licensing

 

The patenting of genes and issues surrounding access to genetic knowledge are the subjects of extensive and ongoing public debate in many countries.  By way of example, the Australian Law Reform Commission conducted two inquiries into the social uses of genetic information.  The patents we hold over uses of “non-coding” DNA have a broad scope and these have also been the subject of debate and some criticism in the media.  A risk we may face is that individuals or organisations in any of the countries in which these patents have issued could potentially take legal action to seek their amendment, revocation or invalidation.

 

Furthermore, any time that we initiate legal action against parties that infringe our patents we face a risk that the infringer will defend itself through a counter-claim of patent invalidity.  Subsequent legal action could potentially overturn, invalidate or limit the scope of our patents.

 

Under the relevant Patent Act in most, if not all, of the countries in which our non-coding patents have issued, the relevant judicial system has rights to impose compulsory licensing.  The relevant governments typically hold “march-in” rights by which they may unilaterally choose to exploit the technology.  To the extent that the Company’s non-coding technology is used in the conduct of genetic research, we also face risks, uncertainty and controversy over the licensing of our technology to those conducting research.  Whether or not researchers should be exempted from obligations to take licenses to the relevant patents was the subject of another government inquiry being conducted by the Australian Council for Intellectual Property who recommended the creation of a research exemption.

 

Genetic testing

 

There is a risk that a moratorium on genetic testing by the Australian Institute of Sport may impact on the commercialization of our sports performance genetic test for the elite competitor market in Australia.  However, this moratorium should not impact our ability to distribute this test throughout the rest of the world.  There is also a view held by some elements of the medical and academic communities that the marketing of some of our cancer predisposition tests is done solely with a commercial objective in mind.  In essence, some parties have indicated that, in their view, the risk of inheriting certain types of cancer is too low to warrant the marketing of genetic testing services to the wider cancer community where such promotion may increase anxiety unnecessarily.  Guidelines laid down by the Australian National Health Medical Research Council also prevent us from promoting our testing in a manner which may “cause any unnecessary alarm”.

 

In recent years, health care payors as well as federal and state governments have focused on containing or reducing health care costs.  We cannot predict the effect that any of these initiatives may have on our business.  In particular, gene-based therapeutics, if successfully developed and commercialized, are likely to be costly compared to currently available drug therapies.  Health care cost containment initiatives focused either on gene-based therapeutics or on genetic testing could result in the growth in the clinical market for genetic testing being curtailed or slowed.  In addition, health care cost containment initiatives could also cause pharmaceutical companies to reduce research and development spending.  In either case, our business and our operating results could be adversely affected.  Further, genetic testing in clinical settings is often billed to third-party payors, including private insurers and governmental organizations.  If our current and future clinical products and services are not considered cost-effective by these payors, reimbursement may not be available to users of our services.  In this event, potential customers would be much less likely to use our services and our business and operating results could be harmed.

 

12



Table of Contents

 

ITEM 4.                             INFORMATION ON THE COMPANY

 

Item 4.A                          History and Development of the Company

 

We were incorporated under the laws of Western Australia on January 5, 1987 as Concord Mining N.L.  On August 13, 1991, we changed our name to Consolidated Victorian Gold Mines N.L.  On December 2, 1991, we changed our name to Consolidated Victorian Mines N.L.  On March 15, 1995, we changed our name to Duketon Goldfields N.L.

 

On October 15, 1999, the type of company was changed from a No Liability Company to a company limited by shares.      On August 29, 2000, we changed our name to Genetic Technologies Limited, which is our current name.  We were originally incorporated as a mining company and gradually phased out our mining activities and became a biotechnology company with the acquisition of GeneType AG in August 2000.  Our Australian Company Number (ACN) is 009 212 328.  Our Australian Business Number (ABN) is 17 009 212 328.  We operate pursuant to our constitution, the Australian Corporations Act 2001, the Australian Securities Exchange Listing Rules, the Marketplace Rules of NASDAQ and, where applicable, local legislation.

 

Our registered office, headquarters, laboratory and business activities are all located at 60-66 Hanover Street, Fitzroy, Victoria, 3065 Australia.  Our telephone number is +61 3 8412 7000.  Our website address is www.gtg.com.au.  Information on our website and websites linked to it does not constitute part of this Annual Report.

