Data protection and extension of patent rights TRIPS requirements

1
Data protection and extension of patent rights
TRIPS requirements TRIPS-plus provisions

• Carlos Correa

2

• Test data protection

3
Medicines are subject to two sets of rules
Patents
Registration requirements
The right to exclude But not the right to market
or to use
Authorization to put a medicine on the market
4
Test data
Safety Efficacy
Preclinical and clinical trials


5
TRIPS Article 39.3 Members, when requiring, as a
condition of approving the marketing of
pharmaceutical or of agricultural chemical
products which utilize new chemical entities, the
submission of undisclosed test or other data, the
origination of which involves a considerable
effort, shall protect such data against unfair
commercial use. In addition, Members shall
protect such data against disclosure, except
where necessary to protect the public, or unless
steps are taken to ensure that the data are
protected against unfair commercial use.
6
Unfair commercial use

• -The Drug Regulatory Authority (DRA) may not
  request the data (approval by reference)
• Even if the DRA does use the data, it is not
  commercial use

7
Data exclusivity During the data exclusivity
period, Authorities cannot use or rely on test
data to register generic equivalents
8
As long as data exclusivity lasts Generic
manufacturers will have to submit their own data
to prove safety and efficacy
gt They will have to repeat the clinical trials
and other tests
Alternatively, they can only enter the market
after expiry of the data exclusivity period
9
NCE, standard situation
Registration market entry
End patent term
Patent
Data exclusivity
10
2. Second indication
Registration 2nd indication
Registration market entry
Patent
End patent term
Data exclusivity
Data exclusivity
11
1. NCE, compulsory licensing
Registration market entry
End patent term
Patent
Data exclusivity
12
Directive 2004/27/EC

• Article 10
• 1. ..without prejudice to the law relating to the
  protection of industrial and commercial property,
  the applicant shall not be required to provide
  the results of pre-clinical tests and of clinical
  trials if he can demonstrate that the medicinal
  product is a generic of a reference medicinal
  product which is or has been authorised under
  Article 6 for not less than eight years in a
  Member State or in the Community.
• A generic medicinal product authorised pursuant
  to this provision shall not be placed on the
  market until ten years have elapsed from the
  initial authorisation of the reference product.

13
Directive 2004/27/EC

• 5. In addition to the provisions laid down in
  paragraph 1, where an application is made for a
  new indication for a well-established substance,
  a non-cumulative period of one year of data
  exclusivity shall be granted, provided that
  significant pre-clinical or clinical studies were
  carried out in relation to the new indication.

14
Directive 2004/27/EC

• Article 10a
• By way of derogation from Article 8(3)(i), and
  without prejudice to the law relating to the
  protection of industrial and commercial property,
  the applicant shall not be required to provide
  the results of pre-clinical tests or clinical
  trials if he can demonstrate that the active
  substances of the medicinal product have been in
  well established medicinal use within the
  Community for at least ten years, with recognised
  efficacy and an acceptable level of safety in
  terms of the conditions set out in Annex I. In
  that event, the test and trial results shall be
  replaced by appropriate scientific literature.

15
Data protection Directive 2004/27/EC 821
-Prevents authorities from assessing
applications for generics during 8 years
-Marketing of generics can only be authorized
after ten years -One additional year for new
indications of known products
16
Regulation (EC) No 1901/2006 of the European
Parliament and of the Council of 12 December 2006
on products for paediatric use -Paediatric-Us
e Marketing Authorisation (PUMA) 10 years of
market exclusiviity -A medicinal product that
has obtained a PUMA can use the existing brand
name of the corresponding authorised
product
17
European Parliament and Council Regulation (EC)
No 141/2000 of 16 December 1999 on orphan
medicinal products
-Diagnosis, prevention or treatment of a
condition affecting fewer than five per ten
thousand persons in the Community -exclusive
marketing rights for a ten-year period. Athe
request of a Member State, this period can be
reduced to six years if that Member State can
establish that the conditions justifying the
designation as an orphan medicinal product are no
longer met or that the price being charged for
the medicinal product in question is
excessive. -Exclusivity does not prevent the
marketing of a second medicinal product if the
holder of the marketing authorisation of the
original orphan medicinal product has given his
consent to the second applicant, or if he is
unable to supply sufficient quantities of the
medicinal product, or if another medicinal
product proves safer, more effective or otherwise
clinically superior to the first.
18
Ukraine Article 9-Law on Pharmaceutical Products

• If the pharmaceutical product is registered in
  Ukraine, it is prohibited, for five years after
  the date of such registration (regardless of the
  validity of any patent which concerns the medical
  product), to use the registration information for
  filing an application for state registration of
  another pharmaceutical product, except for cases
  when the right to refer or use such information
  is received in a due manner.

19
Patent term extension
20
US patent term extension to compensate for delay
in approval of medicines (35 USC156)
-Maximum five years -Total period of
effective patent protection may not exceed 14
years (the original patent term, shortened by the
regulatory review period, plus the extension)
21
Council Regulation (EEC) No 1768/92 of 18 June
1992-

• The product is protected by a basic patent in
  force
• The product, as a medicinal product, has been
  granted a marketing authorisation
• The product has not already been the subject of a
  certificate
• The marketing authorisation is the first
  authorisation to place the product on the market
  as a medicinal product
• The certificate applies to the product in the
  same way as the patent from which it benefits
• The certificate cannot be granted for a period
  exceeding five years
• The duration of protection afforded by a patent
  and by the certificate cannot exceed 15 years
  overall for the holder's first marketing
  authorisation.

22

• Impact of TRIPS-plus data exclusivity

23
Impact of TRIPS-plus on the price of medicines in
Costa Rica-2030
-Number of new products under exclusive rights
from 9 en 2010 to 28 in 2030 -Annual increase
in social security costs 31
24
Colchicine effects of data exclusivity -Wid
ely available as a generic drug in the USA since
the 19th century second-line treatment for
gout -Tests with 185 patients, one week
shortened dosing regime (fewer adverse effects)
3 years of data exclusivity - Familial
Mediterranean fever (FMF) (genetic
inflammatory Disorder) 7 years of exclusivity
under Orphan Drug Act - Lawsuits to remove any
other versions of colchicine from the market
-Price increase by a factor of more than 50,
from 0.09 per pill to 4.85 per pill.