E-DRUG: AZT patented? (cont)
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Dear WB,
Let me attempt to respond to your query line by line:
OK, the *product* AZT is old from 1964 (and its product patent has thus
expired) but the *indication* AIDS is new and patented in 1986. But if I
wanted to use AZT for, say, (just an example) treatment of eczema, would
that then NOT be protected by patent if the patent holder had not filed a
patent for the *use* of eczema?
The answer is Yes and No. The *use* of AZT for eczema would NOT be
protected if the indication (in this case eczema) was not claimed by the
earlier patent. You may even apply for a patent for this specific use in
US, Europe and Canada and obtain patent. Would you be able to market the
drug AZT for the treatment of eczema before to the expire of the earlier
patent?? That is where the "No" answer appears, at least in the case of
AZT. The reason being is that you may infringe *formulation* claim(s) and
not *use* claim (say claim 1 of Canadian patent no 1238277 if you were to
market AZT in Canada). However, if you market the active compound
(3-azido-3-deoxythymidine) per se ( i.e., without *formulating* the active
with a pharmaceutically acceptable carrier thereof) you would NOT infringe
Burroughs Wellcome Canadian Patent.
The *use* would then not be patented but would the *product* still be
patented?
The NEW *use* ( say for treating eczema) of the OLD product (say AZT) is
PATENTABLE. Please note that patentability of a particular product ( say
NEW *use*, a NEW *process* for manufacturing the old compound) doesn't mean
that one would sell/market the patented product. There may be other earlier
patents (still enforce) which may bar you from MARKETING the patented
*use* or process.
If that is true, would drug companies then not 'invent' a new indication
for the same drug every 19 years and have 'eternal' patent protection for
the product??
In some cases you are absolutely correct. In the case of AZT, for example,
the active compound was first identified in 1964 (J.P. Horowitz et al.,J.
Org. Chem., 28, 2076, 1964) and was later found to have antiviral activity
(see E. Declerq et al., BioChem. Pharma Col., 29, 1849, 1980). The
question is if these publication teach " a pharmaceutical formulation
comprising as active ingredient, AZT, and a pharmaceutical carrier
thereof". If these published prior art references describe such a
pharmaceutical composition (AZT and a carrier), then some of the claims, if
not all the claims, of Burroughes patents may be invalid. Thus, eliminating
the "eternal" patent protection for the product (*formulation* claims).
And how would a patent office or someone else control for what
*indication* I am using a particular product? WB]
The patent office has nothing to do when it comes to enforcement of any
drug. It is the responsibility of the regulatory agencies (FDA, TPP, etc.,
) to control the marketing of a drug and the indication you are using for.
Yo may have a patent for a drug, but you can not market same until you have
approval for same.
I hope I have responded to your queries.
Regards,
Teka AbaMacha
[Thanks!
Let us continue my desperate but naive hypothesis that AZT works for
eczema.
1. So IF I patented the *new use* of AZT for eczema, AND I used just the
active, 'unformulated' compound, then I would be able to obtain a patent?
2. If I then would 'donate' the patent to, say, WHO (or ACT-UP?) then we
would be able to produce an 'un-formulated' generic AZT for the indication
of 'eczema'.
3. We might have some trouble in proving that AZT is effective in 'eczema',
but if we convinced a Regulatory Authority, then it would register that
indication. (there are enough other unproven ineffective drugs
registered...)
4. If we then had a good quality generic, we could start selling AZT for
the official indication 'eczema' at much lower prices than if the label
said it was for AIDS.
5. The fact that a doctor then prescribes it for AIDS is not controllable
by the Regulatory Authority, nor by the patent holder.
6. So we finally have lowered the price of AZT for all those 30 million
HIV+ people in the poorest countries of this world?
7. What is wrong in my above naive hypothesis?
WB]
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