 

On August 29, 2000, we acquired 100% of GeneType AG, including all of its valuable patents, and we changed our focus exclusively to the area of biotechnology.  We also changed our name to Genetic Technologies Limited to better reflect our new business.  In September 2000, our listing was duly transferred from the mining board of the ASX to the industrial board and our shares were thereafter classified under the industry group “Health and Biotechnology”, completing our transformation from a mining and resources company into a biotechnology company.  During 2001, we also acquired 10% of the issued and outstanding shares in Cytomation Inc., based in Fort Collins, Colorado.  At that time, Cytomation was a leader in the manufacture and sales of flow cytometers and cell sorters.  Also, in December 2001, we acquired an initial shareholding of less than 1% in the issued capital of XY, Inc., a company also based in Fort Collins.  In July 2001, we acquired the business of DNA-ID Labs in Perth, Western Australia, as part of our strategy of expanding our paternity testing business in Australia.  In March 2002, we formed AgGenomics Pty. Ltd., based in Melbourne, in order to expand our genetic testing services into the field of plant genetics.  In May 2003, we acquired the fixed assets of the business Genetic Science Services in Melbourne, in order to further expand into the field of genetic testing.  In May 2007, we sold all of our shares in XY, Inc.  The total proceeds received from the sale were $332,709 which resulted in a loss on sale of $33,307.  In July 2008, we acquired all of the issued shares of Frozen Puppies Dot Com Pty. Ltd. based in Calga, New South Wales, which is Australia’s leading provider of canine reproductive services.

 

Since the acquisition of GeneType AG, the directors have disposed of all remaining mining interests so that our activities now focus solely on emerging opportunities in the field of biotechnology.  Our current activities in biotechnology primarily concentrate on three clearly defined areas of activity which are covered under Item 4.B “Business Overview”.

 

13



Table of Contents

 

In early calendar year 2002, we commenced the process of out-licensing our non-coding patents, announcing several early successes.  Since then, we have granted commercial licenses to a total of 38 licensees and 6 research licenses to the following parties, which are listed in reverse chronological order of their effective dates:

 

Commercial licensees

 

Research licensees

 

 

 

38. Millennium Pharmaceuticals Inc., USA

 

6. Texas A&M University (Merlogen Inc.), USA

37. GeneDx (Bio Reference Laboratories Inc.), USA

 

5. Colorado State University, USA

36. General Electric Company, USA

 

4. University of Technology Sydney, Australia

35. Prometheus Laboratories Inc. USA

 

3. King’s College, London, England

34. Kimball Genetics Inc., USA

 

2. University of Sydney, Australia

33. BioSearch Technologies Inc., USA

 

1. University of Utah, USA

32. Syngenta Crop Protection AG, Switzerland

 

 

31. Monsanto Company (swine genetics), USA

 

 

30. Thermo Fisher Scientific Inc., USA

 

 

29. Monsanto Company (plant genetics) USA

 

 

28. Sciona Inc., USA

 

 

27. Genosense Diagnostics GmbH, Austria

 

 

26. Innogenetics NV, Belgium

 

 

25. Bovigen LLC, USA

 

 

24. Optigen LLC, USA

 

 

23. Applera Corporation, USA

 

 

19 - 22. Four agriculture groups, New Zealand

 

 

18. Australian Genome Research Facility Limited, Australia

 

 

17. Bionomics Limited, Australia

 

 

16. C.Y. O’Connor ERADE Village Foundation, Australia

 

 

15. ViaLactia Biosciences Limited, New Zealand

 

 

14. MetaMorphix Inc., USA

 

 

13. Genzyme Corporation, USA

 

 

12. Ovita Limited, New Zealand

 

 

11. Laboratory Corporation of America Holdings, USA

 

 

10. TM Biosciences Corporation, Canada

 

 

9. Quest Diagnostics Inc., USA

 

 

8. Orchid Biosciences Inc., USA

 

 

7. ARUP, USA

 

 

6. Biotage AB, Sweden

 

 

5. Myriad Genetics Inc., USA

 

 

4. Perlegen Sciences Inc., USA

 

 

3. Nanogen Inc., USA

 

 

2. Sequenom Inc., USA

 

 

1. Genetic Solutions Pty. Ltd., Australia

 

 

 

It is a priority for the Company to continue to identify additional parties who would benefit from taking a license to the Company’s non-coding patents.  We are now pursuing negotiations with a number of companies and organizations in USA and Europe that would benefit from taking a license to our non-coding patents or from collaborations with our service testing business.

