Download Second medical use or indication claims (Q238) (Egypt)

Question Q238
National Group:
Egyptian National Group
Title:
Second medical use or indication claims
Contributors:
Eman MOHEY, Gamal ABOU ALI
Reporter within
Working Committee:
Ahmed ABOU ALI
Date:
May 11, 2014
Questions
I.
Current law and practice
1)
Does your country permit patents covering any aspect of new uses of known
pharmaceutical compounds (hereafter referred to as second medical use claims)?
If yes, please answer Questions 2) to 7) inclusive before proceeding to the questions
in Parts I and II. If no, please proceed directly to the questions in Parts II and III.
No. Egypt does not permit patents covering any aspect of new uses of known
pharmaceutical compounds. According to Article 1 of the Egyptian Intellectual
Property Law No. 82 of 2002 (“IP Law”), a patent shall be granted to any industrially
applicable invention, which meets the requirements of novelty and inventive step,
whether it is connected with new industrial products, new industrial processes, or a
new application of known industrial processes. Second medical use lacks the
inventive step requirement. In addition to the limitation imposed by this definition, the
Egyptian Patent Office (“EPO”) considers second medical use as a “discovery” that is
not patentable under Article 2 of the IP Law.
2)
If the answer to Question 1) is yes, please answer the following sub questions.
a)
What is the basis for patent protection?
b)
What types of second medical use are patentable? See, for example,
paragraphs 14) - 17) above/WGLs.
c)
Are any types of second medical use impermissible subject matter? See, for
example, paragraphs 14) - 17) above/WGLs.
d)
What forms of second medical use claims are permissible? See, for example,
paragraphs 26) - 33) above/WGLs.
e)
What forms of second medical use claims are not permissible? See, for
example, paragraphs 26) - 33) above/WGLs.
f)
Has any guidance been provided by courts or the national patent office in
relation to the meaning, scope and/or effect of 'treatment', 'treating' or 'use to
treat' integers in second medical use claims? See, for example, paragraphs
34) - 39) above WGLs.
3)
If your country permits second medical use claims:
a)
Who may be liable for infringement of such claims? For example:
i) the party marketing the drug with label instructions which describe the
patented use;
ii) the physician prescribing the drug for such use;
iii) the pharmacist dispensing a drug for such purpose;
iv) the patient using the drug for such purpose?
b)
Are any parties exempt from infringement or liability for infringement of such
claims. If so, what classes of party?
c)
Are such claims enforceable on the basis of direct or indirect infringement?
Please provide details.
4)
If a drug is approved for more than one indication, one or more of which (but not all)
falls within the claims of a patent, is it an infringement if a party makes, supplies or
uses a generic version of the drug for any use?
5)
If the answer to Question 4) is yes, please answer the following sub questions in that
context.
a)
Is each of the acts of making, supplying and using a form of infringement? If
not, please specify which (or any other) acts which constitute infringement.
b)
Is it necessary for a finding of infringement that the party making, supplying or
using the generic version of the drug does so in connection with the infringing
use?
c)
If yes to b), is it necessary that the party knows that their actions are in
connection with the infringing use?
d)
If yes to c), what standard of knowledge is required? See, for example,
paragraphs 38) and 47) above.
6)
How do the courts determine infringement of a second medical use claim? What are
the legal tests and evidentiary requirements?
7)
What relief is available for infringement of a second medical use claim:
a)
at a preliminary / interim / interlocutory level?
b)
by way of final relief?
8)
In respect of Question 7)a), can a preliminary / interim / interlocutory injunction be
granted solely upon the statements provided in the product packaging or based on
the writing of a prescription? If not, what is the basis for relief?
9)
In respect of Question 7)b), what level of proof is required to obtain a final injunction?
II.
Policy considerations and proposals for improvements to your current law
10)
If your country permits second medical use claims, please answer the following sub
questions.
a)
What are the policy reasons behind permitting such claims?
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b)
Are such claims as are currently permissible in your country considered to
strike the right balance between the interests of relevant stakeholders?
c)
Is it considered that such claims better serve the interests of some
stakeholders and/or are detrimental to other stakeholders?
d)
If there is any empirical or anecdotal data available, please address the
following.
i) What is the prevalence of second medical use claims in your country?
ii) What is the profile of patentees for second medical use claims in your
country?
11)
If your country does not permit second medical use claims, please answer the
following sub questions.
a)
What are the policy reasons behind not permitting such claims?
Considering a second medical use claims as non patentable is due to the
legal characterization of the claims. Second medical use claims do not involve
any inventive step in order to make them different from original patented
compounds. In addition, such claims lack novelty which makes Patents Office
characterize them as discoveries rather than inventions.
b)
Would such claims serve the interests of relevant stakeholders?
Refusal to grant patents to second medical use claims does not mean that
such claims cannot be utilized commercially. The Egyptian General
Administration of Pharmaceutical Affairs (“GAPA”) may approve registration of
a medicine even if it is based on a second medical use; provided that, the
producing company submits all relevant studies supporting such new
indication.
The above scheme allows other pharmaceutical companies to compete with
the inventor/discoverer of the second medical use. Although the above
scheme is intended to favor consumers by lowering the price of medicines, it
does decrease the incentive of the inventor to enter the local market. This may
be offset by the fact that the local market is big – with the population nearing
90 million – which incentivizes pharmaceutical companies to enter the local
market even if the margin of profit is less than desired.
c)
Would such claims be considered to better serve the interests of some
stakeholders and/or be detrimental to other stakeholders?
These claims, if allowed, would better serve the interest of the inventor
pharmaceutical company and to the consumer – if the incentive rationale is
followed – but it might adversely affect competitors and consumers, with
respect to pricing; although the Government can resort to mandatory
pricing/licensing to mitigate this effect.
12)
To what extent does your country's law in relation to second medical use claims affect
the pharmaceutical industry (originator and generic) in your country?
Egypt does not have a significant pharmaceutical industry which is based on local
inventions, but it has a large market which is based on generic products and a market
focusing on local production of foreign invented products. Thus, most medicines are
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initially approved outside Egypt prior to their commercial use in Egypt. The more
significant effect therefore relates to availability and pricing to consumers.
III.
Proposals for harmonisation
13)
Is it desirable to permit second medical use claims?
It is desirable to permit second medical use claims whether to the original inventor or
the discoverers of the second medical use in order to open the market for a wider
range of products as well as incentivize local pharmaceutical companies to allocate
more resources and effort to research and development. Although pricing for the
consumers is always a key issue, it can be addressed through pricing mechanisms. A
shorter term of protection may be considered as a compromise between the interests
of consumers, local producers and international pharmaceutical companies.
14)
Is harmonisation of laws relating to second medical use claims desirable?
Yes. Harmonization of laws relating to second medical use claims, and more
generally to intellectual property rights in the pharmaceutical industry, is desirable as
it provides more certainty and predictability for pharmaceutical companies; therefore
facilitating their entry into newer markets.
15)
Please provide a standard that you consider to be best in each of the following areas
relating to second medical use claims.
a)
Types of second medical use constituting permissible subject matter. See, for
example, paragraphs 14) - 17) above/WGLs.
The following examples may constitute permissible grounds for patentability:
b)

