Two Seperate Inquiries

(1) What kinds of improvements are relevant to granting a patent on modifications of

lead drugs? (i.e. along what dimensions?)
(2) How much of an improvement should we require? (i.e. how much?)
(1) Possible Spectrum from Narrow to Broad
(2) Possible formulations
Narrowly-construed therapeutic efficacy / unexpected results
increased potency or decreased toxicity
Broadly-construed therapeutic efficacy / unexpected results
Goes to how the drug works in the body but might not relate exactly to toxicity / potency
side effects which are not about toxicity but improve patient use (e.g. decreased discomfort, less
frequent dosages required, etc.)
All consumer-relavant properties
increased flow, heat stability, long term storage .
Arg for not including these factors it doesnt require the kind of risky, costly research to develop so there isnt the need to
incentivize drug companies to engage in this research. it will follow naturally. Its going to happen
any way.
Arg for including access to the drug may be significantly dependent on these factors for some populations
(2) Perhaps the significant distinction between broad therapeutic efficacy and all consumer
relevant properties can be drawn by asking whether the modifications that require a new clinical
trial
What about flash of genius?
Significance analysis: is it (1) a genuine advance (one that we really value as an
improvement in our available medicines) and (2) an advance that needed patent
protection to come up with?

Gleevec:
Bioavailability (how much of the drug is required for ingestion to affect the body)
Amorphous form / Base: no bioavailability. basically just sits in the stomach
Beta

Alpha: 30% increase in bioavailability over beta

3(d) & TRIPs - Compliance

Harmonization
Not if you choose to have a certain set of laws, you cant discriminate between nations but
must have a similar set of laws
All members must implement a similar set of requirements and provide a similar set of rights
and protections to incentivize the dissemination of technology

Article 27 Requirements
1)...
2) right to exclude
3) member nations can adapt the making using permissible in their territory
4) all definitions of rights and remedies should be constructed in light of the overarching purpose
-- disseminate technology

TRIPs Arg - Free Riding

US, Switzerland, Canada, and a handful of other countries housing the worlds most influential
drug developers pay (in the form of domestic patent protections). All countries should pay for the
creation of these rights rather than benefitting from innovation in pharma that is sponsored
solely by Western Euro and US

TRIPs Arg - Incentive to Create

Doubling and tripling the amount and scope of patent protection isnt justified. The fact that we
are expanding the markets and sales for pharma so drastically