 

In order to increase the rate at which these licenses can be secured, the licensing team at the Company’s headquarters in Melbourne, Australia has been expanded in recent years by the appointment of additional staff to accelerate the preparation of dossiers on potential licensees.  Internationally, independent licensing contractors were engaged to represent the Company “on the ground” in our major markets.

 

14



Table of Contents

 

Item 4.B                          Business Overview

 

We are a biotechnology company, now pursuing commercial opportunities in three main areas of activity:

 

(i)                     out-licensing our non-coding patents globally;

 

(ii)                  expanding our genetic service testing business in the Asia-Pacific Region; and

 

(iii)               supporting certain late-stage research projects in which we are already involved.

 

Industry Background

 

The Human Genome Project announced (in April 2003) the completion of the first draft of the entire sequence of the human genome.  The biotechnology industry is now working to build upon the vast amount of knowledge generated by that program in order to develop a better understanding of the genetic basis of human health and disease.  Increasingly, genetics is being shown to play a key role in the diagnosis and treatment of many diseases in humans, as well as diseases in animals and plants.  Our growing understanding of genetics is now providing new information for understanding such predisposing or causative factors in many of these diseases.

 

Prior to the Human Genome Project, the successful mapping of the Mouse Genome (published in December 2002) permitted, for the first time, a detailed comparison of human genes and mouse genes.  One of the key findings that has arisen from this work is the significant role that non-coding DNA plays in controlling gene function in both human genes and mouse genes.  For some scientists, but not for our company, these findings - of the great significance of non-coding DNA to gene function - were new, significant and totally unexpected.

 

A major focus in science is now the identification and analysis of genetic variations and disease-associated genes within the genome.  These genetic variations, or polymorphisms, in the DNA sequences vary between individuals.  The most common genetic variations are Single Nucleotide Polymorphisms, or SNPs, which are merely a difference in a single nucleotide.  The first draft of the human genome identified over 1.4 million SNPs that can be useful as positional signposts for disease-associated DNA sequences in a gene or as markers to map genes along a chromosome.  A significant number of these SNPs (perhaps more than 97%) are now known to be non-coding.

 

Genomics

 

A genome is an organism’s complete set of DNA and the study of that DNA is called genomics.  Genomes vary in size, with bacteria displaying the smallest known genome at 600,000 DNA base pairs, while human and mouse genomes have over 3 billion.  The DNA of the human genome is organized into 24 distinct chromosomes that contain from 50 million to 250 million base pairs on each chromosome.  The DNA on each chromosome contains genes that are specific sequences that encode proteins that actually perform the work within a cell and also make up the cell itself.  Surprisingly, only about 2% to 5% of the human genome is organized into coding DNA, with the remainder being considered to be non-coding DNA.  Our patent portfolio is centered on proprietary methods for utilizing the valuable information contained within these non-coding regions.

 

Genetic Variability

 

Almost 99.9% of an individual’s genome is identical to that of every other individual’s genome.  However, even slight variations in sequence can drastically change how a gene functions.  Variations can lead to harmless changes, such as blue eyes instead of brown, or to major diseases such as cancer, cystic fibrosis, or cardiovascular disease.  Genetic variations can also be responsible for many of the differences in the ways individuals respond to drug therapies.  As a result of this knowledge, routine analysis of SNPs and other genetic variations is expected to play an increasingly important role in the discovery and development of new drugs, as well as in a variety of diagnostic therapeutic and other medical and life science applications.  Industry sources estimate there are millions of genetic variations in the human genome, creating demand for products and technologies that can quickly and accurately detect and analyze these variations.  It is thought that the medicine of the future will be dispensed to a patient based on his or her own specific DNA variations.  This type of “personalized medicine” will require sophisticated genetic tests to determine the genetic composition of an individual, and it is now recognized that such genetic make-up depends not only on the form of the coding DNA, but also the form of the associated non-coding DNA.

 

15



Table of Contents

 

Genetic Tests

 

Most genes come in many different forms, called alleles.  One or more allele may be associated with a particular disease state.  Genetic testing involves the direct examination of an individual’s DNA for a DNA marker associated with the allele of interest.  The determination of the particular alleles an individual has within his or her DNA is called genotyping.