Where a drug is developed for a certain purpose and after research
was found to be useful for another medical purpose.

Unsuccessful compounds used originally to treat specific conditions
and subsequently used successfully to treat other diseases.
Types of any second medical use constituting impermissible subject matter.
See, for example, paragraphs 14) - 17) above/WGLs.
Dosage and method of administration should not be patentable as this is more
difficult to demonstrate. In addition, in many cases there is no agreement
within the scientific community regarding the dosage and methods of
administrations. It may also be the case that dosage and method of
administration require less research and development cost, especially if
intended to treat the same disease.
c)
Form of permissible claims. See, for example, paragraphs 26) - 33)
above/WGLs.
The EBA decision G2/08 seems to be a good standard for allowing second
medical use claims: “Substance X for use in the treatment of condition Y”. We
understand that this standard requires more than merely using the same
substance without any additions/amendments to treat a different condition. It
is therefore possible to pass a more lenient inventive step test.
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d)
Form of impermissible claims. See, for example, paragraphs 26) - 33)
above/WGLs.
We are of the opinion that the new dosage regime should be a form of
impermissible claims.
e)
Who may be liable for infringement?
Producers of the same compounds for different treatment may be liable for
infringement.
f)
Any parties/institutions that should be exempted from infringement or liability
for infringement.
It may be difficult and impracticable to hold doctors prescribing a medicine for
a second medical use liable. It may also not be desirable to require the
competent authority – GAPA in Egypt’s case – to be held liable for authorizing
second medical use as this may result in a restrictive approach by GAPA
which may result in refusing to allow medicines that may otherwise not be
violating second medical use claims.
g)
Where a drug is approved for more than one indication, one or more of which
(but not all) falls within the claims of a patent, the acts that should constitute
patent infringement, and in particular, the standard of knowledge of the
alleged infringer.
Patent infringement should be invoked only where the producer of the drug
markets it expressly for the second medical use (i.e. one or more the
indications which falls within the claims of a patent) but not with respect to
unprotected claims. Actual knowledge, in this approach, would be presumed
without need for evidence by the infringed party if the claims are patented (i.e.
a “knew or should have known” standard should be applied).
h)
Relief available upon a finding of infringement:
i) at a preliminary / interim / interlocutory level; and
ii) by way of permanent relief.
A preliminary / interim / interlocutory level would be more desirable so as to
avoid the prevention of the drug’s use for unprotected claims.
i)
In each case for h)i) and h)ii), the level of proof for the granting of such relief.
The standard of proof is that the infringer “knew or should have known”.
Summary Q238
Egypt does not permit second medical use claims, on the grounds that they do not meet the
requirements of novelty and inventive step. Refusal to grant patents to second medical use
claims does not mean that such claims cannot be utilized commercially.
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It is desirable to permit second medical use claims in order to open the market for a wider
range of products as well as incentivize local pharmaceutical companies to allocate more
resources and effort to research and development.
A good standard for allowing second medical use claims is: “substance X for use in the
treatment of condition Y,” as it requires more than merely using the same substance and
may therefore pass a more lenient inventive step test.
Doctors and relevant health authorities should not be held liable for second medical use
infringement. Patent infringement should be invoked against producers who knew or should
have known of the infringement.
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