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Drug Patents Under the Spotlight. Sharing practical knowledge about pharmaceutical patents
(2003; 40 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. Four key concepts to understanding drug patents
Open this folder and view contents3. The patent system should respond to countries' public interest
View the document4. How to read and use the patent table
View the document5. Conclusions
View the document6. References
View the documentAnnex A - Patent Table
View the documentAnnex B - The anatomy of a patent
 

Annex A - Patent Table

Expected (0) patent expiry date (patent number) in

INN (1)

Originator's Trade mark

Patent holder (2) (manufacturer)

Basic patent priority date (number)

International patent application

RepresentativeEuropean corresponding patent

                           
           

Brazil (3)

Cambodia (4)

China (5)

Guatemala (6)

Kenya

Malawi (7)

OAPI (8)

Peru (9)

South Africa

Thailand (10)

Uganda (11)

Ukraine

Zambia (7)

Zimbabwe

Amphotericin B

Fungizone

Olin Mathieson (Bristol Myers Squibb)

28.12.1954 (US478014)

No

No

No

No

No

No

No

No

No

No

No

No

No

No

No

No

liposomal

Ambisome

Vestar (Gilead-NeXstar)

12.11.1987 (US119518)

No

EP0317120

No

No

No

No

No

No

?

No

No

No

No

No

No

No

Arthemeter+ Lumefantrine (benflutemol)

Coartem/Riamet (13)

Ciba-Geigy (Novartis)

08.08.1990 (CN106722)

WO92/02217

EP0500823

No

No

08.08.05
(CN1058717)

No

12.06.11 (AP231)

12.06.07 (AP231)

?

No

12.06.11 (ZA9104490)

No

31.01.08 (AP231)

?

12.06.07 (AP231)

12.06.11 (AP231)

Azithromycin

Sumamed

Pliva (+Pfizer)

06.03.1981 (YU592)

No

GB2094293

No

No

No

No

No

No

No

No

No

No

No

No

No

No

crystalline dihydrate

Zithromax

Pfizer

09.07.1987 (PCT/US87/01612)

WO89/00576

EP298650

No

No

08.07.03
(CN1016785)

No

15.06.08 (AP44)

15.06.04 (AP44)

abandoned (OA8743)

No

07.07.08 (ZA8804925)

No

27.07.04 (AP44)

?

15.06.04 (AP44)

15.06.08 (AP44)

Ciprofloxacin

Cipro, Ciproxin

Bayer

03.09.1980 (DE3033157)

No

EP0049355

No

No

No

No

expired 21.08.01 (KE3545)

No

No

No

expired 01.09.01 (ZA8106080)

No

No

No

No

No

tablet formulation (12)

Cipro, Ciproxin

Bayer

21.01.1986 (DE3601566)

No

EP0230881

No

No

expired 21.01.02
(CN1084188)

No

No

No

No

No

No

No

No

No

No

No

Fluconazole (general)

 

ICI

02.06.1980 (GB8017959)

No

EP0044605

No

No

No

No

expired 14.05.01 (KE3733)

No

No

No

expired 19.05.01
(ZA8103354)

No

No

No

No

No

specific

Diflucan

Pfizer

06.06.1981 (GB8117379)

No

EP0069442

No

No

No

No

expired 22.04.02 (KE3771)

No

No

No

expired 04.06.02 (ZA8203934)

No

No

expired 01.06.02 (UA8019)

No

No

Footnotes:

(0) Except when stated differently, this expiry date is 20 years from the filling date, but note that the patent may expire before if the patent holder abandons it (i.e. stops paying the annual fees).

(1) Patents may be granted to protect the basic molecule of a medicine, but also

e.g. to protect the manufacturing process, a specific therapeutic indication, or a specific formulation of the said molecule. Note that a product patent usually covers also a manufacturing process.

(2) Note that only the first patent holder is named where there are more than one.

(3) In Brazil, patent protection for pharmaceuticals was only introduced on May 14th 1997. However, between May 15th 1996 and May 15th 1997 it was possible to register a preexisting foreign patent or pending patent application in Brazil in order to obtain pipeline patent protection, i.e., patent protection for medicines which are patent protected abroad but which have not been marketed yet.