 

The most commonly tested marker of a particular allele is a SNP.  As much as 98% of the human genome is considered to be non-coding DNA, the majority of the identified 1.4 million SNPs are also located in non-coding regions of DNA.  We believe that a license to our proprietary methods of analyzing non-coding regions of DNA will be absolutely necessary for many of the genetic tests of the future.  Similarly, tests for genetic abnormalities or mutations may involve not just individual SNPs, but also groups of SNPs or even larger sequences of DNA, and such abnormal sequences - large or small - may be located either in the coding region alone, or in the non-coding region alone, or in both the coding and non-coding regions of the gene (or genes) under examination.  Clearly, the variations within genes that may be responsible for a disease are now known to be much more complicated than was previously understood, and the role of non-coding DNA is now being found to be highly relevant in a growing number of diseases.  This similarly applies to genetic disorders in animals and in plants.  Accordingly, more and more genetic testing will in future look not only at coding variations, but also at the non-coding variations within a particular gene.

 

Our Patent Portfolio

 

The acquisition of GeneType AG gave our company ownership rights to a potentially significant portfolio of issued patents.  The major families of patents in the portfolio include:

 

(a)          Intron Sequence Analysis;

 

(b)         Genomic Mapping;

 

(c)          Electrophoresis Standards;

 

(d)         Ancestral Haplotypes;

 

(e)          Sports Performance;

 

(f)            Immunotherapeutics;

 

(g)         Antiparasitics; and

 

(h)         Fetal Cell Recovery.

 

(a)   The Intron Sequence Analysis patents - allow for the detection of specific motifs within the genetic material in the non-coding regions of DNA which have been shown may be linked to certain alleles or haplotypes within the coding region of the gene.  In other words, whereas most geneticists previously looked at the genetic information located within the coding region alone, our inventions have provided a means of also looking at additional useful information which is located within the non-coding part of the gene, and which is now known to also be important in influencing gene function and, in particular, protein production.  The method is useful, for example, in the determination of tissue typing for transplantation in order to test for possible likely acceptance or rejection of bone marrow or tissue grafts.  The method is also useful in the detection of genetic changes or mutations in the non-coding region of certain genes associated with a higher incidence of certain genetic diseases, such as cystic fibrosis, susceptibility to breast cancer, multiple sclerosis, Alzheimer’s Disease, etc.  It is also now known that more than 100 human diseases are associated with genetic changes in the non-coding part of a particular gene and which are linked to the function of the coding part of that gene.  Similar applications also exist in animals and plants.  Several important markers in livestock, for example, have been shown to be located in the non-coding part of the DNA and also linked to particular coding function - for example, marbling or tenderness.  It has also been shown that variations in the non-coding DNA of plants can influence their function, including the color of flowers and the timing of germination and growth.

 

(b)   The Genomic Mapping patents - describe methods for analyzing genetic material collected from various selected populations to identify and locate genes and markers of interest, by identifying highly polymorphic sites throughout the genome and particular haplotypes associated with such sites, all based on a reading of sequence information in both the coding and the non-coding portions of the genome.

 

(c)   The Electrophoresis Standards patents - describe a method for identifying band positions in an electrophoretic separation by also including a control, which serves as an internal standard.

 

(d)   The Ancestral Haplotypes patents - describe a method for determining ancestral haplotypes using haplospecific geometric elements within the major histocompatibility complex multi-gene cluster and methods of genetic analysis involving the amplification of complimentary duplicons.  These patents were acquired from the C.Y. O’Connor ERADE Village Foundation in Western Australia.

 

16



Table of Contents

 

(e)   The Sports Performance patents - describe a method that enables aspects of athletic performance to be predicted based on detection of various forms of the alpha actinin 3 (ACTN3) gene.

 

(f)    The Immunotherapeutics patents - describe various methods aimed at improving the efficacy of cancer therapy and treatment of HIV-AIDS and form the basis of the ImmunAid project.

 

(g)   The Antiparasitic patents - describe means to identify and to control a variety of species of parasites.  The patent applications describe the use of modern genetic technologies to identify celluar targets for two novel classes of chemicals which can be used to control the major parasitic worms of sheep and cattle.  These nematodes are responsible for extensive economic losses to the sheep and cattle industries and are rapidly developing resistance to the existing chemicals.  The novel classes of chemical described in these patents offer a safe and highly effective alternative.

