TRANSLATED FROM ORIGINAL
29 October 2003
Director of Operations
Syarikat Megah Pharma & Vaccines (M) Sdn Bhd
Suite E1103, Block E
Pusat Dagangan Phileo Damansara 1
46350 Petaling Jaya
Sir,
Authorisation for exploitation of patented invention in Malaysia
By virtue of Section 84(1)(a), Patents Act 1983, Syarikat Megah Pharma &
Vaccines (M) Sdn Bhd (Company No: 552048-H) is hereby authorised to
exploit patented inventions for the following drugs:
i. Didanosine 100mg tablets produced by Bristol-Myers Squibb;
ii. Didanosine 25mg tablet produced by Bristol-Myers Squibb;
iii. Zidovudine 100 mg capsule produced by GlaxoSmithKline; and
iv. Lamivudine 150mg + Zidovudine 300mg tablet produced by GlaxoSmithKline.
2. The authorisation is valid for two years, commencing November 1 2003.
It is subject to the following conditions:
i. the authorisation shall be limited to the importation of the above
listed drugs from Cipla, India;
ii. the drugs to be imported shall only be for supply to government
(public) hospitals;
iii. importation of the said drugs shall be subject to the terms and
conditions as specified by the Ministry of Health, Malaysia;
iv. the quantity to be imported shall be as specified by the Ministry of
Health, Malaysia;
v. all packaging of the drugs shall be labelled with the words
“KEMENTERIAN KESIHATAN MALAYSIA” (Ministry of Health, Malaysia);
vi. the name (brand), shape or colouring of the tablets or capsules
shall be differentiated from that of the patented products in Malaysia;
vii. the company shall be required to register the sale in the scheduled
poisons register (please check this – think it refers to the Scheduled
Poisons regulations);
viii. the ceiling price for the said drugs to be supplied to the
Ministry of Health, Malaysia shall not exceed the following:
(a) Didanosine 100 mg tablet - RM74.58 (per box of 60 tablets)
(b) Didanosine 25 mg tablet - RM22.80 (per box of 60 tablets)
(c) Zidovudine 100 mg capsules - RM5.89 (one set of 10 capsules)
(d) Lamivudine 150mg +
Zidovudine 300mg tablet - RM153.50 (per box of 60 tablets)
ix. Payment of compensation shall be made to the patent holder(s) within
2 months of each import of the said drugs. The rate of compensation is
to be determined at a later date.
3. The above terms and conditions may be amended or varied as deemed
appropriate.
4. The authorisation may be terminated at any time in the event of
non-compliance with the terms and conditions as specified above.
(signature)
(TAN SRI DATO’MUHYIDDIN BIN HJ. MOHD YASSIN)
(Minister of Domestic Trade and Consumer Affairs,
Malaysia)