Intellectual Property issues
in the Local Pharmaceutical
Manufacturing Industry
Karin Pramberger
15 February 2011
Malta
Pharmaceutical business in Malta

About 15 foreign companies operating in Malta

mainly generics companies

Over 1.000 people employed

Exports by Pharma Industry:

2008
€169.6 million

2009
€157.3 million

2010 (Jan – Sep)
ho €176.1 million
l
Corporación Medichem in Malta




Medichem & Combino Pharm both
started in 2005/2006
2009: 8% of Medichem´s sales
2011: ~ 35% of Medichem´s sales
cGMP and FDA approved
ho
l
Why is Malta so attractive?
800
700
600
500
400
300
200
100
0
years 1986-2006
Number of pharmaceutical patent filings in
Malta:

1986: 1

1999: 48

2003: ~ 200

2005: ~ 800
ho
l
History of Patent Law in Malta



Industrial
Property
(Protection)
Ordinance: 1899
Patents and Designs Act: 2002
Malta becomes a member state of the
PCT and EPO: 1 March 2007
ho
l
PCT: 142 member states
Malta is covered for 2,5 years after the
first priority filing
howith the PCT filing
l
EP: 38 member states and 2
extension states
ho
l
Consequences
ho
l
Some examples
Drug
Exp. of
constraining
patent in US
Sales in US
in 2010 ($)
% of market
share of
innvovator in
US
Prilosec
(omeprazole)
1999
> 1 bio
´03: 37%
´06: 10%
´10: 0.7%
Prosac
(fluoxetin)
1999
300 mio
´02: 15%
´09: 2%
Protonix
(pantoprazole)
2010
1,7 bio
´09: 85
Paxil
(paroxetine)
1992/2007
1,7 bio
´02: 90%
´04: 7%
´08: 0.6%
Plavix
(clopidogrel)
2011
> 5 bio
´09: 100%
……..
ho
l
All perfect in Malta?
Priorities (Atorvastatin):






US sales in 2010: 7.5 bio
US Patent expiries: ´10, ´11, ´17
Litigation outcome: settlement to launch in
2011
3 equivalent patents in Malta but:
Appl. Dates in 1999 without priority
US/EP equivalents published in ´87, ´93,
´99
ho
l
Patents under the Ordinance




Grounds for invalidity do NOT include
inventive step!
Suddenly the situation is reversed!
The MT patent contains broader
claims than its EP or US counterparts!
Medichem can produce in Spain but
NOT in Malta!
Is this the advantageous situation
Malta had foreseen???
ho
l
Patents granted under the
Patents Act 2002





Only formal examination carried out
Many MT patent granted with broader claims
than the EP or US equivalents
Nullity Action is filed with the “Civil Court” –
a non specialised court with little or no
experience in patent issues!
Again: Medichem experiences situations
where it could produce in Spain but NOT in
Malta!!!
Is this the advantageous situation Malta had
foreseen???
ho
l
Improvements patent applications
Big improvement with MT becoming a
member state of the EPO:
 National path after PCT is closed
 Every MT patent filed through PCT
will have been examined by EPO
 Examination carried out, open to
third party observations and
oppositions
 Situation in MT and rest of Europe
is harmonised
ho
l
Improvements - granted patents:
still necessary

Deal with patents with clearly invalid or
no priority claims in a quick proceeding
 Establish a specialised court to
limit/invalidate Maltese patents
 Provide
possibility
of
limiting/invalidating patents also on
grounds of inventive step to bring in
line with equivalent EP patents.
ho
l
Thank
you!
ho
l