 

(h)   The Fetal Cell Recovery patents - the older patents describe a novel and safe method for the isolation and collection of fetal cells from the peripheral blood of a pregnant woman, utilizing various HLA or other markers plus flow cytometry - all without any invasive procedure that might endanger the mother or the child.  Together with more recent patents, these form the basis of the intellectual property associated with the RareCellect project.

 

The many issued, allowed and pending patents claimed by GeneType AG, and which are now owned by our Company, distinguish us from competitors by giving us the legal right to claim ownership of proprietary methods and compositions for analysis of DNA using information contained within non-coding regions and for isolation of fetal cells.  The methods and compositions for analysis of DNA may be used to identify a particular form of a gene or to map the location of a disease-associated gene along a chromosome.

 

In total, we own 8 issued patents and 11 patent applications in the United States.  Reflecting our international business strategy, we have also sought and been granted foreign patents by many other major industrialized nations, corresponding to each of the major patents already issued in the United States.

 

Generally, United States patents filed with the United States Patent Office prior to June 8, 1995 have a term of 17 years from the date of issuance, and 20 years from the application filing date or earlier claimed priority date in the case of patents issued from applications filed on or after June 8, 1995.  For applications filed after May 29, 2000, the term is 20 years from the date of filing.  A minimum term of 17 years is assured, provided the applicant causes no delays during prosecution.  Patents in most other countries have a term of 20 years from the date of filing the patent application.  Our issued United States patents will begin to expire in 2009.  We intend to continue to file patent applications as we develop new products, technologies and patentable enhancements.  Prosecution practices have been implemented to avoid any applicant delays that could compromise the 17-year minimum term.  There can be no guarantee that such procedures will prevent the loss of a potential patent term.  This is particularly true in the short-term as the patent rules implementing the most recent patent term changes are largely new and untested.

 

Complex legal and factual determinations and evolving law make patent protection uncertain.  As a result, we cannot be certain that patents will be issued from any of our pending patent applications or from applications licensed to us or that any issued patents will have sufficient breadth to offer meaningful protection.  In addition, our issued patents may be successfully challenged, invalidated, circumvented or rendered unenforceable so that our patent rights would not create an effective competitive barrier.  Moreover, the laws of some countries may not protect our proprietary rights to the same extent as do the United States patent laws.

 

In addition to patent protection, we rely on trade secret protection of our intellectual property.  We attempt to protect our trade secrets by entering into confidentiality agreements with third parties, employees and consultants.  Our employees and consultants are required to sign agreements to assign to us their interests in discoveries, inventions, patents, trademarks and copyrights arising from their work for us.  They are also required to maintain the confidentiality of our intellectual property, and refrain from unfair competition with us during their employment and for a certain period of time after their employment with us, which includes solicitation of our employees and customers.  We cannot be certain these agreements will not be breached or invalidated.  In addition, third parties may independently discover or invent competing technologies or reverse engineer our trade secrets or other technologies.

 

In the future, we may become involved in lawsuits in which third parties file claims asserting that our technologies or products infringe on their intellectual property.  We cannot predict whether third parties will assert such claims against us or against the licensors of technologies licensed to us, or our licensees, or whether those claims will hurt our business.  We may be forced to defend against such claims, whether they are with or without merit or whether they are resolved in favor of or against our licensors or us and may face costly litigation and diversion of Management’s attention and resources.  As a result of such disputes, we may have to develop costly non-infringing technologies or enter into licensing agreements.  These agreements may oblige us to accept costly terms, which could seriously limit the ability to conduct our operations and affect adversely our financial condition.

 

17



Table of Contents

 

In addition, we may become involved in lawsuits in which third parties file claims asserting that one or more of our patents are invalid.  We cannot predict whether third parties will assert such claims against us or against the licensees of such patents, or whether those claims will have an adverse impact on our business.  We may be forced to defend against such claims, whether they are with or without merit or whether they are resolved in favor of or against our licensees or us and may face costly litigation and diversion of Management’s attention.  During the period from February 2001 through March 31, 2002, we had in place a patent insurance policy, placed with GE Reinsurance Corporation through Dexta Corporation Limited, their managing general agents in Australia.  Although the policy was not renewed on its expiry, since we had advised Dexta of 13 companies prior to March 31, 2002 as potential infringers, a significant portion of our expenses incurred to date relating to the prosecution of our claims have been covered by the policy.

