Patents and Generics
Ragnheidur Sigurdardottir
My task
• The relevance of IP for the operations of your
company in general, both with respect to patent
searches on prior art as well as any activity with
respect to the filing of new patents
• The role of Malta's IP regime on their decisions to
set up in Malta, the implications of Malta's
accession to the EPO in this respect and the
company's views on the sustainability of the
Pharmaceutical Manufacturing Industry in Malta.
Basic patent worldwide
• While developing and marketing generics,
it is essential to evaluate patents owned
by the originator and other generics
• Usually there is a basic patent that
protects the active material and this
patent is regarded as blocking
Expiry dates world wide
• Actavis has prepared a comprehensive
ever-changing excel document with dates
showing when markets open up for each
product in most markets of the world
• 207 pharmaceuticals in 80 countries
The other patents
• Usually the basic patent expires first but there
are other patents and patent applications in most
countries that protect inter alia:
• Pharmaceutical compositions
• Crystalline form and salt of the active material
• Process of preparation for the active material
and pharmaceutical composition
• Indications
• Particle size, impurities and packing
method/material
Patent search and report
• When a product has been approved, Actavis orders a
search – commonly more than thousand hits – and a
screening is performed
• A patent report is prepared, taking into account all
relevant patents and patent applications
• This patent report is a reference document in the
development and marketing of the product
• Continuous monitoring and updating of the report is
essential
Methods for not infringing patents
1) Amendment of the pharmaceutical
2) Opposition (mostly at the EPO)
3) Invalidation in each market
4) Buying license
5) Constant monitoring:
a) filing of new patent applications;
b) possible amendment of claims (scope) of the
monitored patent applications; and
c) the grant of patents that should be opposed.
Amending
• The first and best solution is to amend the
product from the one that is protected by a
patent by employing for example different
excipients (the inactive ingredients) in the
pharmaceutical formulation
• Sometimes it is possible to employ what was
known earlier (prior art – even from the basic
patent) since there should be no further patent
protection
Examples on amendments
• Protected by patent
1) Lactose as excipient
2) Bisulphate salt of the
active material
3) Packed in blister
4) Crystalline form I or II
5) Parkinson’s disease
protected but not
restless-leg-syndrome
• The generic way
->Use another sugar
-> Use besylate salt of
active material
-> Use bottles
-> Use amorph
-> Parkinson’s disease
deleted from leaflet
and marketed with
RLS
Different patent protection
• To complicate matters, national patents can
include different set of claims and therefore
different scope of protection
• In the case of the biggest and most protected
product the solution was to develop four
different formulation choosing from:
• 2 crystalline forms, 2 salt of the active material
and 2 pharmaceutical formulations.
Opposition
• In the case of a blocking patent application
where prior art is located that should destroy the
patentability, one way is to oppose the grant of
the patent and invalidate the patent in many
European countries at the same time
• After grant of a patent there is a 9 months
opposition period for a case to be prepared
• When an opposition is successful the patent is
invalidated in 36 contracting states
Opposition
• Actavis has opposed the grant of 28
patents at the EPO
• 15 cases have been successful and some
have been appealed and are still pending
• The opposition and appeal can take 5 – 7
years
Invalidation
• If the opposition period has expired it is
possible to invalidate a certain patent in
the most valuable markets
• Invalidation is very expensive compared
with opposition
• Actavis has gone through many
invalidation cases
License
• To buy a license to employ a patent can be a
good solution but expensive
• The obvious advantage compared with opposition
and invalidation is that the market is not opened
up for other competitors as well
• License have been used to some extent in
Actavis and we have also sold licenses to our
patents
Filing of patent applications
• In cases of successfully formulating a noninfringing product with methods not known in
the prior art, it is necessary to apply for own
patent
• This is a valuable way to prohibit competitors to
apply for the same invention later on and block
the market for already developed product
• Actavis has filed over 100 patent applications
Actavis in Malta - before
• Delta bought Pharmamed in 2001 to benefit from
the manufacturing site and favorable IP
environment
• Few or no patents were filed in Malta, probably
because the market was regarded too small for
protection
• There was a window for generic companies to
develop and stock-pile in Malta and to be ready
to enter other markets on the date of patent
expiry
Actavis in Malta – today
• Malta’s Patent Act was amended in 2002 to be in
line with EU directives
• The patent environment has become the same as
in other countries
• Actavis designs the development for the bigger
markets and this will therefore not change the
development itself since the patent strategy is
clear and simple: not to infringe any patents
The Bolar convention
• In Malta the so called Bolar convention is valid,
which allows generic companies to develop and
apply for market authorization but not to
manufacture and stock pile for marketing
• Therefore the main difference after Malta's
accession to the EPO is the fact that no
manufacturing and stock-piling is or will be
possible until relevant patents have expired
Thank you