(4) There is no patent law in force in Cambodia. A draft Patent Law was passed by the National Assembly on November 28th 2002. This law is then supposed to go to the Senate for confirmation and is expected to be in force in 2003.

(5) Chinese Patent Law was amended, with effect on January 1st 1993, to extend patent protection from 15 to 20 years.

(6) Guatemala only introduced patent protection for pharmaceuticals on November 1st 2000.

(7) In Malawi and Zambia, patents are granted for an initial term of 16 years from the filing date, with a possible extension.

(8) OAPI patents are effective in the 16 member States of the Organisation Africaine de la Propriété Intellectuelle (Benin, Burkina Faso, Cameroon, Central African Rep., Congo, Ivory Coast, Gabon, Guinea, Guinea Bissau, Equatorial Guinea, Mali, Mauritania, Niger, Senegal, Chad, and Togo).

(9) Patent protection for pharmaceutical products was only introduced on December 11th 1991 in Peru, as in all other members of the Andean Community (Bolivia, Colombia, Ecuador, and Venezuela).

(10) Patent protection for pharmaceutical products has only been available in Thailand since September 30th 1992, including pending applications at this date.

(11) In Uganda, patents are granted for 15 years from the date of grant, and may be extended for 5 additional years if the patent is worked locally.

(12) Note that other patents protect aqueous solutions and flavoured-masqued compositions of ciprofloxacin.

(13) Coartem: name in poor countries/Riamet: name in rich countries. WO refers to patent applications filed under the system of the Patent Cooperation Treaty (PCT). The PCT allows patent applicants to file a kind of "worldwide" patent application, by designating countries among PCT Member States in which they intend to obtain a patent. However, the applicant must then confirm this wish in each designated country/region and the patent can only be granted by the patent office of the said country/region.

Where '?' appears, the information was not available.

 


     

Expected (0) patent expiry date (patent number) in

                               

INN (1)

Originator's Trade mark

Patent holder (2) (manufacturer)

Basic patent priority date

International patent application

Representative European corresponding patent

                           
           

Brazil (3)

Cambodia (4)

China (5)

Guatemala (6)

Kenya

Malawi (7)

OAPI (8)

Peru (9)

South Africa

Thailand (10)

Uganda (11)

Ukraine

Zambia (7)

Zimbabwe

Abacavir (racemic mixture)

 

Wellcome (GSK)

27.06.1988 (GB8815265)

No

EP0349242

27.06.08 (BR1100288)

No

No

No

26.06.09 (AP101)

26.06.05 (AP101)

No

No

25.06.09 (ZA8904837)No

 

23.10.05 (AP101)

No

26.06.05 (AP101)

26.06.09 (AP101)

Abacavir (enantiomer)

Ziagen

Wellcome (GSK)

22.12.1989 (US455201)

No

EP0434450

No

No

21.12.05 (CN1028106)

No

21.12.10 (AP196)

21.12.06 (AP196)

No

No

20.12.10 (ZA9010365)No

 

30.06.07 (AP196)

21.12.10 (UA29382)

21.12.06 (AP196)

21.12.10 (AP196)

Didanosine - ddI

 

USAGov (BMS)

26.08.1985 (US769016)

WO87/01284

EP0216510

No

No

No

No

No

No

No

No

No

No

No

No

No

No

improved oral formulation

Videx

BMS

22.07.1991 (US733547)

No

EP0524579

No

No

21.07.07 (CN1042299)

No

No

No

No

No

20.07.12 (ZA9205484)

07.07.12 (7600)

No

No

No

No

Efavirenz

Stocrin/Sustiva

Merck (MSD, BMS)

07.08.1992 (US926607)

WO94/03440

EP0582455

07.08.12 (BR1100250)

No

06.08.13 (CN1051767)

No

No

No

No

No

06.08.13 (ZA9305724)

30.07.13 (11367)

No

06.08.13 (UA42699)

No

No

Indinavir (including sulfate)

Crixivan

Merck (MSD)

08.11.1991 (US789508)

WO93/09096

EP0541168

No

No

No

No

No

No

No

No

06.11.12 (ZA9208563)

No

No

03.11.12 (UA45945)

No

No

(related) Indinavir

 

Merck

07.05.1993 (US059038)

WO94/26717

EP0696277 (withdrawn)

No

No

under examination (CN1126469)

No

No

WO94/26717?