 

Of those 13 so identified, we have secured licenses with six, relinquished our claims against four and commenced proceedings against Applera, Covance and Nuvello.  The suits against Covance and Nuvello were subsequently settled.  On December 12, 2005, we announced the final settlement of our patent dispute with Applera Corporation, further to a settlement conference held in San Francisco, California.  The parties had executed a number of binding agreements, including a final Settlement Agreement plus license agreements and a supply agreement and, subsequently, they jointly applied to Northern California District Court requesting that all claims and counterclaims in the legal action be dismissed forthwith.  The total value of the consideration receivable by us is approximately $15 million, payable partly in cash and partly in kind, including agreements supplying the Company with certain Applera equipment, reagents and intellectual property rights.  Recognition of in-kind consideration as revenue is subject to us meeting certain revenue recognition criteria including, but not limited to, the measurement of fair value at the time of receipt.

 

Our Patents

 

Our current patent portfolio is described below.  “Numbers” refers to either provisional, application, publication or patent number.

 

 

 

Country / region

 

Numbers

 

Granted

 

Pending

 

 

 

 

 

 

 

 

 

 

 

INTRON SEQUENCE ANALYSIS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intron sequence analysis method for detection of adjacent and remote locus alleles as haplotypes

 

Australia

 

AU654111

 

·

 

 

 

Earliest priority August 25, 1989

 

 

 

AU672519

 

·

 

 

 

 

 

Austria

 

AT144797

 

·

 

 

 

 

 

Belgium

 

EP414469

 

·

 

 

 

 

 

Canada

 

CA2023888

 

·

 

 

 

 

 

Denmark

 

DK414469

 

·

 

 

 

 

 

Europe

 

EP414469

 

·

 

 

 

 

 

France

 

EP414469

 

·

 

 

 

 

 

Germany

 

DE69029018

 

·

 

 

 

 

 

 

 

DD299319

 

·

 

 

 

 

 

Great Britain

 

EP414469

 

·

 

 

 

 

 

Greece

 

GR3022410

 

·

 

 

 

 

 

Hong Kong

 

HK1008053

 

·

 

 

 

 

 

Israel

 

IL95467

 

·

 

 

 

 

 

Italy

 

EP414469

 

·

 

 

 

 

 

Japan

 

JP3206812

 

·

 

 

 

 

 

Liechtenstein

 

EP414469

 

·

 

 

 

 

 

Luxemburg

 

EP414469

 

·

 

 

 

 

 

Netherlands

 

EP414469

 

·

 

 

 

 

 

New Zealand

 

NZ235051

 

·

 

 

 

 

 

Singapore

 

SG47747

 

·

 

 

 

 

 

South Africa

 

ZA9006765

 

·

 

 

 

 

 

Spain

 

ES2095859

 

·

 

 

 

 

 

Sweden

 

EP414469

 

·

 

 

 

 

 

Switzerland

 

EP414469

 

·

 

 

 

 

 

United States

 

US5192659

 

·

 

 

 

 

 

 

 

US5612179

 

·

 

 

 

 

 

 

 

US5789568

 

·

 

 

 

 

18



Table of Contents

 

 

 

Country / region

 

Numbers

 

Granted

 

Pending

 

 

 

 

 

 

 

 

 

 

 

GENOMIC MAPPING

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genomic mapping method by direct haplotyping using intron sequence analysis

 

Australia

 

AU647806

 

·

 

 

 

Earliest priority July 11, 1990

 

Austria

 

AT185377

 

·

 

 

 

 

 

Belgium

 

EP570371

 

·

 

 

 

 

 

Canada

 

CA2087042

 

·

 

 

 

 

 

Denmark

 

DK570371

 

·

 

 

 

 

 

Europe

 

EP570371

 

·

 

 

 

 

 

France

 

EP570371

 

·

 

 

 

 

 

Germany

 

DE69131691

 

·

 

 

 

 

 

Great Britain

 

EP570371

 

·

 

 

 

 

 

Ireland

 

IE912426

 

·

 

 

 

 

 

Israel

 

IL98793

 

·

 

 

 

 

 

Italy

 

EP570371

 

·

 

 

 

 

 

Japan

 

JP3409796

 

·

 

 

 

 

 

Luxemburg

 

EP570371

 

·

 

 

 

 

 

Netherlands

 

EP570371

 

·

 

 

 

 

 

New Zealand

 

NZ238926

 

·

 

 

 

 

 

South Africa

 

ZA9105422

 

