The two companies, who represent both sides of the
pharmaceutical industry, sponsored a conference at UCL IBIL in London
this week, attended by a mix of lawyers, judges, regulators and
In summary, the
problem is: is there sufficient incentive to encourage research
into second and subsequent medical uses of known compounds?
While second medical uses can in principle be protected by
intended use claims, these may be of limited value.
That’s because as soon as the first patent (or
SPC) expires, generics can enter the market with competing
products – and it is almost inevitable that some of
these will be prescribed or used for treatments that infringe
the second medical use patent.
Such off-label prescriptions may not be approved by the
generic (and scrupulous manufacturers will ensure their
packaging and information make clear what their products are
and are not approved for). But they are unavoidable, given the
price difference between branded and generic products and the
pressures from payers (governments and health insurers).
The result is everyone loses. Innovative companies lose
sales and may decide it is not worth investing in research on
new uses, meaning that patients are deprived of new products.
Generics are putting themselves at risk of indirectly
infringing patents even though they are producing drugs
legally. And patients may not be getting the latest, best
treatments for their conditions. The only potential winners
– at least in the short term – are the people
paying the bills.
What’s more, the courts may not be able to
provide an answer. Patent owners won’t sue
pharmacists, doctors or patients. That leaves the generics, who
may be secondarily liable. But the law on secondary liability
in Europe is unclear and continental judges (at least) are
unlikely to grant an injunction in cases where a generic has
clearly carved out certain indications. Judges in the UK may be
more flexible: one suggestion is that an injunction could be
suspended provided a generic pays a royalty to compensate the
patent owner for off-label sales. That’s neat, but
it’s effectively compulsory licensing. And it
raises further questions about what would be appropriate
compensation (and potentially competition issues).
complicate things there is a widely shared recognition that
second medical use patents may be found invalid anyway when
they come before a court. (If you have a drug that is effective
in treating colon cancer, it’s arguably obvious to
see if it works against other forms of cancer too.) That was
the fate of Merck’s patent for alendronate
10 years ago: in the UK litigation Sir Robin Jacob (who
coincidentally hosted this week’s conference at
UCL) wrote: "[T]he patent system does not confer monopolies on
those who develop obvious or old products, even if they have
never been exploited. A workable system for that might be a
good idea, particularly in the field of medicine and analogous
The patent problem creates a societal problem: potentially
useful medicines may not be researched and produced. And it may
be a problem that the patent system itself can’t
solve. Alternative suggestions include some sort of industry
agreement to redistribute earnings from generics to innovators;
creating a new (quasi-)IP right similar to SPCs; and beefing up
regulatory data protection.
This week’s conference showed that there is
broad agreement within industry that something needs to be
done, and there are some constructive suggestions. But whatever
concrete proposals emerge, they will have to be sold to
governments and society at large – and that will be
tough, especially in today’s economic climate.