PATENTS (MEDICINAL PRODUCTS) REGULATIONS (medicinalproducts)

SUBSIDIARY LEGISLATION 417.03

PATENTS (MEDICINAL PRODUCTS)

REGULATIONS

1st January, 2003

LEGAL NOTICE 261 of 2002.

The title of these regulations is the Patents (Medicinal

Products) Regulations.

In these regulations, unless the context otherwise requires -

"Act" means the Patents and Designs Act;

"certificate" means a supplementary protection certificate issued

by the Comptroller for the purposes of these regulations;

"Comptroller" means the Comptroller of Industrial Property;

"medicinal product" means any substance or combination of

substances presented for treating or preventing disease in human

beings or animals and any substance or combination of substances

which may be administered to human beings or animals with a view

to making a medical diagnosis or to restoring, correcting or

modifying physiological functions in humans or in animals;

"patent" rneans a patent as defined in the Act, in relation to a

product;

"product" means the active ingredient or combination of active

ingredients of a medicinal product and includes the process to

obtain such product or an application of such product.

These regulations shall apply to any product protected by a

patent and which is subject, prior to being placed on the market as a

medicinal product, to an authorisation procedure.

(1) Any person who has obtained a market authorisation in

relation to a product may apply for a certificate to the Comptroller.

(2) The application for such certificate shall be lodged within

six months from the date on which the market authorisation has

been granted.

(3) Notwithstanding the provisions of subregulation (2), where

the authorisation to place the product on the market is granted

before the patent is granted, the application for a certificate shall be

lodged within six months from the date on which the patent is

granted.

A certificate shall be granted if on the date of the

application

(a) the product is protected by a patent;

(b) an authorisation to place the product on the market as a

medicinal product has been granted and is in force;

(c) the said authorisation is the first authorisation to place

PATENTS (MEDICINAL PRODUCTS)

the product on the market as a medicinal product; and

(d) the product has not already been granted a certificate.

An application for a certificate shall contain the following

information

(a) the name and address of the applicant;

(b) if the applicant is being represented by an agent the

name and address of such agent;

(c) the registration number of the patent and the title of

the invention;

(d) the date and the number if any, of the first

authorisation to place the product on the market

Provided that if such authorisation has been

previously granted by an authority outside Malta with

which the Govemment of Malta has reciprocal or

international agreement on supplementary protection

certificates, the date, the number if any, and the

country where the authorisation has been first granted;

(e) a copy of the market authorisation together with a

summary of the product characteristics and in the case

that the first market authorisation has been granted by

an authority outside Malta as aforesaid also a copy of

that authorisation together with a summary of the

product characteristics.

The Comptroller shall, on receipt of an application for a

certificate, issue a notice in the Gazette containing the following

information

(a) the name and address of the applicant;

(b) the registration number of the patent;

(c) the title of the patented invention;

(d) the date and the number, if any, of the market

authorisation and the product identified in that

authorisation;

(e) if applicable, the date and the number if any, of the

first authorisation to place the product on the market if

the first authorisation has been granted by an authority

outside Malta.

(1) Where the application for a certificate meets the

requirements established under these regulations the Comptroller

shall grant a certificate.

(2) A certificate shall only be granted to the proprietor of the

patent.

(3) Where in the opinion of the Comptroller the application

does not fully comply with the requirements established under

these regulations he shall notify the applicant accordingly which

notification shall contain the reasons why the application is non-

compliant.

(4) The applicant may, within sixty days from receipt of the

notification mentioned in subregulation (3), rectify his position to

the satisfaction of the Comptroller, failing which the Comptroller

shall reject the application.

(5) The Comptroller shall, on the granting of a certificate, issue

a notice in the Gazette containing the information listed under

regulation 7(a) to (e) together with the date of granting and the date

of expiry of the certificate.

(6) If an application has been rejected, the Comptroller shall

issue a notice to this effect in the Gazette. Such notice shall contain

the information listed under regulation 7(a) to (e).

(7) Any fee paid for an application which has been rejected

under this regulation shall be forfeited.

Where a certificate has been granted under these

regulations, the protection conferred by the patent in relation to the

product shall continue to apply for the duration established under

regulation 10, subject to the same limitations and obligations.

The duration referred in regulation 9 shall commence at the

expiry of the term of the patent and shall continue to have effect for

that period equal to the period elapsed between the first day of the

sixth year following the date of the application for a patent and the

date of the first authorisation to place the product on the market in

Malta or in any other country with which the Government of Malta

has reciprocal or international agreements on supplementary

protection certificates

Provided that the period lapsed as aforesaid shall in no case

exceed five years.

The certificate shall lapse

(a) at the end of the period provided for in regulation 10;

or

(b) if the certificate-holder surrenders it; or

(c) if any fee due is not duly paid; or

(d) if the market authorisation in relation to the product

has been withdrawn.

(1) The certificate shall be invalid if

(a) the provisions of regulation 5 have not been cornplied

with; or

(b) the patent has lapsed before the expiry of its term; or

(c) the patent is revoked or limited to the extent that the

product for which the certificate was granted would no

longer be protected by the claims of the patent or, after

the patent has expired, grounds for revocation exist

which would have justified such revocation or

limitation.

(2) Any person may submit an application to the Comptroller

for a declaration of invalidity of a certificate.

If the certificate lapses as is referred to in regulation 11(b),

(c) and (d) or is invalid as is referred to in regulation 12, the

Comptroller shall notify such event in the Gazette.

In the absence of procedural provisions in these

regulations, the procedural provisions applicable under the Act in

relation to a patent shall, to the extent that they may be applicable,

apply to a certificate.

Any product which, on the date of coming into force of

these regulations, is protected by a patent and for which the first

authorisation to place it on the market in Malta as a medicinal

product was obtained may be granted a certificate. In such a case

the six month period referred to in regulation 4(2) shall commence

on the coming into force of these regulations.