·

 

 

 

 

 

Sweden

 

EP570371

 

·

 

 

 

 

 

Switzerland

 

EP570371

 

·

 

 

 

 

 

United States

 

US5851762

 

·

 

 

 

 

 

 

 

 

 

 

 

 

 

ELECTROPHORESIS STANDARDS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Internal standard for electrophoretic separations

 

Austria

 

AT159589

 

·

 

 

 

Earliest priority July 11, 1990

 

Europe

 

EP466479

 

·

 

 

 

 

 

France

 

EP466479

 

·

 

 

 

 

 

Germany

 

DE69127999

 

·

 

 

 

 

 

Great Britain

 

EP466479

 

·

 

 

 

 

 

Japan

 

JP4232850

 

·

 

 

 

 

 

Sweden

 

EP466479

 

·

 

 

 

 

 

United States

 

US5096557

 

·

 

 

 

 

 

 

 

 

 

 

 

 

 

ANCESTRAL HAPLOTYPES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genetic analysis

 

Europe

 

EP660877

 

·

 

 

 

Earliest priority November 1, 1991

 

France

 

EP660877

 

·

 

 

 

 

 

Germany

 

DE69232726

 

·

 

 

 

 

 

Great Britain

 

EP660877

 

·

 

 

 

 

 

 

 

 

 

 

 

 

 

Method for determining ancestral haplotypes using haplospecific geometric elements within the major histocompatability complex multigene cluster

 

United States

 

US6383747

 

·

 

 

 

Earliest priority November 1, 1991

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Methods of genetic analysis involving the amplification of complementary duplicons

 

Australia

 

AU2006214800

 

 

 

·

 

Earliest priority February 16, 2005

 

Canada

 

CA2597947

 

 

 

·

 

 

 

Europe

 

EP06704883

 

 

 

·

 

 

 

Japan

 

JP2007555425

 

 

 

·

 

 

 

United States

 

US11/816522

 

 

 

·

 

 

19



Table of Contents

 

 

 

Country / region

 

Numbers

 

Granted

 

Pending

 

 

 

 

 

 

 

 

 

 

 

SPORTS PERFORMANCE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACTN3 genotype screen for athletic performance

 

Australia

 

AU2003258390

 

·

 

 

 

Earliest priority September 16, 2002

 

Canada

 

CA2499084

 

 

 

·

 

 

 

China

 

CN1732270

 

 

 

·

 

 

 

Europe

 

EP1546403

 

 

 

·

 

 

 

India

 

599/KOLNP/2005

 

·

 

 

 

 

 

Japan

 

JP2005538710

 

·

 

 

 

 

 

New Zealand

 

NZ538890

 

·

 

 

 

 

 

Russia

 

RU2005111236

 

 

 

·

 

 

 

South Korea

 

KR20050053670

 

 

 

·

 

 

 

United States

 

US2006121478

 

 

 

·

 

 

 

 

 

 

 

 

 

 

 

IMMUNOTHERAPEUTICS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A retroviral immunotherapy

 

Australia

 

AU2003200583

 

·

 

 

 

Earliest priority August 18, 2000

 

New Zealand

 

NZ524280

 

·

 

 

 

 

 

Singapore

 

SG95523

 

·

 

 

 

 

 

South Africa

 

ZA200301694

 

·

 

 

 

 

 

Brazil

 

BR0113354

 

 

 

·

 

 

 

Canada

 

CA2431954

 

 

 

·

 

 

 

China

 

CN1469746

 

 

 

·

 

 

 

Europe

 

EP1311267

 

 

 

·

 

 

 

United States

 

US20030228320

 

 

 

·

 

 

 

 

 

 

 

 

 

 

 

Cancer therapy

 

Singapore

 

SG105902

 

·

 

 

 

Earliest priority February 14, 2002

 

South Africa

 

ZA200407142

 

·

 

 

 

 

 

Australia

 

AU2003203051

 

·

 

 

 

 

 

Brazil

 

BR0307661

 

 

 

·

 

 

 

Canada

 

CA2476366

 

 

 

·

 

 

 

China

 

CN1646155

 

 

 

·

 

 

 

Europe

 

EP1482970

 

 

 

·

 

 

 

Japan

 

JP2005523277

 

 

 

·

 

 

 

New Zealand

 

NZ554840

 

 

 

·

 

 

 

United States

 

US2005180971

 