WO94/26717?

No

05.05.14 (ZA9403104)

under examination (16620)

No

No

No

No

Lamivudine - 3TC (including enantiomer)

Epivir

IAF Biochem (GSK)

08.02.1989 (US308101)

No

EP0382526

No

No

08.02.05 (CN1033640)

No

08.02.10 (AP136)

08.02.06 (AP136)

08.02.10 (OA9193)

No

07.02.10 (ZA9000943)

No

05.08.06 (AP136)

No

08.02.06 (AP136)

08.02.10 (AP136)

enantiomer

Epivir

IAF Biochem

02.05.1990 (GB9009861)

WO91/17159

EP0625150 (rejected)

No

No

30.04.06 (CN1036196)

No

02.05.11 (AP182)

02.05.07 (AP182)

02.05.11* (OA9559)

No

30.04.11 (ZA9103293)

?

30.06.07 (AP182)

No

02.05.07 (AP182)

02.05.11 (AP182)

cristalline form

Epivir

Glaxo

03.06.1991 (GB9111902)

WO92/21676

EP0517145

No

No

No

No

02.06.12 (AP300)

02.06.08 (AP300)

02.06.12* (OA9913)

No

02.06.12 (ZA9204007)

?

20.01.09 (AP300)

02.06.12 (UA41265)

02.06.08 (AP300)

02.06.12 (AP300)

Nelfinavir mesylate

Viracept

Agouron (Roche)

07.10.1993 (US133543)

WO95/09843

EP0722439

07.10.13 (BR1100166)

No

07.10.14 (CN1046269)

No

07.10.14 (AP600)

07.10.14 (AP600)

07.10.14* (OA10718)

No

07.10.14 (ZA9407815)

No

No

No

No

No

Nevirapine

Viramune

Boehringer

17.11.1989 (US438923)

No

EP0429987

No

No

No

No

16.11.10 (AP179)

16.11.06 (AP179)

16.11.10 (OA9852)

No

18.11.10 (ZA9009246)No

 

30.04.07 (AP179)

17.11.09 (UA34420)

16.11.06 (AP179)

16.11.10 (AP179)

Syrup formulation

Viramune

Boehringer

25.08.1997 (US60/056803)

?

?

?

No

?

Potentially in the mailbox

?

?

?

under examination (718-1998)

?

under examination (41541/opp. filed)

?

11.08.18 (UA44370)

?

?

Ritonavir

Norvir

Abbott

29.12.1992 (US998114)

WO94/14436

EP0674513

29.12.12 (BR1100661)

No

No

No

No

No

No

No

No

No

No

?

No

No

Combination w/lopinavir

Kaletra

Abbott

13.12.1995 (US572226)

WO97/21685

EP0882024

13.12.15 (BR1100397)

No

under examination (CN1208405)

Potentially in the mailbox

No

No

No

No

11.12.16 (ZA9610475)

04.12.16 (13302)

No

?

No

No

Saquinavir

Fortovase

Hoffmann-La Roche

11.12.1989 (GB8927913)

No

EP0432695

No

No

10.12.05 (CN1034805)

No

No

18.11.06 (MW9088)

11.12.10 (OA9334)

No

03.12.10 (ZA9009743)

No

No

?

No

13.11.10 (ZW90174)

Stavudine - D4T

Zerit

Yale Univ. (BMS)

17.12.1986 (US942666)

No

EP0273277

No

No

No

No

No

No

No

No

22.09.07 (ZA8707171)

No

No

No

No

No

Pro-drug

 

BMS

06.05.1988 (US190809)

No

EP0340778 (withdrawn)

No

No

No

No

No

No

No

No

04.05.09 (ZA8903348)No

 

No

No

No

No

Zidovudine - AZT

Retrovir

Glaxo Wellcome

16.03.1985 (GB8506869)

No

EP0196185

No

No

No

No

14.03.06 (AP11)

14.03.02 (AP11)

No

No

13.03.06 (ZA8601933)

No

22.12.02 (AP11)

?

14.03.02 (AP11)

14.03.06 (AP11)

AZT - 3TC combination

 

Glaxo Wellcome

16.05.1991 (GB9110624)

WO92/20344

EP0513917

No

No

15.05.07 (CN1045961)

No

No

WO92/20344?

