[Ip-health] Straights Times: The Hoopla Over Viagra Patenting in China

[Mike Palmedo]

http://straitstimes.asia1.com.sg/commentary/story/0,4386,261351,00.html

The hoopla over Viagra patenting in China

By Andy Ho
Straights Times
July 16, 2004

WHAT a rip-off.

Beijing regulators nullified Pfizer's patent on Viagra last week, so the
Chinese must be the bad guys, many assumed. After all, knock-offs are
already widely available in China, so this move just legalises them all
in one fell swoop.

To be sure, while each pill of Viagra costs US drugmaker Pfizer,
currently the world's largest pharmaceutical company, about one yuan (20
Singapore cents) to make, it is sold for 98 yuan a pop. A Chinese copy,
Tigra, sells for only 22 yuan.

But tearing up the Viagra patent isn't quite the same as breaking a
patent to authorise the generic production of a drug - something which
under World Trade Organisation (WTO) rules is permitted during a
health-care emergency.

But clearly, impotence - even widespread impotence - isn't quite that
sort of emergency. So what the Beijing decision confirms, some say, is
that China's intellectual property regime is shaky.

Not so, others counter, and here's why.

Viagra did not start out as Viagra. Under its chemical name sildenafil,
Pfizer first tested - and patented - it as a heart medication. During
testing, however, it was serendipitously observed that, while it didn't
help heart patients, impotent men achieved erections again.

So Pfizer tried to patent this secondary use in the United States, where
it was granted.

There are two lessons from this. One is that a patent means simply that
an invention or idea is, above all, novel. The second is that while
patents typically protect a product from being duplicated in either its
composition, design or manufacture, it is also possible in some
countries to get a patent that protects a particular 'first use'. These
are called 'method-of-use' patents.

 From August 2000, for example, money began to flow to the Massachusetts
Institute of Technology and two of its scientists got just such a patent
on Prozac - the blockbuster anti-depressive - to use it for premenstrual
syndrome (PMS) instead. (PMS is made up of emotional and physical
symptoms ranging from breast tenderness to nausea, from irritability to
rage, which some women get before their period.)

Non-prescription drugs are fair game too. For instance, some diet pills
called carbohydrate blockers are advertised as being patented products.
These are, in fact, method-of-use patents procured by being the first to
assert the idea, say, that a certain combination of a carb blocker with
a 'fat burner' and some oils, makes the blocker more effective.

All these are unregulated ingredients, easily procured on the open
market. Yet, with such a patent in hand, no one else may make that
particular formulation without a licence from you. Others may certainly
combine the carb blocker with, say, vitamins, then market it as a diet
pill - and even patent it. After all, there is no need to produce
studies vouching for a formulation's efficacy to patent.

So who grants these patents?

The US tends to allow such claims, but they are commonly disallowed
elsewhere. In November 2000, London's High Court struck down Pfizer's
application for a Viagra method-of-use patent, on the ground that it was
overly broad. The decision was upheld by the Court of Appeal in January
2002. So Viagra is patented-protected in the US but not in Britain.

The British Court of Appeal's reasoning: Sildenafil belongs to a class
of chemicals called phosphodiesterase 5 (PDE5) inhibitors and Pfizer's
Viagra patent was essentially a broad claim on the use of oral PDE5
inhibitors to treat impotence. However, that use was not novel or
non-obvious, having been anticipated already in 1993 in an article in
the Journal Of The American Geriatrics Society.

The third point then is that even method-of-use patents must be
substantively novel - like all other types of patents.

In July 2001, the European Patent Office also declared Pfizer's Viagra
method-of-use patent invalid in Europe. Similar challenges in Colombia
and Venezuela have resulted in Pfizer's loss. Thus, China's recent
decision sets no precedent at all.

That decision came after a group of Chinese generic makers petitioned
the government to nullify Pfizer's patent, saying it was non-novel.

Whatever the rationale, China's action in rescinding the patent is
permissible under international rules because - and here's the fourth
point - WTO regulations leave member countries considerable discretion
to decide on intellectual property issues, including whether to even
recognise method-of-use patents at all.

Many countries don't.

If you hoped for a case that will serve as a litmus test for the
protection of intellectual property rights in China, this isn't it.
However, the decision doesn't necessarily bode ill for foreign
pharmaceutical firms doing business in China.

Yes, drug makers rely on patent protection to recoup their huge
investments in developing new drugs. True, unreasonably curtailing the
period of market exclusivity for a patented drug will impact on their
production costs. But the very idea of PDE5 inhibitors preceded Viagra,
so its case for a method-of-use patent seems less than justified in any
jurisdiction anyhow.

If Pfizer can argue to the contrary, it should have its day in court.
The company has said it will appeal.