 

 

·

 

 

 

 

 

 

 

 

 

 

 

Strategy for retroviral immunotherapy

 

Singapore

 

SG105903

 

·

 

 

 

Earliest priority February 20, 2002

 

South Africa

 

ZA200407143

 

·

 

 

 

 

 

Brazil

 

BR0307868

 

 

 

·

 

 

 

Canada

 

CA2476956

 

 

 

·

 

 

 

China

 

CN1646156

 

 

 

·

 

 

 

China

 

CN200710199719

 

 

 

·

 

 

 

Europe

 

EP1482971

 

 

 

·

 

 

 

Japan

 

JP2005526729

 

 

 

·

 

 

 

New Zealand

 

NZ554839

 

 

 

·

 

 

 

 

 

 

 

 

 

 

 

Method of therapy

 

Singapore

 

SG121609

 

·

 

 

 

Earliest priority October 24, 2003

 

Australia

 

AU2004283322

 

 

 

·

 

 

 

Canada

 

CA2543490

 

 

 

·

 

 

 

China

 

CN1898569

 

 

 

·

 

 

 

Europe

 

EP1692516

 

 

 

·

 

 

 

Israel

 

IL175141

 

 

 

·

 

 

 

Japan

 

JP2007509078

 

 

 

·

 

 

 

Mexico

 

PA/a/2006/004522

 

 

 

·

 

 

 

New Zealand

 

NZ546873

 

 

 

·

 

 

 

United States

 

US2007202119

 

 

 

·

 

 

20



Table of Contents

 

 

 

Country / region

 

Numbers

 

Granted

 

Pending

 

 

 

 

 

 

 

 

 

 

 

IMMUNOTHERAPEUTICS (cont.)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Therapeutic strategy for treating autoimmune and degenerative diseases

 

Australia

 

AU2005282218

 

 

 

·

 

Earliest priority September 8, 2004

 

Canada

 

CA2579353

 

 

 

·

 

 

 

Europe

 

EP1805510

 

 

 

·

 

 

 

Japan

 

JP2007530544

 

 

 

·

 

 

 

New Zealand

 

NZ553720

 

 

 

·

 

 

 

Singapore

 

SG130540

 

 

 

·

 

 

 

United States

 

US11/574911

 

 

 

·

 

 

 

 

 

 

 

 

 

 

 

ANTIPARASITICS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Compounds, composition and methods for controlling invertebrate pests

 

World

 

PCT/AU2007/001762

 

 

 

·

 

Earliest priority November 15, 2006

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Invertebrate control agents, compositions and methods of use

 

Australia

 

AU2007906474

 

 

 

·

 

Earliest priority November 23, 2006

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FETAL CELL RECOVERY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fetal cell recovery method

 

Australia

 

AU649027

 

·

 

 

 

Earliest priority March 27, 1990

 

Austria

 

AT194166

 

·

 

 

 

 

 

Belgium

 

EP521909

 

·

 

 

 

 

 

Canada

 

CA2059554

 

·

 

 

 

 

 

Denmark

 

DK521909

 

·

 

 

 

 

 

Europe

 

EP521909

 

·

 

 

 

 

 

France

 

EP521909

 

·

 

 

 

 

 

Germany

 

DE69132269

 

·

 

 

 

 

 

Great Britain

 

EP521909

 

·

 

 

 

 

 

Greece

 

GR3034487

 

·

 

 

 

 

 

Ireland

 

IE910996

 

·

 

 

 

 

 

Israel

 

IL97677

 

·

 

 

 

 

 

Italy

 

EP521909

 

·

 

 

 

 

 

Japan

 

JP2965699

 

·

 

 

 

 

 

Liechtenstein

 

EP521909

 

·

 

 

 

 

 

Luxemburg

 

EP521909

 

·

 

 

 

 

 

Netherlands

 

EP521909

 

·

 

 

 

 

 

New Zealand

 

NZ237589

 

·

 

 

 

 

 

Singapore

 

SG79188

 

·

 

 

 

 

 

South Africa

 

ZA9102317

 

·

 

 

 

 

 

Spain

 

ES2149760

 

·

 

 

 

 

 

Sweden

 

EP521909

 

·

 

 

 

 

 

Switzerland

 

EP521909

 

·

 

 

 

 

 

United States

 

US5447842

 

·

 

 

 

 

 

 

 

US5153117

 

·