11.05.12* (OA10058)

No

15.05.12 (ZA9203544)

No

No

No

No

No

Tablet formulation

Combivir

Glaxo Wellcome

31.10.1996 (GB9622681)

WO98/18477

EP0941100 (expected grant 28.05.03)

under examination (BR9712614)

No

under examination (CN1241142)

Potentially in the mailbox

29.10.17 (AP1067)

29.10.13 (AP1067)

29.10.17* (OA11038)

under examination
(965-1997)

29.10.17 (ZA9709726)

under examination
(37164/opp. filed)

01.05.17 (AP1067)

No

No

29.10.17 (AP1067)

AZT + 3TC + abacavir

Trizivir

Glaxo Wellcome

30.03.1995 (GB9506490)

WO96/30025

EP0817637

under examination (BR9607851)

No

28.03.16 (CN1103593)

Potentially in the mailbox

28.03.16* (AP652)

28.03.12* (AP652)

WO96/30025?

No

27.03.16 (ZA9602477)

under examination (28828)

19.06.13* (AP652)

WO96/30025?

No

28.03.16* (AP652)

Tablet formulation

Trizivir

Glaxo Wellcome

29.04.1998 (GB9809213)

WO99/55372

EP1083932 (under examination)

under examination (BR9910071)

No

WO99/55372?

Potentially in the mailbox

WO99/55372?

WO99/55372?

WO99/55372?

No

WO99/55372?

?

WO99/55372?

WO99/55372?

No

WO99/55372?

Footnotes:

(0) Except when stated differently, this expiry date is 20 years from the filling date, but note that the patent may expire before if the patent holder abandons it (i.e. stops paying the annual fees).

(1) Patents may be granted to protect the basic molecule of a medicine, but also e.g. to protect the manufacturing process, a specific therapeutic indication, or a specific formulation of the said molecule. Note that a product patent usually covers also a manufacturing process.

(2) Note that only the first patent holder is named where there are more than one.

(3) In Brazil, patent protection for pharmaceuticals was only introduced on May 14th 1997. However, between May 15th 1996 and May 15th 1997 it was possible to register a preexisting foreign patent or pending patent application in Brazil in order to obtain pipeline patent protection, i.e., patent protection for medicines which are patent protected abroad but which have not been marketed yet.

(4) There is no patent law in force in Cambodia. A draft Patent Law was passed by the National Assembly on November 28th 2002. This law is then supposed to go to the Senate for confirmation and is expected to be in force in 2003.

(5) Chinese Patent Law was amended, with effect on January 1st 1993, to extend patent protection from 15 to 20 years.

(6) Guatemala only introduced patent protection for pharmaceuticals on November 1st 2000.

(7) In Malawi and Zambia, patents are granted for an initial term of 16 years from the filing date, with a possible extension.

(8) OAPI patents are effective in the 16 member States of the Organisation Africaine de la Propriété Intellectuelle (Benin, Burkina Faso, Cameroon, Central African Rep., Congo, Ivory Coast, Gabon, Guinea, Guinea Bissau, Equatorial Guinea, Mali, Mauritania, Niger, Senegal, Chad, and Togo).

(9) Patent protection for pharmaceutical products was only introduced on December 11th 1991 in Peru, as in all other members of the Andean Community (Bolivia, Colombia, Ecuador, and Venezuela).

(10) Patent protection for pharmaceutical products has only been available in Thailand since September 30th 1992, including pending applications at this date.

(11) In Uganda, patents are granted for 15 years from the date of grant, and may be extended for 5 additional years if the patent is worked locally. WO refers to patent applications filed under the system of the Patent Cooperation Treaty (PCT). The PCT allows patent applicants to file a kind of "worldwide" patent application, by designating countries among PCT Member States in which they intend to obtain a patent. However, the applicant must then confirm this wish in each designated country/region and the patent can only be granted by the patent office of the said country/region.

WO? means that we don't know if the PCT application has been confirmed at national level.

* There is an error in the published patent document with regard to the filing date (see section 4). The estimated patent expiry date is therefore based on the assumed correct filing date.

Where '?' appears, the information was not available.

 

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